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자체-의약품-2016-62 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북 A Directory of Outsourcing Service Providers and Strategic Partners in Middle East and Africa Pharmaceutical Market 2016. 12
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중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Feb 09, 2023

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Page 1: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

자체-의약품-2016-62

중동·아프리카 지역 아웃소싱 기업 및전략적 협력사 디렉토리북

중동·아프리카 지역 아웃소싱 기업 및전략적 협력사 디렉토리북

중동

·아프

리카

지역

아웃

소싱

기업

및전

략적

협력

사 디

렉토

리북

A Directory of Outsourcing Service Providers and StrategicPartners in Middle East and Africa Pharmaceutical Market

2016. 12

2016. 12

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중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

2016․ 12

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자체-의약품-2016-62

중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

A Directory of Outsourcing Service Providers and Strategic Partners in Middle East and Africa Pharmaceutical Market

2016 ․12

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제 출 문

이 보고서를 한국보건산업진흥원 2016년 자체사업인 『제약산업 구조선진화

지원 및 해외 인허가 정보제공』과제의 최종 보고서로 제출합니다.

2016. 12.

한국보건산업진흥원

원장 이 영 찬

■ 주관 연구 부서 : 한국보건산업진흥원 제약산업지원단

■ 연 구 책 임 자 : 정 순 규 (제약글로벌지원팀 팀장)

■ 연 구 자 : 황 순 욱 (제약산업지원단 단장) 변 정 훈 (제약글로벌지원팀) 김 경 현 (제약글로벌지원팀) 정 다 혜 (제약글로벌지원팀)

Part�Ⅱ

■ 세 부 책 임 자 : 조 헌 제 (한국신약개발연구조합 이사)

■ 참 여 연 구 원 : 조 시 형 (한국신약개발연구조합, 대리) 허 훈 석 (한국신약개발연구조합, 대리) 정 혜 림 (한국신약개발연구조합, 주임) 이 태 엽 (한국신약개발연구조합, 사원) 임 다 영 (한국신약개발연구조합, 사원)

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중동・아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

차 례

Part 1 중동·아프리카 지역 의약품 정보 구축

제1장 연구배경 /� 3

1. 연구목적 및 배경 ························································································ 32. 연구의 필요성 ··························································································· 123. 연구 목표 및 내용 ···················································································· 174. 연구 추진 체계 ························································································· 18

제2장 중동·아프리카 시장 아웃소싱 그룹 및 전략적 협력사 현황 /� 19

1. 아웃소싱 그룹(CRO, CMO, CSO) 현황 ·················································· 192. 전략적 협력사 현황 ·················································································· 29

Part 2 아웃소싱그룹과 전략적 협력사 디렉토리북 구축 및 전략적 협력모델 구축

제1장 중동·아프리카 지역 아웃소싱 그룹 및 전략적 협력사 디렉토리북 구축 /�39

1. 디렉토리북 표준폼 개발 ·········································································· 392. 글로벌 아웃소싱 그룹 및 전략적 협력사 대상 조사결과 ··························· 413. 조사개요 ··································································································· 434. 글로벌 아웃소싱 그룹 및 전략적 협력사 선정 ·········································· 47

제2장 결론 및 시사점 /� 60

1. 결론 및 시사점 ························································································· 602. 기대효과 ··································································································· 623. 활용 방안 ································································································· 62

부 록 /� 63

1. 글로벌 아웃소싱 그룹 디렉토리 ································································ 652. 전략적 협력사 디렉토리 ·········································································· 6013. 중동·아프리카 전략적 협력사 디렉토리 ··················································· 8544. 국내 CRO 디렉토리 ··············································································· 9195. 주요 아웃소싱 그룹 현황 리스트 ··························································· 10286. 주요 전략적 협력사 현황 리스트 ··························································· 10527. 국내 CRO 기업 조사 업체 리스트 ························································ 1072

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중동・아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

표차례

<표 1> 지역별 세계 의약품 시장 규모(2014) ·················································· 5

<표 2> 우리나라 의약품 시장 규모 및 시장 동향 ··········································· 7

<표 3> 우리나라 의약품 제조업체 직종별 종업원 현황 ··································· 8

<표 4> 연도별 의약품(원료/완제) 수출 현황 ················································· 10

<표 5> 연도별 의약품(원료/완제) 수입 현황 ················································· 11

<표 6> 지역별 글로벌 CRO 시장 점유율 전망(2011~2018) ························· 26

<표 7> 2014년 약효군별 승인 약물 현황 ···················································· 30

<표 8> 세계 상위 20개 제약기업 판매 현황 ················································· 31

<표 9> 상위 20개 글로벌 의약품 매출 순위 ················································· 33

<표 10> 상위 20개 약효군별 세계 시장 현황 ················································· 34

<표 11> 글로벌 아웃소싱 그룹 디렉토리 수록 기업 리스트 144개사

(신규 35개사 및 업데이트 2개사 포함) ··········································· 49

<표 12> 글로벌 전략적 협력사 디렉토리 수록 기업 리스트 128개사

(신규 7개사 포함) ··········································································· 53

<표 13> 중동·아프리카 전략적 협력사 디렉토리 수록 기업 리스트 54개사

(신규 54개사 포함) ·········································································· 57

<표 14> 국내 CRO 디렉토리 수록 기업 리스트

(신규 2개사 및 업데이트 2개사 포함) ············································· 59

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중동・아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

그림차례

[그림 1] 연도별 세계 의약품 시장 규모 ·························································· 4

[그림 2] 세계 의약품 시장 국가별 순위 ·························································· 6

[그림 3] 의약품 생산 현황 추이 ····································································· 9

[그림 4] 연도별 일반/전문의약품 생산실적 ··················································· 10

[그림 5] 국내 제약기업의 기술수출실적 및 상대국 현황 ······························· 14

[그림 6] 약효군별 연구개발중인 국내 신약 Pipeline 현황 ····························· 15

[그림 7] 미충족 의료 수요 질환별 현황 ························································ 15

[그림 8] CRO 동종 그룹 수익 합산 및 평균 영업 마진(2010-2012) ··········· 21

[그림 9] 라이센스 거래 및 거래 가액(2008-2012) ········································ 22

[그림 10] CRO 지역별 동종그룹 수익합산(2010-2012) ································· 23

[그림 11] 글로벌 CRO 시장 수익 전망(2008-2018) ······································ 25

[그림 12] 글로벌 제약 CRO 시장 성장 전망(2008-2018) ······························ 25

[그림 13] 지역별 제약 CRO 시장 수익 전망(2011-2018) ······························ 26

[그림 14] 제품 개발단계별 제약 CRO 시장 수익 전망(2011~2018) ·············· 27

[그림 15] 제품 개발단계별 제약 CRO 시장 수익 비중(2011~2018) ·············· 27

[그림 16] 美 FDA 신약 승인 현황(2005~2014) ··········································· 29

[그림 17] 美 FDA 승인 BLA 현황(2004~2014) ··········································· 30

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Ⅰ중동·아프리카 지역의약품 정보 구축

중동·아프리카 지역 아웃소싱

기업 및 전략적 협력사 디렉토리북

Part

1

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Part� 1.� 중동·아프리카 지역 의약품 정보 구축 ❚ 3

제1장 연구배경

1. 연구목적 및 배경

1.1 연구 목적

◦「2016년 해외 의약품 인허가 시장정보 제공」 사업 중 하나로 중동·아프리카 지역 의 아웃소싱 그룹과 전략적 협력사 디렉토리북 구축을 통해 제약 산업의 해외시장정보 제공을 통한 글로벌 의약품 시장 진출 활성화를 촉진하고자 함

1.2 연구 배경

1) 세계 제약시장 현황

◦2015년 세계 의약품시장 규모는 약 1200조원1) 규모로, 최근 10년간(2005∼2014) 연평균 6.2%의 성장 추이를 보이고 있음 - 2005∼2009년 7∼8%에 이르던 성장률은 이후 성장 속도가 둔화되어 2013년에는

전년 대비 4.9%의 성장을 기록하였으며, 최근 전 세계적인 경기 침체에도 불구하고 의약품 시장이 성장한 것은 상당부분 아시아 및 중남미 지역의 시장 확대에 기인함

1) 1조 723억불, IMS Market Prognosis(2016)

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4� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북◦이러한 세계 의약품 시장의 확대 추세는 최근의 산업 환경 변화에 따른 영향으로

볼 수 있으며, 세계적인 인구고령화 추세에 따라 치매, 중풍, 파킨슨병 등 노인성질환에 대한 치료 수요가 빠르게 증가하고 있음 - 세계보건기구(WHO)는 2020년경 고혈압, 당뇨, 관절염 등 만성질환이 전 세계

질병의 70%를 차지할 것이라는 전망을 내놓은 바 있으며, 소득증대 및 생활패턴의 변화로 삶의 질 향상으로 인한 건강증진 및 유지를 위한 의료분야의 지출이 크게 확대되고 있음

- 파머징 국가는 경제성장 및 소득 수준의 향상에 따라 의료 접근성이 개선되고 인구가 증가함에 따라 의약품 시장의 성장을 주도할 것으로 예상됨

[그림 1] 연도별 세계 의약품 시장 규모

자료:� IMS� Health,� IMS� market� Prognosis,� May.� 2015

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Part� 1.� 중동·아프리카 지역 의약품 정보 구축 ❚ 5◦2014년 지역별 의약품 시장 규모는 미국의 시장점유율이 가장 높았고(4,056억 달

러, 39.5%), 유럽(2,288억 달러, 22.3%), 아시아/아프리카/호주(1,992억 달러, 19.4%), 일본(816억 달러, 7.9%), 중남미(721억달러, 7.0%) 순으로 비중이 높은 것으로 나타남

◦향후 5년간(2014∼18년) 글로벌 제약시장의 성장률은 4.8%가 될 것으로 예상되며, 2019년에 이르러서는 1조 2,986억 달러에 달할 것으로 전망됨

<표 1> 지역별 세계 의약품 시장 규모(2014)

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6� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북◦2015년 기준 세계 의약품시장의 국가별 순위는 미국이 부동의 1위를 차지하고 있

으며, 뒤를 이어 중국, 일본, 독일 프랑스 순으로 나타났으며, 2018년에는 미국 및 중국이 1, 2위를 기록할 것으로 예상되며 브라질이 세계 5위 시장을 차지할 것으로 예측됨- 기존 제약산업 강국을 유지해오던 일본 및 유럽국가들을 제치고 의약품의 거대

수요와 매년 발전하는 의학기술이 결합해 중국, 브라질, 러시아, 인도 등이 신흥강국으로 급부상하면서 세계 제약시장의 판도가 바뀔 것으로 예측됨

[그림 2] 세계 의약품 시장 국가별 순위

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Part� 1.� 중동·아프리카 지역 의약품 정보 구축 ❚ 72) 국내 제약시장 현황

◦국내 제약시장의 2014년 의약품 생산액은 16조 4,194억 원으로 전년에 비해 1.4% 상승하였으며, 2010년부터 2014년 동안 연평균 0.5% 성장함

◦2014년 의약품 산업은 2조 5,314억 원의 수출이 발생하였으며 전년에 비해 9.2% 증가했으며, 수입은 2014년 5조 3,659억 원으로 2013년 5조 1,558억 원 대비 4.1% 증가함

◦우리나라의 의약품 시장규모(생산+수입-수출)는 2014년 19조 2,539억 원의 규모로 전년보다 1.2% 증가하였으며, 2010년부터 2014년 동안 연평균 0.5% 성장함

<표 2> 우리나라 의약품 시장 규모 및 시장 동향(단위: 억원, %)

구분 2010년 2011년 2012년 2013년 2014년전년대비성장률

CAGR('10-’14)

생산 155,696 154,403 155,607 161,918 164,194 1.4 1.3

수출 17,701 19,435 23,095 23,185 25,314 9.2 9.4

수입 51,089 54,471 57,289 51,558 53,659 4.1 1.2

무역수지 -33,389 -35,036 -34,193 -28,373 -28,345 - -

시장규모 189,084 189,438 189,800 190,292 192,539 1.2 0.5

주:� 1)� 의약품의 범위는 완제,� 마약,� 한외마약,� 향정신성,� 원료의약품� � � 2)� 의약품 수출입액은 한국은행 원/달러 연평균환율을 적용하여 계산함자료 :� 한국제약협회(2015),� 한국 의약품 수출입협회(2015)� Facts� &� Survey� Report

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8� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북◦의약품등(완제, 원료, 의약외품) 제조업체 종업원 총 현황은 89,649명이며, 이 중

영업직과 생산직 부문의 인력이 총 인원의 61.4% 가량을 점유하고 있으며 연구직의 비중은 11.8%에 불과함 - 직종별 종업원 비율을 보면 연구직 비중은 꾸준히 증가하거나 유지하는 반면,

영업직 비중은 감소하는 추세에 있으며, 직종별 종업원의 비중 변화를 통해 국내 제약산업은 연구개발 부문에 투자와 인력을 집중시키고 있음을 짐작할 수 있음

<표 3> 우리나라 의약품 제조업체 직종별 종업원 현황

연도 총인력사무직 영업직 연구직 생산직 기타

인원수 비율 인원수 비율 인원수 비율 인원수 비율 인원수 비율

2005 65,003 12,183 18.7 22,915 35.3 5,555 8.5 20,728 31.9 3,622 5.6

2006 70,681 12,833 18.2 24,490 34.6 6,372 9.0 21,633 30.6 5,353 7.6

2007 72,179 13,119 18.2 25,252 35.0 6,845 9.5 22,123 30.7 4,840 6.7

2008 75,406 14,009 18.6 26,721 35.4 7,801 10.3 23,212 30.8 3,663 4.9

2009 81,204 15,924 19.6 27,520 33.9 8,640 10.6 24,354 30.0 4,766 5.9

2010 77,314 14,792 19.1 26,626 34.4 8,699 11.3 24,050 31.1 3,147 4.1

2011 74,477 14,426 19.4 24,535 32.9 8,765 11.8 23,539 31.6 3,212 4.3

2012 78,259 15,403 19.7 24,714 31.6 9,872 12.6 24,942 31.9 3,328 4.3

2013 88,545 16,598 18.7 25,889 29.2 10,613 12.0 28,226 31.9 7,219 8.2

2014 89,649 17,001 19.0 25,496 28.4 10,594 11.8 29,592 33.0 6,966 7.8

(단위: 명, %)

자료 :� 한국제약협회(2015)

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Part� 1.� 중동·아프리카 지역 의약품 정보 구축 ❚ 9◦인구고령화와 경제성장으로 건강에 대한 사회적 관심이 고조되면서 의료서비스와

의약품에 대한 수요가 크게 증가하여 의약품 시장은 지속적으로 성장하고 있음◦2014년 의약품 생산액은 16조 3,300억원을 기록해, 전년(16조 1,920억원)대비

0.8% 증가했으며, 완제 의약품 생산액은 14조 3,900억원으로 2013년(14조 1,330억원) 보다 1.8% 증가하고, 전체 의약품에서 차지하는 비중은 2014년 88.1%로 전년도보다 0.9% 증가함

◦2014년 원료의약품 생산액은 1조 9,400억원으로 전년대비 5.2% 감소했으며, 원료의약품이 의약품에서 차지하는 비중은 2014년 11.9%로 전년도보다 0.8% 감소함

[그림 3] 의약품 생산 현황 추이

주:� 완제의약품은 의약외품을 제외한 완제,� 마약,� 한외마약,� 향정의약품을 포함

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10� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

[그림 4] 연도별 일반/전문의약품 생산실적

주 :� 완제의약품에만 한정,� 괄호(� )� 안의 숫자는 일반/전문의약품 품목수자료 :� 한국제약협회 제약산업 통계집

◦일반의약품 생산액은 2조 4,610억원으로 2013년 2조 4,350억원 대비 1.1% 증가하였고, 전문의약품 생산은 2013년 11조 4,530억원 대비 1.9% 증가한 11조 6,660억원을 기록하였으며, 전문의약품 비중은 2014년 82.6%를 차지하고, 2006년 이후 꾸준히 전문의약품의 생산 비중이 높아지고 있음

<표 4> 연도별 의약품(원료/완제) 수출 현황

구분 2009년 2010년 2011년 2012년 2013년 2014년전년대비성장률

CAGR('09-’14)

원료의약품 614,020 739,517 906,832 1,055,464 1,099,284 1,169,558 � 6.4 14.2

완제의약품 777,449 791,332 847,050 994,031 1,018,010 1,233,932 21.2 � 9.3

합 계 1,391,469 1,530,849 1,753,882 2,049,494 2,117,294 2,403,490 13.5 11.5

(단위: 천 달러, %)

자료:� 한국의약품수출입협회,� Facts� &� Survey� Report,� 각� 연도

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Part� 1.� 중동·아프리카 지역 의약품 정보 구축 ❚ 11◦우리나라의 의약품 교역량은 해마다 증가하고 있어서, 2009년부터 2014년 동안

수출과 수입은 각각 연평균 11.5%와 5.5% 로 증가하며, 수출이 수입보다 빠르게 증가하고 있으나, 수입이 수출보다 3배 이상 큰 구조로 인하여 무역수지 적자는 여전히 지속되고 있음

◦2014년 의약품의 수출은 24억 달러로 전년 대비 3억 달러(13.5% 증가), 수입은 51억 달러로 전년 대비 4.0억 달러(8.2%) 증가하여 무역수지 적자(27억 달러)가 지속된 것으로 나타남

◦의약품 수출은 전년 대비 원료의약품 6.4%, 완제의약품 21.2% 증가했으며, 의약품 수입은 전년 대비 원료의약품 0.4%, 완제의약품 12.6%가 증가함

<표 5> 연도별 의약품(원료/완제) 수입 현황

구분 2009년 2010년 2011년 2012년 2013년 2014년전년대비성장률

CAGR('09-’14)

원료의약품 1,754,005 1,898,384 1,981,487 2,075,579 1,695,215 1,702,652 � 0.4 -0.6

완제의약품 2,127,130 2,520,095 2,934,138 3,008,258 3,013,133 3,392,108 12.6 � 9.7

합 계 3,881,136 4,418,478 4,915,625 5,083,837 4,708,348 5,094,760 � 8.2 � 5.5

(단위: 천 달러, %)

자료:� 한국의약품수출입협회,� Facts� &� Survey� Report,� 각� 연도

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12� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

2. 연구의 필요성

1) 국내 제약기업의 중동·아프리카 시장 진출을 위한 우수 아웃소싱그룹 정보

제공

◦한국제약기업들이 내수시장의 한계를 극복하고 글로벌 경쟁력을 갖추기 위해서는 글로벌 스탠다드에 부합되는 연구개발활동이 이루어져야 하고 이를 위해서는 규모의 경제실현을 통한 막대한 연구개발 투자가 이루어져야 함

◦현재의 재무구조 하에서는 글로벌 스탠더드에 부합되는 연구개발이 사실상 곤란한 상황에서 우리 기업의 실정에 적합한 해외시장 진출 전략수립이 절실한 상황임

◦글로벌시장에 진출하기 위해서는 해당 국가의 인허가 당국 기준에 부합되는 비임상, 임상데이터 창출과 원료 및 완제품 생산을 통해 우리기업의 높은 품질과 기술력을 입증 받을 수 있어야 함

◦현재 국내에는 해외 허가당국이 요구하는 기준에 부합되는 전임상/임상시설과 생산시설이 부족하고 허가당국의 인허가절차 등에 정통한 인허가 컨설팅기관이 부족한 상황임에 따라 이를 체계적으로 지원해 줄 수 있는 글로벌 현지 전문기관과의 파트너쉽 형성이 필요한 상황임

◦우리나라의 경우 전임상기관, 임상시험기관에 대한 지정현황이 공개되고 있으나, 전세계 대다수 허가당국은 공식인증절차 없이 실사를 통해 기준에 부합될 경우 데이터를 인정하고 있고 기준에 부합되는 전문기관(비임상/임상CRO, CMO, CSO)에 대한 현황을 공개하지 않고 있어 전문기관과 전문가에 대한 정보파악이 용이하지 않은 상황임

◦2015년 제약기업 대상으로 수요 조사를 실시했을 때, 의약품 해외 진출시 필요사항으로 인허가 신청 가이드라인(48%)이 가장 높았고, 다음으로 아웃소싱 및 협력사현황·의약품 시장정보(42%)에 대한 수요가 높아, 해외진출시 필요한 정보 부족으로 인해 상당수 애로를 안고 있는 실정임

◦이에 따라 국내 기업들의 글로벌시장 진출 촉진을 위해서는 글로벌 스탠더드(Global Standard)에 부합되는 전임상시험, 임상시험, 원료 또는 완제품 생산, 인허가업무수행, 의약품유통을 글로벌 현지에서 지원할 수 있는 우수 아웃소싱 그룹

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Part� 1.� 중동·아프리카 지역 의약품 정보 구축 ❚ 13(CRO, CMO, CSO)의 체계적 정보지원이 필요함※ 현재 국내기업과 파트너쉽 관계에 있는 해외 CRO등에 대한 정보공개 및 정보공유는 기업별 비즈니

스전략과 이해관계가 상충됨에 따라 쉽지 않은 상황이며, 정보제한에 따라 신규 CRO 등과의 파트너쉽 형성이 용이치 않은 상황임

2) 국내 제약기업의 글로벌 전략적 제휴그룹에 대한 정보제공

◦글로벌 다국적 제약사들은 R&D 생산성 급감, 투자비용 증가, 인허가 규제심화, 유망 후보물질 파이프라인 고갈, 블록버스터 약물 특허만료에 따른 제네릭의약품에 대한 경쟁심화, 의약품 광고료 급증 등 생산성 한계에 직면하고 있는 상황에서 이를 대체할 수 있는 신성장 동력 확보를 위해 전세계 시장을 대상으로 공격적인 오픈이노베이션 전략을 과감히 실행하고 있음

◦현재 주요 글로벌제약기업들은 생산성저하 문제 해소를 위해 연구개발부문에 있어 개발 중인 파이프라인에 대한 구조조정 및 선택과 집중 추세에 있으며, 매출급감문제 해소를 위해 제네릭시장에 눈을 돌리고 있는 추세를 감안할 경우 연구개발부문과 생산, 마케팅 부문에 있어 경쟁력을 갖춘 파트너와의 협력 수요가 충분히 존재하고 있음

◦주요 글로벌제약기업들의 연구개발 및 생산, 마케팅 부문에서의 문제점과 애로사항, 이를 극복하기 위한 외부 그룹과의 수요가 명확히 규명될 경우 한국제약기업들과의 협력가능성도 배제할 수 없는 상황임

◦이에 따라 글로벌 주요 제약기업들의 협력 수요를 파악하여 이를 디렉토리화하고 한국제약기업들에 관련 정보를 제공해 줄 경우 향후 해외 제약기업들과의 연구개발, 생산, 마케팅 부문에서의 제휴 가속화를 통한 해외시장 진출 가능성을 제고할 수 있을 것으로 예상됨

◦제휴모델은 연구개발, 생산, 마케팅 등 전부문에 걸쳐 다양하게 존재할 수 있음◦예를 들어, 연구개발부문의 경우 국내 제약기업들의 기술수준이 이미 글로벌 시장

에서 충분히 경쟁력을 갖추었음을 감안하여 충분히 제휴가능성이 존재하고 있다고 볼 수 있고, 이는 그동안의 미국 및 유럽 등 선진국을 대상으로 다수의 기술수출실적을 통해 알 수 있으며, 현재 연구개발이 진행중인 약효군별 품목을 분석해 보면 주로 거대시장을 형성하고 있는 질환군임을 감안할 때 글로벌 다국적제약사

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14� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북들이 지니고 있는 Unmet Needs를 자극할 수 있을 것으로 판단됨

◦국내 제약사의 보유기술 및 유망파이프라인에 대한 해외기술수출과 병행하여 역으로 글로벌 해외 기술 또는 유망파이프라인에 대한 국내 실시권 및 판권 도입도 다국적제약사들이 지니고 있는 Unmet Needs를 자극함과 동시에 상호 상생협력을 통한 글로벌 시장 진출의 촉진제가 될 수 있음

◦이외에도 각 질환군별로 현재의 의약품으로는 치료수단이 없고, 심지어 연구개발파이프라인도 존재하지 않는 다수의 질환이 존재함에 따라 이들 질환군별 시장에서 차별성과 신규성을 요하는 혁신활동이 지속적으로 요구됨을 감안할 때 국내제약사와 글로벌 제약사간 상생협력을 위한 제휴 가능성이 충분히 있을 것으로 판단됨

[그림 5] 국내 제약기업의 기술수출실적 및 상대국 현황

자료:� 2015� 한국 제약산업 연구개발 백서,� 한국신약개발연구조합

Page 21: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Part� 1.� 중동·아프리카 지역 의약품 정보 구축 ❚ 15

[그림 6] 약효군별 연구개발중인 국내 신약 Pipeline 현황

자료:� 2015� 한국 제약산업 연구개발 백서,� 한국신약개발연구조합*� 식품의약품안전처 의약품분류 체계

[그림 7] 미충족 의료 수요 질환별 현황

자료:� www.orpha.net� 자료 인용 재구성

Page 22: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

16� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북◦생산, 마케팅 부문의 경우에도 이와 유사한 협력메커니즘 생성이 가능할 것으로

고려되며, 다수의 글로벌 제약기업들은 투자생산성 확보를 위해 현재 유망 파이프라인 선점을 위한 오픈 이노베이션 전략을 실행중에 있으며 심지어는 제네릭시장에 신규진출을 고려하고 있는 것으로 파악되고 있음 - 이들 기업의 유망파이프라인 선점 등 글로벌 아웃소싱 수요와 제네릭시장 신규

진출 등에 대한 수요가 명확히 파악되고, 국내기업의 보유역량이 이들 기업의 수요와 일치될 경우 국내기업 보유 유망후보물질에 대한 공동연구, 기술수출, 제네릭 생산 및 마케팅, 국내기업 보유 신약 생산, 마케팅에 있어 새로운 기회가 조성될 수 있음

◦이에 따라 우수 아웃소싱 그룹에 대한 체계적 정보지원과 함께 글로벌 제약기업 등과의 연구개발, 생산, 마케팅 제휴촉진을 위해 글로벌 주요 거점 제약사들의 현황분석 및 이들 기업들의 제휴 수요파악 및 디렉토리북 구축을 통해 국내제약사들의 글로벌 제약기업들과의 협업 및 제휴 활동을 촉진할 필요가 있음

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Part� 1.� 중동·아프리카 지역 의약품 정보 구축 ❚ 17

3. 연구 목표 및 내용

추진목표 연구 내용 조사 항목/분석

우수

아웃소싱

그룹

디렉토리

북 구축

∙사전 수요조사 실시

� (국내 제약기업 대상)

-� 표준폼 필수 항목에 대한 의견수렴

-� 아웃소싱 그룹 선정시 고려사항

-� 아웃소싱 그룹 위탁 진행시 애로사항

-�아웃소싱 그룹에 대한 협력현황,�협력수요,�협력요구조

건 등

∙표준폼 개발

� (CRO,� CMO,� CSO)

-�일반정보,�평판 및 신뢰도,�전문역량(시설,�인적),�서비스

범위,� 비용 효과,� 품질 시스템 등

-� 사전 수요조사 내용을 기반으로 작성

-� 전문가 리뷰를 통한 표준폼 검증

∙설문조사 실시

-� 표준폼에 수록된 내용을 중심으로 기 확보된 중동

및 아프리카 지역 등 글로벌 아웃소싱 그룹(CRO,�

CMO,� CSO),� 국내 CRO를 대상으로 설문조사 실시

∙전문가 리뷰를 통한 아웃소싱

그룹정보에 대한 심층 검토-� 국내외 전문위원회 구성 및 운영

∙디렉토리북 구축-� 우수 아웃소싱 그룹에 대한 정보 표준화

-� 디렉토리북 구축

전략적

협력사

디렉토리

북 구축

∙사전 수요조사 실시

� (국내 제약기업 대상)

-� 표준폼 필수 항목에 대한 의견수렴

-� 협력사와의 제휴 과정에서의 애로사항

-�협력사와의 협력현황,�제휴희망 내용 및 정도 파악 등

∙표준폼 개발

-�일반정보,�제품별 특성화,�연구개발협력,�생산협력,�마케

팅 협력 등

-� 사전 수요조사 내용을 기반으로 작성

-� 전문가 리뷰를 통한 표준폼 검증

∙설문조사 실시

-� 글로벌 전략적 협력사 대상으로 설문조사 실시

-�연구개발,�사업개발(BD)�등 관련 국내외 전문가 그룹을

통한 정보교류 및 의견수렴

-�관련 문헌 및 홈페이지 검색,�보유자료 등을 통한 광범위

한 정보입수

∙전문가 리뷰를 통한 전략적 협

력사 정보에 대한 심층 검토-� 국내외 전문위원회 구성 및 운영

∙디렉토리북 구축-� 전략적 협력사에 대한 정보 표준화

-� 디렉토리북 구축

Page 24: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

18� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

4. 연구 추진 체계

Page 25: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Part� 1.� 중동·아프리카 지역 의약품 정보 구축 ❚ 19

제2장 중동·아프리카 시장 아웃소싱 그룹 및

전략적 협력사 현황

1. 아웃소싱 그룹(CRO, CMO, CSO) 현황

1) 아웃소싱 개념

◦제약회사의 아웃소싱은 아래 사항과 같은 장점 때문에 위탁서비스제공업체(Contract Service Provider, 이하 CSP)의 네트워크에 의해 약품개발이 이루어지는 경우가 증가하고 있음- 시설, 인력, 전문지식, 경험 등을 신속하게 획득할 수 있어 새로운 시장 진입을

짧은 시간에 가능하게 함- 대규모 시설투자에 따른 위험도와 부채부담을 줄여줌으로써 사업의 유연성을

제공함- 아웃소싱을 통해서 제약회사는 다수의 임상개발 프로젝트를 효과적으로 관리하

게 되어 약품 개발의 생산성을 높여주고 약품개발 기간을 줄여주어 비용 절감에 도움이 됨

※ 대략 1,100개의 CSP들로 이루어져 있는 총 CSP시장은 매년 14~16%씩 성장하고 있음◦현재 CSP가 제공하는 서비스의 범위는 초기발견부터 임상개발, 생산, 판매에 이르

기까지 매우 광범위함

Page 26: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

20� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북- 임상시험관리, 중앙연구서비스, 제제연구, FDA 등록신청 서비스, 기타 보조 서

비스 등을 포함하여 세분화되어 있음- 임상단계 및 허가 대행 전문기업 그룹을 CRO(Contract Research Organization)

그룹, 임상시료 및 생산 대행 전문기업 그룹을 CMO(Contract Manufacturing Organization)그룹, 의약품 마케팅/영업 대행 전문기업을 CSO(Contract Sales Organization)그룹이라고 함

2) 아웃소싱 시장 동향

◦의약품 허가 및 규제의 강화, 신약축시 지연에 따른 규모의 불경제 등 제약시장의 변화는 제약 연구개발 생산성 감소, 수익창출력 감소로 이어져, 제약기업들은 연구개발 비용 절감을 위해 임상시험 아웃소싱을 확대하는 추세로 특히 선진국을 중심으로 급격히 확산되고 중요성이 부각되고 있음

◦Global Data 에 따르면 대표적인 CRO 기업들이 창출한 수익을 합산하면 2011년 124억 달러에서 2012년 136억 달러로 전년대비 10.2%의 증가세를 보였으며, 가장 큰 성장을 보인 기업은 Quintiles로 12억 달러 증가분에서 약 3억 9700만 달러를 차지함- Quintiles의 수익은 2012년 37억 달러로 전년 대비 12.1% 성장하여 2위 업체

Covance의 21억 달러를 크게 앞질렀으며, 대부분의 제약 CRO가 2012 년도에 전년대비 흑자 성장률을 기록함

- CRO 부분은 2012년도 강한 성장제를 기록하여 2011년 기록된 동종 그룹의 합산 수익 증가율 6.8%를 크게 앞지름

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Part� 1.� 중동·아프리카 지역 의약품 정보 구축 ❚ 21

[그림 8] CRO 동종 그룹 수익 합산(백만달러) 및 평균 영업 마진(2010-2012)

자료:� Global� Data,� CRO� 벤치마크 리포트

◦CRO 가 수행한 전략적 인수 및 제휴는 동종 그룹의 수익 제고에도 일조함- 2012년 Patheon은 제약산업 및 영양업계용 독점 소프트겔 캡슐의 세계 최대

제조사에 속하는 Banner Pharmacaps를 2억 5500만 달러에 인수하여 멕시코와 라틴아메리카 시장으로 지역을 확대함

- Catalent Pharma Solutions는 2월에 Aptuit사의 임상시험 용품(CTS) 사업부문을 4억 1000만 달러에 매입하여 임상 공급 솔루션의 최대 글로벌 사업자로 발돋움하였으며, 분석화학과 호흡기 제품 개발, 규제 컨설팅 서비스를 구성에 추가함

- Clinipace Worldwide는 Paragon Biomedical의 매입을 통해 유럽에서 치료 전문지식과 지역의 입지를 확대함

- 업계 거대기업 Accenture는 기존에 IT 아웃소싱 업무로 알려졌으나 Octagon Research Solutions를 매입하여 Octagon의 독점 소프트웨어 플랫폼과 심층 규제 지식에 힘입어 데이터 관리 능력을 보완함

◦CRO업계는 특히 중소제약회사(SMB)가 가치를 극대화하고 위험을 최소화하는데 일조하기 위하여 새롭게 변화하고 있음- Allume은 Quintiles가 도입한 종합 시장진출 서비스로 컨설팅과 임상서비스, 상

업 전문지식, 정보기술을 통합하였으며, 이를 이용하면 신제품을 효율적으로 출

Page 28: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

22� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북시하고 피크 매출에 소요되는 시간을 단축하는 한편 전략적인 기업 자산의 통제를 유지하는데 도움이 됨

- Parexel은 서비스 라인을 출시하는 대신 중소기업이 개발 목표를 달성하는데 도움이 될 수 있도록 중소기업 고유의 요구를 전담하는 사업 부문인 Parexel BioPharm Unit을 창설하였으며, Parexel의 BioPharm Unit은 협력팀 기반 접근법에 따라 환자 모집을 단축하고 연구 시작 속도를 높이며 주요 개발 일정 준수를 위한 전체 효율을 개선할 수 있는 기회를 중소기업에 제공함

◦지난 5년간 제약회사와 CRO간에 전략적 제휴가 증가하는 것은 제약회사의 성과를 극대화하고 위험을 최소화할 목적으로 통합 접근법을 통해 임상 연구 조직을 고용하고 있음을 알 수 있고, 이러한 라이센스 거래 건수는 2011년 40건에서 2012년 36건으로 소폭 하락했으나 전체 라이센스 거래 가액은 2012년 9억 5890만 달러로 2011년에 비해 159% 급증했음- Merck는 전체 R&D 구조를 근본적으로 재편하기 위한 5년 임상개발 협력에

Quintiles를 고용함- Covance는 지난 몇 년간 발견 지원과 독물학, 중앙 실험실, I-IV상 임상시험

관리를 비롯하여 다양한 출시 및 R&D 서비스를 수행하기 위해 Bayer Healthcare, Eli Lilly, Sanofi와 다년간 아웃소싱 계약을 체결함

[그림 9] 라이센스 거래 및 거래 가액(백만 달러)(2008-2012)

자료 :� Global� Data,� CRO� 벤치마크 리포트

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Part� 1.� 중동·아프리카 지역 의약품 정보 구축 ❚ 23◦신흥시장은 전체 비용이 낮고 모집 및 유지율이 높고 연구진과 최신 치료제가 필

요한 모집단이 풍부하기 때문에 이 시장에서 수행되는 임상시험은 필수 전략이 되고 있으며, 환자의 안전과 데이터 품질을 침해하지 않고 비용과 시간을 절감하는 효율을 고객에게 제공할 수 있는 능력을 보유한 CRO는 신흥시장에서 고수익을 창출할 수 있음

◦GlobalData에 따르면, 주요 CRO 기업이 신흥시장에서 거둔 전체 동종 그룹 수익은 2012년 3억 9410만 달러로 14.6% 증가했으며, 아시아와 중남미, 동유럽 신흥시장은 대규모 환자군에 대한 손쉬운 접근과 저렴한 인건비 및 제조 원가, 능력이 뛰어난 의료진으로 인해 제약 아웃소싱에 유리한 지역임

[그림 10] CRO 지역별 동종그룹 수익합산(백만 달러)(2010-2012)

자료 :� Global� Data,� CRO� 벤치마크 리포트

◦임상시험과 비핵심 R&D 운영 업무의 아웃소싱은 지난 수 년간 증가일로를 걸어왔고 이에 따라 아웃소싱 서비스 전달 모델 또한 변화되어왔는데, CRO 비즈니스 모델은 크게 완전 통합 서비스 모델(FIS)과 기능 서비스 모델(FS)로 구분됨

◦완전 통합 서비스(FIS) 모델에서는 의약품 개발 과정의 모든 연구 활동은 서비스 사업자에게 전량 아웃소싱하는데, CRO는 임상시험의 수행과 임상 운영, 데이터 관리, 바이오통계, 컨설팅, 규제 업무와 같은 필수 분야의 경험이 풍부하며 저비용과

Page 30: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

24� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북일정의 단축을 제공하며, 이 모델의 장점은 아래와 같음- R&D 비용뿐 아니라 출시 시간이 단축되기 때문에 효율이 증가함 - 바이오제약회사는 의약품 개발의 발견 단계에서부터 승인후 단계에 이르기까지

다양한 서비스를 선택하고 사업상 필요한 문제를 해결하고 유연성 제고를 통해 시험 중단을 신속하게 시정할 수 있음

- 신규 프로젝트 개시에 따른 재정 부담과 비용을 절감하는 위험 분담 계약을 통해 위험을 분산시킬 수 있음

◦기능 서비스(FS) 모델에서 바이오제약회사는 경험과 전문지식을 토대로 데이터 관리나 임상 운영, 규제 서비스와 같은 개별 기능만 여러 서비스 사업자에게 아웃소싱하는데, 경력직 이용이나 지리/문화/규제 지식, 치료분야 전문지식과 같은 장점이나 능력을 활용하기 위해 특정 주요 업무는 직능 전문가에게 아웃소싱되며, 이 모델의 장점은 아래와 같음- 특정 업무를 실행하는 광범위한 경험, 일정 단축, 비용 효율 개선- 경험이 풍부한 직능 지식 기반 전문가의 지속적 개선- 의사소통과 투명성 개선에 도움이 될 수 있는 각 아웃소싱 직능별 단일 연락처

Page 31: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Part� 1.� 중동·아프리카 지역 의약품 정보 구축 ❚ 253) 아웃소싱 시장 전망

◦GBI Research에 따르면 글로벌 제약 시장 CRO 수익은 연평균 12.8% (2008~2018)로 높은 성장이 전망되며, 그에 따라 시장 수익은 2008년 170억 달러에서 2018년 560억 달러 규모로 10년새 3배 이상 성장할 것으로 예측함

[그림 11] 글로벌 CRO 시장 수익 전망(2008-2018)

자료 :� GBI� Research(2012)

◦2008년 기준 세계 제약 연구개발 지출의 22.8%, 2011년 26.5%를 아웃소싱 시장이 차지한 것으로 추산되며, 향후 연평균 성장률 5%(2008-2018)로 지속 성장해 2018년 37.1%로 그 비중이 증가될 것으로 예상됨

[그림 12] 글로벌 제약 CRO 시장 성장 전망(2008-2018)

자료 :� GBI� Research,� 2012

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26� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북◦제약산업의 연구개발은 주로 북미, 서유럽 등 선진국에서 이루어져 2007년까지

전세계 임상시험의 66%를 북미, 서유럽이 차지하였으나, 제약산업의 생산성 악화로 인한 규모 축소, 인허가기관의 감독 강화, 약가 인하 기조 등으로 인도, 중국, 중남미 등이 제약 R&D 분야의 이머징 마켓으로 부상하게 됨

[그림 13] 지역별 제약 CRO 시장 수익 전망(2011-2018)

자료 :� GBI� Research,� 2012

◦지역별 제약 CRO 시장 수익 전망에서도, 미국이 2011년 기준 전체 CRO 수익의 52.6%(1백27억 달러)를 차지하며 2018년에는 54.3%를 점유할 것으로 예상되고, 뒤를 이어 유럽이 전체의 24.7%(60억 달러)를 차지하나 향후 전체 시장에서 차지하는 비중은 감소해 2018년에는 21.4%에 그칠 것으로 예측되며, 반면 아시아(인도, 중국, 일본, 동남아시아)는 전체 11%(20억 달러)를 차지하고 있으나, 향후 시장규모가 가장 빠르게 확대될 것으로 전망됨

<표 6> 지역별 글로벌 CRO 시장 점유율 전망(2011~2018)

  2011 2012 2013 2014 2015 2016 2017 2018CAGR(%)

미국 52.6 52.9 53.1 53.4 53.6 53.8 54.1 54.3 0.5

유럽 24.7 24.2 23.8 23.3 22.8 22.3 21.9 21.4 -2.0

아시아 11.0 11.3 11.6 12.0 12.3 12.6 12.9 13.3 2.7

기타 11.6 11.5 11.5 11.4 11.3 11.2 11.1 11.0 -0.7

총계(%) 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0  

자료 :� GBI� Research,� 2012

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Part� 1.� 중동·아프리카 지역 의약품 정보 구축 ❚ 27◦제품 개발 단계별 제약 CRO 시장 수익 전망을 보면, 전임상 서비스 부분이 연평균

15.4%로 가장 높은 성장률로 증가하는 하며, 그에 따라 전임상의 수익 비중은 24.0%(‘11년)에서 27.8%(’18년)로 증가하는 반면, 임상 1상~4상의 수익 비중은 감소할 것으로 추정됨

[그림 14] 제품 개발단계별 제약 CRO 시장 수익 전망(2011~2018)

자료 :� GBI� Research,� 2012

[그림 15] 제품 개발단계별 제약 CRO 시장 수익 비중(2011~2018)

자료 :� GBI� Research,� 2012

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28� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북4) 아웃소싱 전략

◦대형제약회사는 프로젝트를 진행할 수 있는 훈련된 인력, 시설, 전문지식 등을 이미 많이 가지고 있을 것이므로 좁은 범위의 아웃소싱을 필요할 것임- 사내에 가지고 있지 못하는 독특한 기술이나 특정설비에 대한 접근이 필요한

경우- 사내 용량이 부족한 경우 자체적인 용량 부담을 줄이고자 아웃소싱 파트너를

구하는 경우(예: 완제용량개발이나 외부생산 등)◦소형/신생제약회사는 대형제약사와는 다른 아웃소싱을 필요로 할 것임

- 내부자원, 소유기술, 인력, 경험과 전문지식 등을 비롯한 사내역량이 아예 부재하거나 불충분한 경우

◦제약회사는 각자 다른 아웃소싱요구 분야에 따라서 다른 아웃소싱모형을 사용하는 것이 바람직함- 가격경쟁(Price competition) 모형

∙ 가장 낮은 구매가격을 확보하기 위해서 다수의 CSP들을 경쟁에 부치며, 비용 효율성에 대한 요구가 가장 높은 업무를 위탁하기 위해서 사용

∙ 약물학, 독성학, 분석학, 허가등록지원 등 위탁계약의 결과가 쉽게 측정가능하고 결과물의 통제가 가능한 분야에서 사용

- 프로젝트별(Project selection) 모형∙ CSP의 선정을 기존에 추려진 소수의 업자들 중에서 CSP의 핵심역량이 특정

프로젝트의 요구와 잘 맞는 지를 결정하고 그에 따라서 선정하며 가장 많이 사용하는 모델

∙ 특정 치료제분야나 약품개발의 특정단계에 따라서 가장 잘 맞는 업체를 선정- 전략적 파트너쉽(Strategic partnership) 모형

∙ 소수의 선발된 우선적인 서비스제공업체에게 우선적인 기회를 주는 전략적인 아웃소싱모형으로 모든 적용 가능한 서비스에 사용할 수 있음

∙ Full service 초기발견 서비스계약을 들 수 있으며, 주로 발견연구와 화학합성 등 분야에 가장 많이 사용됨

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Part� 1.� 중동·아프리카 지역 의약품 정보 구축 ❚ 29

2. 전략적 협력사 현황

1) 신약 승인현황으로 본 전략적 협력사 동향

◦FDA 발표자료에 따르면 2014년 승인된 신약은 41개로 나타났으며, 이는 신약 승인이 다소 저조했던 2013년의 27개보다 14개(52%) 증가한 수치이며 2000년대 이후 가장 높은 수치임

[그림 16] 美 FDA 신약 승인 현황(2005~2014)

자료:� FDA� CDER,� New� drug� review �

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30� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북◦생물학적 제제 품목허가 (BLA, Biologics License Application) 승인 건수는 2014

년 11건(27%)으로 단 2건 승인에 그쳤던 2013년과 매해 6건의 BLA가 승인된 2009년∼2012년과 비교하여 크게 증가함

[그림 17] 美 FDA 승인 BLA 현황(2004~2014)

자료:� FDA� CDER,� New� drug� review,� Pharma� etrack� 재가공

<표 7> 2014년 약효군별 승인 약물 현황

약효군 승인 약물 수 비율(%)

항감염제 11 27

항암제 9 22

대사성/내분비질환 7 17

중추신경계 3 7

소화기계 3 7

호흡기계 3 7

조영제 2 5

심혈관계 1 2

면역질환 1 2

근골격계 1 2

희귀질환 16 39

자료 :� FDA,� 2014

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Part� 1.� 중동·아프리카 지역 의약품 정보 구축 ❚ 31

2014RANK

기업명 국가 2013 2014전년대비성장률

1 Novartis 스위스 50,444 51,307� 3.7

2 Pfizer 미국 44,213 44,929� 3.6

3 Sanofi 프랑스 38,020 40,037� 8.1

4 Roche 스위스 36,395� 37,607� 4.9

5 Merck� &� Co 미국 35,818� 36,550� 3.9

6 Johnson� &� Johnson 미국 30,663� 36,442� 20.9

7 AstraZeneca 영국 32,250� 33,313� 4.9

8 GlaxoSmithKline 영국 32,102� 31,470� -0.3

9 Teva 이스라엘 24,271� 26,001� 8.6

◦2014년 승인 약물 중 항감염제의 비율이 27%로 가장 많은 비중을 차지하고, 이어서 항암제의 비율이 22%를 차지하고 있는 것으로 나타났으며, 대사/내분비 질환 (12%), 신경계 질환 (10%) 등도 다수를 점유하고 있음- 2013년 승인 현황과 비교할 때, 항감염제의 비율이 2배가량 크게 증가했고 대

사/내분비 질환 관련 약물의 비율 또한 소폭 증가한 반면, 2012, 2013년 연속 30% 이상의 비율을 점유하던 항암제의 비율은 다소 감소했으며 심혈관계 약물의 비율 또한 4% 감소한 것으로 나타남

2) 주요기업 매출 순위

◦2014년 전세계 제약기업 중 판매 1위는 전년에 이어 Novartis가 513억 달러를 기록하며 차지하였고, Pfizer와 Sanofi가 각각 449억 및 400억 달러의 매출을 기록하여 2, 3위를 차지함- 전년대비 성장률이 가장 큰 기업으로는 Gilead Science로 블록버스터급 C형간

염 치료제 소발디(Sovaldi) 발매로 매출이 전년 대비 114.8% 급증한 237억달러를 기록하였으며, 상위 20위권 내의 기업은 미국이 8개로 가장 많고, 다음으로 유럽국가, 일본 및 이스라엘 등으로 나타남

<표 8> 세계 상위 20개 제약기업 판매 현황(단위: 백만달러, %)

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32� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

2014RANK

기업명 국가 2013 2014전년대비성장률

10 Gilead� Sciences� 미국 11,092� 23,673� 114.8

11 Amgen 미국 18,646� 20,473� 10.4

12 Lilly 미국 23,175 19,909� -13.5

13 Abbvie 미국 18,204 19,049 5.5

14 Bayer 독일 17,477 18,347 8.1

15 Boehringer� Ingelheim 독일 17,272� 17,650 4.5

16 Novo� Nordisk� 덴마크 14,592 16,831 17.0

17 Actavis 아일랜드 16,170� 15,978� -0.8

18 Takeda 일본 13,356� 13,376 4.8

19 Otsuka 일본 11,065 12,290 14.1

20 Mylan 미국 11,271� 11,980 7.0

상위 20개 기업 판매액 합계 496,496 527,192 6.2

총 판매액(Global� Market) 879,631 936,511 8.8

주 :� 시장규모(판매액)는 분기별 환율 적용,� 처방의약품 및 일부 OTC� 포함한 제조가격(출하액)� 기준임자료 :� IMS� Health� MIDAS,� December� 2014

3) 주요제품 매출 순위

◦2014년 전 세계 주요제품 매출 순위를 보면 Humira(관절염, 척추염 치료제)가 118 억 달러를 기록하며 세계 매출 1위를 기록했고, 그 뒤로 란투스(Lantus, 당뇨병 치료제)가 103억 달러, 소발디(Sovaldi, C형 간염치료제)가 94억 달러, 아빌리파이(Abilify, 정신질환 치료제)가 93억 달러 순으로 나타남

◦전년대비 성장률을 보면 Sovaldi(C형간염 치료제)가 전년 대비 13,262%의 돋보적인 성장을 하였고, Lantus(당뇨병용제)가 30.4%, Humira 역시 22.1% 성장을 하며 높은 성장을 이어가며, Lyrica(중추신경용약), Abilify(정신신경용제), Symbicort(진해거담제) 등도 두 자리수 이상의 높은 성장을 이어감

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Part� 1.� 중동·아프리카 지역 의약품 정보 구축 ❚ 33<표 9> 상위 20개 글로벌 의약품 매출 순위

(단위: 백만달러, %)2014RANK

제품명 기업명 적응증 2013 2014전년대비성장률

1 휴미라(Humira) AbbVie� 류마티스 관절염 9,784 11,844 22.1

2 란투스(Lantus) Sanofi-Aventis 당뇨병용제 8,014 10,331 30.4

3 소발디(Sovaldi) Gilead� Sciences C형간염 치료제 70 9,375 13,262.2

4 아빌리파이(Abilify) Bristol-Myers�Squibb 정신분열증,� 조증,� 우울증 7,824 9,285 19.2

5 엔브렐(Enbrel) Amgen� 류마티스 관절염 7,918 8,707 11.0

6 세레타이드(Seretide) GlaxoSmithKline� 천식치료 9,198 8,652 -5.3

7 크레스토(Crestor) AstraZeneca� 콜레스테롤혈증,� 고지혈증 8,140 8,473 5.6

8 레미케이드(Remicade) Johnson�&�Johnson 크론병,� 류마티스 관절염 7,648 8,097 7.7

9 넥시움(Nexium) AstraZeneca� 역류질환식도염(위식도) 7,867 7,681 -1.4

10 맙테라(Mabthera) Roche림프종,� 백혈병,� 류마티스관절염

6,363 6,552 4.3

11 아바스틴(Avastin) Roche 항악성종양 5,793 6,070 6.4

12 리리카(Lyrica) Pfizer 말초,�중추신경병증성통증치료 5,107 6,002 19.0

13 허셉틴(Herceptin) Genentech 항악성종양 5,261 5,564 7.2

14 스피리바(Spiriva) Boehringer� Ingelheim 만성폐쇄성폐질환 유지요법제 5,283 5,483 4.8

15 자누비아(Januvia) MSD 당뇨병용제 4,457 4,991 14.0

16 코팍손(Copaxone) Teva 다발성 경화증 4,691 4,788 2.8

17 노보래피드(Novorapid) NovoNordisk� 당뇨병용제 4,071 4,718 17.1

18 뉴라스타(Neulasta) Kyowa� Kirin 항악성종양 4,397 4,627 5.5

19 심비코트(Symbicort) AstraZeneca� 진해거담제 3,885 4,535 18.9

20 루센티스(Lucentis) Novartis 황반변성 치료제 4,382 4,437 2.2

상위 20개 의약품 판매액 합계 120,153 140,212 16.7

총 판매액(Global� Market) 879,631 936,511 8.8

주 :� 시장규모(판매액)는 분기별 환율 적용,� 처방의약품 및 일부 OTC� 포함한 제조가격(출하액)� 기준임자료 :� IMS� Health� MIDAS,� December� 2014

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34� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북4) 약효군별 시장 현황

◦2014년 상위 20개 약효군별 세계시장 규모는 6,697억 달러로 전체 의약품 시장의 71.5%를 차지하며, 항암제가 744억 달러로 2013년에 이어 가장 많이 판매되었고, 당뇨병치료제 및 진통제가 635억, 597억 달러 순으로 시장규모가 큼- 바이러스 간염 치료제, 당뇨병 치료제 및 자가면역질환 치료제 등은 전년 대비 10%

이상 판매액이 증가한 반면, 항 고혈압제 및 항궤양제의 경우 전년보다 판매액이 감소함<표 10> 상위 20개 약효군별 세계 시장 현황

(단위: 백만달러, %)2014RANK

약효군 2013 2014전년대비성장률

1 항암제 (Oncologics) 67,486 74,449 12.2

2 당뇨병 치료제 (Antidiabetics) 54,850 63,573 18.0

3 진통제 (Pain) 57,625 59,786 6.5

4 항고혈압제 (Antihypertensives,� Plain� &� Com) 49,648 47,537 -1.2

5 항생제 (Antibacterials) 40,823 40,272 0.8

6 호흡기계 약물 (Respiratory� Agents) 37,985 39,570 5.6

7 정신건강 약물 (Mental� Health) 39,533 39,134 0.6

8 자기면역질환 치료제 (Autoimmune� Diseases) 30,952 35,906 17.5

9 고지혈증약 (Lipid� Regulators) 28,947 28,412 0.2

10 피부 치료제 (Dermatologics) 26,561 28,223 9.5

11 항응혈제 (Anticoagulants) 24,198 26,619 12.5

12 장항생제 (Gi� Products) 23,667 25,135 9.9

13 항궤양제 (Anti-Ulcerants) 25,650 24,811 -1.1

14 HIV� 항바이러스제 (HIV� Antivirals) 20,615 22,678 10.9

15 기타의 심혈관제 (Other� Cardiovasculars) 21,277 22,625 9.3

16 신경계 장애약물 (Nervous� System� Disorders) 20,191 22,106 11.7

17 기타의 중추신경계약 (Other� CNS) 19,036 19,652 5.5

18 바이러스 간염치료제 (Viral� Hepatitis) 5,941 18,079 212.6

19 한방의약품 (Kanpo,� Chinese� Medicines) 14,662 16,054 9.5

20 백신류 (Vaccines� (Pure,� Comb,� Other)) 14,265 15,116 8.4

상위 20개 약효군 합계 623,912 669,737 7.3

총 판매액(Global� Market) 879,631 936,511 8.8

주 :� 1)� 시장규모(판매액)는 분기별 환율 적용,� 처방의약품 및 일부 OTC� 포함한 제조가격(출하액)� 기준임2)� 각� 약효군에 대한 정의는 아래와 같음

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Part� 1.� 중동·아프리카 지역 의약품 정보 구축 ❚ 35

Therapy� classes� defined� as: ATC/Product

ONCOLOGICS L1,�L2,�V3C,�REVLIMID,�XGEVA,�PROLEUKIN,� �POMALYST

ANTIDIABETICSA10C,� A10D,� A10E,� A10H,� A10J,� A10K,� A10L,� A10M,�

A10N,� A10P,� A10S,� A10X,� � H4B,� T2D

PAIN M1A,� M1B,� M2,� M3,� M5X,� N1,� N2

ANTIHYPERTENSIVES,�PLAIN�&�COM C2,� C3,� C7,� C8,� C9

ANTIBACTERIALSJ1A,�J1B,� J1C,�J1D,�J1E,� J1F,�J1G,�J1H,� J1K,� J1L,� J1M,�J1P,�

J1X,� J3A,� � J8

RESPIRATORY� AGENTS R3

MENTAL� HEALTH N5A,� N6A

AUTOIMMUNE� DISEASES M1C,� L4B,� STELARA,� AMEVIVE,� RAPTIVA

LIPID� REGULATORS C10A,� C10C,� C11

DERMATOLOGICS D

ANTICOAGULANTS B1,� B2C

GI� PRODUCTS A1,� A2A,� A2C,� A3,� A5,� A6,� A7,� A15A

ANTI-ULCERANTS A2B

HIV� ANTIVIRALS J5C

OTHER� CARDIOVASCULARS C1,� C4,� C5,� C6,� C10B

NERVOUS� SYSTEM� DISORDERS N3A,� N4A

OTHER� CNS N5B,� N5C,� N6C,� N6D,� N6E,� N7B,� N7C,� N7E,� N7F,� N7X

VIRAL� HEPATITIS J5B1

KANPO,� CHINESE� MEDICINES V3B

VACCINES� (PURE,� COMB,� OTHER) J7

자료:� IMS� Health� MIDAS,� December� 2014

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Part

2Ⅱ아웃소싱그룹과 전략적 협력사

디렉토리북 구축 및 전략적 협력모델 구축

중동·아프리카 지역 아웃소싱 기업

및 전략적 협력사 디렉토리북

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Part� 2.� 중동·아프리카 지역 아웃소싱 그룹 및 전략적 협력사 디렉토리북 구축 ❚ 39

제1장 중동·아프리카 지역 아웃소싱 그룹 및

전략적 협력사 디렉토리북 구축

1. 디렉토리북 표준폼 개발

□ 기존 기업일반정보 중심의 정보제공 뿐만 아니라 전문성/경험, 비즈니스 정보, 친

숙도 중심의 실질적인 정보를 수록한 디렉토리북 구축

1.1 글로벌 아웃소싱 그룹 및 국내 CRO 관련 디렉토리북 표준폼

□ 기업 일반 정보

◦기업명 및 기업 형태◦주요연혁 및 회사소개, 조직◦종업원수 및 재무현황◦주소 및 홈페이지 주소◦담당자(한국)

□ 서비스/비즈니스영역 정보

◦주요 서비스영역◦지역별 비즈니스영역◦전문 용역 서비스영역◦제품 영역

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40� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북□ 비즈니스 정보

◦고객사 구성 및 자체보유시설◦전문질환분야 및 전문서비스 항목◦용역서비스 제공가능 규모◦고객사와의 커뮤니케이션

□ 기업경쟁력

◦종합적인 측면(가격, 기간, 인허가당국의 서비스 결과 인정여부, 자체품질보증, 직무교육실시여부, 주요 실적, 임직원의 전문성) 등을 고려하여 기업 경쟁력에 대한 기술

◦허가당국의 실사횟수◦외부기관으로부터 인증보유현황

□ 아시아기업과의 협력 경험

◦협력 경험보유 국가현황◦아시아 기업유형별 비중 및 최근 3년간 협력 횟수◦협력업무 수행 주요 내용

□ 기타 협력 관련 제안사항 등

1.2 글로벌 전략적 협력사 관련 디렉토리북 표준폼

□ 기업 일반 정보

◦기업명 및 인터넷 사이트 주소◦협력관련 담당자(한국) 정보(성명, 주소, 연락처, E-mail)

□ 사업 협력에 대한 설명

◦R&D Co-works, In-Licensing, Out-Licensing, Manufacturing, (Co-) Marketing & Sales, etc...

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Part� 2.� 중동·아프리카 지역 아웃소싱 그룹 및 전략적 협력사 디렉토리북 구축 ❚ 412. 글로벌 아웃소싱 그룹 및 전략적 협력사 대상 조사결과

2.1 글로벌 아웃소싱 그룹 및 전략적 협력사, 국내 CRO 자료 수집

1) 글로벌 아웃소싱 그룹 자료 수집

◦2011 북미 조사, 2012 유럽 조사, 2013 중국, 인도, 동남아, 2014 러시아 및 CIS, 2015 중남미 조사 회신 기업 리스트

◦관련 협회, 단체 회원사 리스트 확보 및 협조요청- 유럽 CRO협회, 유럽 제네릭의약품협회, 미국 생명공학산업협회, 미국제네릭협회,

메디콘밸리, 이외 아시아지역(중국, 인도, 동남아, 중동, 대만), 러시아제약협회(ARPM) 남아프리카공화국 혁신제약협회(IPASA) 등

◦홈페이지 검색 : http://www.contractpharma.com◦국내외 행사 및 학회 참가 리스트 확보

- 2016 US BIO- CPhI KOREA 2016- 2012 - 2016 BIOKOREA- 2013 API CHINA, KOREA PHARM 2013, 2011 ToxExpo

2) 전략적 협력사 자료 수집

◦2011 북미 조사, 2012 유럽 조사, 2013 중국, 인도, 동남아, 2014 러시아 및 CIS, 2015 중남미 조사 회신 기업 리스트

◦관련 협회, 단체 회원사 리스트 확보 및 협조요청- 유럽 CRO협회, 유럽 제네릭의약품협회, 미국 생명공학산업협회, 미국제네릭협

회, 메디콘밸리, 이외 아시아지역(중국, 인도, 동남아, 중동, 대만), 러시아제약협회(ARPM), 남아프리카공화국 혁신제약협회(IPASA) 등

◦국내외 행사 및 학회 참가 리스트 확보- 2016 US BIO- CPhI KOREA 2016- 2012 - 2016 BIOKOREA- 2013 API CHINA, KOREA PHARM 2013, 2011 ToxExpo

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42� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북3) 국내 CRO 자료 수집

◦2011 북미 조사, 2012 유럽 조사, 2013 중국, 인도, 동남아, 2014 러시아 및 CIS, 2015 중남미 조사 회신 기업 리스트

◦한국보건산업진흥원 자체 보유 리스트◦국내외 행사 참가 리스트 확보 : 2013 API CHINA, KOREA PHARM 2013. 2013 -

2016 BIOKOREA, CPhI KOREA 2016

4) 글로벌 아웃소싱 그룹 및 전략적 협력사, 국내 CRO 자료 수집 종합 현황

구 분 아웃소싱그룹 전략적 협력사 국내 CRO

자체조사 리스트(중동,� 아프리카 지역) 76 130 2

2011� 북미조사 및 2012� 유럽조사,

2013� 중국,� 인도,� 동남아,� 2014� 러시아 및 CIS지역,

2015� 중남미 지역 조사 리스트

2,182 2,037 30

합 계(개사) 2,258 2,167 32

※� 아웃소싱그룹 및 전략적 협력사 자료 수집 기업리스트 :� 별첨

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Part� 2.� 중동·아프리카 지역 아웃소싱 그룹 및 전략적 협력사 디렉토리북 구축 ❚ 433. 조사개요

3.1 해외

◦전문가 의견, 한국보건산업진흥원 의견 등을 반영하여 글로벌 아웃소싱 그룹과 전략적 협력사 대상 Official Survey Form을 완성함

◦협조 요청을 위한 한국신약개발연구조합, 한국보건산업진흥원 CEO의 Letter, 아웃소싱 그룹 및 전략적 협력사 디렉토리북 구축을 위한 사업 개요 소개자료, 조사기관(한국신약개발연구조합) 및 한국 제약산업 현황 소개자료 등은 한국보건산업진흥원의 검토를 통해 수정 보완하여 완성함

◦조사기관 CEO의 Letter, 사업 개요 소개자료(아웃소싱 그룹, 전략적 협력사), 조사기관 및 한국제약산업 현황 소개자료, Official Survey Form(아웃소싱 그룹, 전략적 협력사)을 자료 Kit로 구성하여 글로벌 아웃소싱 그룹 및 전략적 협력사를 대상으로 조사를 착수함

◦조사기간 : 2016. 7. 21 ~ 2016. 9. 30◦조사대상 : 사전에 조사․확보한 글로벌 아웃소싱 그룹 및 전략적 협력사 업체 대상

- 글로벌 아웃소싱 그룹 리스트 : 별첨 참조- 전략적 협력사 리스트 : 별첨 참조

◦조사방법- 확보된 조사 리스트업체 조사 협조 메일 전송지(조사자료 Kit 포함) 이메일전송

및 이메일접수- 국내외 전문가 그룹 활용 조사 협조 요청(남아프리카공화국 혁신제약협회)

◦조사내용 : 조사 자료 Kit 별첨 참조(글로벌 아웃소싱 그룹, 전략적 협력사)◦회신기업 : 총 325개사 ※ 별첨 참조(기조사 자료 포함)

- 글로벌 우수아웃소싱 그룹 : 144개사 ∙ CRO(Contract Research Organization) : 122개사 ∙ CMO(Contract Manufacturing Organization) : 24개사 ∙ CSO(Contract Sales Organization) : 18개사 ∙ Consulting : 58개사

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44� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북 ※ 신규 추가(35개사) : ACDIMA BioCenter, Arab Pharmaceutical Industry Consulting Company,

ASREGTEC, ASUNTOS REGULATORIOS TÉCNICOS, Clinserv, CO RESEARCH, CROTURK, Elezaby Pharmacy, Endopoint, ETHIC, FARMA TEAM, Farzan Clinical Research, International Pharmaceutical Research center (IPRC), Klinar CRO, mediSMART, meneresearch, Monitor, Nagy Research, NOVA TRIALS, NOVAGENIX, Optimum, Optimumclintrial, Perfection-CRO, Pharmaceutical Research Associates, Inc, Pharmaseed, Q-Trials Ltd., QUADRO CRO, R2S, RAY, Scidre, TCA Clinical Research Ltd., TechnoSTAT, Techtrials Pesquisa e Tecnologia Ltda., Triumpharma, LLC, XCENE Research, ZEINCRO

※ 업데이트(2개사) : Symbiosis Group SA, WCCT Global, Inc.- 글로벌 전략적 협력사 : 182개사 ※ 신규 추가(61개사) : Accelera Srl, Afrab-Chem Limited, Africa Medec Limited, Al Mojil Drug

Company, AlfaCure Pharmaceuticals, AnaPath Services GmbH, atco pharma for harmaceutical IND, BCN Limited, Beta healthcare, Biopharma, BSL BIOSERVICE Scientific Laboratories GmbH, Cadila Pharmaceuticals (EA) Ltd, Carrot-Top Drugs Limited, Chemiron International Limited, Cloriti Pharmaceuticals (EA) Ltd, Cosmos Limited, DANADAMS PHARMACEUTICAL INDUSTRY GHANA LIMITED, Dawa Ltd, DBK harmaceutical, Drogueria Eurofarma SA, Elys Chemical Industries Ltd, Emzor Pharmaceuticals Limited, Entrance Pharmaceuticals & Research Center, Ernest Chemists Limited Head Office, Escorts Pharmaceuticals Ltd, Evans Medical Limited, Fidson Healthcare Limited, Gemini Pharma Limited, Haltons Pharmacy, Harley’s Ltd, Impact Chemicals Ltd, INRAD, Kampala Pharmaceutical Industries, Kuwait Saudi Pharmaceutical Industries Co., Kwality Afro Asia, Lab and Allied, Lords Healthcare Ltd, M&G Pharmaceuticals Ltd, Mansoor Daya Chemicals, Max Pharmaceuticals Ltd, Medipharm Industries (E.A.) Ltd, MTK Uganda Limited, Namiki Shoji Co.,. Ltd., Neros Pharmaceuticals Limited, Ningbo Menovo Pharmaceutical Co., Ltd., Orange Drugs Limited, Oss-Chemie (K) Ltd, Pharmaken Ltd, PluriCell Biotech, Quality Chemical Industries, Radiance Pharmaceuticals Limited, Reals Pharmaceuticals Limited, Regal, Rene Industries Ltd, Skylight Chemicals, Square Pharmaceuticals, Surgilinks Ltd, Universal Corporation, Vacsera, Vortex pharma, Zenufa Limited

3.2 국내

◦해외아웃소싱그룹(CRO, CMO, CSO등)과의 협력 활성화방안 모색 이전에 우선적으로 국내 CRO와의 협력이 선행되어야 함을 감안

◦향후 국내기업의 해외시장진출을 위한 핵심 연구개발 동반자로서 국내에서 활동중인 전임상시험, 임상시험분야 CRO기관에 대한 정보를 동 디렉토리북에 수록

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Part� 2.� 중동·아프리카 지역 아웃소싱 그룹 및 전략적 협력사 디렉토리북 구축 ❚ 45◦국내에서 활동중인 전임상, 임상분야 CRO기업과 국내 제약, 바이오기업간 긴밀한

협력활성화 기여◦조사기간 : 2016. 8. 17 ∼ 2016. 9. 23◦조사대상 : 전임상, 임상시험분야 국내 CRO 기업◦조사항목

- 기업 일반 정보 ∙ 기업명 및 기업 형태 ∙ 주요연혁 및 회사소개, 조직 ∙ 종업원수 및 재무현황 ∙ 주소 및 홈페이지 주소 ∙ 담당자(한국)- 서비스/비즈니스영역 정보 ∙ 주요 서비스영역 ∙ 지역별 비즈니스영역 ∙ 전문 용역 서비스영역 ∙ 제품 영역- 비즈니스 정보 ∙ 고객사 구성 및 자체보유시설 ∙ 전문질환분야 및 전문서비스 항목 ∙ 용역서비스 제공가능 규모 ∙ 고객사와의 커뮤니케이션- 기업경쟁력 ∙ 종합적인 측면(가격, 기간, 인허가당국의 서비스 결과 인정여부, 자체품질보

증, 직무교육실시여부, 주요 실적, 임직원의 전문성) 등을 고려하여 기업 경쟁력에 대한 기술

∙ 허가당국의 실사횟수 ∙ 외부기관으로부터 인증보유현황

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46� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북- 아시아기업과의 협력 경험 ∙ 협력 경험보유 국가현황 ∙ 아시아 기업유형별 비중 및 최근 3년간 협력 횟수 ∙ 협력업무 수행 주요 내용- 기타 협력 관련 제안사항 등

◦회신기업 : 총 23개사 ※ 별첨 참조(기조사 자료 포함)- 임상시험 : 13개사 ∙ 드림씨아이에스, 서울CRO, 씨엔알 리서치, 에이디엠코리아, 엘에스케이글로벌

파마서비스, ICON plc, 퀸타일즈트랜스내셔널코리아, 파마크로, SCAS-BTT Bioanalysis, 서초CRO, Novotech Pty Limited, StarTech Science, Ginapath

- 전임상시험 : 10개사 ∙ 대구가톨릭대학교 GLP센터, 산업안전보건연구원, 한국건설생활환경시험연구

원, 한국화학융합시험연구원, 안전성평가연구소, 메드빌, 바이오인프라(임상1상까지), 바이오톡스텍, 켐온, 레퍼런스 바이오랩

※ 신규 추가(2개사) : StarTech Science, Ginapath ※ 2016년도 업데이트 : 엘에스케이글로벌파마서비스, 켐온

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Part� 2.� 중동·아프리카 지역 아웃소싱 그룹 및 전략적 협력사 디렉토리북 구축 ❚ 474. 글로벌 아웃소싱 그룹 및 전략적 협력사 선정

4.1 해외

◦아웃소싱 그룹 및 전략적 협력사 정보에 대한 심층 검토◦글로벌 아웃소싱 그룹 선정 : 별첨 참조

- 글로벌 아웃소싱 그룹 총 144개사 선정(기조사 자료 포함)- 서비스 영역별 아웃소싱그룹 선정 현황

∙ CRO : 122개사∙ CMO : 24개사∙ CSO : 18개사∙ Consulting : 58개사

- 본사 기준 국가별 아웃소싱그룹 선정 현황∙ 미국 : 45개사∙ 중국 : 17개사∙ 터키 : 12개사

∙ 인도 : 10개사∙ 이스라엘 : 7개사

∙ 영국 : 6개사∙ 아르헨티나 : 5개사∙ 이집트 : 5개사∙ 브라질 : 5개사∙ 프랑스 : 5개사∙ 요르단 : 4개사∙ 멕시코 : 3개사∙ 독일 : 3개사∙ 스웨덴 : 2개사∙ 아일랜드 : 2개사∙ 나이지리아 : 2개사

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48� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북∙ 기타 : 10개사(덴마크, 그리스, 싱가포르, 네덜란드, 폴란드, 호주, 이탈리아,

우루과이, 에콰도르, 이란, 모로코, 홍콩)◦전략적 협력사 선정 : 별첨 참조

- 전략적 협력사 총 182개사 선정(기조사 자료 포함) ※ 기조사 자료 121개사 ※ 신규 추가(61개사) : 중동·아프리카 지역 54개사 및 기타지역 7개사

∙ 케냐 : 22개사∙ 나이지리아 : 11개사∙ 우간다 : 7개사∙ 이집트 : 6개사∙ 가나 : 4개사∙ 쿠웨이트, 탄자니아 : 각각 2개사∙ 브라질, 아르헨티나, 이탈리아, 중국, 일본, 독일, 스위스 : 각각 1개사

4.2 국내

◦국내 CRO 선정 : 총 23개사 ※ 별첨 참조(기조사 자료 포함)- 임상시험 : 13개사 ∙ 드림씨아이에스, 서울CRO, 씨엔알 리서치, 에이디엠코리아, 엘에스케이글로

벌파마서비스, ICON plc, 퀸타일즈트랜스내셔널코리아, 파마크로, SCAS-BTT Bioanalysis, 서초CRO, Novotech Pty Limited, StarTech Science, Ginapath

- 전임상시험 : 10개사 ∙ 대구가톨릭대학교 GLP센터, 산업안전보건연구원, 한국건설생활환경시험연구

원, 한국화학융합시험연구원, 안전성평가연구소, 메드빌, 바이오인프라(임상1상까지), 바이오톡스텍, 켐온, 레퍼런스 바이오랩

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Part� 2.� 중동·아프리카 지역 아웃소싱 그룹 및 전략적 협력사 디렉토리북 구축 ❚ 49

순번 기업명 국가 페이지 2015 2016

1 ACDIMA� BioCenter� 요르단 70 ○(신규)

2 ActivaCRO 아르헨티나 71 ○ ○

3 Alliance� Pharma� Inc. 미국 72 ○ ○

4 Almac� Ltd 영국 77 ○ ○

5 AMRI 미국 83 ○ ○

6 ANTHEM� BIOSCIENCES� PVT� LTD 인도 90 ○ ○

7 Aptuit 미국 96 ○ ○

8 Arab� Pharmaceutical� Industry� Consulting� Company 요르단 103 ○(신규)

9 Arriello� Group 아일랜드 104 ○ ○

10 ARTIMMUNE 프랑스 110 ○ ○

11 ASREGTEC,� ASUNTOS� REGULATORIOS� TÉCNICOS 에콰도르 114 ○(신규)

12 Binzhou� Hollyally� Pharmaceutical� Co.,Ltd. 중국 121 ○ ○

13 BioInvent� International� AB 스웨덴 126 ○ ○

14 Biologics� Consulting� Group 미국 133 ○ ○

15 Biomedcode� Hellas� SA 그리스 138 ○ ○

16 BioStata� ApS 덴마크 142 ○ ○

17 Brock� Capital� Group 미국 146 ○ ○

18 Cato� Research� Ltd. 미국 149 ○ ○

19 Cegedim� Dendrite 프랑스 152 ○ ○

20 Celerion,� Inc. 미국 155 ○ ○

21 Charles� River� Laboratories 미국 163 ○ ○

22 Chiltern 브라질 166 ○ ○

23 CiToxLAB 프랑스 167 ○ ○

24 CLEARSYNTH� LABS� LTD 인도 172 ○ ○

25 Clinipace� Worldwide 미국 176 ○ ○

26 Clinserv 이집트 182 ○(신규)

27 ClinStar,� LLC 미국 183 ○ ○

28 Cmed� Clinical� Services 영국 189 ○ ○

29 CO� RESEARCH 터키 192 ○(신규)

30 Covance� Inc. 미국 193 ○ ○

31 CPR� Strategic� Marketing� Communications,� Inc. 미국 200 ○ ○

32 CROTURK 터키 203 ○(신규)

33 Cunningham� &� Associates 미국 204 ○ ○

34 Cyprotex� Discovery� Ltd 영국 210 ○ ○

35 D2� Pharma� Consulting,� LLC 미국 217 ○ ○

<표 11> 글로벌 아웃소싱 그룹 디렉토리 수록 기업 리스트 144개사(신규 35개사 및 업데이트 2개사 포함)

Page 54: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

50� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북순번 기업명 국가 페이지 2015 2016

36 Dragon� Bio-Consultants,� Ltd. 홍콩 222 ○ ○

37 Ecron� Acunova� Ltd� 인도 227 ○ ○

38 Elezaby� Pharmacy 이집트 237 ○(신규)

39 Emergent� BioSolutions� Inc. 미국 238 ○ ○

40 Encap� drug� delivery 영국 246 ○ ○

41 Endopoint 이스라엘 249 ○(신규)

42 ERA� Consulting� (Australia)� Pty� Ltd� 독일 250 ○ ○

43 Estern� Medical 멕시코 255 ○ ○

44 ETHIC 터키 256 ○(신규)

45 Eurotrials 브라질 257 ○ ○

46 Excel� PharmaStudies� Inc 중국 258 ○ ○

47 Exponent,� Inc. 미국 259 ○ ○

48 FARMA� TEAM 터키 265 ○(신규)

49 Farzan� Clinical� Research 이란 266 ○(신규)

50 Garphi� Biosciences� Pvt.� Ltd. 인도 267 ○ ○

51 Giant� Med-Pharma� Services,� Inc. 중국 272 ○ ○

52 Global� Engage� Ltd. 영국 273 ○ ○

53 GUANGDONG� BOHONG 중국 276 ○ ○

54 Guangzhou� Boji� Clinical� Research� Center 중국 277 ○ ○

55 GVK� BIOSCIENCES� PVT.� LTD. 인도 278 ○ ○

56 Harlan 미국 285 ○ ○

57 HCM� Enterprise� LLC 미국 290 ○ ○

58 HD� Biosciences� (China)� Co.,� Ltd. 중국 294 ○ ○

59 Henan� Purui� Pharmaceutical 중국 303 ○ ○

60 Huntingdon� Life� Sciences 미국 304 ○ ○

61 ICON� plc 아일랜드 312 ○ ○

62 ICR 멕시코 319 ○ ○

63 INC� Research 미국 320 ○ ○

64 iNovacia� AB 스웨덴 323 ○ ○

65 International�Pharmaceutical�Research�center�(IPRC)� 요르단 327 ○(신규)

66 Intrials 브라질 328 ○ ○

67 inVentive� Health� Inc. 미국 329 ○ ○

68 JOINN� LABORATORIES.,� Ltd. 중국 331 ○ ○

69 KCR,� SA 폴란드 336 ○ ○

70 KEOSYS� Medical� Imaging 프랑스 342 ○ ○

71 Key-Obs 프랑스 351 ○ ○

72 Kinesis� Pharma� B.V. 네덜란드 355 ○ ○

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Part� 2.� 중동·아프리카 지역 아웃소싱 그룹 및 전략적 협력사 디렉토리북 구축 ❚ 51순번 기업명 국가 페이지 2015 2016

73 Kinexum� Services 미국 359 ○ ○

74 Klinar� CRO 터키 363 ○(신규)

75 KLIXAR 아르헨티나 364 ○ ○

76 Laboratorios� � Silanes� S.A.� de� C.V. 멕시코 365 ○ ○

77 Lal� Clinica 브라질 371 ○ ○

78 LBBM 아르헨티나 372 ○ ○

79 LEPING� SAFELTY� PHARMACEUTICAL 중국 373 ○ ○

80 Marin� Biologic� Laboratories 미국 374 ○ ○

81 McguireWoods� LLP 미국 378 ○ ○

82 mediSMART 터키 381 ○(신규)

83 Medpace,� Inc 미국 382 ○ ○

84 meneresearch 터키 388 ○(신규)

85 Midas� Pharma 독일 389 ○ ○

86 Monitor 터키 392 ○(신규)

87 Myoderm 미국 393 ○ ○

88 Nagy� Research 이집트 397 ○(신규)

89 NOVA� TRIALS 터키 398 ○(신규)

90 NOVAGENIX 이스라엘 399 ○(신규)

91 Novotech 호주 400 ○ ○

92 Ocimum� Biosolutions� Ltd 인도 407 ○ ○

93 OnCall� LLC. 미국 414 ○ ○

94 Optimum 터키 416 ○(신규)

95 Optimumclintrial 나이지리아 417 ○(신규)

96 Pacific� BioLabs 미국 418 ○ ○

97 PAREXEL� INTERNATIONAL� LLC. 미국 421 ○ ○

98 Parthys� Reverse� Informatics� Analytic� Solutions 인도 430 ○ ○

99 PDI� Inc. 미국 436 ○ ○

100 Penn� Pharma 영국 437 ○ ○

101 Perfection-CRO 이스라엘 440 ○(신규)

102 PHARMA� TRADE 이탈리아 441 ○ ○

103 Pharmaceutical� Advisors 미국 444 ○ ○

104 Pharmaceutical� Regulatory� Services,� Inc. 미국 447 ○ ○

105 Pharmaceutical� Research� Associates,� Inc 미국 452 ○(신규)

106 PharmaNet/i3 미국 461 ○ ○

107 Pharmaseed 이스라엘 468 ○(신규)

108 Polaris� Life� Sciences 미국 469 ○ ○

109 PPD,� Inc. 미국 473 ○ ○

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52� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북순번 기업명 국가 페이지 2015 2016

110 PRA� International 미국 476 ○ ○

111 Q-Trials� Ltd. 터키 479 ○(신규)

112 QUADRO� CRO 이스라엘 480 ○(신규)

113 Quintiles 미국 481 ○ ○

114 R2S 이집트 487 ○(신규)

115 RAY 모로코 488 ○(신규)

116 ReachBio� LLC 미국 489 ○ ○

117 Research� &� Development� RA.� S.A. 아르헨티나 496 ○ ○

118 Ricerca� Biosciences,� LLC 미국 498 ○ ○

119 Scidre 이집트 503 ○(신규)

120 Shanghai� Cares� Biotech� Co� Ltd 중국 504 ○ ○

121 Shanghai� Genomics,� Inc. 중국 505 ○ ○

122 Shanghai� Loudon� Marketing� Consultant� Co� Ltd 중국 507 ○ ○

123 SHIVA� ANALYTICALS� (INDIA)� PRIVATE� LIMITED 인도 509 ○ ○

124 SHJNJ� PHARMgATECH� INC 중국 513 ○ ○

125 Sinolite� Industrial� Co.Ltd 중국 517 ○ ○

126 SolucionesGXP� Infodynamics� s.r.l. 우루과이 521 ○ ○

127 SRK� Strategies,� LLC 미국 525 ○ ○

128 SSS� International� Clinical� Research� GmbH 독일 530 ○ ○

129 Sundia� MediTech� Company,� Ltd. 중국 537 ○ ○

130 Symbiosis� Group� SA 아르헨티나 543 ○○

(업데이트)

131 Syngene� International� Limited 인도 547 ○ ○

132 Target� Health� Inc 미국 556 ○ ○

133 TCA� Clinical� Research� Ltd. 이스라엘 561 ○(신규)

134 TechnoSTAT 이스라엘 562 ○(신규)

135 Techtrials� Pesquisa� e� Tecnologia� Ltda. 브라질 563 ○(신규)

136 Theorem� Clinical� Research,� Inc. 미국 567 ○ ○

137 Tigermed� Consulting� Co� Ltd 중국 577 ○ ○

138 Triumpharma 요르단 579 ○(신규)

139 Truven� Health� Analytics� Inc. 미국 580 ○ ○

140 VIMTA� LABS� LIMITED 인도 585 ○ ○

141 WCCT� Global,� LLC 미국 593 ○○

(업데이트)

142 XCENE� Research 나이지리아 596 ○(신규)

143 ZEINCRO 터키 597 ○(신규)

144 Zhiwe� Chem-Tech� lnc 중국 598 ○ ○

Page 57: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Part� 2.� 중동·아프리카 지역 아웃소싱 그룹 및 전략적 협력사 디렉토리북 구축 ❚ 53

순번 기업명 국가 페이지 2015 2016

1 ABL 브라질 605 ○ ○

2 Accelera� Srl 이탈리아 606 ○(신규)

3 Access� Bio 미국 608 ○ ○

4 AGIO 인도 609 ○ ○

5 Akrikhin 러시아 611 ○ ○

6 Alkor� Bio 러시아 615 ○ ○

7 Amgen 미국 616 ○ ○

8 AnaPath� Services� GmbH 스위스 618 ○(신규)

9 APOTEX 멕시코 619 ○ ○

10 Apsen 브라질 620 ○ ○

11 ARTERIUM 우크라이나 622 ○ ○

12 AstraZeneca 영국 624 ○ ○

13 AVID 미국 627 ○ ○

14 AZT� Pharma� K.B. 러시아 629 ○ ○

15 bcpp 우크라이나 630 ○ ○

16 BEPTEKC 러시아 632 ○ ○

17 Bestpharma 칠레 633 ○ ○

18 Binzhou� Hollyally.Pharmaceutical� Co.,Ltd. 중국 634 ○ ○

19 Biocad 러시아 635 ○ ○

20 BioInvent� International� AB 스웨덴 637 ○ ○

21 BIOLA 카자흐스탄 641 ○ ○

22 BioRelix 미국 642 ○ ○

23 Biosano 칠레 643 ○ ○

24 BIOSINTEZ 러시아 645 ○ ○

25 Blisfarma 브라질 646 ○ ○

26 BMS 미국 648 ○ ○

27 BSL� BIOSERVICE� Scientific� Laboratories� GmbH 독일 650 ○(신규)

28 Celgene 미국 652 ○ ○

29 CHEM 러시아 655 ○ ○

30 Chengdu� CSHPHARM� Co.,Ltd. 중국 656 ○ ○

31 Clinical� Development� Services� Agency 인도 657 ○ ○

32 CMIC� Korea� Co,.� LTD. 한국 658 ○ ○

33 DiaProph� Med 우크라이나 660 ○ ○

34 Drogueria� Eurofarma� SA 아르헨티나 664 ○(신규)

<표 12> 글로벌 전략적 협력사 디렉토리 수록 기업 리스트 128개사(신규 7개사 포함)

Page 58: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

54� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북순번 기업명 국가 페이지 2015 2016

35 EBIME 멕시코 665 ○ ○

36 Ecron� Acunova� Ltd� 인도 666 ○ ○

37 EKOlab 러시아 669 ○ ○

38 Eli� Lilly� &� Co 미국 671 ○ ○

39 Farmak 우크라이나 674 ○ ○

40 Farmamed 러시아 676 ○ ○

41 Farmproekt 러시아 677 ○ ○

42 FERANE 러시아 678 ○ ○

43 Ferrer� Argentina� S.A. 아르헨티나 681 ○ ○

44 G.� C.� CHEMIE� PHARMIE� LTD 인도 684 ○ ○

45 GalenoPharm 러시아 685 ○ ○

46 GENOSCO 미국 688 ○ ○

47 GEROPHARM 러시아 689 ○ ○

48 Gramón� -� Bagó� de� Uruguay� S.A. 우루과이 691 ○ ○

49 GSK 영국 692 ○ ○

50 GUANGDONG� BOHONG�MEDICINE� CO.,� LTD. 중국 695 ○ ○

51 GVK� BIOSCIENCES� PVT.� LTD. 인도 697 ○ ○

52 H.� Lundbeck� A/S 덴마크 699 ○ ○

53 Janssen� Korea� Ltd. 미국 704 ○ ○

54 JURABEK 우즈베키스탄 707 ○ ○

55 KRKA 슬로베니아 712 ○ ○

56 Kyiv� Vitamin� Factory 우크라이나 716 ○ ○

57 Laboratorio� Dosa� S.R.L. 아르헨티나 719 ○ ○

58 LaboratorioDr.Lazar&Cia.S.A.Q.eI� 아르헨티나 720 ○ ○

59 Laboratorio� Elea� S.A.C.I.F.� y� A. 아르헨티나 722 ○ ○

60 LABORATORIOS� AC� FARMA� S.A. 페루 723 ○ ○

61 Laboratorios� Bagó� S.A. 아르헨티나 724 ○ ○

62 Laboratorios� Bernabó� S.A. 아르헨티나 725 ○ ○

63 Laboratorios� Fabra� S.R.L. 아르헨티나 726 ○ ○

64 Laboratorios� IMA� S.A.I.C. 아르헨티나 727 ○ ○

65 Laboratorios� LIOMONT 멕시코 728 ○ ○

66 Laboratorios� Phoenix� S.A.I.C.� y� F. 아르헨티나 729 ○ ○

67 Laboratorios� Poen� S.A.C.I.F.I. 아르헨티나 730 ○ ○

68 Lekhim 우크라이나 732 ○ ○

69 LS� SAVAL 칠레 734 ○ ○

Page 59: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Part� 2.� 중동·아프리카 지역 아웃소싱 그룹 및 전략적 협력사 디렉토리북 구축 ❚ 55순번 기업명 국가 페이지 2015 2016

70 MEGA 태국 735 ○ ○

71 Merck 미국 740 ○ ○

72 MICRO� GEN 러시아 744 ○ ○

73 Moscow� Endocrine� Plant 러시아 746 ○ ○

74 MosFarma 러시아 748 ○ ○

75 MSD� Korea 미국 750 ○ ○

76 MSP 카자흐스탄 754 ○ ○

77 NALpharma 미국 756 ○ ○

78 Namiki� Shoji� Co.,.� Ltd 일본 758 ○(신규)

79 NEKTAR 미국 760 ○ ○

80 NEOLPHARMA 멕시코 763 ○ ○

81 Ningbo� Menovo� Pharmaceutical� Co.,� Ltd. 중국 764 ○(신규)

82 Novartis� AG 스위스 766 ○ ○

83 NPO� PETROVAX� PHARM 러시아 769 ○ ○

84 Pfizer 미국 770 ○ ○

85 PHARM� SINTEZ 러시아 772 ○ ○

86 PHARMASOFT 러시아 773 ○ ○

87 Pharmasset 미국 774 ○ ○

88 PHARMASYNTEZ 러시아 776 ○ ○

89 Phs� Pharmstandard 러시아 778 ○ ○

90 PIQ� Pharma 러시아 779 ○ ○

91 PiSA 멕시코 781 ○ ○

92 PluriCell� Biotech 브라질 783 ○(신규)

93 POLYSAN 러시아 784 ○ ○

94 PROTEK 러시아 787 ○ ○

95 PTC 미국 789 ○ ○

96 Purdue 미국 791 ○ ○

97 RANDALL� LABORATORIES 멕시코 794 ○ ○

98 RC� CORP 미국 795 ○ ○

99 Ricerca� Biosciences 미국 796 ○ ○

100 Roemmers� S.A.I.C.F. 아르헨티나 798 ○ ○

101 SANOFI 프랑스 800 ○ ○

102 Serendex� aps 덴마크 805 ○ ○

103 SERVIER 프랑스 806 ○ ○

104 Shanghai� Tenry� Pharmaceutical� Co.,� Ltd 중국 809 ○ ○

Page 60: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

56� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북순번 기업명 국가 페이지 2015 2016

105 SHJNJ� PHARMATECH� INC. 중국 810 ○ ○

106 SibEnzyme 미국 812 ○ ○

107 Silanes 멕시코 814 ○ ○

108 SINOLITE� INDUSTRIAL� CO.,LTD 중국 816 ○ ○

109 SINTEZ 러시아 817 ○ ○

110 SomaGenics,� Inc. 캐나다 818 ○ ○

111 STADA� CIS 러시아 820 ○ ○

112 STENDHAL 멕시코 824 ○ ○

113 TATCHEPHARMPREPARATY 러시아 826 ○ ○

114 THERAMYT� NOVOBIOLOGICS� PRIVATE� LIMITED 인도 831 ○ ○

115 Tuteur� S.A.C.I.F.I.A 아르헨티나 832 ○ ○

116 UNIPHARM 멕시코 833 ○ ○

117 Unitedmedical 브라질 834 ○ ○

118 Valeant 미국 835 ○ ○

119 VaxInnate 미국 836 ○ ○

120 veropharm 러시아 838 ○ ○

121 Vesalius� pharma� SA 칠레 842 ○ ○

122 WCCT� Global,� LLC 미국 844 ○ ○

123 YURiA-PHARM 우크라이나 845 ○ ○

124 ZHEJIANG� EXCEL� PHARMACEUTICAL� CO.,� LTD 중국 848 ○ ○

125 Zhiwe� Chem-Tech� lnc 중국 849 ○ ○

126 Zodiac 브라질 850 ○ ○

127 Zuellig� Pharma� Korea 싱가포르 851 ○ ○

128 zvezda 우크라이나 852 ○ ○

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Part� 2.� 중동·아프리카 지역 아웃소싱 그룹 및 전략적 협력사 디렉토리북 구축 ❚ 57

순번 기업명 국가 페이지

1 Afrab-Chem� Limited 나이지리아 856

2 Africa� Medec� Limited� 케냐 858

3 Al� Mojil� Drug� Company 쿠웨이트 859

4 AlfaCure� Pharmaceuticals� 이집트 860

5 atco� pharma� for� pharmaceutical� IND 이집트 861

6 BCN� Limited 나이지리아 862

7 Beta� healthcare 케냐 864

8 Biopharma 케냐 865

9 Cadila� Pharmaceuticals� (EA)� Ltd 케냐 867

10 Carrot-Top� Drugs� Limited 나이지리아 868

11 Chemiron� International� Limited 나이지리아 869

12 Cloriti� Pharmaceuticals� (EA)� Ltd 케냐 870

13 Cosmos� Limited 케냐 871

14 DANADAMS� PHARMACEUTICAL� INDUSTRY� GHANA� LIMITED 가나 872

15 Dawa� Ltd 케냐 873

16 DBK� Pharmaceutical 이집트 874

17 Elys� Chemical� Industries� Ltd 케냐 875

18 Emzor� Pharmaceuticals� Limited 나이지리아 876

19 Entrance� Pharmaceuticals� &� Research� Center 가나 878

20 Ernest� Chemists� Limited� Head� Office 가나 879

21 Escorts� Pharmaceuticals� Ltd 우간다 880

22 Evans� Medical� Limited 나이지리아 881

23 Fidson� Healthcare� Limited 나이지리아 882

24 Gemini� Pharma� Limited 나이지리아 883

25 Haltons� Pharmacy 케냐 884

26 Harley’s� Ltd 케냐 885

27 Impact� Chemicals� Ltd 케냐 887

28 INRAD 이집트 889

29 Kampala� Pharmaceutical� Industries 우간다 891

30 Kuwait� Saudi� Pharmaceutical� Industries� Co. 쿠웨이트 893

31 Kwality� Afro� Asia 우간다 894

32 Lab� and� Allied 케냐 895

33 Lords� Healthcare� Ltd 케냐 896

34 M&G� Pharmaceuticals� Ltd 가나 897

<표 13> 중동·아프리카 전략적 협력사 디렉토리 수록 기업 리스트 54개사(신규 54개사 포함)

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58� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북순번 기업명 국가 페이지

35 Mansoor� Daya� Chemicals 탄자니아 898

36 Max� Pharmaceuticals� Ltd 케냐 899

37 Medipharm� Industries� (E.A.)� Ltd 우간다 900

38 MTK� Uganda� Limited 우간다 901

39 Neros� Pharmaceuticals� Limited 나이지리아 902

40 Orange� Drugs� Limited 나이지리아 903

41 Oss-Chemie� (K)� Ltd 케냐 904

42 Quality� Chemical� Industries 우간다 905

43 Pharmaken� Ltd� 케냐 906

44 Radiance� Pharmaceuticals� Limited 케냐 907

45 Reals� Pharmaceuticals� Limited 나이지리아 908

46 Regal 케냐 909

47 Rene� Industries� Ltd 우간다 910

48 Skylight� Chemicals 케냐 911

49 Square� Pharmaceuticals 케냐 912

50 Surgilinks� Ltd 케냐 914

51 Universal� Corporation 케냐 915

52 Vacsera 이집트 916

53 Vortex� pharma 이집트 917

54 Zenufa� Limited 탄자니아 918

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Part� 2.� 중동·아프리카 지역 아웃소싱 그룹 및 전략적 협력사 디렉토리북 구축 ❚ 59

순번 분야 기업명 페이지 2015 2016 비고

1 전임상 대구가톨릭대학교 GLP센터 920 ○ ○

기조사양식

2 전임상 메드빌 922 ○ ○

3 전임상 바이오인프라 926 ○ ○

4 전임상 바이오톡스텍 928 ○ ○

5 전임상 산업안전보건연구원 930 ○ ○

6 전임상 한국건설생활환경시험연구원 932 ○ ○

7 전임상 한국화학융합시험연구원 934 ○ ○

8 임상 ADM� Korea� Inc. 937 ○ ○

글로벌조사양식

9 임상 C&R� RESEARCH,� Inc. 944 ○ ○

10 전임상 Chemon� Inc. 952 ○○

(업데이트)

11 임상 DreamCIS� Inc. 957 ○ ○

12 임상 Ginapath,� co,� Ltd 963 ○(신규)

13 임상 ICON� plc 966 ○ ○ 기조사양식

14 전임상 Korea� Institute� of� Toxicology 968 ○ ○

글로벌조사양식

15 임상 LSK� Global� Pharma� Services� Co.,� Ltd 974 ○○

(업데이트)

16 임상 Novotech� Pty� Limited 983 ○ ○

17 임상 PharmaCRO� Inc. 989 ○ ○

18 임상 Quintiles 994 ○ ○

19 전임상 Reference� Biolabs� Inc 1002 ○ ○

20 임상 SCAS-BTT� Bioanalysis� Co.,� Ltd 1008 ○ ○

21 임상 SeoCho� CRO 1014 ○ ○

22 임상 Seoul� CRO� Co.,� Ltd 1017 ○ ○

23 임상 StarTech� Science� LLC. 1024 ○(신규)

<표 14> 국내 CRO 디렉토리 수록 기업 리스트(신규 2개사 및 업데이트 2개사 포함)

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60� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

제2장 결론 및 시사점

1. 결론 및 시사점

◦글로벌시장에 진출하기 위해서는 미국 FDA기준 및 유럽 EMA에 부합되는 비임상, 임상데이터 창출과 원료 및 완제품 생산을 통해 우리기업의 높은 품질과 기술력을 입증 받을 수 있어야 함

◦현재 국내에는 미국 FDA 및 유럽 EMA 등 해외 허가당국이 요구하는 기준에 부합되는 전임상/임상시설과 생산시설이 부족하고 허가당국의 인허가절차 등에 정통한 인허가 컨설팅기관이 부족한 상황임에 따라 이를 체계적으로 지원해 줄 수 있는 미국 현지 전문기관과의 파트너쉽 형성이 필요한 상황임

◦우리나라의 경우 전임상기관, 임상시험기관에 대한 지정현황이 공개되고 있으나, 미국, 유럽 등 전세계 대다수 허가당국은 공식인증절차 없이 실사를 통해 기준에 부합될 경우 데이터를 인정하고 있고 기준에 부합되는 전문기관(비임상/임상CRO, CMO, CSO)에 대한 현황을 공개하지 않고 있어 전문기관과 전문가에 대한 정보파악이 용이하지 않은 상황임

◦이에 따라 국내 기업들의 글로벌시장 진출 촉진을 위해서는 글로벌 스탠더드(Global Standard)에 부합되는 전임상시험, 임상시험, 원료 또는 완제품 생산, 인허가업무수행, 의약품유통을 글로벌 현지에서 지원할 수 있는 우수 아웃소싱 그룹

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Part� 2.� 중동·아프리카 지역 아웃소싱 그룹 및 전략적 협력사 디렉토리북 구축 ❚ 61(CRO, CMO, CSO)의 체계적 정보지원이 필요함 ※ 현재 국내기업과 파트너쉽 관계에 있는 해외 CRO등에 대한 정보공개 및 정보공유는 기업별 비즈니

스전략과 이해관계가 상충됨에 따라 쉽지 않은 상황이며, 정보제한에 따라 신규 CRO 등과의 파트너쉽 형성이 용이치 않은 상황임

◦현재 미국, 유럽 등 주요 선진제약기업들은 생산성저하 문제 해소를 위해 연구개발부문에 있어 개발중인 파이프라인에 대한 구조조정 및 선택과 집중 추세에 있으며, 매출급감문제 해소를 위해 제네릭시장에 눈을 돌리고 있는 추세를 감안할 경우 연구개발부문과 생산 부문에 있어 경쟁력을 갖춘 파트너와의 협력 수요가 충분히 존재하고 있는 상황임

- (필요정보) 국가별 의약품 수출에 필요한 정보는 기업체의 수요를 바탕으로 지원책 필요

※ 의약품 시장(1위, 26.6%), 인허가(2위, 20.2%), 기업(10.5%), 마케팅(9.7%), 정책, 약가, 특허(6.5%) 등

◦(제품분야) 의약품 수출은 분야별로 관련 인허가 규정, 의약품가격결정 등 마케팅이 상이하여 선택적이고 맞춤형으로 종합적인 정보제공이 필요함

☞�의약품수출확대를 위해서는 ①�수출에 필요한 정보의 수집 및 분석을 통한 정보

제공,� ②�제품 분야별 맞춤형 정보제공이 선행되어야 함

☞�따라서,�국내 제약산업의 환경변화를 극복하고 수출전략을 분야별 맞춤형 지원

을 통해 수출활로를 지원하고자 함

Page 66: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

62� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

2. 기대효과

◦국내 제약기업이 글로벌 스탠더드에 부합되는 전임상시험, 임상시험, 원료 또는 완제품 생산, 인허가 업무수행, 의약품유통을 글로벌 현지에서 지원할 수 있는 우수 아웃소싱 그룹(CRO, CMO, CSO)들의 정보를 파악하고 아웃소싱 그룹 디렉토리북 구축 및 제공을 통해 국내 제약기업의 저렴하고 우수한 파트너선정, 글로벌 시장 진출 활성화가 촉진될 수 있을 것으로 기대됨

3. 활용 방안

◦국내 제약기업들이 글로벌시장에 진출하는데 소요되는 우수 아웃소싱 그룹에 대한 정보를 파악하는데 핵심단서 제공- 우수 아웃소싱 그룹(CRO, CMO, CSO) 정보 수집시 활용하는 홈페이지 및 기존

정보자료(상용 디렉토리북)는 수록 내용에 한계가 있음 → 기업의 필수 기업 정보가 수록되어 있는 본 사업을 통해 구축된 디렉토리북 활용◦국내 제약기업들에게 디렉토리북 관련 정보 제공시 향후 글로벌 제약기업들과의

연구개발, 생산, 마케팅, 부문에서의 제휴 가속화를 통한 글로벌시장 진출 가능성을 제고할 수 있음

Page 67: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

부 록

❶�글로벌 아웃소싱 그룹 디렉토리

❷�글로벌 전략적 협력사 디렉토리

❸�중동·아프리카 전략적 협력사 디렉토리

❹�국내 CRO�디렉토리

❺�주요 아웃소싱 그룹 현황 리스트

❻�주요 전략적 협력사 현황 리스트

❼�국내 CRO�기업 조사 업체 리스트

Page 68: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 65

순번 기업명 국가 CRO CMO CSO Consulting Page

1 ACDIMA� BioCenter� 요르단 ○       70

2 ActivaCRO 아르헨티나 ○ 71

3 Alliance� Pharma� Inc. 미국 ○       72

4 Almac� Ltd 영국 ○ ○ ○ ○ 77

5 AMRI 미국 ○ ○   ○ 83

6 ANTHEM� BIOSCIENCES� PVT� LTD 인도 ○ ○     90

7 Aptuit 미국 ○ ○   ○ 96

8 Arab�Pharmaceutical� Industry�Consulting�Company� 요르단 ○ 103

9 Arriello� Group 아일랜드       ○ 104

10 ARTIMMUNE 프랑스 ○       110

11 ASREGTEC,�ASUNTOS�REGULATORIOS�TÉCNICOS 에콰도르 ○ 114

12 Binzhou� Hollyally� Pharmaceutical� Co.,Ltd. 중국 ○ ○ ○ ○ 121

13 BioInvent� International� AB 스웨덴 ○       126

14 Biologics� Consulting� Group 미국       ○ 133

15 Biomedcode� Hellas� SA 그리스 ○       138

16 BioStata� ApS 덴마크 ○     ○ 142

17 Brock� Capital� Group 미국     ○ ○ 146

18 Cato� Research� Ltd. 미국 ○     ○ 149

19 Cegedim� Dendrite 프랑스     ○   152

20 Celerion,� Inc. 미국 ○     ○ 155

21 Charles� River� Laboratories 미국 ○       163

22 Chiltern 브라질 ○       166

23 CiToxLAB 프랑스 ○       167

24 CLEARSYNTH� LABS� LTD 인도 ○ ○     172

【부록 1】� �글로벌 아웃소싱 그룹 디렉토리

본 디렉토리북 수록내용은 해당 기업의 회신 내용을 바탕으로 수록된 내용으로서 신뢰성 여부는 주최측이

보증하지 않음을 유의하시기 바랍니다. 따라서, 글로벌 시장 진출시 본 디렉토리북 내용에 수록된 기업과의

접촉시 업체별로 신뢰성 여부에 대한 사전 조사를 당부드립니다.

■�글로벌 아웃소싱 그룹 디렉토리 수록 기업 리스트 144개사

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66� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

순번 기업명 국가 CRO CMO CSO Consulting Page

25 Clinipace� Worldwide 미국 ○     ○ 176

26 Clinserv 이집트 ○ 182

27 ClinStar,� LLC 미국 ○     ○ 183

28 Cmed� Clinical� Services 영국 ○       189

29 CO� RESEARCH 터키 ○ 192

30 Covance� Inc. 미국 ○ ○     193

31 CPR� Strategic� Marketing� Communications,� Inc. 미국       ○ 200

32 CROTURK 터키 ○ 203

33 Cunningham� &� Associates 미국       ○ 204

34 Cyprotex� Discovery� Ltd 영국 ○     ○ 210

35 D2� Pharma� Consulting,� LLC 미국   ○ ○ ○ 217

36 Dragon� Bio-Consultants,� Ltd. 홍콩 ○       222

37 Ecron� Acunova� Ltd� 인도 ○       227

38 Elezaby� Pharmacy 이집트 ○ 237

39 Emergent� � BioSolutions� Inc. 미국   ○     238

40 Encap� drug� delivery 영국 ○ ○     246

41 Endopoint 이스라엘 ○ 249

42 ERA� Consulting� (Australia)� Pty� Ltd� 독일       ○ 250

43 Estern� Medical 멕시코 ○       255

44 ETHIC 터키 ○ 256

45 Eurotrials 브라질 ○       257

46 Excel� PharmaStudies� Inc 중국 ○       258

47 Exponent,� Inc. 미국 ○     ○ 259

48 FARMA� TEAM 터키 ○ 265

49 Farzan� Clinical� Research 이란 ○ 266

50 Garphi� Biosciences� Pvt.� Ltd. 인도 ○ ○ ○ ○ 267

51 Giant� Med-Pharma� Services,� Inc. 중국 ○       272

52 Global� Engage� Ltd. 영국       ○ 273

53 GUANGDONG� BOHONG 중국 ○       276

54 Guangzhou� Boji� Clinical� Research� Center 중국 ○       277

55 GVK� BIOSCIENCES� PVT.� LTD. 인도 ○ ○     278

56 Harlan 미국 ○       285

57 HCM� Enterprise� LLC 미국     ○ ○ 290

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 67

순번 기업명 국가 CRO CMO CSO Consulting Page

58 HD� Biosciences� (China)� Co.,� Ltd. 중국 ○       294

59 Henan� Purui� Pharmaceutical 중국 ○       303

60 Huntingdon� Life� Sciences 미국 ○     ○ 304

61 ICON� plc 아일랜드 ○       312

62 ICR 멕시코 ○       319

63 INC� Research 미국 ○       320

64 iNovacia� AB 스웨덴 ○       323

65 International�Pharmaceutical�Research�center(IPRC)� 요르단 ○ 327

66 Intrials 브라질 ○       328

67 inVentive� Health� Inc. 미국 ○   ○ ○ 329

68 JOINN� LABORATORIES.,� Ltd. 중국 ○     ○ 331

69 KCR,� SA 폴란드 ○     ○ 336

70 KEOSYS� Medical� Imaging 프랑스 ○     ○ 342

71 Key-Obs 프랑스 ○       351

72 Kinesis� Pharma� B.V. 네덜란드 ○     ○ 355

73 Kinexum� Services 미국 ○     ○ 359

74 Klinar� CRO 터키 ○ 363

75 KLIXAR 아르헨티나 ○       364

76 Laboratorios� � Silanes� S.A.� de� C.V. 멕시코     ○   365

77 Lal� Clinica 브라질 ○       371

78 LBBM 아르헨티나 ○       372

79 LEPING� SAFELTY� PHARMACEUTICAL 중국 ○       373

80 Marin� Biologic� Laboratories 미국 ○ ○     374

81 McguireWoods� LLP 미국         378

82 mediSMART 터키 ○ 381

83 Medpace,� Inc 미국 ○     ○ 382

84 meneresearch 터키 ○ 388

85 Midas� Pharma 독일 ○ ○   ○ 389

86 Monitor 터키 ○ 392

87 Myoderm 미국       ○ 393

88 Nagy� Research 이집트 ○ 397

89 NOVA� TRIALS 터키 ○ 398

90 NOVAGENIX 이스라엘 ○ 399

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68� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

순번 기업명 국가 CRO CMO CSO Consulting Page

91 Novotech 호주 ○     ○ 400

92 Ocimum� Biosolutions� Ltd 인도 ○   ○ ○ 407

93 OnCall� LLC. 미국     ○   414

94 Optimum 터키 ○ 416

95 Optimumclintrial 나이지리아 ○ 417

96 Pacific� BioLabs 미국 ○     ○ 418

97 PAREXEL� INTERNATIONAL� LLC. 미국 ○     ○ 421

98 Parthys� Reverse� Informatics� Analytic� Solutions 인도 ○     ○ 430

99 PDI� Inc. 미국     ○   436

100 Penn� Pharma 영국 ○ ○   ○ 437

101 Perfection-CRO 이스라엘 ○ 440

102 PHARMA� TRADE 이탈리아   ○     441

103 Pharmaceutical� Advisors 미국       ○ 444

104 Pharmaceutical� Regulatory� Services,� Inc. 미국 ○     ○ 447

105 Pharmaceutical� Research� Associates,� Inc 미국 ○ ○ 452

106 PharmaNet/i3 미국 ○     ○ 461

107 Pharmaseed 이스라엘 ○ 468

108 Polaris� Life� Sciences 미국 ○ ○ ○ ○ 469

109 PPD,� Inc. 미국 ○     ○ 473

110 PRA� International 미국 ○     ○ 476

111 Q-Trials� Ltd. 터키 ○ 479

112 QUADRO� CRO 이스라엘 ○ 480

113 Quintiles 미국 ○   ○ ○ 481

114 R2S 이집트 ○ 487

115 RAY 모로코 ○ 488

116 ReachBio� LLC 미국 ○       489

117 Research� &� Development� RA.� S.A. 아르헨티나 ○       496

118 Ricerca� Biosciences,� LLC 미국 ○ ○     498

119 Scidre 이집트 ○ 503

120 Shanghai� Cares� Biotech� Co� Ltd 중국 ○       504

121 Shanghai� Genomics,� Inc. 중국 ○       505

122 Shanghai� Loudon�Marketing� Consultant� Co� Ltd 중국 ○       507

123 SHIVA� ANALYTICALS� (INDIA)� PRIVATE� LIMITED 인도 ○       509

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순번 기업명 국가 CRO CMO CSO Consulting Page

124 SHJNJ� PHARMgATECH� INC 중국 ○ ○ ○ ○ 513

125 Sinolite� Industrial� Co.Ltd 중국 ○ ○ ○ ○ 517

126 SolucionesGXP� � Infodynamics� s.r.l. 우루과이   ○ 521

127 SRK� Strategies,� LLC 미국 ○ ○ ○ ○ 525

128 SSS� International� Clinical� Research� GmbH 독일 ○ ○ 530

129 Sundia� MediTech� Company,� Ltd. 중국 ○ ○ 537

130 Symbiosis� Group� SA 아르헨티나   ○ ○ 543

131 Syngene� International� Limited 인도 ○ ○ 547

132 Target� Health� Inc 미국 ○ ○ 556

133 TCA� Clinical� Research� Ltd. 이스라엘 ○ 561

134 TechnoSTAT 이스라엘 ○ 562

135 Techtrials� Pesquisa� e� Tecnologia� Ltda. 브라질 ○ ○ 563

136 Theorem� Clinical� Research,� Inc. 미국 ○ ○ ○ 567

137 Tigermed� Consulting� Co� Ltd 중국 ○ 577

138 Triumpharma 요르단 ○ 579

139 Truven� Health� Analytics� Inc. 미국   ○ 580

140 VIMTA� LABS� LIMITED 인도 ○ 585

141 WCCT� Global,� LLC 미국 ○ ○ 593

142 XCENE� Research 나이지리아 ○ 596

143 ZEINCRO 터키 ○ 597

144 Zhiwe� Chem-Tech� lnc 중국 ○ ○ 598

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1. ACDIMA BioCenter

1.� Corporate� General� Information

Corporate� Name ACDIMA� BioCenter�

Head� Office� Address P.O.� Box:� 925161� ­� Amman,� 11190-Hashemite� Kingdom� of� Jordan

Facilities� City� &� Country Jordan

Web-site� Address www.acdima.com

Contact

(Korean�

Business)

Telephone +962� 6� 582� 1618

E-mail [email protected]

Company� Description� &� Organization

[Mission]

Is� to� make� sure� that� our� clients� and� partners� are� delivering� their� products� effectively� and� help� in�

speeding� up� the� process,� which� in� turn� will� maximize� profits� on� their� investments.

[Vision]

Is� to� be� the� pioneer� and� the� leader� in� Jordan� and� the� region� by� constantly� focusing�on� innovating�our�

products� and� services,� delivering� them�with� first-rate� quality� with� the� continual� improvement� of� all� of�

our� business� aspects.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 71

2. ActivaCRO

1.� Corporate� General� Information

Corporate� Name ActivaCRO

Head� Office� AddressAv.� Santa� Fe� 1592,� 3rd� Floor,� C1060ABO�

Ciudad� Autónoma� de� Buenos� Aires,� Argentina

Facilities� City� &� Country Argentina

Web-site� Address www.activa-cro.com

Contact

(Korean�

Business)

Telephone +54.11.4878.1008

E-mail [email protected]

Company� Description� &� Organization

Activa� Cro� is� a� full-service� contract� research� organization� (CRO)� with� operations� in� Latin� America,�

that� provides� the� biotechnology,� pharmaceutical� and� medical� device� industry,� with� a� range� of�

services� related� to� clinical� development� of� health� products.�

The� company� was� founded� in� 2003,� in� Buenos� Aires,� Argentina� and� rapidly� expanded� to� Chile� in�

2004� and� Uruguay� a� couple� of� years� later� (2007)� becoming� a� “southern� cone”� provider.�

In� 2008� Activa� Cro� started� operations� in� México� DF,� and� finally� Brazil,� Perú,� Colombia� and� Panamá�

was� added� to� the� scope� of� LA� countries,� conforming� a� true� “regional”� CRO.�

Activa� Cro� brings� today� an� experience� of�more� than� 50� projects� in� all� clinical� phases� of� development�

and� major� therapeutic� indications,� including� Oncology,� Hematology,� Cardiovascular,� Orphan�

Diseases,� CNS,� First� in� Human� and� Pivotal� studies� in� Medical� Devices,� with� senior� project� managers�

that� bring� an� average� of� 10� years� of� experience� in� clinical� research� operations.�

Activa� Cro� remains� and� presents� itself� as� a� “boutique”� CRO,� offering� personalized� products� and�

services.�

We� endeavor� to� satisfy� our� “clients� &� partners”� requirements� and� expectations,� by� “working� closely”�

with� them� to� facilitate� the� efficient� management� of� their� projects� and� the� success� of� our� business�

partnerships.�

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3. Alliance Pharma Inc.

1.� Corporate� General� Information

Corporate� Name Alliance� Pharma� Inc.

Corporate� Ownership Private� Company

Head� Office� Address 17� Lee� Blvd.

Facilities� City� &� Country Malvern,� USA

Web-site� Address http://www.alliancepharmaco.com,� www.glplab.com

No.� of� Employees 20

Financial� Status

Sales� Revenue� in�

2010(US� K$)Capital(US� K$) Dept-equity� Ratio(%)

5� million 3� million -

Contact

(Korean�

Business)

Name Shawn� Li

Address 17� Lee� Blvd

Telephone 610-296-3152

E-mail [email protected]

Company� History

It� was� established� in� 2007.� � We’ve� been� operating� at� our� new� facility� at� 17� Lee� Boulevard� in�

Malvern,� PA� since� early� March� of� this� year.� The� facility(∼36,800� sft)� is� nearly� 10� times� larger� than�

our� former� space.

Company� Description� &� Organization

Alliance� Pharma,� Inc.� is� a� contract� research� organization(CRO)� specializing� in� advanced� bioanalytical�

for� both� small� molecule� and� large� molecule� drugs� and� DMPK� support� services.� � It� was� founded� in�

2007.� � Our� scientists� are� from� major� CROs� and� DMPK� departments� of� large� pharmaceutical�

companies� with� extensive� and� diverse� industry� experiences� in� immunoassay� and� DMPK.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 73

2.� Corporate� Service� &�Business� Area

Corporate� Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US ○ US US US

Canada ○ Canada Canada Canada

EU ○ EU EU EU

Asia ○ Asia Asia Asia

Global ○ Global Global Global

Other Other Other Other

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research ○ API

APIs

R&D

Pre-Clinical ○

R&D� Strategy

&�

ManagementPre-clinical

Test� Sample

Phase� I ○ Clinical� Trials

Phase� II ○Clinical� Test

Sample

Finished

Products

Regulatory

Affairs

Phase� III ○Business

DevelopmentFinished

ProductPhase� IV

Sales� &

Marketing

Corporate�

Product� Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

Generics APIs Devices Others

○(Service)

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3.� Corporate� Business�Overview

Clients'� Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

75% 15% 5% 5%

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

○ ○

Focusing� Therapeutic�

AreaOncology,� diabetics,� inflammatory,� CNS,� Cancer� etc.

General� Overview

of� Corporate's� Key

Contract� Services

Biopharmaceutical� analysis,� cell� based� assays,� biomarker,� bio-analytical�

method� development� and� validation� for� large� molecule� drugs� using� ELISA�

and/or� other� technologies�

In� vitro� metabolism� studies� using� microsomes,� S9,� Cyp450� isozyme� and�

hepatocytes� from� human� and� other� species,� and� protein� binding� studies;�

LC-MS/MS� bioanalytical� method� development,� optimization,� validation� and�

sample� analysis� to� support� pre-clinic� and� clinic� studies�with�GLP� compliance�

for� in� vivo� and� in� vitro� pharmacokinetic,� toxicokinetic,� bioavailability,� and�

bioequivalence� analysis.

Contract� Service�

Capacity� Affordable� by�

Service� Area

method� development,� optimization,� validation� and� sample� analysis.

Communication� with�

Clients

Dispositoion� of

Project� Manager

Responsible

client� communication,� oversee� project� progress,� prove�

experiments� and� coordinate� with� QA/management.�

Providing�

Realtime

Service� Delivery

All� QC’ed� data� will� be� sent� within� 2days� after�

completion� of� experiment�

Realtime

Feed-backClient’s� questions� will� be� answered� within� 2� days.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 75

4.� Corporate� Competitiveness

Corporate

Competitiveness

Alliance� Pharma� Inc.� is� a� contract� research� organization� (CRO)� specializing� in�

advanced� bioanalytical� for� both� small� molecule� and� large� molecule� drugs� and�

DMPK� support� services.� � Our� scientists� have� extensive� and� diverse� industry�

experience� in� immunoassay,� and� DMPK� from� CRO� or� DMPK� department� of�

major� pharmaceutical� companies.�

We� have� completed� Phase� I� in� the� building� of� 22� labs� dedicated� to� the�

metabolism� and� bioanalysis� of� both� small� and� large� molecule.� � Phase� II�

construction� is� currently� underway.� � We� have� built� up� all� the� GLP� compliance�

related� infrastructures� important� for� drug� development:� � Rees� temperature�

monitoring� system� for� sample� storage;� FM200� fire� suppression� system� for� both�

IT� and� archives;� 110� KW� electricity� generator� for� backup� power;� Watson� LIMS�

system.� �

We� have� had� successful� client� audits� for� 4� different� companies� since� our�move�

to� the� new� facility.� � In� addition,�we� have� hired� an� independent�GLP� compliance�

company� for� 3� days� thorough� audit� and� training.� �

We� are� Agile,� adaptable,� responsive,� attention� to� detail� and� result� oriented.� �We�

use� high� standard� and� top� quality.� � We� have� strong� technical� expertises� with�

competitive� pricing� and� fast� turnaround.

No.� of� Regulatory

Inspections

Classification FDA(US) EMA(EU) PMDA(Japan) Others

Pre-Clinical� Area ○

Clinical� Area

Manufacturing� Area

Others

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5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� toChina,� Korea

Asian� Clients'

Composition(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

70% 5% 20% 5%

No.� of� Asian� Clients

in� recent� 3� years3

Major� Service� Range

with� Asian�

Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales�&

MarketingConsulting

Research ○API

APIs

R&D

Pre-Clinical ○

R&D� Strategy

&�

ManagementPre-clinical

Test� Sample

Phase� I ○ Clinical� Trials

Phase� II ○Clinical� Test

Sample

Finished

Products

Regulatory

Affairs

Phase� III ○Business

DevelopmentFinished

Product

Phase� IVSales� &

Marketing

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 77

4. Almac Ltd

1.� Corporate� General� Information

Corporate� Name Almac� Group

Corporate� Ownership Private� Company

Head� Office� Address

Global� Headquarters� :� Almac� House� 20� Seagoe� Industrial� Estate�

Craigavon� BT63� 5QD� United� Kingdom

US�Headquarters� :� 25� Fretz� Road� Souderton� PA18964�United� States�

of� America

Facilities� City� &� CountryDurham,� NC(USA),� Audubon,� PA(USA),� San� Francisco,� CA(USA),�

Elvingston(UK)

Facilities� City� &� CountryNone� as� yet� but� we� have� the� ability� to� operate� via� several� partner�

companies.�We� will� establish� a� formal� Asian� presence� in� Q1� 2013.

Web-site� Address www.almacgroup.com

No.� of� Employees 3,300+

Financial� Status

Sales� Revenue� in�

2011� (US� K$)Capital(US� K$) Dept-equity� Ratio(%)

391,533� (2010) 442,608� (2010) 21.2%(2010)

Contact

(Korean�

Business)

Name Jonathan� Calderwood�

AddressAlmac� ,� 9� Charlestown� road,� Seagoe� industrial� Estate� ,� Craigavon,�

BT63� 5PW� UK

Telephone +442838362436

E-mail [email protected]

Company� History

The� organisation� was� originally� known� as� Galen� Ltd� and� commenced� Pharmaceutical� Manufacturing�

in� Craigavon�N,� Ireland� in� 1978.� � It� established� Clinical� Trial� Supply� operations� in� 1988� and�during� the�

1990’s� added�API�Manufacturing� services� and� expanded� to� the�US�with�Clinical� Trial� Supply� operations�

to� Audubon,� PA,� USA.� � It� subsequently� purchased� a� Clinical� Technology� facility� in� Princeton,� NJ,� USA.�

The� organisation� was� rebranded� as� Almac� in� 2002.� � Since� then,� Almac� has� expanded� rapidly� on� its�

site� in� N,� Ireland� and� introduced� Biomarker� Discovery� &� Development� and� also� invested� in� a� state� of�

the� art� North� American� Headquarters� in� Pennsylvania,� USA.� �

Company� Description� &� Organization

provides� a� broad� range� of� pharmaceutical� services� from� biomarker� discovery� and� development,� API�

manufacture,� formulation� development,� clinical� trial� supply� and� IVRS/IWRS� technology,� to�

commercial-scale�manufacture.�Almac� provides� services� to�more� than�600� companies,� including� all� the�

world� leaders� in� the� pharmaceutical� and�biotech� sectors,� testament� itself� to� the� quality,� innovation� and�

efficiency� of� our� business� as� proven� over� the� past� 30+� years.� � The� company� employs� over� 3,300� and�

is� headquartered� in� Craigavon,� Northern� Ireland.� Its� North� American� Headquarters� are� in� Souderton,�

Pennsylvania� and� the� company� also� has� sites� at� North� Carolina� and� California.

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2.� Corporate� Service� &�Business� Area

Corporate� Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

○ ○ ○ ○

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US ○ US ○ US ○ US ○

Canada Canada Canada Canada

EU ○ EU ○ EU ○ EU ○

Asia Asia Asia Asia

Global Global Global Global

Other Other Other Other

Focusing� Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research ○ API ○

APIs ○

R&D ○

Pre-Clinical ○R&D� Strategy

&� Management○

Pre-clinical

Test� Sample○

Phase� I ○ Clinical� Trials ○

Phase� II ○Clinical� Test

Sample○

Finished

Products○

Regulatory

Affairs○

Phase� III ○Business

Development○

Finished

Product○

Phase� IV ○Sales� &

Marketing○

Corporate� Product�

Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

○ ○ ○

Generics APIs Devices Others

○ ○ ○ ○

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 79

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

○ ○ ○ ○ ○

Focusing� Therapeutic�

Area

Almac’s� services� listed� below� are� available� for� any� of� the� above� therapeutics.� �

Almac� works� with� small� and� large� pharmaceutical� organisations� alike,�

providing� consulting� services� such� as�Drug� Supply�Management� and�Qualified�

Person� release� into� the� EU� that� enhance� and� supplement� the� global� clinical�

supply� chain,� alongside� our� core� manufacturing,� packaging� and� distribution�

activities.

Almac� also� helps� pharmaceutical� and�biotech� companies� speed� the� process� of�

getting� new� drugs� to� market� by� increasing� productivity� in� the� management�

of� sites,� patients,� and� clinical� trial� supplies.� Through� our� industry-leading�

integrated� IVR� /� Interactive� Web� Response� technology,� Almac� offers� flexible�

solutions� for� patient� enrollment,� screening,� randomisation,� drug� assignment,�

inventory� management,� patient� compliance,� electronic� Patient-Reported�

Outcomes,� and� adaptive� trials.�

General� Overview

of� Corporate's� Key

Contract� Services

Almac’s� integrated� solutions� extend� from� research� to� commercialisation� and�

include:� (Full� information� can� be� found� on� our� website�

www.almacgroup.com)� �

Biomarker� Discovery� &� Development�

-� Companion� Diagnostic� Development

-� Genomic� Services

-� Bioinformatics� Consultancy

-� Proprietary� Discovery� Arrays

API� Services� &� Chemical� Development:�

-� API� Development� &� Manufacture

-� Peptide� &� Protein� Technology

-� Accelerated� First� in� Man� Solution

-� Solid� State� Services

-� Isotope� Chemistry

-� Biocatalysis

� � �

Pharmaceutical� Development:� �

-� Preformulation� &� Early� Stage� Development

3.� Corporate� Business�Overview

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80� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

-� Scale� Up� and� Late� Stage� Development

-� Clinical� Trial� Manufacture

-� Contained� Development� &� Manufacture

Analytical� Services

-� Physical� &� Chemical� Characterisation

-� Method� Development� &� Validation

-� API� &� Drug� Product� Testing

-� Stability� Testing

Clinical� Trial� Supply

-� Comparator� Blinding

-� Packaging� &� Labelling

-� QP� Release� into� EU

-� Global� Distribution� &� Supply� Chain� Management

Clinical� Technologies

-� IVR� /� Web

-� ePRO� (electronic� Patient� Reported� Outcomes)

-� Statistical� Services�

Commercial� Services

-� Manufacturing� &� Packaging

-� Product� Launch� &� Distribution

Contract� Service�

Capacity� Affordable� by�

Service� Area

All� Almac� service� areas� have� large� capacities.� � For� further� information,� please�

visit� the� Almac� website:� www.almacgroup.comoremail

Communication� with�

Clients

Dispositoion� of

Project� Manager

Responsible

Our� project� managers� are� all� educated� to� a� minimum� of�

degree� standard.� � They� are� fully� trained� in� all� aspects� of�

the� operations,� which� they� are� responsible� for� and� can�

provide� timely� advice� and� assistance� to� customers.� �

Providing�

Realtime

Service� Delivery

Almac�provides� instantaneous� customer� support� on� a� 24hr�

basis,� enabling� our� clients� to� cope� with� complex� and�

mission-critical� situations� so� that� there’s� little� to� no�

downtime� or� lost� productivity.� �

Realtime

Feed-back

Almac� have� a� number� of� ‘Real-Time’� monitoring� &� data�

systems� throughout� the� organisation� providing� instant�

information� to� our� clients.� This� in� return� helps� to� boost�

our� customer� service� levels.� �

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 81

4.� Corporate� Competitiveness

Corporate

Competitiveness

Almac� is� an� established,� international� brand� with� a� reputation� for� innovation,�

quality� and� customer� service.

The� advantage� that� Almac� offers� is� having� such� a� wide� range� of� service�

offerings� from� discovery� to� delivery� of� finished� product� in� the� one� organisation�

and� being� able� to� manage� the� flow� of� information� between� business� areas�

seamlessly� thereby� enabling� our� sponsor� companies� to� reach� commercialisation�

of� their� finished� product� in� a� timely� and� cost� effective� manner.� �

Most� importantly,� the� vast� majority� of� work� carried� out� by� Almac� is� with�

customers� who� have� already� been� using� us� for� a� considerable� period� of� time.� �

This� perhaps� proves� the� value� of� the� focused� relationships,� which� Almac� form �

that� ultimately� benefit� both� organisations� forming� the� partnership.

Special� emphasis� is� placed� throughout� the� company� on� building� Almac� brand�

values.� Almac� brand� values� set� out� to� meet� client’s� individual� needs.� By�

recruiting� the� best� people� and� through� continual� training� and� development,� the�

Almac� team� member� is� empowered� in� the� Almac� experience� ­� delivering� the�

ultimate� in� customer� satisfaction.� Innovative� customer� experiences� drive� interest�

in� our� company� and� deliver� best� value,� loyalty� and� trust.� Through� an� emphasis�

on� personal� and� professional� growth,� Almac� staff� members� are� trained� in� an�

unsurpassed� service� ­� always� to� the� benefit� of� the� Almac� customer.� � The� depth�

of� experience� found� throughout� the�Almac� team� is� the� backbone� of� this� global�

and� highly� successful� business.

No.� of� Regulatory

Inspections

Classification FDA(US) EMA(EU)PMDA(Japan

)Others

Pre-Clinical� Area N/A N/A N/A N/A

Clinical� Area

Only� inspect�

on� a� needs�

basis

Min� 5� MHRA,�

MCA- -

Manufacturing� Area TBC TBC TBC TBC

Others TBC TBC TBC TBC

Current� Status� of

Accredited�

Certification

GMP,� GLP,� GDP� GCP,� ISO� accreditation� ­� all� appropriate� quality� standards�

required

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82� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� toJapan,� Korea,� China,� (Australia)

Asian� Clients'

Composition(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

50% 30% 20% 0%

No.� of� Asian�

Clients

in� recent� 3� years

15

Major� Service�

Range

with� Asian�

Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs ○

R&D

Pre-Clinical

R&D� Strategy

&�

ManagementPre-clinical

Test� Sample

Phase� I Clinical� Trials ○

Phase� II ○Clinical� Test

Sample○

Finished

Products

Regulatory

Affairs

Phase� III ○Business

DevelopmentFinished

ProductPhase� IV

Sales� &

Marketing

6.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

Almac� will� be� expanding� into� Asia� in� January� 2013.� We� will� be� opening� two� locations;� one� in�

Singapore� and� one� in� Japan� were� we� will� have� a� number� of� support� personnel� (focused� on� client�

development,� project� oversight� and� logistics� support� activities)� that� will� be� placed� in� each� location.�

These� personnel� will� be� the� key� point� of� contact� for� Korean� pharmaceutical� companies� and� will�

oversea� all� aspects� of� project� management.�

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 83

5. AMRI

1.� Corporate� General� Information

Corporate� Name AMRI

Corporate� Ownership Private� Company

Head� Office� Address 26� Corporate� Circle,� Albany,� NY� 12203

Facilities� City� &� CountryHarrisonville(USA),� West� Lafayette(USA),� Verona(Italy),� Glasgow(UK),�

Oxford(UK),� Hyderabad(India)

Korean� Business� Office Seoul� Guro-gu,� Guro-dong,� 33-9

Web-site� Address http://www.amriglobal.com/

No.� of� Employees 1,400

Financial� Status

Sales� Revenue� in� 2012�

(US� K$)Capital(US� K$) Dept-equity� Ratio(%)

227,000

Contact

(Korean�

Business)

Name Park� ,� Soo� Ho

Address Seoul� Guro-gu,� Guro-dong,� 33-9

Telephone 82-10-4545-2709

E-mail [email protected]

Company� History

Inaugurated� in� 1991� as� Albany�Molecular� Research,� Inc.,� AMRI� was� founded� by� Thomas� E.� D’Ambra,�

Ph.D.� and� Chester�Opalka.�Dr.� D’Ambra� continues� to� serve� as� chairman,� president� and� CEO.�As�AMRI,�

the� company� has� been� a� publicly� traded� company� on� the� NASDAQ� since� 1999.

Company� Description� &� Organization

AMRI� is� a� global� contract� research� and�manufacturing�organization� offering� customers� fully� integrated�

drug� discovery,� development� and� manufacturing� services.� For� over� 21� years� AMRI� has� demonstrated�

its� adaptability� as� the� pharmaceutical� and� biotechnology� industries� have� undergone� tremendous�

change� in� response� to�multiple� challenges.� This� experience,� a� track� record� of� success� and� locations� in�

North� America,� Europe� and� Asia� provides� our� customers� with� SMARTSOURCING™,� a� full� range� of�

value-added� opportunities� providing� customers� informed� decision-making,� enhanced� efficiency� and�

more� successful� outcomes� at� all� stages� of� the� pipeline.

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84� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

○ ○ ○

Geographical

Business�Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US ○ US ○ US US ○

Canada Canada Canada Canada

EU EU EU EU

Asia ○ Asia ○ Asia Asia ○

Global Global Global Global

Other Other Other Other

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research ○ API ○

APIs

R&D ○

Pre-Clinical Pre-clinical

Test� Sample○

R&D� Strategy

&� Management

Phase� I Clinical� Trials

Phase� IIClinical� Test

Sample

Finished

Products

Regulatory

Affairs

Phase� IIIFinished

Product

Business

Development

Phase� IVSales� &

Marketing

Corporate�

Product� Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

○ ○ ○ ○

Generics APIs Devices Others

○ ○

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 85

Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

60% 20% 10% 10%

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

○ ○

General� Overview

of�Corporate's�Key

Contract� Services

AMRI� works� with� large� global� and� small-to-medium-size� biotech/specialty�

pharmaceutical� companies,� and� government� and� nonprofit� organizations.

AMRI� provides� services� in� Drug� Development� ,� Discovery� and� API� Manufacturing

Contract� Service�

Capacity�

Affordable� by�

Service� Area

Contract� Research/Discovery

� AMRI� SMARTSOURCING™�embraces� every� facet� of� drug�discovery� to� help� you� put�

candidates� in� the� clinic.� You� receive� fully� integrated,� customer-focused� services�

utilizing� a� collaborative� and� flexible� approach� to� attain� program�goals.� Embrace� the�

entire� drug� discovery� platform� ­� including� custom� assay� development� and� in� vitro�

biology,� DMPK,� computational� and� medicinal� chemistry,� custom� library� synthesis�

and� fragment-based� drug� discovery.� Our� dedicated� project� leadership� team� works�

on� your� behalf� to� coordinate� activities� and� fully� manage� projects� to� meet� critical�

timelines� and� handle� all� complexities� during� the� discovery� stage.

•� Assay� Development� and� Design�

•� Screening�

•� Libraries�

•� Lead� Optimization�

•� CADD�

•� In� vitro� ADMET�

•� Preparative� Chromatography�

•� Natural� Product� Services�

•� Bioanalytical� Services�

Drug� Development

� AMRI� SMARTSOURCING™� provides� state-of-the-art� facilities� and� capabilities� to�

deliver� integrated�pharmaceutical� drug� development� programs� through� the� clinic� to�

commercial.� We� help� clients� assess� and� choose� the� best� solid� form� for� progression�

into� animal� and� human� dosing� trials;� our� Pre-Formulation� Development,�

Formulation� Services� &� CTM,� Process� Development,� and� Analytical� Services� are�

available� for� a� variety� of� dosage� forms,� from� Powder-in-a-Bottle� (PIB)� and� capsules�

to� advanced� oral,� topical� and� sterile� formulations.� AMRI� also� has� the� capabilities�

required� to� provide� a� reliable� and� cost-effective� supply� of� drug� product� through�

commercial� production,� as� well� as� API� from� pre-clinical� to� post-NDA� commercial�

3.� Corporate� Business�Overview

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production.

•� Process� Research� and� Development�

•� Custom� Synthesis�

•� Process� Safety� Assessment�

•� Scale-up� Capabilities�

•� High� Potency� and� Controlled� Substances�

•� IND� Support� Service�

•� Preformulation�

•� Preparative� Chromatography�

•� Fermentation�

•� Analytical� Services

Contract� Manufacturing

� Backed� by� an� excellent� compliance� history� and� track� record,� AMRI’s� worldwide�

manufacturing� facilities� are� equipped� for� Phase� I� through� commercial� API�

manufacturing.�

AMRI� SMARTSOURCING™� also� provides� an� added� advantage� as� you� move� your�

compound� from� discovery� to� high� potency� manufacturing.� Our� global� sites� in� the�

United� States,� Europe� and� Asia� are� positioned� to� provide� tailored� solutions� and� to�

enable� the� efficient,� cost-effective� transfer� of� pre-clinical� and� commercial� drug�

products� ­� from� small-scale� to� large-scale� production.�We� can�provide� raw�materials,�

starting� materials� and� cGMP� manufacturing� of� API.� We� have� an� experienced� staff�

utilizing� substantial� global� capacity.�

•� Phase� I� to� Phase� IV�

•� High� Potency� Products�

•� Controlled� Substances�

•� Generic� Drugs�

•� Regulatory� Support/Quality� Assurance�

•� API� in� Capsule� formulation

Analytical� Services�

� AMRI� provides� broad� analytical� support� for� drug� discovery,� pharmaceutical�

development� and�manufacturing.� State-of-the-art� technologies� and� instrumentation�

along�with� close� collaboration�with� synthetic� organic� chemists� ensures� that� the� right�

questions� are� asked� and� the� right� tools� are� used� to� solve� even� the� most� difficult�

problem.�

•� Impurity� ID� &� Structure� Elucidation�

•� Method� Development,� Qualification,� Validation�

•� Preformulation� and� Physical� Characterization

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 87

•� Formulation� Development� �

•� Quality� Control�

•� Regulatry� Support/Quality� Assurance�

•� Preparative� Chromatography�

•� Stability� Services�

•� Bioanalytical� Services�

Aseptic� Fill� and� Finish

� As� part� of� its� fully� integrated� global� contract� services� offering,� AMRI� provides�

aseptic� manufacturing� services.� In� the� company’s� state-of-the� art� cGMP�

manufacturing� facility,� in� Burlington,� Mass.,� AMRI� offers� customers� aseptic�

processing� services,� including� aseptic� filling� of� syringes,� vials� and� other� custom�

containers;� ly¬ophilization;� and� the� very� latest� in� Stability� Optimization� Services�

(SOS).� AMRI� supports� clients� from� pre-clinical� stages� of� develop¬ment� through�

cGMP� clinical� and� commercial� scale� production� of� liquid-filled� parenterals.�

•� Emulsions�

•� Viscous� gels�

•� Suspensions�

•� Liposomes�

•� Proteins�

•� Small� and� Large� Molecules�

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Corporate

Competitiveness

1.� Proven� track� record� in� Drug� Discovery� and� Drug� Development

2.� High� Ph.D.� ratio

3.�Many� of� our� scientists� being� trained� or� having�working� experience� in� the�West

4.� Secure� IP� situation� in� particular� vs.� China.

5.� Low� turnover

6.� No� extra� charge� for� intellectual� input� such� as� compound� design,� that� all�work�

would� be� on� an� FTE� basis.

7.�Our� track� record� of� optimizing�molecules,� our� experience� in�working� in� various�

areas� including�GPCR� and� kinase� targets,� and� the� ability� to� tap� into� our� global�

expertise

8.� Lower� FTE� rate� compared� to� US/Europe�

No.� of� Regulatory

Inspections

ClassificationFDA

(US)

EMA

(EU)

PMDA

(Japan)

CFDA

(China)

DCI

(India)Others

Pre-Clinical� Area

Clinical� Area

Manufacturing� Area 0 0 0 0

Others

Current� Status� of

Accredited�

Certification

GLP/GMP

4.� Corporate� Competitiveness

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 89

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� toJapan,� China,� India,� Taiwan,� Hongkong,� Indonesia,� Malaysia

Asian� Clients'

Composition(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

70% 20% 8% 2%

No.� of� Asian� Clients

in� recent� 3� years45� companies

Major� Service� Range

with� Asian�

Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research ○ API ○

APIs

R&D ○

Pre-Clinical Pre-clinical

Test� Sample○

R&D� Strategy

&�Management

Phase� I Clinical� Trials

Phase� IIClinical� Test

Sample

Finished

Products

Regulatory

Affairs

Phase� IIIFinished

Product

Business

Development

Phase� IVSales� &

Marketing

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90� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

6. Anthem Biosciences PVT LTD

1.� Corporate� General� Information

Corporate� Name Anthem� Biosciences� PVT� LTD

Corporate� Ownership Private� Company

Head� Office� AddressNo.49� Canara� Bank� Road,� Phase1� ,� Bommasandra� Industrial� Area,�

Bangalore� 560� 099

Facilities� City� &� Country Bangalore(INDIA)

Web-site� Address www.anthembio.com

No.� of� Employees 350

Financial� Status

Sales� Revenue� in� 2012�

(US� K$)Capital(US� K$) Dept-equity� Ratio(%)

USD� 25� million USD� 1.5� million 3.2%

Contact

(Korean�

Business)

Name Prakash� Kariabettan

AddressNo.49,� Canara� Bank� Road,� Bommasandra� Industrial� Area,� Bangalore�

560099.� India

Telephone +91-80-6672� 4025� /� � +91-9243� 5555� 07

E-mail [email protected]

Company� History

Anthem� Biosciences� is� located� in� an� industrial� park� in� Bangalore.� Currently� the� company� employs� over� 300�

scientists� with� plenty� of� room� left� for� adding� extra� capacity� in� labs� and� people.�

The� people� at� Anthem� Biosciences� bring� years� of� relevant� experience� to� the� company.� A� team� of�

experienced� Chemists,� Biologists,� Engineers� and� Business� people� own� the� responsibility� of� transparent� and�

ethical� dealing� with� customers.�

Anthem� Biosciences�works� on� various� business�models� like� FTE� (Full� Time� Equivalent)� basis� or� project� basis�

or� a� combination� of� the� above� depending� on� the� complexity� of� the� task� and� the� need� of� the� client.� The�

company� is� flexible� in� its� approach� to� evolve� sensible� and� efficient� models� that� suit� each� client.

In� the� ever� crowding� space� of�CROs,�Anthem�Biosciences� distinguishes� itself� as� a� top� tier� organization�with�

a� highly� skilled� team,� quality� services� and� on-time� performance.�

Company� Description� &� Organization

Anthem� Biosciences� is� a� Bangalore� based� DRAP� (Discovery� Research� Alliance� Partner)� dedicated� to�

supporting� research� efforts� in� the� discovery� of� new� compounds� by� pharmaceutical,� biotechnology,�

specialty� chemicals,� agriculture� chemicals� and� material� science� companies.

We�provide� services� in� the� area� of�Medicinal� Chemistry,� Process�Chemistry,� Custom�Synthesis,�Discovery�

Research� and� Analytical� Research� &� Development.�

With� its� best� in� class� infrastructure,� Anthem� Biosciences� can� do� GMP� synthesis� from� milligram� to�

kilogram� and�multi-kilogram� scale.� Apart� from�modern�well� equipped� labs,� the� company� has� a� cGMP�

kilo� lab� and� a� versatile� GMP� pilot� plant.�

In�Discovery� Research,�we�provide� pharmaceutical� clients� services� from�generation�of� hits,� transforming�

hits� to� leads,� optimization�of� leads� up� to� developable� drug� candidates� against� known�or� client’s� targets.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 91

2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

○ ○

Geographical

Business�Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US ○ US ○ US US

Canada ○ Canada ○ Canada Canada

EU ○ EU ○ EU EU

Asia ○ Asia ○ Asia Asia

Global Global Global Global ○

Other Other Other Other

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research ○ API ○

APIs

R&D

Pre-Clinical ○R&D� Strategy

&� ManagementPre-clinical

Test� Sample○

Phase� I Clinical� Trials

Phase� IIClinical� Test

Sample○

Finished

Products

Regulatory

Affairs

Phase� IIIFinished

Product

Business

Development

Phase� IVSales� &

Marketing

Corporate�

Product� Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

○ ○ ○

Generics APIs Devices Others

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92� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

50% 20% 20% 10%

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

○ ○ ○

Focusing�

Therapeutic� Area

(%)

Oncologics Lipid� RegulatorsRespiratory�

AgentsAnti-ulcerants

Angiotensin� II�

Antagonists

AntipsychoticsAutoimmune�

agentsAntidepressants Analgesics Others

Being� a� service� organization,�we�do�not� restrict� our�work� to� any� specific� Therapeutic�

Area.� We� take� up� projects� on� all� the� areas� where� there� is� in-house� expertise.

General� Overview

of�Corporate's�Key

Contract� Services

Anthem� works� on� three� models� in� the� contract� services

1.� Fee� for� Service� (FFS)

2.� Full� time� equivalent� (FTE)

3.� Hybrid� model� of� both� FTE� and� FFS

Contract� Service�

Capacity�

Affordable� by�

Service� Area

Chemistry� Services

-� Early� stage� discovery� needs

-� Process� Chemistry

•� Route� scouting

•� Process� improvement� /� Process� optimization

•� Impurity� Profiling

•� Analytical� Research� &� Development

-� cGMP� Scale-up� ­� mg� to� multi-kilogram� quantities

•� Scale-up� ­� Kilo� Lab

•� cGMP� Pilot� Plant� (200-1500� L� scale)

Discovery� Services

-� Computer� aided� drug� design� (CADD):� Ligand� and� Structure� based� design�

-� Medicinal� chemistry

•� Synthesis� of� NCEs� from� virtual� library

•� Analogues� syntheses� in� fast-follower� projects

•� Prodrugs� and� salt-selection� studies

-� In� vitro� Biology

•� Assay� development:� Cell� based� and� enzyme� based

•� Library� screening� against� targets

•� Radiometric� assays

3.� Corporate� Business�Overview

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 93

•� Antibacterial� and� antifungal� screening

-� In� vivo� Biology:� Efficacy� studies� in� various� disease� models

-� ADME� Studies� (in� vitro� and� in� vivo)

-� Safety� studies:� In� vitro,� acute� and� chronic� toxicity� studies

-� Discovery� projects:� hit/lead� identification� &� lead� optimization�

Communication�

with� Clients

Dispositoion� of

Project� Manager

Responsible

•�Regular� updates� are� communicated� to� the� client� by�means� of�

e-mail� and� telephone

•� Positive� and� negative� results� are� communicated

•� Updates� are� aimed� to� help� problem� solving

•� To� make� key� project� decisions� easier� at� clients� end�

•� To� ensure� flow�of� information� and� expertise� in� both� directions

•� Agreed� timelines� are� considered� most� important

Providing�

Realtime

Service� Delivery

•� A� senior� management� team� supervises� projects�

•� Professional� procurement� team� with� exposure� to� all�

international� markets�

•� Scientist� to� scientist� communication� via� e-mail,� phone� &�

teleconferencing�

•� Regular� project� updates� with� successes� and� failures�

•� Logistics� support� until� products� reach� client’s� site

Realtime

Feed-back

•� Scientist� to� scientist� communication� via� e-mail,� phone� &�

teleconferencing�

•� Regular� project� updates� with� successes� and� failures�

•� Updates� are� aimed� to� help� problem� solving

•� To� make� key� project� decisions� easier� at� clients� end�

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94� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate

Competitiveness

•� Team� of� scientists� with� several� years� of� proven� CRO� track� record

•�Very� few� offer� discovery� services.� � Both� chemistry� and�discovery� services� under�

one� roof.

•� Management� team� focused� solely� on� contract� research

•� IP� rests� with� the� client�

•� Dissemination� of� information� on� a� need� to� know� basis�

•� First� CRO� to� implement� complete� virtualization�

•� Completed� over� 1000� projects� in� a� period� of� six� years

•� Success� rate� >� 98%� in� execution� of� projects.

No.� of� Regulatory

Inspections

ClassificationFDA

(US)

EMA

(EU)

PMDA

(Japan)

CFDA

(China)

DCI

(India)Others

Pre-Clinical� Area

Clinical� Area

Manufacturing� Area 0 0

Others

Current� Status� of

Accredited�

Certification

The� facilities� have� been� inspected� by� qualified� persons,� Client�QA� and� third� party�

auditors.�

� USFDA� inspection� is� in� progress

� -� AAALAC� inspection� is� scheduled� for� November� 2013.

� Accreditations� planned� (2013� -2014):�

� Integrated� Management� Systems�

� -� ISO� 9001:2008� (Quality� Management� Systems)

� -� ISO� 14001:2004� (Environmental� Management� Systems)

� -� OHSAS18001:2007� (Occupational� Health� and� Safety� Management� Systems)

� -� OECD� GLP� certification� by� NGCMA� (National� GLP� Compliance� Monitoring�

Authority)�

4.� Corporate� Competitiveness

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 95

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� toIndia,� Japan� &� Korea

Asian� Clients'

Composition(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

20% 50% 20% 10%

No.� of� Asian� Clients

in� recent� 3� yearsThe� number� of� Asian� clients� is� about� 20� in� these� various� sectors.

Major� Service� Range

with� Asian�

Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research ○ API

APIs

R&D

Pre-Clinical ○Pre-clinical

Test� Sample○

R&D� Strategy

&�Management

Phase� I Clinical� Trials

Phase� II Clinical� Test

Sample

Finished

Products

Regulatory

Affairs

Phase� IIIBusiness

DevelopmentFinished

ProductPhase� IV

Sales� &

Marketing

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96� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

7. Aptuit, LLC

1.� Corporate� General� Information

Corporate� Name Aptuit,� LLC

Corporate� Ownership Private� Company

Head� Office� Address 2� Greenwich� Office� Park� Greenwich,� CT06831� USA

Facilities� City� &� CountryHarrisonville(USA),� West� Lafayette(USA),� Verona(Italy),� Glasgow(UK),�

Oxford(UK),� Hyderabad(India)

Web-site� Address www.aptuit.com

No.� of� Employees

Aptuit� staff� worldwide� is� approximately� 800� people,� over� 400� employees�

work�at� the�Aptuit�Centre� for�Drug�Discovery�and�Development,� in�Verona,�

Italy

Financial� Status

Sales� Revenue� in� 2011�

(US� K$)Capital(US� K$) Dept-equity� Ratio(%)

346,536 369,429� (assets) 2.5� %

Contact

(Korean�

Business)

Name Nick� Johnson.� Strategic� Account� Manager

Address Two� Greenwich� Office� Park,� Greenwich,� CT� 06831,� USA.

Telephone +1� 302-764-1842

E-mail [email protected]

Company� History

Aptuit�was� formed� in� July�2005�however�many�of� the� companies� that�have� been� acquired� since� 2005�have�

more� than� 15� years� in� business.� The� Verona� R&D� Center� is� in� place� since� late� ‘80s.

Aptuit� acquired� the� Verona� facility� from�GSK� in� 2010� and� combined� its� expertise� in� the� CRO�market� with�

the�project�management�approach�developed�by�GSK:� collocated,� interdisciplinary� teams�working� to� improve�

the�quality�of� clinical� candidates� under�development�while�accelerating� the�associated�project� timeline.� �We�

work� with� clients� in� many� therapeutic� areas,� including� (but� not� limited� to)� oncology,� CNS� medicine,�

Cardiovascular� medicine� and� anti-infectives.

Company� Description� &� Organization

Aptuit� is� a� leading� global� Contract� Research� Organization� (CRO)� focused� on� the� early� to� mid-stage�

Pharmaceuticals� development� space.� From� our� facilities� in� Italy,� the� United� states� and� the� United� Kingdom�

we� deliver� one� of� the� most� fully� integrated� development� service� platforms� for� NCE� candidates� (both� small�

molecule� and� biologics)� in� � the� US� or� Europe.�

Aptuit� is� privately� owned.� � Subsidiaries� to� Aptuit,� LLC� include� the� following� (all� wholly� owned):

Aptuit� Consulting,� Inc

Aptuit� (Verona)� Srl

Aptuit� (Scientific� Operations),� LLC

Aptuit� (West� Lafayette),� LLC

Aptuit� (Oxford)� Limited

Aptuit� (Glasgow)� Limited

Aptuit� (Asia)� Private� Limited

Aptuit� Management� Company.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 97

2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

○ ○ ○

Geographical

Business�Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US US US US

Canada Canada Canada Canada

EU EU EU EU

Asia Asia Asia Asia

Global ○ Global ○ Global Global ○

Other Other Other Other

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research ○ API ○

APIs

R&D ○

Pre-Clinical ○R&D� Strategy

&� Management○

Pre-clinical

Test� Sample○

Phase� I ○ Clinical� Trials ○

Phase� II ○Clinical� Test

Sample○

Finished

Products

Regulatory

Affairs○

Phase� III ○Finished

Product○

Business

Development

Phase� IV ○Sales� &

Marketing

Corporate�

Product� Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

○ ○ ○

Generics APIs Devices Others

○ ○ ○ ○

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98� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

10% 40% 30% 20%

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

○ ○ ○ ○

Focusing�

Therapeutic� Area

(%)

Oncologics Lipid� RegulatorsRespiratory�

AgentsAnti-ulcerants

Angiotensin� � � II�

Antagonists

10 5 10 5 5

AntipsychoticsAutoimmune�

agentsAntidepressants Analgesics Others

20 5 20 10 10

Aptuit� Clinical� Sciences� includes� activities� such� as� clinical� pharmacology,� clinical� trial�

management,�pharmacokinetics�and�statistical� services,�which�span�from� the�design�and�

implementation� of� multi-faceted� projects� up� to� proof� of� concept,� through� the� design�

and� implementation� of� single� areas�within� the� client’s� clinical� development� plan.� Aptuit�

Clinical� Sciences� in� Verona,� Italy,� has� a� world� class� reputation� for� neuroscience�

development,� spanning� Psychiatry� and� Neurology� diseases� and� in� this� area� offers�

long-standing� scientific� expertise� in� the� design�of� standard� phase� 1� and�patient� studies,�

human� model,� challenge� and� imaging� studies.� Aptuit� Clinical� Sciences’� experience� in�

clinical� development� and� translational� medicine� offers� an� innovative� approach� in� many�

other� therapeutic� areas,� such� as� Oncology,� Respiratory,� Anti-invectives,� Cardiovascular�

and� Metabolic� disease� as� well� as� Nutraceuticals.� Furthermore� the� Clinical� Sciences�

established�network�of�clinical�centers,� expert�medical� advisors,� and�other� clinical� services�

preferred� providers,� expands� the� portfolio� of� services� that� can� be� offered� to� the� client.

General� Overview

of�Corporate's�Key

Contract� Services

Our� Verona� facility� in� particular� demonstrates� the� benefits� clients� can� gain� from� close�

geographic� integration� of� services.� � Our� offering� comprises� all� of� the� following� in� one�

building:

-� Target� Validation

-� Lead� optimization

-� Safety� Pharmacology

-� ADME

-� Toxicology� (rodent,� dog� and� primate)

-� Bioanalysis� (from� preclinical� through� to� clinical� stage)�

-� Formulation� development� (on� site� in� Verona� for� solid� oral� formulations� and� through�

a� sister� facility� for� injectable� forms)�

-� Analytical� method� development� for� both� small� molecule� and� large� molecule� NCEs

-� Medicinal� Chemistry

3.� Corporate� Business�Overview

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 99

-� API� Synthesis� under� both� GMP� and� non� GMP� conditions

-� Biomarkers� studies

-� Clinical� trial� support

-� Formally� trained� and� dedicated� project� management

-� Consulting� Services

Contract� Service�

Capacity�

Affordable� by�

Service� Area

The� Aptuit� Verona� site� has� a� scientific� staff� of� just� over� 300� people.� � More� than� 20% �

of� these� staff�have�a�Post�Graduate�education.� �The�split�of� staff�by�department� is� shown�

below.

Preclinical� Biosciences� ­� 130

Drug� Design� &� Discovery� -� 60

Chemistry� Manufacturing� &� Control� -� 100

Clinical� Sciences� ­� 15

Communication�

with� Clients

Dispositoion� of

Project� Manager

Responsible

The� project� manager� is� responsible� for� maintaining� a� cohesive� and�

highly� effective� project� team� during� all� phases� of� the� project.� The�

project� manager� will� serve� as� the� primary� point� of� contact� for� the�

team� and� will� ensure� that� open� lines� of� communication� are�

established� and� maintained� throughout� the� project� life� cycle.� In�

addition� to� these� responsibilities,� the� project� manager� will:

-� Strive� to� understand� the� client’s� goals� and� will� manage� the�

strategy� to� meet� those� goals

-� Lead� the� performance� of� the� project� tasks� per� the� agreed� upon�

scope� of� work

-� Act� as� the� focal� point� for� all� internal� and� external� project�

communication

-� Schedule,� monitor� and� communicate� the� status� of� the� project�

tasks� to� the� project� team

-� Conduct� team� meetings

-�Generate�and�distribute�concise�meeting�minutes,� action� items�and�

status� reports

-� Prepare� the� overall� project� and� communication� plan� with� the�

assistance� of� the� project� team

-�Monitor� the� compliance� to� the� project� plan� and� update� the� plan�

as� needed

-� Ensure� the� project� team�members� are� focused� on� a� common� set�

of� objectives

-�Ensure� that� the� project�objectives� and�deliverables�have� been�met�

on� time

Providing�

Realtime

Service� Delivery

This� is� Aptuit’s� standard� way� of� working

Realtime

Feed-backThis� is� Aptuit’s� standard� way� of� working

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100� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate

Competitiveness

As� far� as� in-house� Quality� Assurance� (QA)� functions,� they� are� supporting� the� areas�

working� to�GMP� (Good�Manufacturing�Practice),�GLP� (Good�Laboratory�Practice)� and�

GCP� (Good� Clinical� Practice).�QA� also� includes� the� Archiving� function� responsible� for�

storing� all� relevant� documentation� produced� by� the� site,� in� agreement� with� client�

expectations� and� applicable� regulations.�

Specifically,� the� GMP� Quality� assurance� function� is� responsible� for� ensuring� that�

Production� and� Quality� Control� functions� operate� according� to� the� international�

standards� as� applied� to� Investigational� Medicinal� Products� for� human� use.� This� is�

achieved� by

-� Periodic� review,� through� a� site� audit� plan,� of� all� the� aspects� of� manufacturing,�

testing,� release,� etc� which� can� have� an� impact� on� the� final� clinical� trial� material

-� Verification� and� approval� of� Standard� Operating� Procedures� (SOPs)�

-� Management� of� deviations

-� Verification� of� manufacturing� and� analytical� documentation� for� approval� of� clinical�

batches

-� Management� of� customer� complaints�

-� Coordination� of� validation� activities

-� Verification� of� the� GMP� compliance� of� electronic� systems

4.� Corporate� Competitiveness

Corporate

Competitiveness

Aptuit�has� clients� from�all�major�Pharmaceutical�development�markets� in�Asia,� the�EU�

and� the� US.� � Our� pricing� models� vary� extensively� by� business� area� and� are� more�

complex� than� can� be� displayed�here,� since�we� serve� literally� every� aspect� of� the� drug�

development� endeavor.� � Area� specific� details� can� be� provided� upon� request� but� are�

scaled� to�provide�complete�coverage�of�multiple�projects� in� the�pre-IND� through�Phase�

2b� stages.

Preclinical� animal� capacity� is� as� displayed� below.

-� 43� housing� rooms� for� rodents� with� max� capacity� of� 35.000� mice,� 6.000� rats� and�

250� guinea� pigs

-� 5� housing� rooms� for� rabbits� with� max� capacity� of� 120� rabbits

-� 5� kennels� with� max� capacity� of� 100� dogs

-� 5� rooms� for� NHP� with� max� capacity� of� approx� 100� Cynomologous� monkeys�

-� 1� room� for� marmosets� max� capacity� 50� animals

Our� pricing� models� are� competitive� with� European� industry� market� levels� and� are�

continually� reviewed� in� the� market.� Of� more� interest� to� clients� however� are� the�

economies� that� can� be� made� in� terms� of� both� time� and� funding� by� using� our�

integrated� development� model.� �

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 101

-� GMP� training�

Similarly,� the�GLP� �QA� function� � is� responsible� for� ensuring� that�preclinical� studies� on�

animals� are� conducted� according� to� the� generally� accepted� international� GLP�

standards� by� carrying� out� the� activites� described� below:

-� Verify� that� the� study� plan� contains� the� information� required� for� GLP� compliance�

-� Conduct� internal� inspections� to� the� preclinical� facilities� �

-� Inspect� the� final� study� reports� to� confirm� that� the� methods,� procedures,� and�

observations� are� accurately� described,� and� that� the� reported� results� accurately�

reflect� the� raw� data

-� Promptly� report� any� inspection� results� in� writing� to�management� and� to� the� Study�

Directors/Principal� Investigators� .�

-�Provide�GLP� training� courses� for� all� the�staff,�and� in�particular� for� the�Study�Directors�

and� Principal� Investigators

-�Manage� and�host� clients� and�Regulatory�Authorities� inspections� and� implement� the�

corrective� actions�

GCP� activities� are� also� supported,� by� close� interaction� with� the� Verona� Clinical�

Sciences� Department.

No.� of� Regulatory

Inspections

Classification FDA(US) EMA(EU) PMDA(Japan) Others

Pre-Clinical� Area 0 0 0 1(MoH)

Clinical� Area 0 0 0 0

Manufacturing� Area 0 0 0 4� (AIFA)�

Others 1� (QC&stab) 0 0 0

Current� Status� of

Accredited�

Certification

GLP� certification� n.� 002/2012� dated� 02� Feb� 2012

GMP� licenses� in� place� for� both� API� (n.� aMP� 166� 01� Aug� 2012)� and� DP� (N.� aM �

52/2012� 13� Apr� 2012)

GCP� accreditation� to� act� as� CRO� obtained� by� AIFA� since� Jan� 2011�

AAALAC:� contact� A.� Tamellini,� LAS

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102� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� to

Australia,� Austria,� Belgium,� Brazil,� Canada,� Croatia,� Denmark,� Finland,� France,�

Germany,� Hungary,� India,� Ireland,� Israel,� Italy,� Japan,� Luxembourg,� Netherlands,� New�

Zealand,�Norway,�Poland,�Portugal,� South�Korea,� Spain,� Sweden,�Switzerland,� Taiwan�

(Republic� of� China),� United� Kingdom,� United� States,� Uruguay

Asian� Clients'

Composition(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

25% 35% 20% 20%

No.� of� Asian� Clients

in� recent� 3� yearsAt� a� global� level� Aptuit� had� approximately� 25� Asian� Clients�

Major� Service� Range

with� Asian�

Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research ○ API ○

APIs ○

R&D ○

Pre-Clinical ○R&D� Strategy

&�Management○

Pre-clinical

Test� Sample○

Phase� I ○ Clinical� Trials ○

Phase� II ○ Clinical� Test

Sample○

Finished

Products○

Regulatory

Affairs○

Phase� III ○Business

DevelopmentFinished

Product○

Phase� IV ○Sales� &

Marketing

6.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

Aptuit’s� offering� is� unique� among� CROs� based� in� either� the� EU� or� the� USA.� � We� offer� the� only� truly�

integrated� Pharmaceutical� Development� service� package� that� enables� our� clients� to� outsource� either�

individual� studies�or� a� complete�program.� �Our� team�has�worked�on�numerous�programs� in�a�wide� range�

of� therapeutic� areas� bringing� together� activities� as� diverse� as� API� synthesis,� toxicology,� ADME,�

pharmaceutics�development,�bioanalysis� and� clinical� trials� services.� These�are�handled�all� under� the� same�

roof� in� our� Verona� facility� and� normally� under� one� contract�with� the� same� project�manager� overseeing�

activity.� � Accordingly�we� can� reduce� time� to� such� key�milestones.� � For� example� our� INDiGO� program� is�

a� tested� and� proven� methodology� to� allow� clients� to� reach� IND� submission� within� 6� months.�

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 103

8. Arab Pharmaceutical IndustryConsulting Company

1.� Corporate� General� Information

Corporate� Name Arab� Pharmaceutical� Industry� Consulting� Company�

Head� Office� Address P.O.� Box:� 1084,� Zip� code� Sweileh� 11910

Facilities� City� &� Country Jordan

Web-site� Address www.pru.com.jo

Contact

(Korean�

Business)

Telephone +� 962� 6� 5358290

E-mail [email protected]

Company� Description� &� Organization

[Mission]

To� provide� our� sponsors�with� an� exceptional� experience� that� includes� strong� project� outcomes� delivered� in�

a� responsive,� thoughtful� and� trustful� way� of� partnering.

[Vision]

It’s� all� about� people,� science� and� service� here� at� PRU.� This� strategy,� combined� with� our� consistent� quality�

and� attention� to� detail,�means� that�we�have� the� capability� and� the�will� to� deliver� significant� change� to� our�

pharmaceutical� clients.� We� aim� to� compress� timelines,� maintain� quality� and� reduce� the� cost� of� bringing�

drugs� to� market� on� a� global� scale� by� offering� critical� expertise,� technologies,� facilities,� ideas� and� services.

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104� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

9. Arriello Group

1.� Corporate� General� Information

Corporate� Name Arriello� Group

Corporate� Ownership Private� Company

Head� Office� Address Bracetown� Business� Park,� Clonee,� Dublin� 15,� Ireland

Facilities� City� &� CountryPrague(Czech� Republic),� Bucharest(Romania),� Barcelona(Spain),�

Lyon(France),� Riadh(Saudi� Arabia)

Web-site� Address www.arriello.com

No.� of� Employees 25� -� 30

Financial� Status

Sales� Revenue� in� 2011

(US� K$)Capital(US� K$) Dept-equity� Ratio(%)

3,547,811 347,000 0.5

Contact

(Korean� Business)

Name Alan� White

Address Bracetown� Business� Park,� Clonee,� Dublin� 15,� Ireland

Telephone +353� 863� 313� 243

E-mail [email protected]

Company� History

Founded� in� 2007�by�Alan�White� and�Anna� Lukyanova,�Arriello� has� grown�over� the� last� few� years� increasing�

the� number� of� services� and� number� of� clients� around� the� world.�

During� the� first� years� we� were� focused� in� offer� Readability� Testing� and� Translation� Services.� Nowadays� we�

offer� a� huge� range� of� services:� Regulatory� Affairs� &� Registrations,� Medical� Writing,� Translation� Services,�

Pharmacovigilance,� Business� Development� and� Medical� Devices� (our� new� market).�

We�have�a�proactive�approach� thinking� focused� in�offer� services� that�will� help�our�clients� to�be� the� first�ones�

in� their� market,� delivering� our� services� through� our� experienced� team� with� project� oriented� work.

Company� Description� &� Organization

We� are� a� full� service� provider� to� the� Life� Science� Industry.� Our� Pharmaceutical� division� comprises� of�

Regulatory� Affairs� and� Registrations,� Pharmacovigilance,� Translations,� Medical� Writing� and� Business�

Development.�Moreover,�we� have� a� full�Medical� Devices� division.�We� are� based� in� Ireland� and� have� affiliate�

offices� in� Czech� Republic,� Romania,� Saudi� Arabia� and� a� network� of� affiliates� worldwide.� We� can� create,�

register� and� hold� your� dossier/MA,� provide� full� Pharmacovigilance� system� in� house� and� translate� any�

document.� We� are� ready� to� be� your� end� to� end� partner.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 105

2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Geographical

Business�Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US US US US

Canada Canada Canada Canada

EU EU EU EU

Asia Asia Asia Asia

Global Global Global Global ○

Other Other Other Other

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D ○

Pre-Clinical Pre-clinical

Test� Sample

R&D� Strategy

&� Management○

Phase� I Clinical� Trials ○

Phase� IIClinical� Test

Sample

Finished

Products

Regulatory

Affairs○

Phase� IIIFinished

Product

Business

Development○

Phase� IVSales� &

Marketing○

Corporate�

Product� Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

○ ○ ○ ○ ○

Generics APIs Devices Others

○ ○ ○ ○

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106� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

5% 65% 20% 10%

General� Overview

of�Corporate's�Key

Contract� Services

Regulatory� Affairs� &� Registrations

Arriello� can� help� you� registering� products� where� you� need� it� providing� EU,� US,� CIS� &�

Middle� East� Registration� Support� acting� as� MAA/MAH� for� you.� Other� services:� GMP�

Audits,� Readability� Testing� and� eCTD� Publishing.

Translation� Services

With� a� Complete� Translation� Knowledge,� we� specialize� in� translating� Life� Science� text,�

from�pharmaceutical� text� (medical,� legal,�marketing)� to� technical� text� for�medical�devices�

and� clinical� trial� materials.� Other� services:� Compliant� with� EN-15038� and� Artwork�

Integration� &� DTP.

Medical� Writing

Our� expert� medical� writers� are� able� to� make� your� dossier� “Registration� Ready”� for�

whichever

market� you� are� going� in� to.� Other� services:� NtA� to� eCTD� Conversion,� Non� Clinical� &�

Clinical� Overviews,� CTA� &� IMPD,� Paediatric� Investigation� Plans� and� Bioequivalence�

Studies/Waivers.

Pharmacovigilance

We� have� a� Full� PV� System� in� house� (EU� QP� and� Deputy� QP)� we� can� take� care� of� your�

products� and� be� compliant� with� the� new� PV� legislation.� Other� services:� XEVMPD�

Support,� SOP/QMS� Preparation� and� Maintenance� Documents� -� PSURs,� RMPs,� REMS.

Medical� Devices

We� can� be� you� European� Authorized� Representative,� help� you� with� Audits� and�

SOP/QMS� Preparation.� Other� services:� Document� Preparation� for� CE-Mark,� 510� (k)�

Clearance,� RMP� Guidance� Compliant� with� ISO� 14971,� Vigilance,� Monitoring� of�

Standards,� Local� Support,� Labeling� and� Registrations.

Contract� Service�

Capacity�

Affordable� by�

Service� Area

We�have�an�experienced�team� in�house� to�deliver�our�services�according� to�our� customer�

requirements� in� terms� quality� and� time.� The� processes� are� controlled� by� our� Quality�

Management� System.

In� addition�we� have� a� list� of� local� and� global� trusted� partners� to� ensure� the� delivery� of�

any� kind� of� request� in� time� and� anywhere� our� client� need� to� act.� We� have� scalability�

3.� Corporate� Business�Overview

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 107

to� supply� the� services� required� by� our� customers� with� the� objective� to� be� ready� for�

market� their� products� as� soon� as� possible.

We� rely� on� three� premises:

Proactive�approach:�we�are�up� to�date� so�we�can�help�our� customers� to�be� the� first�ones�

in� access� to� the� market� and� offer� new� and� innovative� solutions� that� other� service�

providers� can’t� offer.

Project� Oriented:� every� service� required� by� the� client� is� processed,� managed� and�

delivered� as� a� project.

Experienced� Team:� we� know� that� experience� means� quality� and� knowledge,� so� every�

part� of� our� team� needs� to� have� experience� in� their� fields� to� provide� the� best� services�

to� our� customers.

Communication�

with� Clients

Dispositoion� of

Project� Manager

Responsible

Our� clients�are� the�priority;� it�means� that�each�Project�Manager�will�

take� care� of� each� client� with� the� best� disposition.� They� can� be�

contacted� by� email,� phone,� conference� or� face� to� face� meeting.

Providing�

Realtime

Service� Delivery

All� employees� must� answer� emails� received� from� clients/vendors�

within�working� hours� of� the� day� the� email�was� received.� Exception�

allowed� to� last� minute� emails.� A� simple� reply� confirming� that� the�

email� has� been� correctly� received� with� the� content� is� enough.�

Realtime

Feed-back

We� have� feed-back� before;� during� and� after� deliver� our� services,�

through� direct� communications� and� quality� surveys.

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108� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate

Competitiveness

Our� Quality� Policy� (QP)� aims� to� achieve� sustainable,� profitable� growth� by� providing�

professional� services� that� consistently� satisfy� the� needs� and� expectations� of� our�

customers.

This� high� level� of� quality� is� achieved� through� the� implementation� of� a�

well-documented� system�of� standardized�procedures� that�provides�a�clear�guidance� to�

our�employees� as� to� the�best� practices,� perform�duties� and� respond� to� clients’�needs.�

The� system� reflects� the� competences� of� the� Company� to� systematically� deliver� added�

value� for� a� range� of� identified� professional� services.� It� serves� as� the� beacon� for� any�

kind� of� operational� or� quality� audits� and� can� as� such� be� shown� to� both� existing� and�

potential�customers�as�well�as� to�official�authorities�and� independent�auditing�bodies.�

To� implement� our� QP� and� achieve� its� goals,� Arriello� involves� the� entire� staff� of� the�

company.� Each� member� of� staff� is� informed� and� trained� about� our� QP� and� about�

what� it� specifically� means� for� the� execution� of� his/her� own� function.�

To� ensure� that� the� QP� is� actually� adhered� to� and� that� the� Quality� Standards� are�

achieved�day-in�and�day-out,�Quality�Assurance�also�performs� regular� spot� checks�and�

reports� any� potential� variance� to� the� top� management� who� ultimately� remains�

responsible� for� ensuring� that� our� Management� and� their� teams� are� responsible�

towards� our� clients� and� other� stakeholders.�

The� objectives� of� the� QMS� are:

•To� maximize� customer� satisfaction� at� all� times,� understanding� client� requirements�

and� supplying� the� highest� quality� products� and� services� possible� to� meet� all�

expectations.

•To� ensure� compliance� with� all� relevant� statutory� and� regulatory� requirements.

•To� maintain� an� effective� system� complying� with� International� Standard� ISO� 9001.

•To�maintain�operational� excellence�performing�continuous� improvement� focusing�on�

adding� value� for� the� customer.

•Continued� growth� cultivating� strong� customer� relationships� and� enhancing� the�

Company’s� reputation� and� brand� name.

No.� of� Regulatory

Inspections

Classification FDA(US) EMA(EU) PMDA(Japan) Others

Pre-Clinical� Area

Clinical� Area

Manufacturing� Area

Others 2� from� Clients

Current� Status� of

Accredited�

Certification

We� are� in� a� process� to� be� audited� and� accredited� with� ISO� 9001� certificate.

We� provide� GMP� audits� provided� by� a� Qualified� Person� with� Diploma� in�

Pharmaceutical� Manufacturing� Technology,� (Trinity� College� Dublin).� This� Diploma�

fulfills� the� academic� requirements� of� the� Qualified� Person� as� defined� by� the� EU�

Directive.

We� have� certificates� from� some� clients� that� audit� us� to� ensure� the� quality� of� their�

suppliers.

4.� Corporate� Competitiveness

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 109

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� toIndia,� China,� Korea,� Indonesia,� Vietnam,� Singapore,� Malaysia

Asian� Clients'

Composition(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

10% 35% 30% 25%

No.� of� Asian� Clients

in� recent� 3� years35

Major� Service� Range

with� Asian�

Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D ○

R&D� Strategy

&�Management○Pre-Clinical

Pre-clinical

Test� SamplePhase� I Clinical� Trials ○

Phase� IIClinical� Test

Sample

Finished

Products

Regulatory

Affairs○

Phase� IIIBusiness

Development○

Finished

ProductPhase� IV

Sales� &

Marketing○

6.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

We� are� able� to� help� any� company� in� Korea� become� GMP� compliant� with� our� pre� audit� experience.� �

Moreover�we�can� take�your�dossier�and�make� it� (e)CTD�compliant� for� all�western� countries�and� the�Middle�

East.� �

We� can� translate� anything� for� you� to� help� you� get� your� message� to� right� audience,� in� any� language.� �

And� we� can� ensure� full� PV� compliance� in� any� part� of� the� globe.

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110� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

10. ARTIMMUNE

1.� Corporate� General� Information

Corporate� Name ARTIMMUNE

Corporate� Ownership Private� Company

Head� Office� Address Centre� d’innovation,� 16� rue� léonard� de� vinci,� 45100� Orléans� -� France

Facilities� City� &� Country Orléans,� France

Web-site� Address www.artimmune.com

No.� of� Employees 9

Financial� Status

Sales� Revenue� in� 2010

(US� K$)Capital(US� K$) Dept-equity� Ratio(%)

96 40 45

Contact

(Korean�

Business)

Name Trovero� fabrice

Address -

Telephone +� 33� 238� 646� 068

E-mail [email protected]

Company� History

The�company�has� been� founded� in�2010.� It� results� from�a�partnership�between�Key-Obs� (preclinical� contract�

research� company� specialized� in� brain� diseases� which� was� founded� 12� years� ago)� and� the� laboratory� of�

Immunology�of�CNRS� in�Orleans� France.� The�6� year�partnership�has�allowed�to�establish� relevant�experimental�

models� of� lung� diseases� which� are� offered� in� an� expert� environment.� Since� two� years,� the� company� grows,�

due� to� interest� of� pharma� companies� in� the� the� relevant� research� services� offered.�

Company� Description� &� Organization

ArtImmune� is� a� contract� research� company� which� offers� consulting� and� preclinical� research� services� in�

immunology� and� inflammation� with� an� emphasis� on� lung� diseases.

ArtImmune� has� a� very� strong� expertise� in� preclinical� investigations� of� lung� functions� including�

plethysmography,� bronchoalveolar� lavage,� cytology,� histology,� immunohistochemistry,� and� analysis� of�

biochemical,� immunologica� land� molecular� parameters.

The� effects� of� novel� drug� candidates� are� tested� in� mice� and� rats� modeling� lung� diseases� such� as� allergic�

asthma,� chronic� bronchitis,� lung� fibrosis,� emphysema� and� acute� respiratory� distress� syndrome.�

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 111

2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Geographical

Business�Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US ○ US US US

Canada Canada Canada Canada

EU ○ EU EU EU

Asia Asia Asia Asia

Global ○ Global Global Global

Other Other Other Other

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research ○ API

APIs

R&D

Pre-Clinical ○ Pre-clinical

Test� Sample

R&D� Strategy

&� Management

Phase� I Clinical� Trials

Phase� IIClinical� Test

Sample

Finished

Products

Regulatory

Affairs

Phase� IIIBusiness

DevelopmentFinished

ProductPhase� IV

Sales� &

Marketing

Corporate�

Product� Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

Generics APIs Devices Others

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112� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

30% 70%

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

○ ○

Focusing�

Therapeutic� AreaImmunology� :� inflammation,� infection

General� Overview�

of�Corporate's�Key�

Contract� Services

Large� platform� for�mouse� and� rat� work,� with� SPF� animal� facilities.�Modern� laboratories�

and� equipments� to� have� a� one� stop� service.� ISO� 9001� accreditation� of� the� research�

platform

Some� in� vivo� preclinical� models:

Allergic� asthma

Acute� respiratory� distress� syndrome� (ARDS)

Chronic� bronchitis� and� obstructive� pulmonary� disease� (CPOD)

Injury� induced� inflammation� and� lung� fibrosis

Lung� emphysema

Immune� complex� alveolitis

Polymicrobial� peritonitis� (CLP)

Models� of� IBD,� experimental� colitis�

Experimental� arthritis

Contract� Service�

Capacity�

Affordable� by�

Service� Area

Animal� facilities� 5000� mice,� 2000� rats.�

Communication�

with� Clients

Dispositoion� of

Project� Manager

Responsible

studies� are� conducted� with� the� sponsor� with� a� follow-up� on-line

Providing�

Realtime

Service� Delivery

1�month�average�delay� from�contact� to�design�and�starting�a�study.�

A� study� is� around�2� to� 4�weeks�duration� time.� Results� are� available�

in� realtime.� Delay� of� report� delivery� 2� weeks.

3.� Corporate� Business�Overview

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 113

4.� Corporate� Competitiveness

Corporate

Competitiveness

competitive�price� according� to� great�quality� and�great�expertise� in� the� field.�Price� are�

provided� per� animal,� in� order� to� facilitate� the� design� of� the� study� by� the� sponsor.�

According� to� the�model,� prices� comprised�between�5� and�40�K$� to� establish� efficacy�

of� a� candidate� drug.� No� delay� for� delivery� of� information� regarding� protocols,�

planning�availability…studies�are�planned�with� the� sponsor,�with�expected�deliverables�

.� Expriments� conducted� by� well� trained� technicians� and� managed� by� expert�

researchers,� authors� of� recognized� publications� in� the� field.�

Current� Status� of

Accredited�

Certification

ISO� 9001

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11. ASREGTEC, ASUNTOS REGULATORIOS TECNICOS

1.� Corporate� General� Information

Corporate� Name ASREGTEC,� ASUNTOS� REGULATORIOS� TÉCNICOS

Corporate� Ownership Private� Company

Head� Office� Address QUITO

Facilities� City� &� Country QUITO,� ECUADOR

Web-site� Address www.asuntosregulatoriosec.com

No.� of� Employees Two� /� Deisy� Criollo� and� Monica� Toasa

Financial� Status

Sales� Revenue� in� 2015

(US� K$)Capital(US� K$) Dept-equity� Ratio(%)

40,000 6,000 -

Contact

(Korean�

Business)

Name Deisy� Noemi� Criollo,� Monica� Toasa

Address Quito-� Ecuador� (Latin� America)

Telephone 593� 0987380733

E-mail [email protected],� [email protected]

Company� History

ASREGTEC,�ASUNTOS�REGULATORIOS�TÉCNICOS,� is� an�Ecuadorian�consulting� firm� that�was� created� in�March�

2015�to�provide� technical,� legal� regulatory�advice�and�support� in� the� implementation�of� systems� such�as�good�

manufacturing�practices,�good� strage�practices� to�different� national� and� foreign� industry� products�of� human�

use� and� consumption� subject� to� control,� fulfilling� the� responsibility� to� care� for� the� health� of� our� population.

To� Perform� this� work� are� been� staffed� with� long� experience� in� the� field� of� consulting� and� comprehensive�

advice,� so� it� has� managed� to� create� confidence� in� our� customers.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 115

Company� Description� &� Organization

ASREGTEC,� Asuntos� Regulatorios� Tecnicos,� is� an� Ecuadorian� consulting� firm� to� provide� technical,� legal�

regulatory�advice�and� support� in� the� implementation�of� systems� such�as�good�manufacturing�practices,�good�

storage�practices� to� different�national� and� foreign� industry� products�of�human�use�and� consumption� subject�

to� control,� fulfilling� the� responsibility� to� care� for� the� health� of� our� population.

Mission

provide� technical� and� legal� regulatory� advice� to� different� industries� of�Medicines,�Medical� Devices,� Reagents�

&� Biochemicals,� Natural� Products,� Food� Products,� Cosmetics,� Personal� Care� and� Household� Products,�

Industrial� Use� Products,� with� qualified� and� full� staff,� creating� confidence� in� our� clients.

Vision

Achieve� a� degree� of� excellence� in� regulatory� matters� in� order� to� become� members� of� our� customers�

unconditional� ensuring� their� success� and� being� responsible� with� health� care� in� our� country

Quality� politics

The� commitment� of� the� highest� compliance� and� regulations,� in� post� of� legal� reserve� and� the� commercial�

development� of� our� customers.

Serve� the� customer�with�warmth,� efficiency� and� effectiveness� in� strict� compliance�with� the� legal� basis� linked�

to� the� various� services� provided.

Our� services:

◦�Technical�and� legal� advice� for�obtaining�health� registration�and�notification� to� the�Ecuadorian�and� foreign�

companies� of� products� of� human� use� and� consumption,� complying� with� the� law� of� the� country� to� market�

their� products.

◦� Attend� meetings� with� regulatory� authorities� for� review,� monitoring,� observation� and� approval� of�

regulations� for� private� enterprises.

◦� Preparation� and� submission� of� dossiers� for� further� control.

◦� Check� and� monitor� compliance� with� the� labeling� of� products� subject� to� control� by� the� competent�

authority.

◦� Training� for� foreign� companies� to� verify� online� health� records� approved� in� Ecuador� from� the� country� of�

origin.

◦� Consulting� and� implementation� of:� Good� Storage� Practices� (GSP),� Good�Manufacturing� Practices� (GPM)�

of� Food� and� Drugs� and� ISO� 13485

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2.� Corporate� Service� &�Business� Area

Corporate�Main�

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing Consulting

GeographicalBusiness�Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing Consulting

MiddleEast

MiddleEast

MiddleEast

MiddleEast

Africa Africa Africa Africa

US US US US ○

EU EU EU EU ○

Asia Asia Asia Asia ○

Russia&CIS

Russia&CIS

Russia&CIS

Russia&CIS

Cemtral&South�America

Cemtral&South�America

Cemtral&South�America

Cemtral&South�America

ROW ROW ROW ROW

Focusing�Contract

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing Consulting

Research API

APIs

R&D

Pre-ClinicalPre-clinicalTest� Sample

R&D� Strategy&� Management

Phase� I Clinical� Trials

Phase� II Clinical� TestSample

FinishedProducts

RegulatoryAffairs ○

Phase� III BusinessDevelopment

FinishedProduct

Phase� IV Sales� &Marketing

Corporate

Product� Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

Generics APIs Devices Others

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 117

3.� Corporate� Business�Overview

Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

25 12.5 12.5 50

Contract� Service�

Capacity�

Affordable� by�

Service� Area

After� reaching�an�agreement�and� if� the� customer� requires�our� services,� then�proceed� to�

sign� a� contract� for� professional� services,� in� which� the� following� are� mentioned:

FIRST:� OBJECT.-� The� client� hires� ASREGTEC� group� of� professionals� who� provide� their�

services� autonomously� and� independently,� by:� making� the� documentary� analysis,�

technical� review� of� documents� in� accordance� with� regulations� of� the� competent�

authority,� and� monitoring� to� obtain� sanitary� registration� or� certificate.� THE�

CONTRACTORS� declare� that� they� are� in� the� capacity� to� conclude� the� contract,� under�

which� they� are� familiar� and� trained�with� the�matter� stated� therein�under� the� terms� and�

conditions� required� by� the� CONTRACTOR.

SECOND:� TERM.-� The� term� of� this� contract� may� be� terminated� once� the� work� of� the�

same� material� have� been� received� to� the� satisfaction� and/or� agreement� between� the�

parties.

THIRD:� OBLIGATIONS� OF� THE� CONTRACT� contractors� are� required� to:

•� Conduct� its� activities� with� full� transparency,� thoroughness� and� honesty.

•� Maintain� the� confidentiality� of� the� information� and� data� provided� by� the�

CONTRACTOR.

•�Responsible� for� the�management,�use�of� the� submitted�documentation�and� technical�

quality� of� the� tasks� assigned.

FOURTH:� FEES� AND� FORM� OF� PAYMENT.-� The� parties� agree� to� establish� professional�

fees� as� reach� an� agreement� with� the� customer� previously.

In� the� event� that� the� Employer� desist� proceeding� with� the� contract,� the� value� given� in�

advance,�will� be� for� the� benefit� of�CONTRATATISTAS,� since� it� is� his�will� not� continue� in�

the� contracted� activity.

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Contract� Service�

Capacity�

Affordable� by�

Service� Area

FIFTH:� For� its� part� the� contractor� promises� to� deliver� in� a� timely�manner� all� documents�

and� requirements� applying� contractor,� for� which� it� shall� record� by� email� or� trade� with�

which� the� document� delivery� is� made.

The� CONTRACTOR� is� responsible� for� the� authenticity,� originality� and� legality� of� all�

documents� he� hands� over� to� contractors,� the� same� to� be� delivered� properly� legible�

signatures� of� responsiblility� and� more� demands� determining� the� rules,� and� if� necessary�

submit� documents� consularized� apostille� or� in� the� case� of� foreign� documents.

SIXTH.� -�RELATIONSHIP�BETWEEN�CIVIL�parties:�Parties�This�Agreement� is� civil� in�nature,�

subject� to� common� law� and� particularly� the� rules� of� the�Mandate.� Therefore,� between�

the� contractor� and� contractors� there� is� no� employment� relationship� or� a� dependency,�

nor,� consequently� submission� to� the� Labour�Code�and�Law�of�Social� Insurance.�No� legal�

subordination� or� any� other� species� that�might� mean� working� relationship� between� the�

parties� or� their� dependents,� since� professional� provide� services� to� the� contractor� free,�

independent� and� autonomous.� Personnel� using� a� contractor� does� not� acquire� any�

dependent� relationship� with� the� Employer.

Through�this� contract� the� idea� is� to�ensure� the�ability�of�our�work�and� the� confidentiality�

of� our� customer� information� you� provide,� so� that� the� client� feels� safe� to�work�with� us.

Communication�

with� Clients

Providing�

Realtime

Service� Delivery

ASREGTEC� is� an� Ecuadorian� company� that� provides� regulatory�

affairs� for� regulating�products� of� human�use� and� consumption.�We�

guarantee� the�efficient�and�effective�procedure� for� the�sole�purpose�

to� fully� satisfy� our� customers.� Established� communication� channels�

with� our� clients� are:� via� email,� video� calls,� and� telephone� service�

wats� up.

Emails� are� answered� within� 24� hours;� phone� calls� and� service� are�

answered� wats� up� 08:00am-05:00pm� in� the� ime� zone� of� Ecuador�

and� video� calls� program� according� to� client� availability.

Realtime

Feed-back

Asrecteg� customer� feedback� since� the� service� process� starts,�

providing� the�necessary� information� required� in�accordance�with� the�

law�of� the� country.�By� reviewing� the�documentation�provided�by� the�

customer,� income�of� the� request� to� the� regulatory�agency,� reporting�

the� status� of� the� application,� through� reports,� which� can� be�

provided� by� mail,� video� conferences,� and� phone� calls� in� a� timely�

manner.

Once� the� service� ended� and� the� final� product� dossier� with� the�

relevant� documentation� delivered� to� the� customer� to� sustain� in� a�

later� control.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 119

4.� Corporate� Competitiveness

Corporate

Competitiveness

Our� business� competitiveness� reflected� in� agile� and� efficient� procurement� service�

provided.� For�which� continuous�monitoring�of� the� states� of� procedure�done� correctly�

entering� documentation� regulatory� agencies� in� accordance�with� regulations� in� force.�

Our� goal� is� to� not� only� get� the� best� results� but� also� that� these� results� are� the� best�

in� the� business� of� our� customers.

We� provide� quality� service,� reliability� and� effectiveness� through� a� high� and� technical�

expertise� in� regulatory� affairs,� so� that� no� time� elapses� without� regulatory� agencies�

have� timely� results.

It� has�highly� experienced�qualified� staff:� in� regulation�of�medical�devices,�biochemical�

reagents,�drugs,�biologics,�natural�products,� food,� cosmetics,� industrial�products,�with�

over� 4-10� years� of� expertise.� In� the� same�way� it� staffed� having� a�master’s� degree� in�

systems� management� quality,� certified� lead� auditor� in� Implementation� of� ISO� 13485�

(Good� Manufacturing� Practices� in� Medical� Devices),� highly� trained� in� good�

manufacturing�practices�and�storage,� certificates� compliance.�Also,�we�had�conducted�

training� in� health� systems� provided� by� NHIS,� WHO,� UNESCAP,� MOHW,� HIRA� and�

KHIDI� in� South� Korea� in� February� 2015� and� July� 2016.

Our� directors� on� regulatory� technical� issues� are� highly� trained,� because� continually�

being� updated� in� regulations� and� laws� for� the� regulation� of� products� of� human� use�

and� consumption

No.� of� Regulatory�

Inspections

ClassificationFDA

(US)

EMA

(EU)

PMDA

(Japan)

Russia

&CIS

Central

&� South

America

Middle

EastAfrica Others

Pre-Clinical�

Area

Clinical� Area ○ ○ ○ ○

Manufacturing�

Area○ ○ ○ ○

Others

Current� Status� of

Accredited�

Certification

ISO� 13485

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5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in�recent� 3� years

Countries� which

clients� belong� toChina,� Korea,� Turquia,� Israel

Asian� Clients'

Composition(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

40 20 20 20

No.� of� Asian� Clients

in� recent� 3� yearsThree� including� Mitsubishi� Tanabe� Pharma� Corporation� and� Daiichi� Sankyo

Major� Service� Range

with� Asian�

Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D

Pre-Clinical Pre-clinical

Test� Sample

R&D� Strategy

&�Management

Phase� I Clinical� Trials

Phase� IIClinical� Test

Sample

Finished

Products

Regulatory

Affairs○

Phase� IIIBusiness

DevelopmentFinished

ProductPhase� IV

Sales� &

Marketing

6.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

We� provide� our� services� autonomously� and� independently,� taking� care� of� the� analysis� and� technical� review�

of� documents� in� accordance� with� regulations� of� the� competent� authority� for� Registration� or� Notification� of�

Sanitary� and� foreign� manufacture

We�guarantee� the�ability� to�provide�our� services,�we�are�under� trained�and� familiar�with� the�matter� indicated.�

The� idea� is� that� the� process� is� not� observed� and� wasting� time.

Currently,�we�have�a� friend�who�works� in� the�Ministry�of�Health�of�Afghanistan�who� is� interested� in� importing�

some� products� from� Korea,� we� will� comment� on� the� services� we� provide,� for� this� reason� it� is� interested� in�

Korean�products,�we�would� like�wholeheartedly� to� contribute� to� carry�out� this� type�of�business�opportunities.

Thank� you� very�much� for� the� application� form� sent,� if�we� can� help� and� contribute�with� our� knowledge� and�

ability� in� the� areas� of� regulatory� affairs� for�which� it� transacts� business� between� countries� in� the�Middle� East�

and� Asia� with� Korea,� will� be� a� pleasure� to� be� part� of� your� team� of� work.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 121

12. Binzhou Hollyally Pharmaceutical Co.,Ltd.

1.� Corporate� General� Information

Corporate� Name Binzhou� Hollyally� Pharmaceutical� Co.,Ltd.

Corporate� Ownership Private� Company

Head� Office� AddressNo.2,The� 9th� Wutong� Rd.,� Binbei� Town,� Binzhou� City,Shandong�

Province,China

Facilities� City� &� Country Binzhou(CHINA)

Web-site� Address www.hollyally.com

No.� of� Employees 200+

Financial� Status

Sales� Revenue� in�2012(US� K$)

Capital(US� K$) Dept-equity� Ratio(%)

2,000 5,000

Contact(Korean�Business)

Name Shirly� Peng

Address No.15� Dapu� Road,Huangpu� District� Shanghai,P.R.China

Telephone 021-62386487

E-mail [email protected]

Company� History

Binzhou� Holly� Pharmaceutical� Co.,Ltd.� was� established� in� 2006� ,its� predecessor� was� Haining� Sino� Fine�Chemical� Co.,Ltd� since� 1995.

With� more� than� 10years� development,We� have� got� the� certificates� of� ISO9001and� ISO014001and� has�

expand� to� 8� production� lines� and� 6�workshops� to� ensure� it� can� continue� to� deliver� on� its� commitments� to�the� customers.

Holly� is� an� innovation� company�with� tradition� of� technology� development� and� research,working�with� a� lot� �

famous� universities� in� China,holly� is� supported� with� industry-leading� processes� of� promising� products�through� innovation.

Would� like� to� high-quality� platform,� industry� elite� to� develop� together.

Company� Description� &� Organization

Founded� in� 1995,� Binzhou�Holy� Pharmaceutical� Co.,� Ltd� is� a�manufacturer� specializing� in� the� Intermediates�

&� Pharmaceutical� products� and� our� products� have� being� exported� to� USA,� Japan,� Europe,� and� South-east�Asia� etc.�

We� are� pursuing� technical� advancement� and� stressing� on� the� R&D� of� new� products� and� the� introduction�

of� human� resource.� we� have� established� a� pharmaceutical� chemical� institute� which� is� specialized� in� the�intermediates� of� medicine� and� dyeing� in� June,� 1996.� our� factory� covers� an� area� of� 20,� 000sqm,� including�

2� workshops� and� a� pilot� factory,� 50� sets� of� 50-5000L� glass� lining� reactor,� 10� sets� of� 500-2000L� stainless�

steel� reactor� and� distill� &� finestill� reactor.� with� complete� public� structure� and� after� treated� equipment,� we�can� provide� diversified� products� for� you� upon� your� requirement.�

Living�on�quality,�we�have�a� complete�quality�control� system.�And�our� laboratory�equips�with�HPLC,�GC�and�

other� equipments� such� as� MP,� acidimeter,� ultraviolet� lamp,� spectrophotometer,� potentiometric� titrimetric,�etc.�

In�a�word,�we�will� provide�you�a�better�quality,� a�competitive�price�and�a� first-class� service,�welcome�to� you�

and� your� cooperation� for� a� mutual� development!

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2.� Corporate� Service� &�Business� Area

Corporate� Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

○ ○ ○ ○

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US US US US ○

Canada Canada Canada Canada

EU EU EU EU

Asia Asia ○ Asia Asia

Global ○ Global Global ○ Global

Other Other Other Other

Focusing� Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research ○ API ○

APIs ○

R&D

Pre-Clinical Pre-clinical

Test� Sample

R&D� Strategy

&�

Management

Phase� I Clinical� Trials

Phase� IIClinical� Test

Sample

Finished

Products

Regulatory

Affairs

Phase� IIIFinished

Product

Business

Development

Phase� IVSales� &

Marketing○

Corporate� Product�

Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

Generics APIs Devices Others

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 123

3.� Corporate� Business�Overview

Clients'� Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

70 15 10 5

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

Manufacturin

g

Custom� Sales

Focusing� Therapeutic�

Area

OncologicsLipid�

Regulators

Respiratory�

AgentsAnti-ulcerants

Angiotensin� � �

II� Antagonists

40 5

AntipsychoticsAutoimmune�

agents

Antidepressan

tsAnalgesics Others

15 15 15 10

Our� products� such� as� the� Veratraldehyde,� Isovanillin� and� Amantadine� HCL� can�

be� used� to� product� the� drugs� in� the� areas� of� anticancer,antiallergic,

anti-depression� etc.Also� they� have� gain� a� sound� identification� � in� the�

pharmaceutical� line.

Communication� with�

Clients

Dispositoion� of

Project�Manager

Responsible

Making� the� overall� plan� for� the� project,� in� charge� of� the�

manufacturing� process� and� control� the� quality� of� products,�

delivery� and� other� issues

Providing�

Realtime

Service� Delivery

We� are� responsible� for� the� delivery� of� the� goods,� being�

through� product� inspection

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4.� Corporate� Competitiveness

Corporate

Competitiveness

Founded� in� 1995,� Binzhou� Holy� Pharmaceutical� Co.,ltd� � is� a� manufacturer�

specialising� in� the� Intermediates�&�Pharmaceutical�products.� and�our�products�

have� beening� exported� to� USA,� Japan,� Europe,� and� South-east� Asia� etc.� �

We� are� pursuing� technical� advancement� and� stressing� on� the� R&D� of� new�

products� and� the� introduction� of� human� resource.� we� have� established� a�

pharmaceutical� chemical� institute� which� is� specilized� in� the� intermediates� of�

medicine� and�dyeing� in� June,1996.� our� factory� covers� an� area� of� 20,000sqm,�

including� 2� workshops� and� a� pilot� factory,� 50� sets� of� 50-5000L� glass� lining�

reactor,� 10� sets� of� 500-2000L� stainless� steel� reactor� and� distill� &� finestill�

reactor.�with� complete� public� structure� and� after� treated� equipment,�we� can�

provide� diversified� products� for� you� upon� your� requirement.�

Living� on� quality,� we� have� a� complete� quality� control� system.� and� our�

laboratory� equiped� with� HPLC,� GC� and� other� equipments� such� as� MP,�

acidometer,� ultraviolet� lamp,� spectrophotometer,� potentiometric� titrimetre,�

etc.

No.� of� Regulatory

Inspections

ClassificationFDA

(US)

EMA

(EU)

PMDA

(Japan)

CFDA

(China)

DCI

(India)Others

Pre-Clinical� Area

Clinical� Area

Manufacturing� Area ○

Others

Current� Status� of

Accredited� Certification

SO9001� international� quality� system� certification� and� ISO14001� environment�

system� certification

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 125

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� toChina,� India,� Japan

Asian� Clients'

Composition(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

75 15 5 5

No.� of� Asian� Clients

in� recent� 3� yearsMore� than� 20

Major� Service�

Range

with� Asian�

Companies

Contract�

Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API ○

APIs ○

R&D ○

Pre-Clinical Pre-clinical

Test�

Sample

R&D� Strategy

&�

Management

Phase� I Clinical� Trials

Phase� II ○ Clinical�

Test

SampleFinished

Products

Regulatory

Affairs

Phase� IIIBusiness

Development

Finished

ProductPhase� IVSales� &

Marketing

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126� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

13. BioInvent International AB

1.� Corporate� General� Information

Corporate� Name BioInvent� International� AB

Corporate� Ownership Public� Company

Head� Office� Address Solvegatan� 41

Facilities� City� &� Country Lund(Sweden)

Web-site� Address www.bioinvent.com

No.� of� Employees 48

Financial� Status

Sales� Revenue� in� 2011

(US� K$)Capital(US� K$) Dept-equity� Ratio(%)

11,500 15,600 0.86

Contact

(Korean�

Business)

Name Kristina� Berggren

Address 223� 70� Lund,� Sweden

Telephone +46� 46� 2868550

E-mail [email protected]

Company� History

BioInvent� was� founded� in� 1985� as� a� CMO� and� developed� its� services� by� an� acquisition� of� a� fully� human�

antibody�discovery� technology� called�nCoDeR®� in�2000.�After� listing� in�2001� the� company�pursued�a�hybrid�

business� model� of� own� development� with� partnering� and� fee� for� service� activities� such� a� contract�

manufacturing� and� antibody� discovery.� Today� it� maintains� a� hybrid� business� model� and� is� focused� on�

oncology� for� its� own� development� programs.

Company� Description� &� Organization

BioInvent� International�AB,� listed�on� the�NASDAQ�OMX�Stockholm�(BINV),� is� a� research-based�pharmaceutical�

company� that� focuses� on�discovery� and� development� of� antibody� drugs.� The� Company� currently� engages� in�

innovative�drug�projects,�primarily� in� cancer�with�one�program� in�phase� I� clinical� trials� (BI-505)�and�two�new�

drug� candidates,� where� the� next� developmental� phase� involves� toxicological� studies.� In� addition� to� these�

projects,� the� Company's� development� activities� include� a� focused� research� program� in� collaboration� with�

Cancer� Research� Technology,� UK,�with� the� goal� of� discovering� novel� drug� candidates� that� inhibit� the� action�

of� tumour-associated� macrophages� in� the� development� of� cancer.� The� company's� competitive� position� is�

underpinned� by� n-CoDeR®� and� F.I.R.S.T.TM,� proprietary� antibody� and� target� discovery� platforms.

In�addition,�BioInvent�develops�antibody�drugs� for�partners.� The� scope�and�strength�of� the�antibody� �discovery�

platform� is� utilised� by� partners,� such� as� Bayer� HealthCare,� Daiichi� Sankyo,� Mitsubishi� Tanabe,� Sevier� and�

others.

The� number� of� full� time� employees� is� 48� with� 39� employees� working� in� research� and� development� hereof�

16� work� in� process� development� and� production.�

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 127

2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Geographical

Business�Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US US US US

Canada Canada Canada Canada

EU EU EU EU

Asia Asia Asia Asia

Global ○ Global Global Global

Other Other Other Other

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research ○ API

APIs

R&D

Pre-Clinical ○R&D� Strategy

&� ManagementPre-clinical

Test� SamplePhase� I ○ Clinical� Trials

Phase� IIClinical� Test

Sample

Finished

Products

Regulatory

Affairs

Phase� IIIBusiness

DevelopmentFinished

ProductPhase� IV

Sales� &

Marketing

Corporate�

Product� Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

Generics APIs Devices Others

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Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

80% 10% 5% 5%

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

○ ○ ○ ○

Focusing�

Therapeutic� Area

(%)

Oncologics Lipid� RegulatorsRespiratory�

AgentsAnti-ulcerants

Angiotensin� II�

Antagonists

100 0 0 0 0

AntipsychoticsAutoimmune�

agentsAntidepressants Analgesics Others

0 0 0 0 0

Target� and� antibody� discovery� based� services� are� applicable� to� any� indication� area�

whereas� preclinical� and� development� services/collaborations� are� focused� on� oncology

General� Overview

of�Corporate's�Key

Contract� Services

Fully� Human� Therapeutic� Antibody� and� Target� Discovery

BioInvent� represents� high�quality� discovery�and�development� of� fully�human� therapeutic�

antibodies.� With� more� than� 20� years� experience� of� antibodies� and� with� cutting� edge�

technology� in-house,� BioInvent� is� the� partner� of� choice� for� therapeutic� antibody�

discovery� and� development.

At� BioInvent�we� combine� a� deep� knowledge� and�understanding�of� target� and� antibody�

biology�with�excellent� infrastructure� for�discovery�and�development,�e.g.�proprietary� fully�

human� n-CoDeR®� antibody� library,� automated� robotic� discovery� system,� high�

throughput� conversion� to� fully� natural� human� IgG,� disease� relevant� in-vitro� and� in-vivo�

functional� testing,� cellline� development,� cGMP� manufacturing� and� pre-clinical� and�

clinical� development� expertise.� � We� are� committed� to� the� success� of� our� partners� and�

we�can�support� your�human�antibody�drug�development�program� from�discovery� to� the�

clinic.

Functionality� and� disease� related� discovery� are� in� focus� at� BioInvent.� The� n-CoDeR® �

discovery�process� can�utilize� cell� lines,�primary� cells,�patient�material� and� soluble� targets�

to� deliver� antibodies� to� proteins,� peptides,� carbohydrates,� trans-membrane� receptors,�

glycoproteins,� post-translationally� modified� proteins� and� small� molecules.�

The� F.I.R.S.T.TM� platform� delivers� superior� functional� antibodies� and� targets� together�

3.� Corporate� Business�Overview

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 129

without� prior� knowledge� of� the� identity� of� these� targets.� The� use� of� primary� patient�

material� throughout� the� discovery� ensures� antibodies� to� clinically� relevant� up-regulated�

targets� or� epitopes.� Patient� material� from� haematological� cancer� e.g.� CLL,� AML,� is�

available� at� BioIvent� for� Antibody� and� Target� discovery.

General� Overview

of�Corporate's�Key

Contract� Services

The� n-CoDeR®andF.I.R.S.T.TMsystem:�

•� Fully� human� phage� display� libraries�

(scFv,� Fab)

•� High� diversity� and� functionality

•� High� affinity� antibodies

Technical� Advantage:�

•� Single� framework

•� High� throughput� conversion� to� IgG

•� Fully� natural� low� immunogenicity� IgG

•� Rapid� discovery

Application:

•� Antibodies

•� Targets

Services� and� out-license� opportunities

Contract� Service�

Capacity�

Affordable� by�

Service� Area

Robotics� capabilities� ensure� high� levels� of� throughput� and� capacity� available.

Communication�

with� Clients

Dispositoion� of

Project� Manager

Responsible

A� program� defined� Project� Manager� is� assigned.� In� addition,� all�

partner� programs� have� an� alliance� manager� assigned.� In� cases�

where� antibody/target� discovery� and� development� work� is�

performed� at� BioInvent,� a� working� group� is� led� by� the� Project�

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Manager� at� BioInvent.� A� project� plan� with� associated� budget� and�

timeline� is�developed� for�which�project�progress� is� reported�against.�

Joint� BioInvent-partner�meetings� are� scheduled� once�monthly� or� as�

otherwise� agreed� and� such� meetings� can� alternate� between�

face-to-face,� telephone� or� videoconference� meetings.� Face-to-face�

meetings� are� recommended� at� least� once� yearly.�

In� cases� where� all� antibody� discovery� and� development� work� is�

performed� at� the� partner� site,� a� technology� support� function� and�

training� is� provided� by� BioInvent

Providing�

Realtime

Service� Delivery

Delivery� is� project� dependent� please� enquire

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 131

4.� Corporate� Competitiveness

Corporate

Competitiveness

As� described� in� section� III� No� 4:�

BioInvent� represents� high� quality� discovery� and� development� of� fully� human�

therapeutic� antibodies.� With� more� than� 20� years� experience� of� antibodies� and� with�

cutting� edge� technology� in-house,� BioInvent� is� the� partner� of� choice� for� therapeutic�

antibody� discovery� and� development.

At� BioInvent� we� combine� a� deep� knowledge� and� understanding� of� target� and�

antibody� biology� with� excellent� infrastructure� for� discovery� and� development,� e.g.�

proprietary� fully� human� n-CoDeR®� antibody� library,� automated� robotic� discovery�

system,� high� throughput� conversion� to� fully� natural� human� IgG,� disease� relevant�

in-vitro�and� in-vivo� functional� testing,� cell� line�development,� cGMP�manufacturing�and�

pre-clinical� and� clinical� development� expertise.� �We� are� committed� to� the� success� of�

our� partners� and� we� can� support� your� human� antibody� drug� development� program�

from� discovery� to� the� clinic.

Functionality� and� disease� related� discovery� are� in� focus� at� BioInvent.� The� n-CoDeR® �

discovery� process� can� utilize� cell� lines,� primary� cells,� patient� material� and� soluble�

targets� to� deliver� antibodies� to� proteins,� peptides,� carbohydrates,� trans-membrane�

receptors,� glycoproteins,� post-translationally� modified� proteins� and� small� molecules.�

The� F.I.R.S.T.TM� platform� delivers� superior� functional� antibodies� and� targets� together�

without� prior� knowledge� of� the� identity� of� these� targets.� The� use� of� primary� patient�

material� throughout� the�discovery�ensures�antibodies� to� clinically� relevant�up-regulated�

targets� or� epitopes.� Patient� material� from� haematological� cancer� e.g.� CLL,� AML,� is�

available� at� BioIvent� for� Antibody� and� Target� discovery.

Current� Status� of

Accredited�

Certification

Certificate� of� GMP� compliance� of� a� manufacturer� issued� be� the� Swedish� Medical�

Products� Agency.

There� are� no� accredited� certification� for� GSP� in� Sweden.� However,� the� research� lab�

work� according� to� GSP.�

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5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� toJapan

Asian� Clients'

Composition(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

100% 0% 0% 0%

No.� of� Asian� Clients

in� recent� 3� yearsThree� including� Mitsubishi� Tanabe� Pharma� Corporation� and� Daiichi� Sankyo

Major� Service� Range

with� Asian�

Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research ○ API ○

APIs

R&D

Pre-ClinicalPre-clinical

Test� Sample○

R&D� Strategy

&�Management

Phase� I Clinical� Trials

Phase� IIClinical� Test

Sample○

Finished

Products

Regulatory

Affairs

Phase� III

Finished

Product○

Business

Development

Phase� IVSales� &

Marketing

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 133

14. Biologics Consulting Group

1.� Corporate� General� Information

Corporate� Name Biologics� Consulting� Group

Corporate� Ownership Private� Company

Head� Office� Address 400� N.� Washington� St� Alexandria,� VA� 22314

Korean� Business� Office#1203� Yongbiuchonga,� Jongno-gu,� Naesu-dong,� Seoul,� Republic� of� Korea�

110-170

Web-site� Address www.biologicsconsulting.com

No.� of� Employees 50

Contact

(Korean�

Business)

Name Julie� Yi,� MedClaris� LLC

Address#1203� Yongbiuchonga,� Jongno-gu,� Naesu-dong,� Seoul,� Republic� of� Korea�

110-170

Telephone +82-10-8963-3652

E-mail [email protected]

Company� History

Biologics� Consulting� Group,� Inc� (BCG)� was� originally� founded� as� Kenimer� Associates� in� 1993� by� James� G.�

Kenimer� Ph.D.,� former� Deputy� Director� of� the� Division� of� Vaccines� and� Related� Products� Applications.� � In�

1998,� the� company� was� reorganized� as� The� Biologics� Consulting� Group,� LLC� and� in� the� next� several� years�

the� staff�grew� to� fifteen� consultants.�By�2001� the� consultants�active� in� the� San�Francisco�Bay�area,�Research�

Triangle� Park,�NC,� and� the� Boston� area.� �Over� the� next� ten� years,� our� reputation� continued� to� grow�as�well�

as� our� consultant� ranks.� In� 2010-2011� BCG� provided� consulting� services� to� over� 500� clients,� including� over�

125� international� companies.� During� this� same� time,� BCG� helped� produce�more� than� 50� original� INDs� (and�

multiple� IND� Amendments)� and� participated� in� 10� of� the� 12� BLAs� approved� in� 2010.

Company� Description� &� Organization

Biologics� Consulting� Group,� Inc.� is� the� leading� regulatory� consulting� firm� in� product� development� and�

regulatory� strategy� for�Biologics,�Drugs,� and�Medical�Devices.� For�almost�20� years,�Biologics�Consulting�Group�

has� supported� clients� in� the� preparation� and� review� of� CBER,� CDER� and� CDRH� regulatory� applications,�

product� development� strategies,� Quality� (or� CMC)� requirements,� pre-clinical� and� clinical� study� designs,�

GLP/GCP/GMP� audits,� and� strategic� business� planning.

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134� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Geographical

Business�Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US US US US ○

Canada Canada Canada Canada ○

EU EU EU EU ○

Asia Asia Asia Asia ○

Global Global Global Global

Other Other Other Other

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D ○

Pre-Clinical Pre-clinical

Test� Sample

R&D� Strategy

&� Management

Phase� I Clinical� Trials

Phase� IIClinical� Test

Sample

Finished

Products

Regulatory

Affairs○

Phase� IIIFinished

Product

Business

Development○

Phase� IVSales� &

Marketing

Corporate�

Product� Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

○ ○ ○ ○ ○

Generics APIs Devices Others

○ ○ ○

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 135

3.� Corporate� Business�Overview

Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

20% 30% 25% 25%

Focusing�

Therapeutic� Area

Biologics� Consulting� Group’s� product� specialities� include:� Blood-Derived� Products,� Cell�

and� Gene� Therapies,� Combination� Products,� Medical� � Devices,� Pharmaceuticals,�

Therapeutic� Proteins,� and� Vaccines.

General� Overview

of�Corporate's�Key

Contract� Services

Biologics� Consulting� Group,� Inc.� (BCG)� specializes� in� providing� regulatory,� product�

development� and� quality� systems� consulting� services� to�manufacturers� of� biologic,� drug�

and� medical� device� products.� Our� staff� consists� of� experts� in� quality� management,�

regulatory�affairs,�product�manufacturing�and�testing,�pharmacology/toxicology,�medical�

device�biocompatibility,� clinical� trial�design�and�evaluation,� statistics,�and�GMP,�GLP,�GCP�

regulatory�compliance.�We�offer�product�development�consulting�services�and� regulatory�

support� based� on� a� full� understanding� of� FDA� regulatory� expectations� and� policies.

BCG’s� services� include:�Clinical�Development,�E-Publishing,�Manufacturing�and�Analytical�

Development,� Medical� Device� Regulatory,� Pharmacology� and� Toxicology,� Product�

Development�Planning,�Project�Management,�Quality�Management,�Regulatory�Support,�

Strategy� Planning,� and� Training.

Contract� Service�

Capacity�

Affordable� by�

Service� Area

Biologics� Consulting� Group� provides� product� development� and� regulatory� strategy� for�

biological� therapeutics,� vaccines,� cell� and� gene� therapies,� pharmaceuticals,� and�medical�

devices.� � BCG� supported� over� 550� clients� in� 2011,� including� serving� as� US� Agent� for�

approximately� 40� international� companies� with� applications� at� the� US� FDA.

Communication�

with� Clients

Dispositoion� of

Project� Manager

Responsible

BCG� has� a� team� of� project�managers� experienced� in� working�with�

international� clients.

Providing�

Realtime

Service� Delivery

BCG� focuses� on� delivering� high� quality� advice� on� schedule� and�

budget.� � We� maintain� active� contact� with� clients� throughout�

projects.

Realtime

Feed-back

BCG� utilizes� a� shared� collaboration� tool,� Central� Desktop,� that�

allows� for� realtime� exchange� of� documents.

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4.� Corporate� Competitiveness

Corporate

Competitiveness

Many�of� our� consultants� are� former� CBER,� CDER,� and�CDRH� reviewers,� certified� FDA�

inspectors,� and� senior� scientists� from� the� biotechnology� industry.� � Our� understanding�

of� the� FDA� enables� us� to� clarify� the� tough� decisions� and� bring� the� right� balance� of�

business,� scientific,� and� regulatory� to� product� development.�

Current� Status� of

Accredited�

Certification

Certified� inspectors� for� GLP,� GCP,� GTP,� GMP.

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� toSouth� Korea,� Taiwan,� India,� Japan

Asian� Clients'

Composition(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

50% 20% 20% 10%

No.� of� Asian� Clients

in� recent� 3� years45� clients

Major� Service� Range

with� Asian�

Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D

Pre-Clinical ○R&D� Strategy

&�ManagementPre-clinical

Test� SamplePhase� I ○ Clinical� Trials ○

Phase� IIClinical� Test

Sample

Finished

Products

Regulatory

Affairs○

Phase� IIIBusiness

Development○

Finished

ProductPhase� IV

Sales� &

Marketing

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 137

6.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

Biologics� Consulting� Group� actively� supports� KFDA� initiatives� for� advancing� drug� regulatory� policy,�

both� in� Korea� and� globally.

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138� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

15. Biomedcode Hellas SA

1.� Corporate� General� Information

Corporate� Name Biomedcode� Hellas� SA

Corporate� Ownership Private� Company

Head� Office� Address 34� Al.� Fleming� Street,� Vari,� 16672

Facilities� City� &� Country ATHENS(GREECE)

Web-site� Address http://www.biomedcode.com

No.� of� Employees 15

Financial� StatusSales� Revenue� in� 2012(US� K$) Capital(US� K$) Dept-equity� Ratio(%)

US$� 1,810� K US$� 81� K

Contact

(Korean�

Business)

Name Maria� C.� Denis,� PhD

Address 34,� Al.� Fleming� str.� -16672� GREECE

Telephone +30� -� 2109655366

E-mail [email protected]

Company� History

Biomedcode�was� founded� in�2006�as�a�spin-off�company�of�Biomedical� Sciences�Research�Center�"Alexander�Fleming”,� capitalizing�on� the� long� lasting�expertise�of� its�Board�of�Directors�and�Scientific�management� team�in� successfully� generating� mouse� models� mimicking� human� inflammatory� diseases.�With� a� primary� focus� on� anti-TNF� therapeutics,� Biomedcode’s� humanized� animal� models� were� instrumental�in� demonstrating� the� therapeutic� efficacy� of� Infliximab� (Remicade®)� currently� one� of� the� most� successful�anti-TNF� therapeutics� in� the� global� anti-rheumatics� market.In� just� 7� years� since� its� establishment,� Biomedcode� rapidly� developed� into� a� highly� successful� enterprise�providing� services� world� wide� to� emerging� biotech� and� global� pharmaceutical� companies.

Company� Description� &� Organization

Biomedcode� Hellas� SA� is� a� Contract� Research� Organization� (CRO)� providing� full� preclinical� drug� evaluation�services�using�a�unique� collection�of�proprietary�humanized�mouse�models� ideal� for� the�evaluation�of�human�therapeutics.Biomedcode� offers� a� diverse� array� of� standardized� preclinical� evaluation� platforms� based� on� proprietary�humanized� animal� models� of� either� spontaneous� or� induced� inflammatory� conditions� closely� resembling�human� inflammatory� diseases� including� Rheumatoid� Arthritis,� Intestinal� Inflammation,� Psoriasis,� Multiple�Sclerosis� and�others.�Biomedcode’s�humanized�mouse�models�have�provided�proof-of-principle�evidence�used�for� FDA,� SFDA� &� EMEA� Investigational� New� Drug� (IND)� and� Biosimilar� applications� for� therapeutics,� some�of� which� have� entered� the� market.Always� aiming� at� high� quality� services� coupled� to� true� customer� focus,� Biomedcode� has� built� its� reputation�steadily�over� the�years�gaining� the� trust�and� respect�of� its�clients,�which� include�worldwide�emerging�biotech,�as� well� as� returning� global� pharmaceutical� companies� from� Europe,� the� United� States,� Asia� and� Australia,�some� of� them� ranked� among� the� top� 5� pharmaceutical� companies� worldwide.�To� sustain� its� lead� in� preclinical� drug� evaluation� outsourcing� services,� BioMedCode�maintains� a� highly� active�R&D� program� that� aims� to� generate� and� exploit� novel� humanized� animal� disease� models,� identify� disease�biomarkers� and� characterize� disease� related� cellular� and� molecular� pathways.� This� activity� is� partially�supported� by� a� number� of� European� and� National� collaborative� funding� programs� further� enhancing� the�networking� of� Biomedcode� both� with� industry� and� academia.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 139

2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Geographical

Business�Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US US US US

Canada Canada Canada Canada

EU EU EU EU

Asia Asia Asia Asia

Global ○ Global Global Global

Other Other Other Other

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D

Pre-Clinical ○R&D� Strategy

&� ManagementPre-clinical

Test� SamplePhase� I Clinical� Trials

Phase� IIClinical� Test

Sample

Finished

Products

Regulatory

Affairs

Phase� IIIBusiness

DevelopmentFinished

ProductPhase� IV

Sales� &

Marketing

Corporate�

Product� Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

○ ○ ○ ○ ○

Generics APIs Devices Others

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140� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

3.� Corporate� Business�Overview

Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

35% 20% 35% 10%

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

○ ○

General� Overview

of�Corporate's�Key

Contract� Services

Biomedcode� provides� full� preclinical� drug� evaluation� services� using� standardized�

proprietary� animal�disease�models�of� chronic� and�acute� inflammation� closely� resembling�

the� human� disease.� With� a� primary� focus� on� anti-hTNF� therapeutics,� Biomedcode's�

Tg197�humanized� TNF� animal�model�of�Arthritis�was� instrumental� in�demonstrating� the�

therapeutic� efficacy� of� Infliximab� and� in� the� past� 7� years� Biomedcode� has� used� the�

Tg197�model� to�evaluate�all� the� commercially� available�anti-hTNF� therapeutics,� including�

Enbrel,� Humira,� Cimzia� and� Simponi,� as� well� as� their� biosimilars� and� biobetters.

In� addition� to� our� expertise� in� the� field� of� Arthritis�we� have� also� developed� proprietary�

animal� disease� models� for� the� evaluation� of� human� therapeutics� targeting� other�

inflammatory� diseases� such� as� IBD,� Psoriasis� and� MS.� Finally,� we� also� perform� custom�

development� of� disease�models� and� assays� for� the� evaluation�of� therapeutics� and�novel�

technological� platforms,� including� small� molecules,� biologics� and� biosimilars.

Contract� Service�

Capacity�

Affordable� by�

Service� Area

Biomedcode� offers� standardized� preclinical� platforms� based� on� humanized� mouse�

models� that� allow� the� evaluation� of� pharmaceuticals� targeting� human� molecules� in�

chronic� and� acute� inflammatory� diseases.� The� services� offered� combine� scientific�

consulting� and� custom-tailored� solutions� optimizing� the� validation� procedure� of� novel�

and� biosimilar� pharmaceuticals� as� well� as� novel� therapeutic� approaches.

As� the� services� we� provide� are� custom-tailored� to� clients’� specific� needs� and�

requirements,� we� always� try� to� accommodate� clients’� schedules� and� time� plans.

Communication�

with� Clients

Dispositoion� of

Project� Manager

Responsible

Biomedcode� has� an� adequate� organizational� structure�with� defined�duties� and� authority.� The� project� manager/study� director� has� the�recourses� and� the� full� authority� to� use� the� planned� and� agreed�recourses�plus�a� certain�degree�of� flexibility� in� special�cases,� to� react�according� to� the�needs�of� the�given�situation�and� for� the�benefit�of�the� study.

Providing�

Realtime

Service� Delivery

All� scientific� personnel� of� the� company� are� available� and� have� the�ability� to� discuss� scientific� and� technical� aspects� of� the� services�provided� when� requested� by� the� client.� Realtime� update� based� on�the� time� plan� of� the� services� can� be� provided� upon� request.�

Realtime

Feed-back

Clients� have� the� opportunity� to� be� updated� real-time� on� the�

progress� of� the� services� provided.� We� develop� long-term �

relationships� with� our� clients� by� ensuring� timely,� reliable� and�

efficient� processes.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 141

4.� Corporate� Competitiveness

Corporate

Competitiveness

Biomedcode‘s� primary� focus� is� always� the� novelty,� uniqueness� and� quality� of� the�

provided� services� and� the� competitiveness� of� the� offered� price.�

Biomedcode� offers� services� based� on� world� wide� unique� humanized� mouse� disease�

models� closely� resembling� the� human� pathology� of� inflammatory� diseases� including�

arthritis,� intestinal� inflammation,� psoriasis� and�Multiple� Sclerosis.� The� combination� of�

humanized� animal�models�with� either� spontaneous� or� induced� inflammatory� diseases�

offers� a� diverse� array� of� preclinical� drug� evaluation� platforms� ideal� for� the� preclinical�

testing� of� therapeutics� targeting� human� disease.

Biomedcode�offers� services� in�a�well� structured,�organized�and� timely� fashion�and�we�

have� always� been� proud� of� the� quality� of� services� we� provide� to� our� clients.� We� do�

this� through� a� team� of� exceptional� scientists,�well� trained� and� competent,�with� solid�

experience� in� their� scientific� field�of� expertise.� Furthermore,�Biomedcode� is� capitalizing�

on� the� long� lasting�expertise�of� its�Board�of�Directors�and�Scientific�management� team�

in� successfully� generating� and� characterizing� humanized� mouse� disease� models.

In� addition,� Biomedcode� is� fully� equipped� to� conduct� cutting� edge� research� having� a�

state� of� the� art� mouse� facility� for� animal� studies,� as� well� as� a� fully� equipped� lab� for�

molecular� and� cellular� analyses.

Biomedcode�has� the� potential� to� address� customers'� needs� from� an� expert's� point� of�

view� providing� personalized� solutions� and� advise� for� top� quality� drug� evaluation�

services.� Even� though�we� are� not�GLP� accredited� yet,�we� follow�GLP�procedures� and�

any�other�provisions�established�by�national� legislation�and�we�always�make� sure� that�

full� documentation� is� in� place� and� at� client’s� disposal.

No.� of� Regulatory

Inspections

Classification FDA(US) EMA(EU) PMDA(Japan) Others

Pre-Clinical� Area

We� are� regularly�audited� by� our�clients� from�

USA,� EU,� Korea

Clinical� Area

Manufacturing� Area

Others

Current� Status� of

Accredited�

Certification

We� work� according� to� GCP

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� toNone� only� US� and� EU� companies

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142� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

16. BioStata ApS

1.� Corporate� General� Information

Corporate� Name BioStata� ApS

Corporate� Ownership Private� Company

Head� Office� Address Symbion� Science� Park,� Fruebjergvej� 3,�

Facilities� City� &� Country DK-2100� Copenhagen,� Denmark

Web-site� Address www.biostata.com

No.� of� Employees 7

Financial� Status

Sales� Revenue� in� 2010�

(US� K$)Capital(US� K$) Dept-equity� Ratio(%)

0.5 0.2 40

Contact

(Korean�

Business)

Name Bjarne� Bodin

Address Symbion� Science� Park,� Fruebjergvej� 3,� DK-2100� Copenhagen,� Denmark

Telephone +45� 2023� 5778

E-mail [email protected]

Company� History

Founded� Feb�2010�by� Bjarne� Bodin.� Based�on�more� than� 20� years� experience� from� the� CRO� industry.�More�

than� 40� DMC� performed� and� now� conducting� clinical� trials� in� more� than� 10� european� countries� and� DMC�

worldwide.� The� company� is� growing� fast.

Company� Description� &� Organization

BioStata� is�an�experienced�CRO� in�Statistics�and�Data�Management�with�experience�and�expertise�also� in�Data�

Monitoring� Committees� (DMC/DSMB).

Our� staff� has� generally� more� than� 15� years� experience� in� clinical� trials� and� we� are� working� in� many�

therapeutic� areas.�We� conduct� multinational� trials� and� participate� in� number� of� DMC� worldwide.�We� have�

a� complete� setup� available� for� DMC� and� a� network� of� international� well� known� statisticians� as� well� as�

clinicians,� to� the� benefit� of� our� clients.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 143

2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

○ ○

Geographical

Business�Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US DMC US US US

Canada DMC Canada Canada Canada

EU All EU EU EU Stat/DM

Asia DMC Asia Asia Asia

Global DMC Global Global Global

Other Other Other Other

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D

Pre-ClinicalR&D� Strategy

&� ManagementPre-clinical

Test� SamplePhase� I ○ Clinical� Trials ○

Phase� II ○Clinical� Test

Sample

Finished

Products

Regulatory

Affairs

Phase� III ○Business

DevelopmentFinished

ProductPhase� IV ○

Sales� &

Marketing

Corporate�

Product� Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

○ ○ ○ ○ ○

Generics APIs Devices Others

○ ○ ○

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144� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

3.� Corporate� Business�Overview

Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

40% 20% 10% 10%

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

Focusing�

Therapeutic� AreaBroad� Stat+DM+DMC

General� Overview

of�Corporate's�Key

Contract� Services

providing� fast� easy� eCRF� solutions� or� pCRF� solutions� all� inclusive� meaning� coding,�

randomization� etc

providing� DMC� setup� or� participation� e.g.� member� or� chair

providing� statistical� input� for� planning� or� reporting

working� with� partners� to� provide� clinical� services.

Contract� Service�

Capacity�

Affordable� by�

Service� Area

Although� just� 7� people� we� conduct� large� scale� trials� as� well� as� small� scale� trial.

Speed�and�quality� is� important�and�delivered�by�experienced�DM,�Stat�or�DMC�providers.

Communication�

with� Clients

Dispositoion� of

Project� Manager

Responsible

Ensure�client� is�updated�at� least�monthly�and�more�often� if� required�

in�periods.�One�main�contact�available�and�updated�on� financial�and�

delivery� issues.�No�change� in� staff� as� long�as� the� staff� allocated�are�

at� BioStata� (turnover� =0).

Providing�

Realtime

Service� Delivery

As�a� small�and�dedicated�CRO�We�work�hard�and�speed�and�quality�

is� what� makes� us� trustworthy� and� competent.� We� agree� on� fast�

timelines� for� deliveries� and� contact� persons� are� 100%� available.

Realtime

Feed-back

We� are� dedicated� and� although� small� we� have� backup� on� all�

positions.� � We� are� available� to� you.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 145

4.� Corporate� Competitiveness

Corporate

Competitiveness

We�have�a�complete�SOP�system�and�we� train�our� staff� frequently.�We�revise�our�SOP�

system� yearly.� We� typically� deliver� clean� file� in� days� or� 1-2� weeks� depending� on� the�

size�and� complexity�of� the� trial.�We�deliver� Key� result�meeting� typically� in� 3� days�and�

we� deliver� data� packages� for� DMC� in� 2-4� working� days� also� depending� on� the�

complexity� of� the� trial.

We�make� fixed� costs� contracts� ­� and�WE�MEAN� FIXED� costs,� on� all� tasks�where� it� is�

realistic� to� estimate� the� costs� fairly� precise.

No.� of� Regulatory

Inspections

Classification FDA(US) EMA(EU) PMDA(Japan) Others

Pre-Clinical� Area 0 0 0 0

Clinical� Area 0 0 0 0

Manufacturing� Area 0 0 0 0

Others 0 0 0 0

Current� Status� of

Accredited�

Certification

We� work� according� to� GCP

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� toNone� only� US� and� EU� companies

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146� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

17. Brock Capital Group

1.� Corporate� General� Information

Corporate� Name Brock� Capital� Group

Corporate� Ownership Private� Company

Head� Office� Address 622� Third� Ave.� 12thFl.� NewYork,� NY10017,� USA

Web-site� Address http://www.brockcapital.com

Contact

(Korean�

Business)

Name James� Lee

Address 622� Third� Ave.� 12th� Fl.� NewYork,� NY10017,� USA

Telephone 212-209-3000

E-mail [email protected]

Company� History

The� Brock� Group� was� organized� in� 2002� to� attract� outstanding� executives� and� professionals� from� diverse�

corporate� and� governmental� backgrounds.� Employing� its� unparalleled� collective� experience� and� networks,�

Brock� Capital� Group� offers� advisory� and� consulting� services� to� companies� and� other� institutions� on� a� broad�

variety� of� matters� at� the� most� senior� level.

Investment� banking� services� complement� Brock� advisory� and� consulting� services.

Capital� markets� and� associated� investment� banking� activities� are� provided� through� Brock� Securities,� a�

registered� broker-dealer,� and� its� Capital� Markets� group.

Brock� Real� Estate� LLC� offers� specialized� real� estate� advisory� and� investment� banking� services.

Brock� Fiduciary� Services,� acting� as� an� independent� fiduciary,� represents� the� interests� of� plan� participants� in�

employee� benefit� plans� holding� employer� stock� or� other� securities.

Brock� Opportunity� Fund� invests� in� selected� companies� for� which� Brock� is� providing� advisory� or� investment�

banking� services.

Company� Description� &� Organization

See� answer� to� "Company� History"� (above)

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 147

2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

〇 〇

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US US US 〇 US 〇Canada Canada Canada 〇 Canada 〇EU EU EU 〇 EU 〇Asia Asia Asia 〇 Asia 〇Global Global Global 〇 Global 〇Other Other Other Other

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs 〇R&D 〇

Pre-ClinicalR&D� Strategy

&� Management〇

Pre-clinical

Test� SamplePhase� I Clinical� Trials 〇Phase� II

Clinical� Test

Sample

Finished

Products〇

Regulatory

Affairs〇

Phase� IIIBusiness

Development〇

Finished

ProductPhase� IV

Sales� &

Marketing〇

Corporate�

Product� Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

Generics APIs Devices Others

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148� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

3.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� toKorea,� USA

Major� Service� Range

with�Asian�Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D 〇

Pre-ClinicalPre-clinical

Test� Sample

R&D� Strategy

&�Management〇

Phase� I Clinical� Trials 〇

Phase� IIClinical� Test

Sample

Finished

Products

Regulatory

Affairs〇

Phase� IIIBusiness

Development〇

Finished

ProductPhase� IV

Sales� &

Marketing〇

4.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

We� at� Brock� Group� would� like� to� explore� possibilities� for� business,� such� as� Brock� helping� Korean� life�

sciences� firms� with� their� needs,� whether� for� capital� raising� (for� growth,� M&A,� going� public� overseas,�

etc.),� for�marketing/branding/in-or-out� licensing,� for� sales/distribution,� for� joint� R&D�with� foreign� firms,�

etc.

Brock� can� help� Korean� life� sciences� firms� find� the� right� foreign� companies� and/or� foreign�

financial/strategic� investors� to�partner�with.� If� it� is� a� really�outstanding� firm�from�Korea,�Brock� can�make�

an� investment� of� its� own� at� some� point� (for� co-investment� along� with� other� investors).

Brock� is� a� boutique� investment� bank� and� a� business� advisory� firm� (www.brockcapital.com).� We� raise�

capital� for� companies�and�also�advise/consult� companies,� funds,�governments,� foundations,�etc.�We�have�

an� opportunity� fund� of� our� own.� You� can� find� info� about� Brock� on� our� firm� website.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 149

18. Cato Research Ltd.

1.� Corporate� General� Information

Corporate� Name Cato� Research� Ltd.

Corporate� Ownership Private� Company

Head� Office� Address 4364� South� Alston� Ave� Durham,� NC� 27713

Facilities� City� &� Country Durham,� NC,� USA

Web-site� Address http://www.cato.com

No.� of� Employees 250

Contact

(Korean�

Business)

Name Jack� Snyder

Address 9605� Medical� Center� Drive,� Suite� 390,� Rockville� MD,� 20850

Telephone 301-309-8242

E-mail [email protected]

Company� History

Cato� Research� is� a� privately� owned� CRO� with� more� than� 20� years� of� worldwide� experience� providing�

innovative� regulatory�solutions�and�customized�clinical� trial� services� to�biotech�and�pharmaceutical�companies.�

We� have� assisted� in� the� highest� rate� of� FDA� approvals� amongst� CROs�of� our� size.�We� specialize� in�multiple�

indications� for� complex� projects� with� a� particular� interest� in� hot� technology� and� orphan� diseases.� Also,� we�

tailor� designs� to� meet� our� sponsors’� needs.

Company� Description� &� Organization

Cato� Research� specializes� in� complex� development� programs� requiring� innovative� regulatory� and� clinical�

strategies,� and� we� have� experience� implementing� and� conducting� successful� clinical� trials� and� development�

programs.� As� a� midsize� CRO,� Cato� Research� offers� a� complete� range� of� services� while� also� being� able� to�

provide� personalized� attention� and� flexibility.� The� relationships� we� create� with� our� clients� produce� positive,�

tangible� results.

Cato�Bioventures,�our� venture�capital� arm,� leverages�our� financial� and� service� investments,� in�addition� to�our�

management� expertise,� to� mature� technologies� for� the� success� of� life� science� companies.

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150� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

〇 〇

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US US US US

Canada Canada Canada Canada

EU EU EU EU

Asia Asia Asia Asia

Global 〇 Global Global Global 〇Other Other Other Other

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D

Pre-Clinical 〇 R&D� Strategy

&� Management〇

Pre-clinical

Test� SamplePhase� I 〇 Clinical� Trials 〇Phase� II 〇 Clinical� Test

Sample

Finished

Products

Regulatory

Affairs〇

Phase� III 〇 Business

Development〇

Finished

ProductPhase� IV 〇 Sales� &

Marketing

Corporate�

Product� Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

〇 〇 〇Generics APIs Devices Others

〇 〇

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 151

3.� Corporate� Business�Overview

Focusing� Therapeutic�

AreaOncology,� Orphan� Diseases,� CNS

General� Overview

of� Corporate's� Key

Contract� Services

•Clinical� Trials� -� Design,� management� and� conduct� of� Phase� 1� through� Phase� 4�

clinical� studies

•Regulatory� Strategy� and� Submissions

•Medical� &� Pharmacovigilance

•Nonclinical� Safety� Consultation� and� Study� Monitoring

•Data� Management� &� Biostatistics

•Chemistry,� Manufacturing� and� Controls

•Medical� Writing

•Quality� Assurance

•Project� Management

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19. Cegedim Dendrite

1.� Corporate� General� Information

Corporate� Name Cegedim� Dendrite

Corporate� Ownership Private� Company

Head� Office� Address127-137� rue� d'Aguesseau,� 92100,� Boulogne� Billancourt,

FRANCE

Facilities� City� &� Country

El� Biar-ALGERIA,� Australia-AUSTRALIA,� Vienna-AUSTRIA,� Drogenbos-BELGIUM,�

São� Paulo-BRAZIL,� Ontario-CANADA,� Shangai-CHINA,� Bogotá-COLOMBIA,�Praha-CZECH� REPUBLIC,� Søborg-DENMARK,� Cairo-EGYPT,� Espoo-FINLAND,�

Boulogne-Billancourt� cedex-FRANCE,� Bensheim� 외 1개-GERMANY,�

Athens-GREECE,� Budapest-HUNGARY,� Maharashtra� 외 1개-INDIA,�

Dublin-IRELAND,�San�Giovanni-ITALY,�Osaka�외 1개-JAPAN,�Selangor-�MALAYSIA,�

MEXICO,� Casablanca-MOROCCO,� Naarden-NETHERLANDS,� Auckland-NEW �

ZEALAND,� Oslo� 외 1개-NORWAY,� Warsaw-POLAND,� Lisboa-PORTUGAL,�

Bucharest-ROMANIA,� Moscow-RUSSIA,� Singapore-� SINGAPORE,� Bratislava-�

SLOVAK�REPUBLIC,� Seoul-SOUTH�KOREA,�Madrid�외 1개-SPAIN,�Stockholm�외 1개

-SWEDEN,� Zürich-SWITZERLAND,� Les� Berges� du� Lac-TUNISIA,� Istanbul-TURKEY,�

Kiev-UKRAINE,� Surrey-UNITED� KINGDOM,� New� Jersey� 외 7개 -UNITED� STATES�

Korean� Business� Office1802� Danam� Bldg,� 120� Namdaemonno� 5-ga,� Jung-gu,

Seoul,� 100-704,� Korea

Web-site� Address http://www.cegedim.com

No.� of� Employees 8,600

Financial� Status

Sales� Revenue� in� 2010

(US� K$)Capital(US� K$) Dept-equity� Ratio(%)

927� million� EUROS - -

Contact

(Korean�

Business)

Name Jeff� Oh

Address1802� Danam� Bldg,� 120� Namdaemonno� 5-ga,� Jung-gu,

Seoul,� 100-704,� Korea

Telephone 82� 2� 790� 1530

E-mail -

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 153

Company� History

Cegedim�was� created� in�1969�by� Jean-Claude� Labrune,� a� French�visionary�entrepreneur�who� focused�on� the�

pharmaceutical� industry� to� provide� companies� with� tailored� services� that� help� them� build� successful�

commercial� strategies.�

In� the� late� 70’s� the� first� Customer� Relationship� Management� solution� designed� for� the� Pharmaceutical�

industry� was� launched� in� France� and� quickly� became� a� standard.� �

With� the� success� of� its� solutions,� Cegedim� quickly� expanded� its� business� internationally.� In� May� 2007,�

Cegedim� reinforced� its� global� presence� and� leadership� with� the� acquisition� of� Dendrite� International,� a� US�

based� company� leading� the� SFA� business� in� the� healthcare� sector� on� its� continent� as� well� as� in� Asia.� This�

successful� integration� gave� birth� to� a� uniquely� capable� global� entity� providing� Life� Sciences� ready� CRM�

solutions.� Today� the� new� company� renamed� Cegedim� Relationship� Management� does� business� in� over� 80�

countries� and� accounts� for�more� than� 50� percent� of� the� Cegedim�Group's� annual� revenues� of� $1.1� billion.� �

Around� the�world,� Cegedim�Relationship�Management�works�with� companies� behind� the� scenes� to� develop�

the� most� appropriate� solutions� that� effectively�manage� the� complex� regulatory� environment,� minimize� risks�

and� decrease� costs.�

Laurent� Labrune,� Group� founder's� son,� is� the� Chief� Executive� Officer� of� the� new� global� organisation� since�

2007.� He� brought� a� wealth� of� creativity,� innovation� and� expertise� with� a� strong� and� knowledgeable�

management� team.� Altogether,� they� effectively�made� strategic� choices� � for� the� long� term� leadership� of� the�

company.

Throughout� the� past� 40� years,� Cegedim� dedicated� its� efforts� to� pro-actively� support� the� Healthcare� sector�

as� a� whole,� extending� its� expertise� alongside� the� evolution� and� the� revolution� of� this� sector.�

Today,� Cegedim� serves� not� only� Pharmaceutical� companies� but� also� the� Health� Insurance� sector� and�

Healthcare� professionals.

Cegedim� uses� its� position� at� the� nexus� of� all� these� players� to� create� strategic� databases� and� software�

solutions.� Our� products� and� services� enable� pharmaceutical� companies'� sales� and�marketing� departments� to�

optimize� their� strategies�and�provide�all� sorts�of�healthcare�professionals�with� the�most�effective� information�

and� tools� available.

Jean-Claude� Labrune� is� now� Chairman� of� the� Board� of� Directors.� He� is� still� very� active� in� inspiring� the�

organization� and�motivating� innovative� initiatives� among� the� 8600� employees� working� for� Cegedim� around�

the� World.

Company� Description� &� Organization

Cegedim� Relationship� Management� helps� its� Life� Sciences� clients� strengthen� their� customer� relationships,�

enhance� sales� effectiveness,� optimize� data� quality,� improve�marketing� performance,� and�mitigate� regulatory�

compliance� risks.�With� a� presence� in�more� than�80� countries,� Cegedim� Relationship�Management� combines�

its� global� expertise� with� a� deep� understanding� of� local� markets� to� help� clients� promote� and� market� their�

products� in� the� most� efficient� and� cost-effective� manner.

Leveraging� our� industry� experience� with� specialized� insight� into� commercial� models� and� federal� and� state�

regulations,� Cegedim� Relationship� Management� offers� companies� of� all� sizes� a� targeted� approach� to�

optimizing� growth� within� the� evolving� Life� Sciences� industry.

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2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US US US ◯ US

Canada Canada Canada ◯ Canada

EU EU EU ◯ EU

Asia Asia Asia ◯ Asia

Global Global Global ◯ Global

Other Other Other ◯ Other

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 155

20. Celerion, Inc.

1.� Corporate� General� Information

Corporate� Name Celerion,� Inc.

Corporate� Ownership Private� Company

Head� Office� Address 621� Rose� Street� Lincoln,� NE� 68502

Facilities� City� &� CountryLincoln,� NE,� Phoenix,� AZ,� Neptune,� NJ� -� USA,� Belfast� -� Ireland,� Zurich� -�

Switzerland� (Bioanalysis� only)

Web-site� Address www.celerion.com

No.� of� Employees 830

Financial� Status

Sales� Revenue� in� 2010

(US� K$)Capital(US� K$) Dept-equity� Ratio(%)

$73,144k $12,000k See� Note

Contact

(Korean�

Business)

Name Kazuko� Aoyagi,� PhD

Address 621� Rose� Street,� Lincoln,� NE� 68502

Telephone +1.609.356.0072

E-mail [email protected]

Company� History

Celerion,� Inc.� is� a� privately� owned� company,� formed� from� the� acquisition� of� the� Early� Clinical� Development�

and� Development� and� Regulatory� Services� of� MDS� Pharma� Services� by� two� private� capital� companies:� Bain�

Capital� and�SV�Life�Sciences.�Both�owners�have� considerable�experience� in�owning�and�operating� life� science�

companies.� The� acquisition� of� a� leading� provider� of� early� clinical� research� services� fit� their� criteria� for�

investment.

SV� Life� Sciences� is� a� leading� international� life� sciences� venture� capital� firm.� SVLS� affiliated� funds� have� been�

investing� in� life� sciences� companies� since� the� early� 1980s� and� the� firm� closed� its� first� dedicated� life� sciences�

fund� in�1994.�The�SVLS� team�manages� five�venture� capital� funds�and�a�publicly� traded� investment� trust�with�

approximately� $2� billion� of� capital� under� management.� The� firm� employs� a� diversified� strategy� within� life�

sciences� in�order� to�selectively� capitalize�on�an�expanding�opportunity� in�biotech,�diagnostics,�medical�devices�

and� health-care� services.� www.svlsa.com

Established� in� 1984,� Bain� Capital� is� one� of� the� world's� leading� private� investment� firms� managing�

approximately� $66� billion� in� assets� under� management.� www.baincapital.com

Company� Description� &� Organization

Celerion� is� the� premier� provider� of� innovative� early� stage� clinical� research� solutions� serving� the�

pharmaceutical,� biotechnology� and� generic� industries.� From� facilities� strategically� located� around� the�world,�

advanced� scientific� and� technological� expertise� is� applied� to� global� clinical� research,� clinical� pharmacology�

sciences,� global� bioanalytical� services� and� drug� development� services.

Celerion� is� the� leader� in� implementing� new� technologies� and� adaptive-like� study� designs� to� enrich� the�

information� gathered� from� early� clinical� research� programs� to� support� better� decisions� for� the� development�

of� new� drug� candidates.

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2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

○ ○

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US ○ US US US ○

Canada ○ Canada Canada Canada ○

EU ○ EU EU EU ○

Asia Asia Asia Asia

Global Global Global Global

Other Other Other Other

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D ○

Pre-Clinical○

(BAS) Pre-clinical

Test� Sample

R&D� Strategy

&� Management○

Phase� I ○ Clinical� Trials ○

Phase� II

(BAS,

CPS)

Clinical� Test

Sample

Finished

Products

Regulatory

Affairs○

Phase� III

(BAS,

CPS)

Business

DevelopmentFinished

Product

Phase� IVSales� &

Marketing

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 157

Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

47% 17% 24%

Other� =� 12%� (7%� Generic,� 4%� CRO,� 1%� other)

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

(BAS)

(BAS)

(ECR� and� BAS)

Focusing�

Therapeutic� Area

Celerion’s� primary� business� focus� in� clinical� conduct� is� in� healthy� normal� volunteers.� In�

addition� healthy� volunteers,� Celerion� can� recruit� special� populations� including� allergics,�

arthritis,� asthmatics,� COPD,� elderly,� GERD,� hypercholesterolemia,� hyperlipidemics,�

long-term�confinement,�obese,�post-menopausal�women,� smokers,� Type� ll� diabetics,� and�

renal� insufficiency.

Further,� Celerion� works� with� specialty� sites� to� conduct� studies� in� renal� insufficient� and�

hepatically� impaired�subjects� that�are�often� required�as�part�of� the�marketing�application�

for� new� drug� (NDA,� MAA).� Although� these� studies� only� involve� between� 12� and� 24�

patients� plus�matching� healthy� control� subjects� depending� on� the� study� design� chosen,�

these� are� difficult� studies� to� do.� Severely� impaired� patients� who� are� healthy� enough� to�

participate� in� these�studies�are�difficult� to� find.� Severely� impaired�patients�with�end� stage�

renal� disease� progress� to� dialysis� quickly� whereas� severely� hepatically� impaired� patients�

are� usually� awaiting� liver� transplant.

General� Overview

of� Corporate's� Key

Contract� Services

Global� Clinical� Research

•Four�global�clinical�Phase�0,� I�and� IIa� facilities� located� in� the�USA� (Phoenix,�AZ;� Lincoln,�

NE;� Neptune,� NJ)� and� Europe� (Belfast,� Northern� Ireland,� UK)

•Over� 730� beds� (including� 24� in-hospital)� and� conduct� over� 200� complete� studies�

annually

•Patient� populations� include:� diabetes,� respiratory,� hyperlipidemia,� obese,�

post-menopausal� women,� elderly,� renal� and� hepatic� insufficiency

•Special� techniques� include:� Hybrid� Phase� I/� ECG� Core� lab,� platelet� aggregation,� PET�

and�MRI� imaging,�gastric� intubation,� radiolabeled�ADME,�microtracer�preparation�and�

study,� ophthalmology� assessments� and� CNS� function� testing

Global� Bioanalytical� Services� (discovery� to� late� stage)

3.� Corporate� Business�Overview

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•Two�global� laboratories� located� in�USA� (Lincoln,�NE)�and�Europe� (Zurich,� Switzerland)

•Small� and� large� molecule� assays,� biomarkers� and� immunogenicity� tests

•Only� CRO� with� global� harmonized� electronic� laboratory� notebook

•Technologies� include:� LC-MS/MS,�ELISA,�RIA,�ECLA�and�Luminex�Clinical�Pharmacology�

Sciences

•Services� include:� modeling� and� simulation,� study� design� and� protocol� development,�

data� management,� biostatistics,� PK/PD,� medical� writing� and� reporting

•Data� management� and� transfer� that� adhere� to� all� CDISC/ADaM� requirements� Drug�

Development� Services

•Drug� development� consulting

•Regulatory� affairs� and� preparation� of� regulatory� submissions� for� USA,� Canada� and�

Europe

•Hepatic� and� renal� insufficiency� studies� at� specialized� sites

Contract� Service�

Capacity� Affordable�

by� Service� Area

•Conduct� of� 150-200� clinical� studies� per� year� across� our� global� sites� ranging� from� first�

in� human,� single� and�multiple� ascending� dose� to� food� effect,� drug-drug� interactions�

studies,� market� image� bioequivalence,� absolute� bioavailability,� pharmaodynamic,�

thorough� QT� studies,� radiolabeled� ADME,� microtracer� and,� as� needed,� population�

pharmacokinetic� assessments.

•One� of� the� largest� Clinical� Pharmacology� Sciences� teams� in� the� industry,� evaluating�

300+� protocols� per� year� and� producing� 200+� reports� annually

Communication�

with� Clients

Dispositoion� of

Project� Manager

Responsible

Global� Project� Managers� lead� functional� team� members� based� on�

your�needs�and�are� responsible� for� the� successful�completion�of� the�

project.

They� retain�overall� internal� responsibility� for� the�project�and� function�

as� your� primary� point� of� contact,� including� with� any� third-party�

contractors.

Providing� Realtime

Service� Delivery

•ClinQuick,� Celerion's� proprietary� electronic� data-acquisition�

system,� is� used� in� all� of� our� Phase� l� clinical� research� facilities� and�

is� CFR� Part� 11-compliant

•Data� on� demand� using� the� SAS� Drug� Development� platform.

•Data� management� and� transfer� that� adhere� to� all� CDISC/ADaM�

requirements

Realtime

Feed-back

As� stated� above,� Celerion’s� ClinQuick� and� SASDD� systems� allow� for�

real-time�acquisition�of�data,� thereby�allowing�opportunities� to�bring�

study� related� feedback� to� clients� throughout� the� conduct� of� the�

services.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 159

4.� Corporate� Competitiveness

Corporate

Competitiveness

Celerion’s�combination�of�experienced�people,� scientific�excellence�and� state-of-the-art�

facilities� strongly� positions� us� as� an� industry� leader� in� the� conduct� of� early� clinical�

research� and� bioanalytical� studies.

Experience� and� expertise

•Leadership� with� extensive� depth� and� breadth� of� experience� in� drug� development

•Clinical� study� design,� execution� and� analysis� that� leverages� the� scientific� experience�

of� our� staff

•25� years+� experience� in� conducting� 300+� First-in-Human� studies� to� provide�

confidence� that� the� inherent� risks� of� early� clinical� research� are� clearly� understood�

and� well� managed

•One�of� the� largest�Clinical� Pharmacology� Sciences� teams� in� the� industry,� evaluating�

300+� protocols� per� year� and� producing� 200+� reports� annually

•Drug� development� consultants� that� help� clients� establish� product� value� through�

design/execution� of� an� integrated� program� of� studies� focusing� on� demonstrating�

early� evidence� of� drug� safety� and� effect

•Regulatory� strategy,� technical� and� strategic� support� for� clinical� trials� and� product�

registrations� in� North� America� and� Europe� Scientific� excellence� that� leverages�

innovative� technologies

•Market� leader� in� early� cardiac� studies� ­first� CRO� with� a� Hybrid� Phase� I/� ECG� Core�

lab� utilizing� Bluetooth� Holter� monitors� and� automated� ECG� review� that� benefit�

clients� with� faster� access� to� data,� lower� costs� and� higher� quality� data

•Data� on� demand� using� the� SAS� Drug� Development� platform.� Celerion� is� the� first�

global� CRO� to� offer� a� fully� integrated� SAS� Drug� Development� platform� to� provide�

a� centralized� system� for� managing,� analyzing,� reporting� and� reviewing� clinical�

research� information

•Electronic� lab� notebooks� in� global� bioanalytical� facilities� drive� efficiency� and� fast�

turnaround� of� PK� information

•Utilization� of� radioactive� microtracers� in� early� clinical� research� at� regulated� clinic�

facilities� enables� understanding� of� PK� and� metabolism� questions� early;� full�

capabilities� for� performing� comprehensive� ADME� programs

•A� USP� <797>� Clean� Room� to� Phase� I� core� capabilities� enables� sterile�

extemporaneous� compounding� inhouse� for� microtracer� studies.� Clients� benefit� by�

accessing� quality� data� earlier� in� drug� development� process.

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No.� of� Regulatory

Inspections

Classification FDA(US) EMA(EU) PMDA(Japan) Others

Pre-Clinical� Area

Clinical� Area8(ECR)

4(BAS)

6� (ANVISA,� MHRA)�ECR

4� (ANVISA,� JAZMP,�Swissmedic)� BAS

Manufacturing� Area

Others

Current� Status� of

Accredited�

Certification

GLP,� GMP,� GCP,� ISO

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 161

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� to

Celerion�works�with� clients� from� Korea,� Japan,� Singapore� and� China.� Kazuko�Aoyagi,�

Celerion’s� Business� Development� Representative� who� works� with� Asian� companies,�

works� with� 5� Korean� companies,� including� a� ten� year+� partnership� with� Daiichi�

Sankyo,� most� Japanese� companies,� large,� medium� and� small� sized,� many� Korean�

companies� large,�medium�and� small� sized,� and� travels� to�Asia/Korea� regularly� 3� times�

per� year.

Asian� Clients'

Composition(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

68% 22% 7% 5%

Other� =� 3%� (2%� Generic,� 1%� other)

No.� of� Asian� Clients

in� recent� 3� years~� 30

Major� Service� Range

with� Asian�

Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research ○ API

APIs

R&D

Pre-Clinical ○R&D� Strategy

&�Management○

Pre-clinical

Test� SamplePhase� I ○ Clinical� Trials ○

Phase� II ○Clinical� Test

Sample

Finished

Products

Regulatory

Affairs○

Phase� III ○Business

DevelopmentFinished

ProductPhase� IV

Sales� &

Marketing

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6.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

Drug� Development� Services:

Drug�Development�Services�helps� you�demonstrate�early� evidence�of� your� compounds'� clinical� efficacy�and�

tolerance� in� humans.� The� knowledge� and� leadership� of� our� scientists� help� you� to� design� and� carry� out�

comprehensive� development� strategies.� Our� integrated� service� spans� the� research� process� for� small� and�

large� molecule� drugs� from� lead� identification� through� clinical� proof-of-concept� and� all� the� way� to� full�

clinical� development.� We� offer� expertise� in� pharmacology,� chemogenomics,� drug� metabolism,�

pharmacokinetics,� analytical� chemistry,� toxicology� and� safety� pharmacology,� bioanalysis,� clinical�

pharmacology,� biomarker� strategies,� early� clinical� research,� regulatory� strategy� and� submissions� support,�

including� CMC� sections� of� regulatory� documents.

Biopharmaceutical� Development:

Celerion� consults� in� the� scientific� and� regulatory� phases� of� biological� product� development.� Celerion’s�

experts�have�worked� in�both� regulatory�agency�and� industry� roles�on�a�wide� variety�of�biologically�produced�

products,� including� innovative� therapeutic� proteins� and� peptides,� therapeutic� vaccines,� monoclonal�

antibodies,� and� biosimilar� drugs.� Our� laboratory� near� Zurich,� Switzerland� is� the� largest� facility� for� the�

bioanalysis�of� large�molecule�drugs�and� immunogenicity� assays� in�Europe�with�a� track� record�of�excellence�

for�over�25�years.�Combining� this� capability�with�Celerion’s� clinical�pharmacology� clinic� and� staff� in�Belfast,�

Northern� Ireland,� makes� Celerion� a� perfect� partner� in� the� early� clinical� assessment� of� biosimilar� products�

in� Europe.

In-hospital� Beds:

In�an�effort� to� improve� safety� for�participants� in� clinical� trials,�while�getting�drugs� to�market� faster� for�our�

clients,�Celerion�has�added� in-hospital�beds� to�our�clinical� capabilities.�An�exclusive�alliance�with�BryanLGH�

Health� Systems� allows� us� to� conduct� clinical� studies� in� a� hospital� environment,� while� providing�

round-the-clock� emergency� care.� BryanLGH� is� a� fully� JCAHO� accredited� Level� II� trauma� center� with� 664�

beds.� The�Celerion-BryanLGH�Clinical�Research�Unit� (CRU)� is� a� fully�dedicated�hospital�wing�with�24�private�

rooms� for� in-patient� or� day� use.

Regulatory� Services:

Celerion� have� staff� have� been� involved� in� the� filing� of� over� 40� INDs� over� the� last� five� years.� Celerion�

contributions� include� complete� authoring� of� all� IND� sections� from� source� documents� including� CMC�

sections,� Investigator� Brochures,� and� protocols.� All� INDs� were� filed� and� adjudicated� as� per� forecast.� INDs�

have�been�authored�according� to�classic�or�CTD�format.�Celerion�has�written�and�published�position�papers�

on� the� IND� process.� Celerion� staff� have� also� contributed� strategic� and� scientific� input� and� support� to�

multiple�NDAs,� including�505(b)2�applications.�RA�staff�has� longstanding�experience�with�CTAs� in�multiple�

regulatory� jurisdictions,� including�Canada,� the�UK,�and�elsewhere� in� the�EU.�The�provided� support� includes�

the� complete� preparation� and� managing� the� entire� submission� process.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 163

21. Charles Ricer Laboratories (CRL)

1.� Corporate� General� Information

Corporate� Name Charles� River� Laboratories� (CRL)

Corporate� Ownership Publicly� traded

Head� Office� Address Wilmington,� Mass.

Web-site� Address http://www.criver.com/

No.� of� Employees ~7,500� worldwide

Financial� StatusSales� Revenue� in� 2010(US� K$) Capital(US� K$) Dept-equity� Ratio(%)

$1.13� billion - -

Contact

(Korean�

Business)

Name -

Address -

Telephone 1.877.CRIVER.1� (1.877.274.8371)

E-mail [email protected]

Company� History

Founded� 60� years� ago,� Charles� River� was� initially� engaged� in� the� production� of� research� models� for�

biomedical� research.� � Over� the� past� six� decades,� we� have� seen� a� dramatic� evolution� in� the� needs� of� our�

customers.� � In�order� to�meet� those�needs,�we�have� launched�new�businesses�and�grown�existing�businesses.� �

These� changes� have� transformed� our� company� into� a� leading� global� provider� of� essential� products� and�

services� that� advance� research� in� the� drug� discovery� and� development� industry.

The� company� works� on� behalf� of� pharmaceutical,� biotechnology,� government� and� academic� organizations�

during�all� stages�of�drug�development:� from�the�discovery�of�new�compounds�and�preclinical�pharmacological�

and� safety� studies,� to� clinical� trials� in� human� subjects.

Company� Description� &� Organization

For�more� than� 60� years,� Charles� River� has� provided� tailored� research�models� and� laboratory� animal� support�

services,� as� well� as� preclinical� and� clinical� services,� to� help� our� global� partners� accelerate� their� research� and�

drug� development� efforts.� Our� offerings� span� the� entire� drug� development� process,� from� discovery� through�

market� approval,� forming� a� seamless� partnership� throughout� the� process.

From� the� global� standardization� of� our� research� models� to� the� high� standards� we� set� for� our� professional�

team�and�our�state-of-the-art� facilities� and� technologies,�we�can�customize�our�products�and� services� to�meet�

your� specific� project� needs.�With� multiple� locations� around� the� world,� Charles� River� is� the� ideal� partner� for�

moving� your� product� from� animal� to� man� in� a� rational,� cost-effective,� and� timely� manner.

Our� partners� include� all� of� the� major� pharmaceutical� and� biotechnology� companies� worldwide,� as� well� as�

government� research� centers� and� leading� hospital� and� academic� institutions.� Our� approach� ­� outstanding�

customer� service� and� commitment� to� scientific� excellence� through� best-in-class� products,� services,� and�

procedures� ­�has� led� to� long-standing� relationships�with�many�of�our� customers.�Because�of� this�commitment,�

we� continue� to� count� each� of� our� top� 20� customers� from� 1990� as� valued� partners� today.

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2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US ○ US US US

Canada ○ Canada Canada Canada

EU ○ EU EU EU

Asia ○ Asia Asia Asia

Global ○ Global Global Global

Other ○ Other Other Other

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research ○ API

APIs

R&D

Pre-Clinical ○R&D� Strategy

&� ManagementPre-clinical

Test� SamplePhase� I ○ Clinical� Trials

Phase� II ○Clinical� Test

Sample

Finished

Products

Regulatory

Affairs

Phase� III ○Business

DevelopmentFinished

ProductPhase� IV ○

Sales� &

Marketing

Corporate�

Product� Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

Generics APIs Devices Others

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 165

3.� Corporate� Business�Overview

Focusing�

Therapeutic� Area

•biosimilars� � � � � � � � � � � � � � � � � � � � � � � � � � � � � •cardiovascular

•central� nervous� system� � � � � � � � � � � � � � � � � •endocrine/metabolic

•inflammation� � � � � � � � � � � � � � � � � � � � � � � � � � � •oncology

•ophthalmology� � � � � � � � � � � � � � � � � � � � � � � � � •skeletal� disease

•vaccines

General� Overview

of� Corporate's� Key

Contract� Services

With� more� than� 20� facilities� in� North� America,� Europe� and� Asia,� Charles� River� is� the�

leading� global� supplier� of� research�models� and� services.� Our� core� programs­Biosecurity,�

International� Genetic� Standardization� (IGS),� Animal� Welfare� and� Model� Quality­are�

designed� to� provide� the� most� reliable� supply� of� standardized� products� and� services� on�

a� global� basis,� ensuring� that� the� integrity� of� your� research�will� be�maintained�over� time�

and� location.

•Research� Animal� Models

•Surgical� Services

•Genetically� Engineered� Models� &� Services� (GEMS)

•Research� Animal� Diagnostic� Services� (RADS)

•Genetic� Testing� Services

•Avian� Vaccine� Services

•Consulting� &� Staffing� Services

•(CSS)� BioModules� &� Isolators

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22. Chiltern

1.� Corporate� General� Information

Corporate� Name Chiltern

Head� Office� Address

Rua� das� Fiandeiras

929� -� Conjs.� 53/54

São� Paulo� ­� SP04545-006

Facilities� City� &� Country Brazil

Web-site� Address www.chilterncareers.com

Contact

(Korean�

Business)

Telephone +55� 11� 3046� 2277

Company� Description� &� Organization

Established� in�1982,�Chiltern� is� a� leading�global�Contract�Research�Organization�with�extensive�experience�

conducting�and�staffing� international�Phase� I� to�Phase� IV�clinical� trials� across�a�broad�range�of� therapeutic�

areas� for� a� wide� variety� of� clients.

Chiltern� has� conducted� trials� in� more� than� 40� countries,� has� 24� offices� and� legal� entities� within� 20�

countries,� resources� in� 37� countries� and� employs� nearly� 1,400� people� globally.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 167

23. CiToxLAB

1.� Corporate� General� Information

Corporate� Name CiToxLAB

Corporate� Ownership Private� Company

Head� Office� Address B.P.� 563� -� 27005� Evreux� cedex.� France

Facilities� City� &� Country Evreux� -� France,� Laval� -� Canada,� Ejby� -� Denmark,� Vezprem� -� Hungary

Korean� Business� OfficeCroen� Research� Inc.� Seongdo� Bldg.,� Sinsa-dong� 587-23,� Gangnam-Gu,� Seoul�

135-747,� Korea

Web-site� Address www.citoxlab.com

No.� of� Employees About� 800

Financial� Status

Sales� Revenue� in� 2010

(US� K$)Capital(US� K$) Dept-equity� Ratio(%)

100,000k� us - -

Contact

(Korean�

Business)

Name Brian� YC� Park,� D.V.M.,� M.S.� CEO� CROEN� Research� Inc.

Address Seongdo� Bldg.,� Sinsa-dong� 587-23,� Gangnam-Gu,� Seoul� 135-747,� Korea

Telephone 82-2-3442-0598

E-mail [email protected]

Contact

(Korean�

Business)

Name Ha-Jung� Sung,� D.V.M.,� Ph.D.� CTO� CROEN� Research� Inc.

Address 864-1,� lui-dong,� Yeongtong-gu,� Suwon-si,� Gyeonggi-do,� 443-270,� Korea�

Telephone 82-31-888-9390

E-mail [email protected]

Company� History

CiToxLAB� was� formed� on� April� 21,� 2011� by� the� merger� of� CiT� of� France� (40� year� old� preclinical� lab)� with�

LAB� Research� Inc.� with� its� Canadian� facilities� (in� operation� since� 1998),� Danish� facilities� (former� Scantox� in�

operation� since� 1977)� and� Hungarian� facilities� (former� TRC� in� operation� since� 1974).

Company� Description� &� Organization

Preclinical� CRO�with� facilities� in� Canada,� France,� Denmark� and� Hungary.� Turn-Key� preclinical� expertise� from�

lead-screening/genomics,�discovery/efficacy� to�development�of�Pharma�and�Biotech�products� (small� and� large�

molecules).� � We� also� have� expertise� in� chemical� and� agrochemical� testing.

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2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US US US US

Canada ○ Canada Canada Canada

EU ○ EU EU EU

Asia Asia Asia Asia

Global Global Global Global

Other Other Other Other

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research ○ API

APIs

R&D

Pre-Clinical ○ Pre-clinical

Test� Sample

R&D� Strategy

&� Management

Phase� I Clinical� Trials

Phase� IIClinical� Test

Sample

Finished

Products

Regulatory

Affairs○

Phase� IIIFinished

Product

Business

Development

Phase� IVSales� &

Marketing

Corporate�

Product� Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

○ ○ ○ ○

Generics APIs Devices Others

○ ○

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 169

3.� Corporate� Business�Overview

Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

40% 20% 35% 5%

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

○ ○

Focusing�

Therapeutic� AreaAll� therapeutic� areas.

General� Overview

of� Corporate's� Key

Contract� Services

Acute� to� chronic� toxicology� (general,� inhalation,� infusion,� juvenile,� repro,� carci,�

transgenics,� ocular,� intra-thecal,� intra-articular� etc.)

Safety� Pharmacology� (CNS,� CV� (telemetry),� Respiratory,� GI,� Renal)

Efficacy� animal� models� and� surgical� expertise

Radiation� Safety

Chemical� and� agrochemical

Ecotoxicology

Lead-screening� and� genomics

ADME� and� PK/PD

Analytical� and� bioanalytical� services

Pathology� and� histopathology

Immunology

Contract� Service�

Capacity� Affordable�

by� Service� Area

Affordability� listed� from� most� expensive� to� least� expensive�

Denmark� ­� France-� Canada� ­� Hungary

Communication�

with� Clients

Dispositoion� of

Project� Manager

Responsible

For� program� a� senior� study� director� is� assigned� as� the� project�

manager� and� a� single� point� of� contact

Providing� Realtime

Service� Delivery

Weekly� summary� reports� can� be� available� to� clients,� daily� critical�

activities� issues� are� passed�on� to� clients� and� a� 28-day� audited� draft�

report� is�provided�7-8�weeks� after� last�necropsy� (can�be� in�6-weeks�

if� requested)

Realtime

Feed-back

We�have� provantis� data� capturing� system,� thus� generated�data� can�

be� sent� to� clients� right� after� availability.

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4.� Corporate� Competitiveness

Corporate

Competitiveness

Our� tag� line� is� “global� expertise,� local� response…”�given�our�4� sites�and�our�over� 120�

years� of� combined� history� and� expertise� in� GLP� preclinical� services� we� have� the�

seasoned� specialist� to� provide� personalized� services,� free� regulatory� advise� and�

uncompromised� accommodation� for� our� clients� budgetary� and� timeline� needs.� � We�

have� QC� and� QA� systems� in� place� with� training� programs� to� make� sure� our� staff� is�

up-to-date�with�new� technology.� �We�have� full� regulatory� inspections� in�place� to�gain�

your� comfort� level� to� enable� you� trust� your� pipeline� development� to� us.� � Our�

track-record� is� documented� and� we� share� with� our� clients� with� full� transparency.

No.� of� Regulatory

Inspections

Classification FDA(US) EMA(EU) PMDA(Japan) Others

Pre-Clinical� Area 3 numerous 1SCC� for�

Canada

Clinical� Area

Manufacturing� Area

Others

Current� Status� of

Accredited�

Certification

FDA/GLP/ISO/AAALAC/CCSC/SCC/GMP

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 171

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� toKOREA,� JAPAN,� AUSTRALIA,� NEW� ZEALAND

Asian� Clients'

Composition(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

40% 40% 20% -

No.� of� Asian� Clients

in� recent� 3� years15

Major� Service� Range

with�Asian�Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D

Pre-Clinical ◌

Pre-clinical

Test� Sample

R&D� Strategy

&�Management

Phase� IClinical� Trials

Phase� IIClinical� Test

Sample

Finished

Products

Regulatory

Affairs

Phase� III

Finished

Product

Business

Development

Phase� IVSales� &

Marketing

6.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

Our�Canadian� site� (former� LAB�Research)�has� conducted�13�million�Canadian�dollars�business�with�Korean�

clients� in� the� last� 5� years.� � We� like� the� loyalty� we� share� with� Korean� clients� and� would� like� to� increase�

our� support� to� the� Korean� business.� � Hence� we� have� recently� signed� an� agreement� with� CRI� (Korean�

consulting� company)� in� order� to� facilitate� business� interactions� and� local� support� for� all� Korean� clients.

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Corporate� Name CLEARSYNTH� LABS� LTD

Corporate� Ownership Public� Company

Head� Office� Address413,� LAXMI� MALL,� LAXMI� IND.� ESTATE,� NEW� ­LINK� ROAD,� ANDHERI-W,�

MUMBAI-400� 053

Facilities� City� &� Country Mumbai(INDIA)

Web-site� Address www.clearsynth.com

No.� of� Employees 50~100

Contact

(Korean�

Business)

Name Vijay� Kumar� Ambati

Address413,� LAXMI� MALL,� LAXMI� IND.� ESTATE,� NEW� ­LINK� ROAD,� ANDHERI-W,�MUMBAI-400� 053

Telephone 91-22-26355700

E-mail [email protected]

Company� History

2012-� Established� US� Office� and� Global� R&D� Centre� in� San� Diego,� CA

2013� -Established� Clearsynth� Research� Centre� in� Hyderabad,� India

Till� date� -�We�are� the� first� to� supply� the� products� to�universities� and� research� labs,� small� SME’s�&�micro� labs�

and� large� companies� for� acceleratingtheir� research.

Creation� of� employment:� Directly� around� 100,� Indirectly� around� 500

Bringing� almost� 100+� high� end� research� products� which� are� first� of� its

kind� in� the� world� and� making� us� currently� the� largest� inventory� which

we� are� proud� of!!!

Company� Description� &� Organization

※�Clearsynth�a� technology� based� research�driven�enterprise�with� global� credentials,� R&D�Centre� in�USA� and�stock� points� in� Japan,� India,� USA.�World's� largest� Inventory� of� Certified� Analytical� Reference� Standards� and�Research� Chemicals.� Over� 288,000� products� available� online� for� accelerating� research.� Clearsynth� offers�Clearsynth� Secondary� Reference� Standards� (CSRS),� Pharmacopoeial� Standards(USP,EP,BP),� Metabolites,�Impurities,� Glucuronides,� Carbohydrates,� Building� Blocks,� Nucleosides,� Peptides,� Nutraceuticals,�Phytochemicals,Chiral�Molecules,� Intermediates,�Natural�Products,� Stable� Isotopes�placing�Deuterium�13C�and�15N� in� the� most� stable� position� to� limit� exchange� to� ensure� quality� of� assay.�

North� America� Clearsynth� Inc.� San� Diego,� USA� +1� 415� 685� 4395

Asia:� Clearsynth� Labs� Limited� Mumbai,� India� +91� 22� 26355700�www.clearsynth.com� [email protected]

24. CLEARSYNTH LABS LTD

1.� Corporate� General� Information

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 173

2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

〇 〇

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US US US US

Canada Canada Canada Canada

EU EU EU EU

Asia Asia Asia Asia

Global 〇 Global 〇 Global Global

Other Other Other Other Russia

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API 〇APIs

R&D

Pre-Clinical 〇 Pre-clinical

Test� Sample

R&D� Strategy

&� Management

Phase� I 〇 Clinical� Trials

Phase� II 〇 Clinical� Test

Sample

Finished

Products

Regulatory

Affairs

Phase� III 〇 Business

DevelopmentFinished

ProductPhase� IV

Sales� &

Marketing

Corporate�

Product� Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

Generics APIs Devices Others

〇 〇 〇

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In-house� Facilities

Research� &�

DevelopmentPreclinical Clinical

Custom�

ManufacturingCustom� Sales

〇 〇 〇

Focusing�

Therapeutic� Area

Oncologics Lipid� RegulatorsRespiratory�

AgentsAnti-ulcerants

Angiotensin� � � II�

Antagonists

10 15 10

AntipsychoticsAutoimmune�

agentsAntidepressants Analgesics Others

15 15 10 25

General� Overview

of�Corporate's�Key

Contract� Services

※�CLEARSYNTH�efforts� focus� from� the�pre-clinical� stage� through� to�phase� III� and� to� the�

successful� technology� transfer� to� manufacturing� locations� throughout� the� world.

This� focus� of� development� includes:

•� Synthetic� scale-up� development

•� Analytical� development� and� validation

•� Stability� test

•� Gram� to� kilogram� synthesis,� both� cGMP� and� non-GMP

•�Technology� transfer� services� :�Our�attention� to�detail,�with�our� focus� to� the�program's�

ultimate� success,� enhances� value� at� each� step� in� the� development� process.

Our� services� are� applied� at� all� stages� of� development.� Clearsynth� considers� all� issues�

related� to:

•� Routes� and� opportunities� for� early� stage� convergence

•� Identification� of� strategic� intermediates� as� candidates� for� nonGMP� outsourcing

•� Process� optimization

•� Raw� material� costs� and� commercial� sources

•� Related� compounds� and� potential� impurities

•� Final� isolations� and� methods

•� Analytical� method� development� and� validation

•� Specification� development

•� Stability� of� the� final� compound� and� intermediates�

3.� Corporate� Business�Overview

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 175

4.� Corporate� Competitiveness

Corporate

Competitiveness

※�We�own� the�world’s� largest� Inventory� of�Certified�Reference� Standards�&�Research�

Chemicals.� Our� new� e-commerce� website� has� over� 359,000� certified� standards�

and� research� chemicals� and� 30,000� biologics� with� pricing� available� online� for�

purchase� with� a� credit� card

No.� of� Regulatory

Inspections

ClassificationFDA

(US)

FDA

(EU)

PMDA

(Japan)

CFDA

(China)

DCI

(India)Others

Pre-Clinical� Area

Clinical� Area

Manufacturing� Area

Others 〇Current� Status� of

Accredited�

Certification

We� are� an� AS/NZS� ISO� 9001:2008� Certified� Company� for� our� Quality� Management�

Systems� having� IQNet� accreditation.

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� toChina,� Japan� ,� Korea,� Indonesia� etc

Asian� Clients'

Composition(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

68% 22% 15% 5%

No.� of� Asian� Clients

in� recent� 3� years500+

Major� Service� Range

with�Asian�Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research ○ API ○

APIs

R&D ○

Pre-Clinical ○ Pre-clinical

Test� Sample○

R&D� Strategy

&�Management

Phase� I ○ Clinical� Trials

Phase� IIClinical� Test

Sample○

Finished

Products

Regulatory

Affairs

Phase� IIIFinished

Product

Business

Development○

Phase� IV ○Sales� &

Marketing○

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Corporate� Name Clinipace� Worldwide

Corporate� Ownership Private� Company

Head� Office� Address 3800� Paramount� Pkwy,� Suite� 100,� Morrisville,� North� Carolina� 27560

Facilities� City� &� Country Morrisville,� United� States

Web-site� Address#1304� West� wing,� Hanshin� intervalley,� 322,� Teheran-ro,� Gangnam-gu,� Seoul,�

135-918

No.� of� Employees http://www.clinipace.com/

Contact

(Korean�

Business)

Name 1000� employees

Address Donghoon� Jang

Telephone #1304� West� wing,� Hanshin� intervalley,� 322,� Teheran-ro,� Gangnam-gu,� Seoul

E-mail +82� 2� 2183� 8888

Company� History

History� of� Clinipace� Korea:

Korea� office� was� established� in� 2008,� as� a� branch� office� of� Choicepharma,� Global� CRO� based� in� UK.� �

Clinipace� Worldwide,� global� dCRO� (Digital� CRO),� and� Choicepharma� had� common� needs� to� enhance� their�

business�model,� and� they�have�decided� to�merge� in�March�2014.�After�merger,�Choicepharma�Korea�became�

Clinipace� Korea

Company� Description� &� Organization

As� a� digital� CRO,� Clinipace� pioneered� an� innovative� service� model� to� transform� drug� and� medical� device�

development� by� delivering� technology-amplified� services� to� improve� performance,� collaboration,� and�

transparency� across� all� stakeholders.

While� similar� in� many� ways� to� a� traditional� CRO,� Clinipace� is� uniquely� built� to� deliver:

s An� innovative� methodology� that� reduces� clinical� development� cost� and� budget� volatilitys A� streamlined,� efficient� operational� approach� that� delivers� the� right� infrastructure� and� resourcess An� expert� global� regulatory� team� to� set� you� on� the� right� paths Experienced,� therapeutically-focused� clinical� development� staff� organized� specifically� for� small� and�mid-tier�firms

s A�user� friendly� trial� and�data�management�platform� that�delivers� real-time�visibility�and�project� control�built�on� an� affordable� and� highly� available� infrastructure

Powered� by� TEMPO™� ­� our� proprietary� eClinical� technology� ­our� teams� ensure� your� success� and� bring�

unsurpassed� efficiency� and� quality� to� your� development� programs.� It’s� the� integrated� approach� combining�

technology� and� study� execution� that� improves� performance,� visibility� and� coordination� for� all� stakeholders;�

and� it’s� a� vital� part� of� the� culture� at� Clinipace� Worldwide.

25. Clinipace Worldwide

1.� Corporate� General� Information

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 177

2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

〇 〇

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US 〇 US US US

Canada Canada Canada Canada

EU 〇 EU EU EU

Asia 〇 Asia Asia Asia

Global Global Global Global

Other 〇 Other Other Other

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D

Pre-Clinical Pre-clinical

Test� Sample

R&D� Strategy

&� Management

Phase� I 〇 Clinical� Trials

Phase� II 〇 Clinical� Test

Sample

Finished

Products

Regulatory

Affairs

Phase� III 〇 Business

DevelopmentFinished

ProductPhase� IV 〇 Sales� &

Marketing

Corporate�

Product� Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

〇 〇 〇 〇 〇Generics APIs Devices Others

〇 〇 〇

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Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

40% 40% 15% 5%

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

Focusing�

Therapeutic� Area

Oncologics Lipid� RegulatorsRespiratory�

AgentsAnti-ulcerants

Angiotensin� � � II�

Antagonists

24

AntipsychoticsAutoimmune�

agentsAntidepressants Analgesics Others

76

Clinipace� worldwide� has� various� therapeutic� area� experiences� include� Hematology,�

Oncology,� Cardiometabolic� diseases,� Infectious,� diseases,� Immunology,� Psychiatry� and�

neurology,�Ophthalmology,�Otolarygnology,�Respiratory�and�etc.�Common� strong�area�of�

Clinipace� worldwide� and� Clinipace� Korea� is� Oncology� studies.

General� Overview

of� Corporate's� Key

Contract� Services

Clinical� development

-� Biostatistics

-� Clinical� monitoring

-� Customized� sourcing� (FSP)

-� Data� management

-� GCP� training

-� Global� study� feasibility

-� Medical� affairs� and� writing

-� Patient� recruitment

-� Pharmacovigilance� and� safety

-� Post-approval� and� registry

-� Project� management

-� Site� selection� and� management

Regulatory� and� Strategic� Development

-� Chemistry,� manufacturing� and� control

3.� Corporate� Business�Overview

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 179

-� Clinical� trial� applications� and� product� registrations

-� GxP� auditing� and� QA� consultancy

-� Legal� representation

-� Product� development� strategy

-� Regulatory� affairs

-� Regulatory� writing� and� publishing

Technology

-� TEMPO� eClinical� platform

-� SAS

Contract� Service�

Capacity�

Affordable� by�

Service� Area

We�are�a� truly�global�CRO�with�centralized�North�American,� South�American,�European,�

and� Asian� hubs� with� the� staff� and� experience� to� help� you� activate� sites� in� many�

countries,� enroll�qualified� patients,� ensure�patient� safety,� and� collect� high�quality� clinical�

trial� data.�

Clinipace� Worldwide� is� headquartered� in� Research� Triangle� Park,� NC,� USA� with�

operations� in� the� following� regions,� offering� a� full� array� of� outsourced� regulatory,�

strategic� development,� clinical� development,� and� post-approval� services:

•� North� America

•� Europe

•� Asia� Pacific

•� Israel� &� Middle� East

•� Latin� America

Communication�

with� Clients

Dispositoion� of

Project� Manager

Responsible

It� will� be� decided� based� on� client’s� request

Providing� Realtime

Service� DeliveryClinipace� provides� real� time� service� delivery.

Realtime

Feed-backClinipace� provides� real� time� feed-back.

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4.� Corporate� Competitiveness

Corporate

Competitiveness

At� Clinipace�Worldwide,� we� have� pioneered� the� digital� clinical� research� organization�

(CRO),�or�digital�CRO�service�delivery�model,� leveraging�clinical� trial� technology�as� the�

foundation� to� all� service� delivery.

This� approach� delivers� unified� clinical� trial� technology� that� enables� integration,�

collaboration,� and� transparency� across� all� stakeholders.�As� a� result� of� the� digital� CRO�

transformation,� clinical� trials�have�better�quality� control,� run�with�enhanced�efficiency,�

greater� transparency,� and� at� reduced� cost.

No.� of� Regulatory

Inspections

Classification FDA(US) EMA(EU) PMDA(Japan) Others

Pre-Clinical� Area

Clinical� Area 〇 〇 〇Manufacturing� Area

Others

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 181

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� toChina,� Hong� kong,� Taipei,� Singapore,� Malaysia,� India,� Vietnam,� Korea,� Japan

Asian� Clients'

Composition(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

50 40 10

No.� of� Asian� Clients

in� recent� 3� yearsAround� 50~60� clients� include� global� and� local� Pharmaceutical/Biotech� companies.

Major� Service� Range

with�Asian�Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D

Pre-Clinical Pre-clinical

Test� Sample

R&D� Strategy

&�Management

Phase� I ○ Clinical� Trials

Phase� II ○Clinical� Test

Sample

Finished

Products

Regulatory

Affairs

Phase� III ○Finished

Product

Business

Development

Phase� IV ○Sales� &

Marketing

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Corporate� Name Clinserv

Head� Office� Address 16,� Adel� Hussein� Rostom� Str.,� 8th� Floor,� Dokki,� Cairo

Facilities� City� &� Country Egypt

Web-site� Address www.clinserv.com

Contact

(Korean�

Business)

Telephone +961-1-275622

E-mail [email protected]

Company� Description� &� Organization

"Customer� satisfaction� is� what� we� aspire� for"

� We� strive� to�meet�and�exceed�our�clients'�needs�and�expectations�of�Excellent�Service�and� to�be� the� leading�

solution� provider� in� clinical� research� in� the� MENA� region.

[Mission]

� To� Support� healthcare� R&D�programs� sponsors�with� the� highest�quality� clinical� research� services�based�on:

•� Strong� international,� medical� and� pharmaceutical� knowledge�

•� Long� expertise� in� international� clinical� trials� (American,� European� and� the� Middle� East)�

•�Compliance�with� international� quality� standards� (� 21CFR,� ICH,�GCP�&� ISO9001)�with� full� respect� of� local�

regulation

26. Clinserv

1.� Corporate� General� Information

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 183

Corporate� Name ClinStar,� LLC

Corporate� Ownership Private� Company

Head� Office� Address 100� Pine� Street,� Suite� 2075

Facilities� City� &� Country San� � � Francisco,� CA

Web-site� Address http://www.clinstar.com

No.� of� Employees 200+

Contact

(Korean�

Business)

Name Erin� King

Address 100� Pine� Street,� Suite� 2075

Telephone +1.415.981.9515

E-mail [email protected]

Company� History

ClinStar� was� founded� in� 1999� in� San� Francisco,� CA� and� began� its� first� clinical� trial� in� Russia� in� 2000.

ClinStar,� has� provided� its� clinical� trial� services� through� its� offices� in�Moscow,� St.� Petersburg,�Kiev,� and�Minsk�

[as�well� as� via�home-based�clinical� research�associates� (CRAs)� in�other�Russian�cities].�Our� clients� include�many�

leading�Pharmaceutical� and�Biotechnology� companies.�We�have�also�worked�with�numerous�global�CROs�on�

multi-national� studies� to� provide� local� expertise� of�which� is� critical� to� the� success� in� these� Eastern� European�

regions.

ClinStar� has� conducted� more� than� 100� clinical� trials� (Phase� I-IV)� in� various� therapeutic� indications.

The� philosophy� and� practices� established� by� the� founders� provided� the� basis� for� fast� organic� growth� of� the�

organization� creating�one�of� the�most� successful�CROs� in�Russia,�Ukraine,� and�other�parts�of�Eastern�Europe.

Company� Description� &� Organization

27. ClinStar, LLC

1.� Corporate� General� Information

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ClinStar,� headquartered� in� San� Francisco,� California,� is� a� contract� research� organization� (CRO)� that�manages�

Phase� I-IV� clinical� research� trials� in� Russia,� Ukraine,� Belarus� and� the� Baltic� States.�We� are� one� of� the� oldest�

and� most� well� established� CROs� in� our� region� with� more� than� 200� professionals� based� in� our� offices� in�

Moscow,� St.� Petersburg,� Kiev� and�Minsk� as� well� as� regionally� throughout� Russia� and� other� parts� of� Eastern�

Europe.

From� regulatory� submissions� to� clinical� affairs� to� medical� monitoring� to� drug� storage� and� distribution,� we�

offer� fully� integrated�services� for�managing�your� trials� in�Russia,�Ukraine�and�other� regions�of�Eastern�Europe.�

We� are� best� known� as� a� Western� CRO� in� Eastern� Europe� providing� faster� patient� recruitment� and� higher�

quality� data� than� that� provided� in� the� West.

Having� an� experienced� and� dedicated� staff� is� a� key� to� the� success� of� any� project.� All� of� our� professionals�

are� full-time� employees� of� ClinStar;� we� do� not� have� any� contractors� in� Russia,� Ukraine� or� Belarus.� Virtually�

all� of� our� employees� (with� few� exceptions� in� the� regions)� are� office-based.

To� cover� a� very� large� geographic� area� efficiently,� we� have� CRAs� located� throughout� Russia,� from� the�

European� part� of� Russia,� to� the� far� reaches� of� Siberia.� Our� CRAs� are� located� in� Moscow,� St.� Petersburg,�

Novosibirsk,� Barnaul,� Nizhni� Novgorod,� Samara,� Saratov,� Minsk,� Kiev,� and� Tallinn.

Our� professionals� are� well� educated;� 95%� of� our� CRAs� and� Project� Managers� have� medical� (M.D.)� or�

doctorate� (Ph.D.)� degrees� (in� the� biological� sciences),� or� both.� All� of� our�Medical�Monitors� hold� both�M.D.�

and� Ph.D.� degrees.

ClinStar� employees� have� good-to-excellent� spoken� and� written� English� skills.� Obligatory� English� classes� for�

employees� are� held� on� a� daily� basis,� with� classes� geared� toward� intermediate� or� advanced� students.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 185

2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

〇 〇

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US 〇 US US US 〇Canada Canada Canada Canada

EU EU EU EU

Asia Asia Asia Asia

Global Global Global Global

Other

Russia/�

Eastern�

Europe

Other Other Other Russia

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D

Pre-Clinical Pre-clinical

Test� Sample

R&D� Strategy

&� Management〇

Phase� I 〇 Clinical� Trials 〇Phase� II 〇 Clinical� Test

Sample

Finished

Products

Regulatory

Affairs〇

Phase� III 〇 Business

DevelopmentFinished

ProductPhase� IV 〇 Sales� &

Marketing

Corporate�

Product� Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

〇 〇 〇 〇Generics APIs Devices Others

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Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

15% 45% 30% 10%

Focusing�

Therapeutic� Area

ClinStar� has� experience� in� the� following� therapeutic� areas� but� is� not� limited� to� these�

areas� clinical� research:

•Cardiovascular� Diseases� � � � � � � � � � •Endocrinology� and� Metabolic� Diseases

•Oncology� and� Hematology� � � � � � � � •Neurology

•Psychiatry� � � � � � � � � � � � � � � � � � � � � � � •Infectious� Diseases

•Gastroenterology� � � � � � � � � � � � � � � � � •Hepatic� Diseases

•Pulmonary� Diseases� � � � � � � � � � � � � � •Autoimmune� Disorders

•Pediatric� Trials

General� Overview

of� Corporate's� Key

Contract� Services

ClinStar’s� key� services� include:

Feasibility

ClinStar� conducts� accurate� feasibility� analyses� for�work� performed� in� Russia� and� Eastern�

Europe.� The� feasibility� managers� work� closely� with� the� regulatory� team� and� medical�

officers� to� evaluate� each� protocol� for� potential� challenges.

Regulatory� Affairs

ClinStar's� dedicated� and� skilled� regulatory� team� manages� all� details� of� your� initial�

submissions� and� on-going� regulatory� maintenance.

Clinical� Affairs

Unlike�most� global� CROs�whose�management� teams�work� in� distant� offices� in�Western�

European� cities,� ClinStar’s� project� managers� and� top� management� are� located� in�

Moscow,� St.� Petersburg,� and� Kiev.� ClinStar's� staff� and� management� share� the� same�

cultural� grounding� and� work� ethic� as� their� Western� counterparts.

Using�a�client-dedicated� team�approach,�ClinStar� caters� to� your� study�needs�and�ensures�

that� your� studies� finish�on� time.�We�perform�a� full� range�of� clinical�affairs� tasks� including�

site� identification,�qualification,� initiation,� interim�monitoring,� close-out,�contracting�with�

sites� and� investigators,� as� well� as� site� management� and� project� management� services.�

In� addition,� our� internal� event� planning� group� organizes� local� investigator� meetings� in�

Russia� and� Ukraine

Medical� Affairs

ClinStar� is� one� of� the� only� CROs� in� our� region� to� offer� dedicated� medical� monitoring�

assistance.� We� provide� you� with� medical� monitors� trained� in� pharmacovigilance� who�

know� the� local�medical�practices�and� languages�and�are� in� the� same� time�zone�with� the�

Investigators.� All� of� our�medical�monitors� come� to� us� with� both�MD� and� PhD� degrees.�

3.� Corporate� Business�Overview

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 187

Their� strong� medical� backgrounds� combined� with� an� understanding� of� local� medical�

practices,� language,� and� culture,� make� it� easy� for� us� to� answer� questions� about� the�

study� protocol� and� patient� eligibility,� as� well� as� facilitate� accurate� SAE� reporting� and�

follow-up.

GCP� Audits

Our� QA� Department� provides� a� full� range� of� GCP� audit� services� in� our� geography� and�

produces� comprehensive� reports� and� audit� certificates� in� accordance� with� client�

specifications.

The� audit� services� include:

•Investigator� Site� Audits� � � � � � � � � � •Trial� Master� File� Audits

•Vendor� Quality� Systems� Audits� � � •Central� Laboratory� Audits

•Drug� Depot� Audits� � � � � � � � � � � � � � •Preparation� for� Regulatory� Inspections

Logistics

ClinStar� has� an� in-house� logistics� department� that� manages� logistics� related� to� the�

conduct� of� clinical� trials,� including� customs� clearance� of� study� product,� equipment,�

laboratory� kits,� and�other� ancillary�materials.�While� these� logistics� can�be� challenging� in�

our� region,�none�of�our� studies�have�been�delayed�due� to�prolonged�customs�clearance.

In�addition� to�our�CRO�services,�we�have�a�wholly-owned� subsidiary� ­� IMP�Logistics� ­that�

manages� clinical� supplies� warehousing� and� distribution� facilities� in� Russia,� Ukraine� and�

soon� in�Belarus.�The� facilities�allow�us� to�make� sure� that� the�drug� is�making� its�way� into�

the� country� and� is� being� distributed� properly� to� sites� on� time.

Communication�

with� Clients

Dispositoion� of

Project� Manager

Responsible

All� ClinStar� Project�Manager’s� are�Medical� Professional’s�with� either�

a�M.D.,�Ph.D�degree�or�both.� � Each�and�every� client� is� treated�with�

the� utmost� of� respect� and� consideration� as� would� expected� in� any�

working� environment.� � Our� PM’s� are� very� conscious� of� various�

cultural� expectations� and� differences.

Providing� Realtime

Service� Delivery

All� of� the� clinical� operations� are� managed� out� of� Moscow,� St.�

Petersburg,�Novosibirsk,�Barnaul,�Nizhni�Novgorod,�Samara,�Saratov,�

Minsk,�Kiev,�and�Tallinn.� �There�would�be�no� issues� in�our�providing�

real� time� service� delivery.� In� Russia� or� Eastern� Europe.

Realtime

Feed-back

All� of� the� clinical� operations� are� managed� out� of� Moscow,� St.�

Petersburg,�Novosibirsk,�Barnaul,�Nizhni�Novgorod,�Samara,�Saratov,�

Minsk,�Kiev,�and�Tallinn.� �There�would�be�no� issues� in�our�providing�

real� time� feed-back� in� Russia� or� Eastern� Europe.

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4.� Corporate� Competitiveness

Corporate

Competitiveness

The� following� key� points� differentiate� ClinStar� from� its� competitors:

1.� Geographical� focus� on� Russia,� Ukraine,� Belarus� and� the� Baltic� States� which� leads�

to� extraordinarily� high� patient� enrolment.

� � � ClinStar’s� Sr.� Project�Managers� and� Project�Managers� are� in� Kiev,�Moscow�and� St.�

Petersburg.� �Most� of� the� global� CROs�who� operate� in� Russia� and�Ukraine� do� not�

have� their� Project� Managers� located� locally.� � Instead,� they� manage� studies� in�

Russia� and� Ukraine� with� Project� Managers� located� in� their� offices� in� Dublin,�

Vienna,� Berlin,� the� UK� and� other� West� European� cities.� � The� latter� model� is� not�

as� efficient� and� result-oriented� as� ClinStar� model.� Furthermore,� while� being� a�

Western� CRO�with�Western� management� philosophy,� ClinStar’s� top�management�

is� also� located� locally.

2.� Unique� company� structure

� � � It� is� very� important� to� note� that� ClinStar� does� not� have� a� matrix� structure� so�

common� to�CROs� and� therefore� is� a�much�more� “flat”�organization.� �ClinStar’s� Sr.�

Project� Managers� and� Project�Managers� are� responsible� for� study� delivery� and� at�

the� same� time� function� as� Line�Managers� to� the� staff� working� under� them.� � The�

Sr.� Project� Managers� report� directly� to� the� President� of� ClinStar� who� is� informed�

of� the� study� progress� on� regular� basis.

3.�Better�quality�of�data� that�comes� from�having�a� very�strong�CRA� training�program.

� � � ClinStar� offers� extensive� training� to� CRAs� and� PMs.� ClinStar� has� in-house� trainers�

in�Moscow,�St.�Petersburg�and�Kiev�who� train�new�CRAs� in� their�native� languages.�

ClinStar� brings� trainers� to�Kiev� and�Russia� for� advanced� training� from� the�UK� and�

the� Vienna� School� of� Clinical� Research.

� � � ClinStar� CRAs� and� PMs� spend�much�more� time� training,� answering�questions� and�

assisting� investigators� than� do� other� CROs�which� operate� in� Russia,� Ukraine,� and�

the� Former� Soviet� Union� (FSU).� � As� a� result� of� spending� more� time� with�

investigators,� ClinStar� enjoys� far� better� relationships� with� investigators� than� its�

competitors.� �Those�better� relationships�usually� result� in� investigator�willingness� to�

make�extra�efforts� to� recruit�patients�on�ClinStar� studies.�Moreover,�95%�of�CRAs�

are� medical� doctors,� and� that� allows� them� to� interact� with� investigators� on�

pier-to-pier� level� and� increases� the� quality� of� data.

� � � ClinStar� has� a� dedicated� Quality� Assurance� Department.� The� QA� department�

consists� of� a� QA� Director,� 2� QA� Auditors,� 2� QA� Training� Managers� and� a� QA�

Administrative� specialist.� All� of� the� QA� department� employees� report� directly� to�

the� QA� Director.� The� QA� auditors� are� mainly� responsible� for� internal� audits�

execution� and� external� audit� assistance,� the� QA� Training� Managers� are� mainly�

responsible� for� preparation� and� delivery� of� the� training� and� co-monitoring� visits�

with� the� CRAs.� The� QA� auditors� are� also� involved� in� the� training� and�

co-monitoring� activities,� though� less� than� the� QA� Training� Managers.� Both� the�

auditors� and� trainers� participate� in� the� process� of� the� SOPs� writing� and� update.�

Internal� audits� help� ClinStar� to� ensure� quality� of� data� and� compliance�with� GCP.�

4.� Culture� of� extraordinarily� high� customer� service.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 189

28. Cmed Clinical Services

1.� Corporate� General� Information

Corporate� Name Cmed� Clinical� Services

Head� Office� AddressHolmwood� -� Broadlands� Business� Campus,� Langhurstwood� Road� Horsham� RH12�

4QP� United� Kingdom

Web-site� Address http://www1.cmedresearch.com

Company� Description� &� Organization

Cmed� Clinical� Services� (Cmed� CS)� is� a� CRO� which� provides� unique� clinical� services� to� drug� development�

organizations� world-wide.

The� key� decision� pharmaceutical� companies� currently� face� is� whether� to� progress� a� molecule� into� phase� III,�

with� its� attenuated�outlay.�Biotechnology� companies,�on� the�other�hand,�need� to�acquire�an�appropriate�data�

set� as� quickly� as� possible� to� build� a� strong� package� for� either� partnering� and� /� or� licensing.

Through� our� unique� solution�of� coupling�our� proprietary� e-clinical� technology,� Timaeus,�with� our� full� service�

trial� delivery� teams,� Cmed� CS� has� the� proven� ability� of� being� able� to� provide� a� bespoke� solution� to� both�

challenges.� We� are� able� to� deliver� early� phase� (I� to� IIb)� clinical� projects� faster� and� more� cost� effectively� as�

well� as� conduct� complex� studies� smoothly.

Our� vision� is� to� provide� our� unique� capabilities� to� customers� so� they� can� collect� the� right� data� at� the� right�

time� in� order� to� make� the� right� decision.

Cmed� CS� has� successfully� delivered� over� 300� clinical� projects� across� all� phases� of� development,� but� our�

speciality� is� early� phase� (I� to� IIb).� These� projects� have� been� both� traditional� and� complex,� such� as� adaptive�

trials,� proof� of� concept,� and� multi-cohort.

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2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US 〇 US US US

Canada Canada Canada Canada

EU 〇 EU EU EU

Asia Asia Asia Asia

Global Global Global Global

Other 〇 Other Other Other

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D

Pre-clinical

Test� Sample

R&D� Strategy

&� ManagementPre-Clinical

Phase� I 〇Clinical� Trials

Phase� II 〇 Clinical� Test

Sample

Finished

Products

Regulatory

Affairs

Phase� IIIFinished

Product

Business

Development

Phase� IVSales� &

Marketing

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 191

3.� Corporate� Business�Overview

General� Overview

of� Corporate's� Key

Contract� Services

•Complete� and� current� access� to� all� clinical� trial� data� (including� third� party)� to� allow�

rapid� and� more� informed� decision-making

•Agility� to�electronically�design�and�build�simple�and�complex� studies�based�on�a� variety�

of� protocols

•Capability� to� capture� and� integrate� data� in� real� time� from� any� source� or� location

•Ability� to�capture�data�directly� from�a�variety�of�mobile�devices� like� tablets� (i.e.,�Apple�

iPad®)� and� mobile� clinical� assistants� (MCAs),� thus� streamlining� data� collection

•Streamlining� global� end-to-end� processes� for� data� entry,� monitoring,� data�

management� and� reporting

•Mid-study� protocol� changes� without� system� shutdown

•Capacity� to� scale� studies—including� adding� new� sites,� patients,� electronic� case� report�

forms� (eCRFs),� etc.—without� downtime� or� interruption

Contract� Service�

Capacity� Affordable�

by� Service� Area

Cmed� CS� provides� unique� services� to� significantly� enhance� the� delivery� of� clinical� trials.

Through� the� coupling� of� our� proprietary� technology,� Timaeus,� with� our� full� service�

project� teams,� we� have� a� proven� track� record� of� delivering� clinical� trials� more�

innovatively� than� ever� before;� faster� and� more� cost� effectively.

•Study� Build� � � � � � � � � � � � � � � � � � � � � � � � � •Accessing� the� Best� Investigators

•Ensure� Investigator� Motivation� � � � � � � � � •Faster� project� timelines

Communication�

with� Clients

Dispositoion� of

Project� Manager

ResponsibleBeing� a� small� to� mid-size� organisation,� Cmed� CS� is� flexible.� This�

allows�us� to� respond� swiftly� to� study�delivery� challenges� in�order� to�

ensure� the� implementation�of� a� solution�which� exceeds� our� client's�

expectations.� Our� flexibility� is� advantageous� to� our� clients� as� they�

differ� in� terms�of� requirements�and�operating�models.� This� flexibility�

is� portrayed� both� from� an� operational� and� financial� perspective.

Providing� Realtime

Service� Delivery

Realtime

Feed-back

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Corporate� Name CO� RESEARCH

Head� Office� Address

Başıbüyük� Mah.� Başıbüyük� Yolu� cad.� Kentplus� Centrium� Sitesi

� B1� Blok� No:16/12

� Maltepe� /� İstanbul� /� TurkeyFacilities� City� &� Country Turkey

Web-site� Address www.co-research.com

Contact

(Korean�

Business)

Telephone +90� 216� 969� 40� 06

E-mail [email protected]

Company� Description� &� Organization

Co-� Research� is� a� full-service� contract� research� organisation� in� Turkey.� Our� area� of� expertise� covers� a� full�

range� of� services� related� to� clinical� trials,� observational� studies,� clinical� trial� training,� data� management,�

medical� writing� and� outsourcing.

We� provide� tailor-made� solutions� to� your� projects.� Co-Research� offers� a� complete� range� of� services� with�

personalized� attention� and� flexibility.� Through� close� cooperation� and� continuous� dialogue� with� customers,�

our� services� can� be� customized� according� to� your� requirements.�

29. CO RESEARCH

1.� Corporate� General� Information

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 193

Corporate� Name Covance� Inc.

Corporate� Ownership Public� Company

Head� Office� Address 210� CarnegieCenter,� Princeton,� NewJersey� 08540� USA

Facilities� City� &� Country

North� America

Alice,� TX,�Chandler,�AZ,�Chantilly,�VA,�Dallas,� TX,�Daytona�Beach,� FL,�Denver,�PA,�

Evansville,� IN,� Greenfield,� IN,� Honolulu,� HI,� Indianapolis,� IN� � Madison,� WI�

Europe

Basel� -� Switzerland,�Geneva� -� Switzerland,�Harrogate� -� England,� Leeds� -� England,�

Alnwick� -� England,� Porcheville� -� France,� Münster� -� Germany

Asia� PacificRim � �

Shanghai� -� China,� Singapore

Korean� Business� OfficeCovance�Korea�13F,�POBA�Gangnam�Tower�343�Hakdong-ro,�Gangnam-gu�Seoul�

135-820,� Korea

Web-site� Address www.covance.com

No.� of� EmployeesAt�December�31,�2013,�we�had�12,501�employees� in�60�countries.�Approximately�

46%� of� our� employees� are� employed� outside� of� the� United� States.

Financial� Status

Sales� Revenue� in� 2013

(US� K$)Capital(US� K$) Dept-equity� Ratio(%)

$2,402,313 $871,311 0.16

Contact

(Korean�

Business)

NameEunhee� Lee� /� Early� Development� Services

Jongho� Ahn� /� Clinical� Development� Services

AddressCovance�Korea�13F,�POBA�Gangnam�Tower�343�Hakdong-ro,�Gangnam-gu�Seoul�

135-820,� Korea

Telephone+82-2-6004-3596/� Early� Development� Services

+82-2-6004-3500� /Clinical� Development� Services

[email protected]� :� Eunhee� Lee/Early� Development� Services

[email protected]� :� Jongho� Ahn� /� Clinical� Development� Services

30. Covance Inc.

1.� Corporate� General� Information

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Company� History

Covance� has� operated� under� the� name� of� Covance� Inc.� since� 1997.� However,� the� history� of� Covance� dates�

back� to� 1946� when� Hazelton� Laboratories� was� established.� Hazelton� Laboratories� was� acquired� in� 1987� by�

Corning,� Inc.� In� 1989,� Corning� also� acquired� G.H.� Besselaar� Associates,� which� had� been� founded� in� 1976.�

These� two� companies� (renamed� Corning�Hazelton,� Inc.,� and� Corning� Besselaar,� Inc.)� became�part� of� the� six�

best-of-class� drug� development� companies� comprising� the� Corning� Pharmaceutical� Services� (CPS)� network.�

In� 1997,� CPS� was� spun� off� as� an� independent,� full-service,� publicly� traded� company� named� Covance,� Inc.

Company� Description� &� Organization

At� Covance,� we� combine� unique� perspectives� and� precision� delivery� to� shape� new� possibilities� for�

pharmaceutical� and�biotech�clients.� Insights� from�our�experienced�scientists,� technicians,� and� staff,�combined�

with� innovative�processes,� expansive�global� footprint,�broad�portfolio,� and� state-of-the-art� facilities,� continue�

to� earn� respect.�Our� comprehensive� business�model� and�broad� spectrum�of� services� support� the� entire� drug�

development�process.�We� focus�on� three� client-oriented� strategies:� revealing� opportunities,�providing�unique�

perspectives,�and� transforming�results.�With�a� commitment� to�operational� excellence,�we�help�clients� identify�

and� commercialize� opportunities� efficiently� and� effectively.� We� provide� an� industry-leading� portfolio� of�

nonclinical� and� clinical� development� and� commercialization� services� delivered� through� the� world’s� largest�

central� laboratory�network�and�a�global� team�of� clinical� trial�professionals� in�more� than�60�countries.�Guided�

by� a�mission� to�make� solutions� real,�we� proactively� provide� personal� attention� and� accountability� to� exceed�

client� goals.� Through� research,� nonclinical,� clinical,� and� commercialization� services,� we� have� supported� the�

development� of� 100� percent� of� the� 50� top-selling� drugs� on� the�market� today.� It� takes� a� range� of� solutions�

to� move� a� drug� from� lead� optimization� to� commercialization.�We� work� with� drug� development� companies�

at� every� stage—and� across� every� stage—to� provide� comprehensive� solutions� tailored� to� client� needs.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 195

2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

○ ○ ○

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US US US US

Canada Canada Canada Canada

EU ○ EU ○ EU EU ○

Asia ○ Asia ○ Asia Asia ○

Global ○ Global Global Global ○

Other Other Other Other ○

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research ○ API ○

APIs

R&D ○

Pre-Clinical ○ Pre-clinical

Test� Sample○

R&D� Strategy

&� Management○

Phase� I ○ Clinical� Trials ○

Phase� II ○Clinical� Test

Sample○

Finished

Products

Regulatory

Affairs○

Phase� III ○Finished

Product

Business

Development○

Phase� IV ○Sales� &

Marketing○

Corporate�

Product� Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

○ ○ ○ ○

Generics APIs Devices Others

○ ○

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196� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Clients'�

Composition

(%)

이Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

We� provide� product� development� services� on� a� global� basis� to,� among� others,� the�

pharmaceutical� and� biotechnology� industries.� In� 2013,� we� served� in� excess� of� 1,000�

biopharmaceutical� companies,� ranging� from� the� world’s� largest� pharmaceutical�

companies�and�biotechnology� companies� to� small�and� start-up�organizations.�Other� than�

one�customer� that� accounted� for� 10.6%�and�another� that� accounted� for� 10.0%�of�our�

aggregate� net� revenue� in� 2013,� no� other� customer� accounted� for� ten� percent� or�more�

of� our� aggregate� net� revenues.�We� had� four� customers� accounting� for� more� than� five�

but� less� than� ten� percent� of� our� net� revenues.� In� our� early� development� segment,� one�

customer� accounted� for� more� than� ten� percent� of� net� revenues� and� two� customers�

accounted� for� more� than� five� but� less� than� ten� percent� of� aggregate� net� revenues.� In�

our� late-stage� development� segment,� two� customers� accounted� for� more� than� ten�

percent� of� net� revenues� and� six� customers� accounted� for�more� than� five� but� less� than�

ten� percent� of� aggregate� net� revenues.

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

○ ○ ○ ○

Focusing�

Therapeutic� Area

With� a� full� suite� of� services� to� take� a� drug� through� all� stages� of� development,� Covance�

has� the� sophisticated� therapeutic� expertise� required� to� develop� a� compound.� Covance�

has�extensive�experience� in�all�major� therapeutic� areas,� such�as�Analgesic,�Anti-infectives,�

Bone� and� Joint� Disease,� Cardiovascular,� Dermatology,� Gastrointestinal,� Hematology,�

Hormonal� Therapy/Endocrinology,� Infectious� Disease,� Inflammation,� Immunology,�

Metabolic,� Neuroscience,� Ocular,� Oncology,� Renal� Disease,� and� Respiratory�

Disease/Pulmonology,�Urogynecology/Women’s�Health.�And�a�global� team�of� therapeutic�

experts� draws� on� the� entire� Covance� organization� to� deliver� results.

General� Overview

of� Corporate's� Key

Contract� Services

Covance� is� a� leading� drug� development� services� company� providing� a� wide� range� of�

early-stage� and� late-stage� product� development� services� on� a� worldwide� basis� primarily�

to� the�pharmaceutical� and�biotechnology� industries.�Covance�also�provides� services�such�

as� laboratory� testing� to� the� chemical,� agrochemical� and� food� industries.� The� foregoing�

services� comprise� two� reportable� segments� for� financial� reporting� purposes:� early�

development� services,� which� includes� discovery� support� services,� preclinical� and� clinical�

pharmacology� service� offerings;� and� late-stage� development� services,� which� includes�

central� laboratory,�Phase� II-IV� clinical�development�and�market�access�services.�Although�

each� segment�has�separate�services�within� it,� they� can�be�and� increasingly�are,� combined�

in� integrated� service� offerings.

Contract� Service�

Capacity� Affordable�

We�believe�Covance� is� one�of� the�world’s� largest�drug�development� services� companies,�

based� on� annual� net� revenues,� and� one� of� a� few� that� are� capable� of� providing�

3.� Corporate� Business�Overview

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 197

by� Service� Area

comprehensive� global� product� development� services.�We� believe� that� it� is� important� to�

provide�a�broad�range�of�drug� research�and�development�services�on�a�global�basis.�We�

have�offices,� regional�monitoring�sites�and� laboratories� in�over�50� locations� in�more� than�

30� different� countries� and� have� employees� in� over� 60� countries.� We� believe� we� are� a�

leader� among� drug� development� services� companies� in� our� ability� to� support� large,�

global� clinical� trial� programs.

Communication�

with� Clients

Dispositoion� of

Project� Manager

Responsible

Each� project� is� assigned� a� dedicated� team� and� support� staff.� If�

project� or� program�management� is� needed,�we� also� offer� program�

management� service,�which�monitors� the�progress�of� studies�across�

multiple� functional� groups� and� assists� the� sponsor� in� arranging�

meetings� or� providing� information� on� all� Covance� services.

Providing� Realtime

Service� Delivery

Across� our� people,� process� and� clients� platform,� we� seek� to� utilize�

technology� to� augment� the� talent� of� our� people,� to� automate�

robust� processes,� and� to� link� us� more� closely� to� our� clients� via�

proprietary� systems� such� as� Xcellerate®,� StudyTracker®,� LabLink.

Realtime

Feed-back

We� realize� that�you�need� timely�access� to� study� information� to�help�

you� facilitate� earlier� go� /� no� go� decisions� regarding� your� study’s�

viability.� StudyTracker™� allows� you� access� to� your� toxicology,�

pathology,� bioanalytical,� and�metabolism� data� in� near� real� time� for�

greater� control,� improved� communication,� and� reduced�

development� time.

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198� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

4.� Corporate� Competitiveness

Corporate

Competitiveness

At� Covance,� our� team� provides� targeted� support� for� your� drug� development� journey�

from� discovery� to�market.�We� offer� scientific,� therapeutic,� diagnostic,� and� regulatory�

expertise� that� our� clients� need� to� advance� molecules.� Our� unique� perspective,� built�

from� decades� of� scientific� expertise� and� precision� delivery� of� the� largest� volume� of�

drug� development� data� in� the� world,� helps� our� clients� identify� new� approaches� and�

anticipate� tomorrow’s� challenges.� This� know-how� helped� us�work� on� 100� percent� of�

all� 50� top-selling� drugs� in� 2013.� Our� history� spans� 80� years� of� drug� development�

solutions� experience.� We� partner� with� thousands� of� small� and� large� pharmaceutical�

and�biotechnology� companies� around� the�world,� helping� them�execute� solutions� and�

achieve� customer�success.�At�Covance,�we�draw�on�our�extensive�background�coupled�

with� constant� innovation� to� shape� new� solutions.� We� offer� integrated� development�

processes�and�an�earned� reputation� that�garnered� the�highest� score� in�both�preclinical�

and� clinical� quality� in� a�Morgan� Stanley� research� study.�Optimizing� study� designs� can�

be� challenging� and�often�overlooked.�Covance�knows�a� unique,�unbiased�perspective�

can� help.� We� can� optimize� your� design� to� create� savings,� without� compromising�

quality,�delivery,�or� regulatory�acceptance.�We�are�driven� to�offer� customized�solutions�

to� move� your� molecule� development� forward.� It� is� just� a� one� of� the� specialized�

attributes� that� prompt� clients� to� cite� Covance� as� the� contract� research� organization�

that’s� “best� positioned”� for� discovery,� preclinical,� and� clinical�work,� according� to� Baird�

Equity�Research.�Maintaining� lasting�client� relationships� is�more� than�delivering� results.�

We� hold� ourselves� to� high� standards� of� integrity� and� commit� 100� percent� to�

partnership� and� your� success.� At� Covance,� we� have� built� a� foundation� of� values�

centered� on� corporate� stewardship� through� strong� governance,� responsible� use� of�

company� resources,� and� active� involvement� in� our� local� communities.

No.� of� Regulatory

Inspections

ClassificationFDA

(US)

EMA

(EU)

PMDA

(Japan)

CFDA

(China)

DCI

(India)Others

Pre-Clinical�

Area8

(1)� Ministry� of� Labor� and�

Social� Health

(1)� Ministry� of� Environment,�

Spacial� Planning� and�

Agriculture

(1)� China� FDA,� (2)� EPA

(10)� MHRA,� (1)� OECD

(1)� COFRAC,� (1)� ANSM

(1)� AFSSsPS

Clinical� Area 11

(5)� MHRA,� (1)� ANSM

(2)� Korea� MDFS,� (1)�

SwissMedic

Manufacturin

g� Area7 1

(1)� Heath� Canada,� (10)�

MHRA,� (1)� UKAS

Others

Current� Status� of

Accredited�

Certification

As� a� leading� global� CRO,� Covance� undergoes� regular� inspections� by� regional�

regulatory�authorities.� � The� list� above� summarizes� inspections�by� regulatory�authorities�

at� our� global� facilities� over� the� past� 5� years.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 199

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� toJapan,� Korea,China,Taiwan,� Thailand,� India

Asian� Clients'

Composition(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

Our� data� are� not� broken� down� by� company� size� and� not� available.

No.� of� Asian� Clients

in� recent� 3� years

We� have� multiple� projects� awarded� from� Asian� Sponsors� and� the� numbers� are�

growing

Major� Service� Range

with�Asian�Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research ○ API ○

APIs

R&D ○

Pre-Clinical ○ Pre-clinical

Test� Sample○

R&D� Strategy

&�Management○

Phase� I ○ Clinical� Trials ○

Phase� II ○Clinical� Test

Sample○

Finished

Products

Regulatory

Affairs○

Phase� III ○Finished

Product

Business

Development

Phase� IV ○Sales� &

Marketing

6.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

SOLUTIONS� MADE� REAL™

At� Covance,� our� people� are� committed� to� advancing� health� care� and� bringing� new�medicines� to� market�

sooner.

Our� unique� perspectives,� built� from� decades� of� scientific� expertise� and� precision� delivery� of� the� largest�

volume� of� drug� development� data� in� the� world,� help� our� clients� identify� new� approaches� and� anticipate�

tomorrow’s� challenges� as� they� evolve.� Driven� by� a� passion� for� excellence� and� a� relentless� commitment� to�

quality,� we� unlock� opportunities� that� advance� innovation� and� deliver� the� promise� of� a� healthier� world.

The� ability� to� leverage� resources� at� Covance� will� help� you� to� reduce� costs,� gain� efficiencies� and� leverage�

expertise� to� progress� the� most� promising� candidates� through� the� drug� development� process.� We� are�

confident� that� Covance� can� conduct� a� full� nonclinical� and� clinical� development� program� for� Korean�

pharmaceutical� companies.

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200� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

31. CPR Strategic Marketing Communications, Inc.

1.� Corporate� General� Information

Corporate� Name CPR� Strategic� Marketing� Communications,� Inc.

Corporate� Ownership Private� Company

Head� Office� Address Home� office:� 475� Market� St,� 2nd� Floor,� Elmwood� Park,� NJ� 07407

Facilities� City� &� Country Elmwood� Park,� USA

Web-site� Address Cpronline.com

No.� of� Employees 24

Contact

(Korean�

Business)

Name Joseph� Carabello

Address 475� Market� Street,� 2nd� Floor,� Elmwood� Park,� NJ� 07407

Telephone 201-641-1911� � x-11

E-mail [email protected]

Company� History

Year� of� Establishment� 1983� Number� of� Employees� 24�

Facility� US� Office� Headquarters� Revenue� (2010)� �

Location� 475� Market� St.� 2nd� floor,� � Elmwood� Park,� NJ� 07407�

Company� Description� &� Organization

A�member�of� the�RHI�Consulting�Group.�CPR�Strategic�Marketing�Communications� is� a� full-service�marketing,�

public� relations� and� advertisingcompany� serving� the� healthcare,� healthcare� information� technology,� and� life�

sciences� industries�worldwide,� spanning�private�and�public�companies.�CPR�principals� and� staff�have�decades�

of� experience� in� corporate� positioning,� branding� and� strategy� planningfor� a� wide� range� of� products� and�

services,� with� an� experienced� team� of� professionals� that� orchestrate� multi-dimensional,� Business-to-Business�

and� Direct-to-Consumer� campaigns� in� all� media� venues� ­including� the� emerging� social� media� channels� and�

digital�publishing.� For�more� than�25+�years,�CPR�has� represented�a�multitude�of� companies� that�manufacture�

and� distribute:�

� -� Pharmaceuticals� :� Rx� ­� Branded� and� Generic;� Orphan� and� Ultra-orphan� Drugs

� -Over-the-Counter� (OTC)

� -Nutraceuticals,� Supplements� �

� -Medical� Foods�

� -Medical� Devices�

� -Biotech�

CPR�brings� a� unique� range� of� capabilities� for�marketing� and� promoting� to� US-based� health� plans,�managed�

care� organizations,� disease� management� organizations� and� self-insured� employers� of� all� sizes.� In� this�

specialized�market�niche,�CPR� is�highly�experienced�with�all� aspects�of�healthcare� information� technology�and�

IT� infrastructure:�Health�Records/Personal�Health�Records,�Health� Information�Exchanges� (HIEs),� E-Prescribing,�

Regional� Health� Information� Organizations� (RHIOS)� and� technology� solutions� for� interoperability,� electronic�

health� data� interchange,� and� mobile� health.� Additionally,� the� firm� represents� leaders� in� pharmacy� benefit�

management,�disease�management,�drug/device�distribution,�discount�health� card�services,� telemedicine�and�

telehealth,� and� other� related� health� innovation� companies.�

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 201

2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US US US US ○

Canada Canada Canada Canada ○

EU EU EU EU ○

Asia Asia Asia Asia ○

Global Global Global Global ○

Other Other Other Other

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D

Pre-ClinicalR&D� Strategy

&� ManagementPre-clinical

Test� SamplePhase� I Clinical� Trials

Phase� IIClinical� Test

Sample

Finished

Products

Regulatory

Affairs

Phase� IIIBusiness

Development○

Finished

ProductPhase� IV

Sales� &

Marketing○

Corporate�

Product� Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

○ ○

Generics APIs Devices Others

○ ○

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202� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

3.� Corporate� Business�Overview

Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

75% 25%

Focusing�

Therapeutic� AreaOrphan� /� Ultra� Orphan� Diseases

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 203

Corporate� Name CROTURK

Head� Office� AddressKazim� Qzalp� Mah.� Koza� Sok.� 33/4

Cankaya� ­� Ankara� Turkey

Facilities� City� &� Country Turkey

Web-site� Address www.croturk.com

Contact

(Korean�

Business)

Telephone +90� 312� 479� 88� 75

E-mail [email protected]

Company� Description� &� Organization

CROTURK� is� a� full-service� contract� service� organisation� in� Turkey.� Our� headquarter� is� located� in� the�

heart� Turkey,� Ankara.� We� provide� distinguished� services� among� all� regions� of� Turkey� and� with� our�

invaluable� partners� we� provide� services� across� Europe� and� MENA� countries.

32. CROTURK

1.� Corporate� General� Information

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204� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

33. Cunningham & Associates

1.� Corporate� General� Information

Corporate� Name Cunningham� &� Associates

Corporate� Ownership Private� Company

Head� Office� Address Home� office:� Princeton� New� Jersey;� Office� in� Washington� D.C.

No.� of� Employees

Cunningham�&�Associates� consultants� and� advisors� are� not� employees� but� rather�

independent� contractors.� We� can� assemble� a� team� to� handle� small,� medium,� or�

large� transactions,� as� needed

Contact

(Korean�

Business)

Name Kevin� F.� Cunningham

Address P.� O.� Box� 328,� Princeton� NJ� 08542-0328,� U.S.A.

Telephone 1-609-497-1200

E-mail [email protected]

Company� History

Kevin� Cunningham� has� over� 20� years� experience� with� Bristol-Myers� Squibb,� major� law� firms,� and�

Cunningham� &� Associates� in� the� pharmaceuticals,� biotech,�medical� devices,� nutritionals,� nutraceuticals,� and�

cosmeceuticals� businesses.� He� has� further� international� experience� in� the� natural� resources� industry.� His�

Associates�all� have� substantial� experience� in� “big�pharma”�and� in�consulting� for� “big�pharma”�and�with�smaller�

integrated� and� specialty� companies� both� in� the� United� States� and� globally.

Company� Description� &� Organization

Cunningham� &� Associates� provides� law� and� business� planning� and� implementation� of� plans� in� the� United�

States� and� outside� the� United� States� for� international� and� domestic� business� &� international� trade� with� a�

specialty� in� the� pharmaceuticals,� biotech,� medical� devices,� nutritionals,� and� cosmeceuticals� industries.

Cunningham� &� Associates� provides� industry,� law,� and� business� counseling,� advice,� and� assistance� to� United�

States�domestic� and� international� companies�as�well�as�non-United�States� large�and�medium�sized�companies�

in� both� integrated� and� specialty�markets.� Services� provided� include:� corporate�matters;� contracts� of� all� sorts;�

intellectual�property;�dispute� resolution� --�United�States�and�globally;�negotiations�and�counseling�with�private�

parties� and� governments;� outsourcing;� human� resources� matters;� and� specific� concerns� of� companies� in�

pharmaceuticals,� biotech,� medical� devices,� nutritionals,� nutraceuticals,� and� cosmeceuticals� industries.

Kevin� Cunningham� has� over� 25� years� experience� in� more� than� 30� countries� dealing� with� domestic,�

international,� and� transnational� matters� ­� working� as� in-house� counsel� with� Bristol-Myers� Squibb,� with� law�

firms,� and� Cunningham� &� Associates.� His� Associates� all� have� substantial� experience� in� “big� pharma”,�

consulting� for� “big� pharma”,� and�with� smaller� integrated� and� specialty� companies� both� in� the� United� States�

and� globally.

Kevin� Cunningham:� J.D.,� Yale� Law� School;� M.B.A.,� Columbia� University.� He� taught� at� Princeton,� Rice,�

Georgetown,� and� Columbia� Universities.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 205

2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US US US US ○

Canada Canada Canada Canada ○

EU EU EU EU ○

Asia Asia Asia Asia ○

Global Global Global Global ○

Other Other Other Other○

(Latin)

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D ○

Pre-Clinical Pre-clinical

Test� Sample

R&D� Strategy

&� Management○

Phase� I Clinical� Trials ○

Phase� IIClinical� Test

Sample

Finished

Products

Regulatory

Affairs○

Phase� IIIFinished

Product

Business

Development○

Phase� IVSales� &

Marketing○

Corporate�

Product� Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

○ ○ ○ ○ ○

Generics APIs Devices Others

○ ○ ○ ○(Nutr/Cosm)

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Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

Constantly� varies Constantly� varies Constantly� varies Constantly� varies

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

NA NA NA NA NA

Focusing�

Therapeutic� Area

Cunningham� &� Associates� have� dealt� with� clients� in� numerous� therapeutic� areas,�

prescription� and� OTC� products,� biologics,� nutritionals,� neutraceuticals,� cosmeceuticals,�

etc.

General� Overview

of� Corporate's� Key

Contract� Services

Cunningham� &� Associates� provides� law� and� business� planning� and� implementation� of�

plans� in� the�United�States�and�outside� the�United�States,� for� international� and�domestic�

business� activities�&� international� trade�with� a� specialty� in� the� pharmaceuticals,� biotech,�

medical� devices,� nutritionals,� and� cosmeceuticals� industries.

Cunningham� &� Associates� provides� industry,� law,� and� business� counseling,� advice,� and�

assistance� to�United� States� domestic� and� international� companies� as�well� as� non-United�

States� large� and� medium� sized� companies� in� both� integrated� and� specialty� markets.�

Services� provided� include:� corporate�matters;� contracts� of� all� sorts;� intellectual� property;�

dispute� resolution� --� in� the�United�States�and�globally;�negotiations�and�counseling�with�

private� parties� and� governments;� outsourcing;� human� resources� matters;�

pharmaceuticals,� biotech,� medical� devices,� nutritionals,� nutraceuticals,� and�

cosmeceuticals.

Kevin�Cunningham�has�over�25� years�experience� in�more� than�30�countries�dealing�with�

domestic,� international,� and� transnational� matters� ­� working� as� in-house� counsel� with�

Chevron� Corporation� and� Bristol-Myers� Squibb,� with� law� firms,� and� Cunningham� &�

Associates.� His� Associates� all� have� substantial� experience� in� “big� pharma”� and� in�

consulting� for� “big� pharma”� and� with� smaller� integrated� and� specialty� companies� both�

in� the� United� States� and� globally.

3.� Corporate� Business�Overview

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 207

Contract� Service�

Capacity� Affordable�

by� Service� Area

Kevin� Cunningham� and� his� Associates� have� over� 25� years� experience� in� more� than� 30�

countries� dealing� with� domestic,� international,� and� transnational� matters� ­� working� as�

in-house� counsel� with� Chevron� and� Bristol-Myers� Squibb,� with� law� firms,� and�

Cunningham� &� Associates.

Billing� is� worked� out� with� clients� based� on� the� types� of� services� needed,� geographic�

scope,�duration�of� the�work� contract,�number�of�professional/support� staff�needed,�etc.

Communication�

with� Clients

Dispositoion� of

Project� Manager

Responsible

Our� Project� Partner� is� available� as� needed.�With� the� agreement� of�

the� client� and� the� needs� of� the� matter� being� worked� on,� less�

experience� personnel�may� be� involved.�We�meet� needed�deadlines.�

We� work� out� a� schedule� which� meets� the� needs� of� the� client.

Providing� Realtime

Service� Delivery

We�meet� needed� deadlines.�We�work� out� a� schedule� which�meets�

the� needs� of� the� client.

Realtime

Feed-back

We�meet� needed� deadlines.�We�work� out� a� schedule� which�meets�

the� needs� of� the� client.

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4.� Corporate� Competitiveness

Corporate

Competitiveness

Kevin�Cunningham�and�his�Associates�have�over�25�years�experience� in�more� than�30�

countries�dealing�with�domestic,� international,� and� transnational�matters� ­�working�as�

in-house� counsel� with� Chevron� and� Bristol-Myers� Squibb,� with� law� firms,� and�

Cunningham� &� Associates.

We� stay� current� on� the� legal,� regulatory,� and�practical� aspects� of� the� business� of� our�

clients.

No.� of� Regulatory

Inspections

Classification FDA(US) EMA(EU) PMDA(Japan) Others

Pre-Clinical� Area NA NA NA NA

Clinical� Area NA NA NA NA

Manufacturing� Area NA NA NA NA

Others NA NA NA NA

Current� Status� of

Accredited�

Certification

Cunningham� &� Associates� assists� clients� with� Regulatory� Inspections� and� obtaining�

and� maintaining� Accreditation� Certifications.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 209

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� toJapan,� US,� Israel

Asian� Clients'

Composition(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

30% 60% 5% 5%

No.� of� Asian� Clients

in� recent� 3� years6

Major� Service� Range

with�Asian�Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D ◌

Pre-ClinicalPre-clinical

Test� Sample

R&D� Strategy

&�Management◌

Phase� I Clinical� Trials ◌

Phase� IIClinical� Test

Sample

Finished

Products

Regulatory

Affairs◌

Phase� IIIBusiness

Development◌

Finished

ProductPhase� IV

Sales� &

Marketing◌

6.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

Cunningham�&�Associates� is�associated�with� law� firms� throughout� the�United�States�and�outside� the�United�

States� ­� including�Korea,�We�are�also�associated�with� specialist�groups� in�all�major� law�and�other� consulting�

disciplines:� M&A,� R&D,� marketing� &� sales,� GMP,� IP,� HR,� US� and� non-US� regulatory� matters.

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Corporate� Name Cyprotex� Discovery� Limited

Corporate� Ownership Public� Company

Head� Office� Address Address:� 15� Beech� Lane,�Macclesfield,� Cheshire,� SK10� 2DR,� United� Kingdom

Facilities� City� &� Country Macclesfield(England),� Watertown(United� States)

Web-site� Address www.cyprotex.com

No.� of� Employees 75

Financial� Status

Sales� Revenue� in� 2011

(US� K$)Capital(US� K$) Dept-equity� Ratio(%)

9.44M USD 9.12M USD 30%

Contact

(Korean�

Business)

Name Daniele� Bemporad

Address 15� Beech� Lane,� Macclesfield,� Cheshire,� SK10� 2DR

Telephone 07876� 746� 955

E-mail [email protected]

Company� History

1999:� Cyprotex� was� founded� by� David� Leahy� (AstraZeneca).

2002:� Cyprotex� started� to� be� traded� in� the� London� Stock� Exchange� (CRX).

Revenues� have� increased� ever� since� and� the� company� is� profitable� since� 2008.

2009:� alliance� with� Sygnature� Discovery� (England),� leading� medicinal� chemistry� CRO.

2010:� acquisition� of� Apredica,� an� ADMETox/DMPK� CRO� based� in� the� United� States.

2010:� opening� of� new� laboratory� space.

2010:� launch� of� proprietary� in-vitro� toxicology� technology� CellCiphr®.

2011:� alliance� with� SOLVO� Biotechnologies� (Hungary),� world� leader� in� in-vitro� transporter� studies.

2012:� alliance� with� Sirius� Analytical� (England),� world� leader� in� physico-chemical� profiling.

2012:� launch� of� genetic� ADME� technology� (gADME®).

34. Cyprotex Discovery Limited

1.� Corporate� General� Information

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 211

Company� Description� &� Organization

Cyprotex� is� the� world's� largest� CRO� fully� dedicated� to� pre-clinical� drug� metabolism,� pharmacokinetics�

and� toxicology� (ADMETox/DMPK).� As� well� as� routine� assays,� we� have� developed� and� validated�

proprietary� technologies� with� major� pharmaceutical� partners,� such� as� gADME®,� CellCiphr®� and�

CloePK®.� From� our� laboratories� in� England� and� the� United� States� we� work� with� 600+� worldwide�

customers,� including� pharmaceutical� and� biotech� companies,� research� institutes� and� academic� groups.�

We� have� developed� a� highly� automated� screening� platform� which� allows� for� fast� turnaround� times,�

accuracy,� reproducibility� and� cost� effectiveness.� We� have� implemented� robust,� industry-validated� and�

FDA-recommended� screening� protocols,� but� we� are� also� able� to� customise� the� experiments� to�

accommodate� specific� requirements.� We� have� no� internal� drug� discovery� programme,� therefore� we�

have� no� conflict� of� interest� and� can� give� unbiased� advice.� Cyprotex� pays� attention� to� good� quality�

customer� care,� with� highly� trained� Principal� Scientists� on� hand� to� explain� results� and� suggest� the�most�

appropriate� experimental� strategy.

In� summary,� Cyprotex� customers� benefit� from� our� proprietary� technologies,� speed,� flexibility,� cost�

effectiveness,� high� quality� adaptable� protocols,� high� capacity,� IT� support,� experience,� dedicated� project�

managers� and� scientist-to-scientist� communication.� Cyprotex� customers� can� achieve� better� preclinical�

compound� selection� more� quickly� and� with� reduced� costs.

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2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

○ ○

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US US US US

Canada Canada Canada Canada

EU EU EU EU

Asia Asia Asia Asia

Global ○ Global Global Global ○

Other Other Other Other

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research ○ API

APIs

R&D ○

Pre-Clinical ○ Pre-clinical

Test� Sample

R&D� Strategy

&� Management○

Phase� I Clinical� Trials

Phase� IIClinical� Test

Sample

Finished

Products

Regulatory

Affairs

Phase� IIIFinished

Product

Business

Development

Phase� IVSales� &

Marketing

Corporate�

Product� Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

○ ○ ○ ○

Generics APIs Devices Others

○ ○

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 213

Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

40 40 10 10

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

○ ○

General� Overview

of� Corporate's� Key

Contract� Services

(1)� In-vitro� ADME/DMPK� (http://www.cyprotex.com/admepk/):

CYP�reaction�phenotyping,�CYP� induction,�CYP� reversible�and� time�dependent� inhibition,�

UGT� reaction� phenotyping� and� inhibition,�metabolic� stability� (microsomes,� hepatocytes,�

plasma,�S9,� etc.),�metabolite�profiling�and� identification,�PXR�and�AhR�Nuclear�Receptor�

Activation,� permeability� (Caco-2,� MDCK),� transporters� (Pgp,� BCRP� and� others),�

bioanalysis,�bioanalytical�method�development�and�validation,�physicochemical�properties�

(CHI,� logD,� logP,� pKa,� solubility),� plasma� protein� binding,� tissue� binding.

(2)� In-vitro� Toxicology� (http://www.cyprotex.com/toxicology/):

high� content� toxicology,� CellCiphr®� (cytotoxicity,� hepatotoxicity,� cardiotoxicity),�

phospholipidosis,� steatosis,� lysosomal� trapping,�3D�microtissue�hepatotoxicity,�hemolysis,�

mitochondrial� toxicity,� reactive� metabolite� assessment,� hERG� inhibition,� drug-drug�

interactions,� toxicological�gene� regulation,� cell� viability,�genotoxicity� (Greenscreen,�Ames,�

in-vitro� Comet,� in-vitro� micronucleus).

Cyprotex� has� invested� in� a� high� content� screening� platform� which� uses� automated�

fluorescence� imaging� to� simultaneously� analyse� multi-parametric� indicators� of�

cytotoxicity.� This� improves� the� prediction� of� toxicological� events� and� allows� a� better�

understanding� of� the� mechanisms� of� drug� toxicity.

(3)� In-silico� PK� (http://www.cyprotex.com/insilico/):

Cloe� PK®� Pharmacokinetic� prediction� using� PBPK� modelling� and� in-vitro� to� in-vivo�

extrapolations,

Cloe� HIA®� Prediction� of� human� intestinal� absorption,

QSAR� and� automation� of� laboratory� workflow.

(4)� genetic� ADME� (http://www.cyprotex.com/gadme/):

gADME®� can� alert� you� to� genetic� variations� in� drug� metabolism,� allowing� for�

personalised� doses,� drug� rescue� and� repositioning.

3.� Corporate� Business�Overview

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Contract� Service�

Capacity� Affordable�

by� Service� Area

Cyprotex� Discovery� has� invested� heavily� in� automation� both� in� terms� of� sophisticated�

laboratory�equipment�and�creation�of�a�customised� laboratory� information�management�

system.� In� addition� to� data� analysis� and� management,� internal� systems� have� been�

developed� for� compound� registration,� service� ordering� and� sample� tracking.� Integration�

of� these� automated� approaches� leads� to� a� dramatic� increase� in� efficiency� by� improving�

capacity�whilst� reducing� turnaround� time�and�ensures� the�generation�of�highly�consistent�

and� reproducible� data.� Therefore� we� have� capacity� in� all� of� our� service� areas.

Communication�

with� Clients

Dispositoion� of

Project� Manager

Responsible

Cyprotex� customers� are� supported� by� dedicated� Project� Managers.�

They�are�highly� trained�and� specialized�ADMETox�experts�with�more�

than� 10� years� of� experience,� who� help� their� customers� with�

commentary,� advice,� guidance,� data� interpretation,� scientific�

discussion� and� logistical� support.

Providing� Realtime

Service� Delivery

Results� are� normally� delivered� to� clients� within� 5-10� working� days�

from� compound� delivery.

Realtime

Feed-backRealtime� feedback� is� available� from� Project� Managers� at� Cyprotex.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 215

4.� Corporate� Competitiveness

Corporate

Competitiveness

Our� experience,� expertise� and� focus� in� the� area� of� ADMETox/DMPK�have� established�

our� reputation�as�world� leaders� in� this� field.�Over� the�past�12� years�Cyprotex�Discovery�

has� provided� services� for� over� 600� different� customers� providing� a� valuable� insight�

into�different�ADMETox�approaches.�Each�of�our� customers�benefits� from�a�dedicated�

and� highly� experienced� project� manager� who� oversees� all� aspects� of� the� study� from�

logistics,� study� management� and� data� reporting� to� specific� advice� and� consultancy.�

We�have�extensive�expertise� in�predictive�modeling,�which� is�attractive� to�many�of�our�

customers,� and�we�are� the�only�ADMETox�CRO� that� can�generate�and� integrate�both�

experimental� and� in-silico� data� together.

Current� Status� of

Accredited�

Certification

Cyprotex� is� non-GLP.

Cyprotex�has� internally�defined�Quality� Standards�dependent�on� the�assays�performed�

and� regulatory� requirements.�Our� Standard�Operating� Procedures� have� been� carefully�

designed� to� meet� recommendations� outlined� in� regulatory� guidelines� and� are� based�

on�high�quality� industry�accepted�methods.� Strict�quality�control�measures�are� in�place�

and�our�use�of�validated,�automated�procedures�ensures�our�protocols�generate�highly�

reproducible� and� reliable� data� for� our� customers.

Our� facilities�have�passed�evaluations�by�many�companies�and�organisations�who�now�

routinely� use� our� services� to� support� their� drug� discovery� and� development�

programmes.

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5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� toSouth� Korea,� India,� Malaysia,� Hong� Kong,� Japan,� China,� Singapore

Asian� Clients'

Composition(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

30% 30% 30% 10%

No.� of� Asian� Clients

in� recent� 3� years16

Major� Service� Range

with�Asian�Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research ○ API

APIs

R&D ○

Pre-Clinical ○Pre-clinical

Test� Sample

R&D� Strategy

&�Management○

Phase� I Clinical� Trials

Phase� IIClinical� Test

Sample

Finished

Products

Regulatory

Affairs

Phase� III

Finished

Product

Business

Development

Phase� IVSales� &

Marketing

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 217

35. D2 Pharma Consulting, LLC

1.� Corporate� General� Information

Corporate� Name D2� Pharma� Consulting,� LLC

Corporate� Ownership Private� Company

Head� Office� AddressHome� office:� 6209� Mid� Rivers� Mall� Drive,� Suite� 125,� Saint� Charles,� MO� 63304,�

USA

Facilities� City� &� Country Saint� Charles,� MO� 63376,� USA

Web-site� Address www.d2rx.com

No.� of� Employees 30

Contact

(Korean�

Business)

Name Dean� P.� Erhardt,� MBA

Address 6209� Mid� Rivers� Mall� Drive,� Suite� 125,� Saint� Charles,� MO� 63304,� U.S.A.

Telephone 314-308-2028

E-mail [email protected]

Company� History

D2�Pharma�Consulting� LLC� is�an� independent� consulting� firm� founded�by� two�partners�with�deep�experience�

in� the�healthcare� sector,� including�all� aspects�of� commercialization/distribution�and�a�broad� scope�of�business�

development� expertise.� Their� goal�was� to� bring� together� industry� experts�with� a� proven� track� record� of� real�

world�experience� to�build�a� truly�best-in-class� consulting� firm� focused�on�providing� cost� effective,�outsourced�

solutions.�

The� D2� team� of� professionals� brings� decades� of� experience� from� the� top� tier� organizations� in� Healthcare�

Distribution,� PBM,� Biopharma� and� Specialty� Pharmacy.� Each�member�of� the�D2� team�brings� a� varying� scope�

of� expertise� that� in� combination� creates� a� powerful� force� providing� excellence� and� value� to� D2� clients.The�

D2� team� provides� over� 400+� years� of� industry� experience.

In� addition,� D2� is� a� member� of� several� key� industry� organizations,� including� the� National� Association� of�

Boards� of� Pharmacy� (NACDS),� Healthcare� Distribution� Management� Organization� (HDMA),� Regulatory�

Harmonization� Institute� (RHI)� and� GS1� US.� D2� team� members� serve� on� various� boards� and� committees�

including�Pharmacist� Letter-�Advisory�Board,�National�Council�of�Prescription�Drugs�Programs� (NCPDP),�Texas�

Pharmacists� Association,� Bio� DFW,� Industry� Board� NACDS,� RHI� and� GS1� EPCIS� Subcommittee.

Company� Description� &� Organization

D2� Pharma� Consulting� LLC� (D2)� is� a� best-in-class� consulting� company� exclusively� focused� on� serving� the� life�

sciences� industry.D2� assists� emerging� and� established� pharmaceutical,� biopharmaceutical� and�medical� device�

manufacturers� to� develop� and� execute� strategicinitiatives,� ensuring� successful� launch,� distribution� and�

reimbursement� to� support� an� ongoing� leadership� position� in� the� marketplace.� D2’s� reach� includes� the� US,�

Canada,� Puerto� Rico� and� over� 20� European� markets.� �

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2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

○ ○ ○

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US ○ US ○ US ○ US ○

Canada Canada Canada ○ Canada ○

EU EU EU ○ EU ○

Asia Asia Asia Asia ○

Global Global Global Global ○

Other Other Other Other

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs ○

R&D

Pre-Clinical Pre-clinical

Test� Sample○

R&D� Strategy

&� Management

Phase� I Clinical� Trials

Phase� IIClinical� Test

Sample○

Finished

Products

Regulatory

Affairs

Phase� IIIFinished

Product○

Business

Development○

Phase� IVSales� &

Marketing○

Corporate�

Product� Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

Generics APIs Devices Others

○ ○

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 219

Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

10% 20% 35% 35%

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

○ ○

Focusing�

Therapeutic� Area

D2� has� 3� pharmacists� on� the� team� and� has� worked� across� all� therapeutic� areas.� � In�

addition� D2� focuses� on� specialty� therapies� including� but� not� limited� to:�

-� Growth� hormone� disorders

-� IVIg/� SCIg

-� Diabetes

-� Hepatitis� C

-� Multiple� Sclerosis� (injectable� and� oral)

-� Psoriasis

-� Rheumatoid� arthritis/Crohn’s� Disease

-� Hemophilia� factor

-� Oncology� (oral� and� injectable)

-� Human� Growth� Hormone

-� Hereditary� Angioedema

Alpha1� Anti-trypsin� Disease�

General� Overview

of� Corporate's� Key

Contract� Services

D2� Pharma� Consulting� -� Core� Services

Strategic� Business� Planning REMS

Executive� Leadership Managed� Care

Third� Party� Logistics� (3PL) Reimbursement

Retail� Distribution/� Channel�Marketing

Government� Markets

Specialty� Pharmacy International� Markets� Reimbursement

Specialty� Distribution Branding� Product� Positioning

Wholesale� Distribution European� Launch

International� Supply� Chain Puerto� Rico� Registration

HUB� ServicesAdvisory� Boards� for� Trade� and� Managed�Care

D2’s� approach� enables� cost� effective� commercialization� for� both� emerging� and�

established� organizations.� Our� outsourced� support� model� enables� companies� to� access�

key� relationships� and� market� expertise.� Our� clients� include� US� and� international�

pharmaceutical,� biotech� and� device� companies.

3.� Corporate� Business�Overview

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Contract� Service�

Capacity� Affordable�

by� Service� Area

D2�Pharma�Consulting� LLC�(D2)�works�with�our� clientsto�develop�a�detailed,� customized�

outline� of� the� deliverables� required� to� implement� their� Statements� of� Work.� � D2�

identifies� timelines� that,� when� put� into� action,� will� ensure� the� successful� trade� launch�

of� products� brought� to� market� by� member� companies.� �

Key� components� of� the� deliverables� outlined� include,� but� are� not� limited� to:

-� Strategic� Planning� �

-� Managed� Care� Services

-� Logistics� Planning� and� Contracting�

-� State� Licensing

-� Order� to� Cash� (3PL)� Strategy� and� Pricing

-� Develop� Trade� Customer� Relationships� and� Establish� Trade� Agreements�

-� Ongoing� Trade

-� Ongoing� Trade� Group� Purchasing� Organizational� Management

Communication�

with� Clients

Dispositoion� of

Project� Manager

Responsible

All� of� D2’s� project� managers� have� no� less� than� 20� years� industry�

experience� in� the� areas� of� service� for� our� clients.

Providing� Realtime

Service� Delivery

Our� consultants�are�available� to�our� clients�24/7�and�are�connected�

through� mobile� services� as� needed.

Realtime

Feed-back

We�provide� continuous� feedback� to� our� clients� in� real� time�and� are�

completely� accessible� at� both� the� account�manager� and� the� Senior�

executive� level.We�meet�needed�deadlines.�We�work�out�a� schedule�

which� meets� the� needs� of� the� client.

4.� Corporate� Competitiveness

Corporate

Competitiveness

All� of� our� consultants� are� world� class� experts� in� their� area� of� service� to� our� clients.� �

The�pricing�of�our� services�are� flexible�with�a�potential�combination�of� retainer,�hourly,�

project� based� or� equity.� � D2’s� area� of� specialization� includes:

Strategic� Business� PlanningREMS(Risk� Evaluation� and� Mitigation�Strategies)

Executive� Leadership Managed� Care

Third� Party� Logistics� (3PL) Reimbursement

Retail� Distribution/� Channel�

MarketingGovernment� Markets

Specialty� Pharmacy International� Markets� Reimbursement

Specialty� Distribution Branding� Product� Positioning

Wholesale� Distribution European� Launch

International� Supply� Chain Puerto� Rico� Registration

HUB� ServicesAdvisory� Boards� for� Trade� and� Managed�

Care

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 221

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� toUSA,� Canada,� EU� and� Korea

Asian� Clients'

Composition(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

- 50% 50% -

No.� of� Asian� Clients

in� recent� 3� years7

Major� Service� Range

with�Asian�Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D

Pre-Clinical Pre-clinicalTest Sample

R&D Strategy& Management

Phase I Clinical Trials

Phase IIClinical TestSample

FinishedProducts

RegulatoryAffairs

Phase IIIFinishedProduct

BusinessDevelopment

Phase IVSales &Marketing

6.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

D2� has� both� the� capabilities� as�well� as� the� relationships� to� support� Korean� companies� in� commercializing�

products� in� the�US,�Canada,�Puerto�Rico�and�over�20�other�European�countries.� � In�addition,�Dean�Erhardt,�

D2� Principal� is� the� President� of� the� Regulatory� Consulting� Institute� whose� members� can� provide� every�

aspect� of� bringing� products� to�market� from� API� access� and� Clinical� trial� design� through� to� patient� access�

to�medications.�D2’s� team�touches�every� commercial�aspect�of� launching� in� the�US�market�and�can�provide�

the� relationships� and� contacts� to� support� cost� effective� support� to� Korean� pharmaceutical� companies.�

Finally� D2’s� relationships� can� also� support� the� identification� of� funding,� manufacturing� and� marketing�

partners� to� develop� success� across� the� pharmaceutical,� biotech� and� medical� device� markets.

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36. Dragon Bio-Consultants, Ltd.

1.� Corporate� General� Information

Corporate� Name Dragon� Bio-Consultants,� Ltd.

Corporate� Ownership Private

Head� Office� Address

Dragon� Bio-Consultants,� Ltd.

Suite� 1802-03,� 18/F,� Olympia� Plaza

255� King's� Road,� Fortress� Hill

North� Point,�

HK� Registered� Company� No.:� 1429099

SKYPE:� virtualdoc77,� virtualdoc08,�

QQ:� virtualdoc08

+86.15021242314� (Cell� China)

+1(615)445-5761� � (Cell� USA)

Web-site� Address http://dragonbio-consultants.com

No.� of� Employees 5

Contact

(Korean�

Business)

Name William� W.� Porter

AddressDragon� Bio-Consultants,� Ltd.� Suite� 1802-03,� 18/F,� Olympia� Plaza,� 255� King's�

Road,� Fortress� Hill,� North� Point,� Hong� Kong,� SAR

Telephone +85292728573

E-mail [email protected]

Company� Description� &� Organization

Dragon� Bio-Consultants,� Ltd.,� is� a� virtual� SME� headquartered� in� Hong� Kong� SAR.� We� are� Hong� Kong�

registered� company,� #� 1429099.� We� are� an� organization� of� experienced� entrepreneurial� senior� executives�

and� strategic� partners� in� the� pharmaceutical� and� biotechnology� sectors.� We� assist� clients� who� wish� to�

conduct�business�or�explore�business�opportunities� in�Hong�Kong�SAR,�PR�China,�Taiwan,�Thailand,�Vietnam,�

Malaysia,� Mongolia,� Singapore� and� South� Korea.� Dragon� Bio-Consultants� believes� that� there� are� abundant�

and� potentially� successful� business� opportunities� when� proper� risk�management� principles� are� implemented�

when�doing�business� in� this� region.�We� aim� to� help� our� clients� get� smarter,�more� engaged,�more� informed�

and� more� organized� through� deep� channel� collaborations.

Our� virtual� business� model� is� to� focus� on� growth� while� maintaining� operational� efficiency� ­� engaging�

ourselves� and� our� clients� more� seamlessly� across� a� wide� range� of� geographic,� functional,� and� generation�

boundaries� and� borders.

It's� been� said� that� art,� creativity,� and� innovation� are� about� the� recognition� and� mastery� of� constraints.� At�

Dragon�Bio-Consultants�we�work�with�our� clients�with� this� focus� in�mind�when�doing�business� in�Asia-Pacific.

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2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US 〇 US US US 〇Canada Canada Canada Canada

EU EU EU EU 〇Asia 〇 Asia Asia Asia 〇Global Global Global Global

Other Other Other Other

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D 〇Pre-Clinical 〇 Pre-clinical

Test� Sample

R&D� Strategy

&� Management〇

Phase� I 〇 Clinical� Trials 〇Phase� II 〇 Clinical� Test

Sample

Finished

Products

Regulatory

Affairs

Phase� III 〇Finished

Product

Business

Development〇

Phase� IVSales� &

Marketing

Corporate�

Product� Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

〇 〇 〇Generics APIs Devices Others

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Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

5% 20% 50% 35%

Focusing�

Therapeutic� AreaWound� healing,� Oncology,� Cardiovascular� neutriceuticals� and� vaccines

General� Overview

of� Corporate's� Key

Contract� Services

Services

Our� focus� is� to� assist� our� clients� with� direction,� protection,� orientation� and� managing�

risk/conflict.

Our� value-added�business�solutions� for�markets� in�Hong�Kong,�PR�China,� Japan,�Taiwan,�

Vietnam,� Thailand,� Taiwan,� Malaysia,� Mongolia,� Singapore� and� South� Korea� include:

•Clinical� Trial� Management� Services� -� MASH™

•CLC� bio’s� bioinformatics� applications� and� solutions� ­� Next� Generation� Sequencing

•Bioprocessing� &� Engineering� Consulting

•Inspection� diligence� services� for� cGCP,� cGLP,� and� cGMP

•Biochip-based� biosensor� technology

•Business� and� commercial� development� services� in� the� Asia-Pacific� pharmaceutical� and�

biotechnology� sectors

•Regulatory� and� resource� mobilization� services� in� the� Asia-Pacific� markets

•Import/Export� services� for� Branded� and� Generic� Pharmaceuticals

Global� Regulatory� and� Consultation� Services�

Dragon� Bio-� will� facilitate� the� regulatory� approval� process� for� Sino� and� Pan� ASEAN�

companies� wishing� to� submit� dossiers� to� European� and� North� American� and� South�

American� countries.

•Global� Drug� Master� File� (DMF)� Preparation� and� Maintenance

•Investigational� New� Drug� Application� (IND),� Amendments,� Safety� Reporting,� and�

Annual� Reports

•New� Drug� Application� (NDA),� Amendments,� and� Supplement� Annual� Reports,� and�

Post-marketing� Reporting

•505(b)(2)� NDA� Application,� Amendments,� Annual� Reports,� and� Post-marketing�

Reporting

•Abbreviated� New� Drug� Applications� (ANDA),� Amendments,� Safety� Reporting,� and�

Annual� Reports

•Premarket� Notification� Application� (510(k))� preparation

•Certificate� of� Suitability

•Clinical� Trials� Application� (CTA)

•Investigational� Medicinal� Product� Dossier� (IMPD)

3.� Corporate� Business�Overview

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 225

•Premarket� Approved� Application� (PMA)

•Investigational� Device� Exemption� (IDE)� preparation� and� maintenance

•Prescription� drug� and� over-the-counter� drug� labeling� preparation

•Orphan� Drug� Designation� Request� (ODDR)� preparation� and� maintenance

•Fast� Track� Requests� preparation� and� maintenance

•Biologics� License� Application� (BLA)� preparation� and� maintenance

•United� States� Adopted� Name� (USAN)� Application� preparation

•Product� Registration

•Establishment� Registration

Preclinical� Toxicology� Consulting

•IND� Enabling� programs

•DMPK� and� TK� programs

Clinical� Pharmacology� Consulting

Animal� Disease� models

•Inflammation

•Cardiovascular

•Metabolic

•Oncology

Animal� Sourcing

•Non-Human� Primate

•Canines�

•Rodent

Partnering

Dragon� Bio-Consultants,� Ltd.� (DBCL)� has� an� innovative� approach� for� partnering� with�

Chinese� research� institutions� and� pharmaceutical� companies.� DBCL� identifies� and� helps�

conclude�a� license� for� the�most�promising�pre-clinical� and�clinical� stage�compounds� from�

the� West� and� in� China,� leverages� and� extends� the� research� efforts� of� its� Western� and�

Chinese�partners,� and�provides�a�bridge� into� the� international�development� process�and�

global� Biopharmaceutical� market.� Because� many� of� the� compounds� have� already� been�

validated� through� a� rigorous� discovery,� selection� and� development� process� in� the�West�

and� in� China,� this� model� streamlines� and� accelerates� development,� while� lowering� risk.�

Moreover,� the� strength� of� DBCL's� relationships� with� its� Chinese� partners� ensures� a�

continuous� source� of� quality� partnering� opportunities� for� the� future.

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4.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� toUS,� � EU,� PRC

Asian� Clients'

Composition(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

50% 25% 25%

Major� Service� Range

with�Asian�Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D 〇

Pre-Clinical 〇Pre-clinical

Test� Sample

R&D� Strategy

&� Management

Phase� I Clinical� Trials 〇

Phase� IIClinical� Test

Sample

Finished

Products

Regulatory

Affairs

Phase� III 〇 Business

Development〇

Finished

ProductPhase� IV

Sales� &

Marketing

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 227

Corporate Name Ecron� Acunova� Ltd�

Corporate Ownership Private� Company�

Head Office AddressEcron�Acunova,�Mobius� Towers� ,� SJR� i-Park,� EPIP,�Whitefield,� � Bangalore� � ­� � 560�

066,� INDIA

Facilities City & Country

Bangalore(INDIA)

Web-site Address www.ecronacunova.com

No. of Employees 347(� includes� all� gobal� locations)

Financial Status

Sales Revenue in 2012(US K$)

Capital(US K$) Dept-equity Ratio(%)

30� million� 12� mil� 25% �

Contact(Korean

Business)

Name Mr.� D.� A.� Prasanna

AddressEcron� Acunova,� Mobius� Towers� ,� SJR� i-Park,� EPIP,� Whitefield,� Bangalore� ­� 560� �

� 066� ,� INDIA�

Telephone +91� 9845061545

E-mail [email protected]

Company History

EA� is� a� CRO� combining� the� strengths� from� four� previously� independent� expert� CROs� serving� established�

clinical� research� geographies� of� Europe,� India� and� South� East� Asia� (SEA).� This� integration� enabled� the� four�

expert� CRO’s� to� increase� the� value� to� sponsors� � �

Manipal� Acunova� � -� � A� CRO� founded� by� D.A.� Prasanna� whose� experience� in� the� healthcare� sector� is�

acknowledged� and� is� known� for� leveraging� Asian� competitiveness� to� build� a� successful� global� business.�

Ecron�Acunova�Company� Ltd� � -� Chula�University� started� a�CRO� in� SEA�and�built� expertise� in� conducting�HIV�

and�nutritional� studies� in�Thailand,�Vietnam,�Cambodia�and�Malaysia.� In�2010,� the�CRO�was� integrated�with�

Ecron� Acunova� as� a� Joint� Venture.�

Ecron� � -�Was� founded�by�Dr�Klaus�Wiedey�was� founded� in�Constance,�Germany;� in�1986�Gradual� expansion�

has� led� to� a�CRO�with� Europe-wide� reach.�Headquartered� in� Frankfurt�Germany,�Manipal�Acunova� acquired�

Ecron� in� 2007� and� formed� Ecron�Acunova.� aCRONordic� A/S� -� aCRONordic� A/S� is� the� CRO�with� the� longest�

experience� in� the� Nordic� region.� Set� up� as� a� data� management� CRO� in� Denmark� it� has� transformed� itself�

into� a� clinical� CRO� in� Sweden,�Norway�&� Finland.� In� 2011,� integration�with� Ecron�Acunova�made� it� the� first�

Nordic� region� CRO� with� global� reach.�

Company� Description� &� Organization

37. Ecron Acunova Ltd

1.� Corporatqe�General� Information

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Ecron� Acunova� is� a� mid-sized� multinational� full� service� global� Clinical� Research� Organization.� Our� �

multinational�presence,� in�19�European�countries,�8�South�East�Asian� countries� in�addition� to� the�USA�allows�

us� to�engage� regulatory�authorities� and� identify�development�and�partnering�opportunities� across� the�world.�

Our� Asian� HQ� is� in� Bangalore,� European� HQ� is� in� Frankfurt� and� American� HQ� is� in� Princeton.� We� have� a�

25� years� track� record� of� accelerating� pharma� time� to� market� cost� effectively.

Our� 350+� workforce� including� 80�MDs� and� PhD.� Our� broad� spectrum� of� services� helps� our� partners/clients�

to� accelerate� their� product� development� starting� from� pre-clinical� strategic� program� to� clinical� study� design�

and� execution� and� finally� licensing� and/or� fund� raising.� �We�have� been� supporting� Pharma,� Biotech,�Device,�

Neutraceuticals� and�Diagnostic� companies�globally.�We�have�been�evaluated�and�worked�with�10�of� the� top�

12� global� pharma� companies� and� we� have� worked� with� top� generic� companies.� � �

Our� investors� include� Orbimed� � ­� � largest� healthcare� fund� management� in� the� USA� having� assets� worth�

$7Billion�and�Manipal�Group� ­�Asia’s� reputed�medical�university.�EA�has�preferred�access� to�Manipal�Medical�

University’s� 19� teaching� hospitals.Most� of� our� investors� are� 7-8� years� old� and� are� stable� group� of� investors�

and� are� interested� in� long� term� investment.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 229

2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Geographical

Business�Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US ○ US US US

Canada ○ Canada Canada Canada

EU ○ EU EU EU

Asia ○ Asia Asia Asia

Global ○ Global Global Global

Other Other Other Other

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D

Pre-Clinical ○ Pre-clinical

Test� Sample

R&D� Strategy

&� Management

Phase� I ○ Clinical� Trials

Phase� II ○Clinical� Test

Sample

Finished

Products

Regulatory

Affairs

Phase� III ○Finished

Product

Business

Development

Phase� IV ○Sales� &

Marketing

Corporate�

Product� Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

○ ○ ○ ○ ○

Generics APIs Devices Others

○ ○

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3.� Corporate� Business�Overview

Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

35% 40.5% 22% 2.5%

In-house� Facilities

Research� &�

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

Focusing�

Therapeutic� Area

Oncologics Lipid� RegulatorsRespiratory�

AgentsAnti-ulcerants

Angiotensin� � � II

Antagonists

20 9 17 13

AntipsychoticsAutoimmune�

agentsAntidepressants Analgesics Others

11 30

We� have� conducted� 300+� studies� in� more� than� 50,000� subjects� at� 2800� sites� since�

2005.� The� distribution� of� studies� in� Asia� Pacific� and� Europe� is� as� per� below.� � �

Asia� ­� Pacific� -�We� have� conducted� 154� studies� in�more� than� 20,000� subjects� at�more�

than�800�sites� in�Asia� ­�Pacific.�We�have� conducted� studies�across� therapeutic� areas� like�

Stem� Cells,� Oncology/Hematology,� Pulmonology,� Cardiovascular� diseases,� Dermatology,�

Gastroenterology,� Neurology,� Metabolic� disorders,� Endocrinology,� Infectiology/� Clin�

Immunology,� Urology/Nephrology,� Opthalmology,� Obstetrics� &� Gynecology,�

Anti-inflammatory�and�Nutrition/Neutraceuticals.�Majority�of�our�experience�comes� from�

Neurology,� Oncology,� Infectiology/� Clin� Immunology� and� Neutraceuticals.�

Europe� � -�We� have� conducted� 171� studies� in�more� than� 30,000� patients� in�more� than�

2000� sites� � in� Europe� since� 2005� across� various� therapeutic� areas.� �We�have� performed�

studies�across� therapeutic� areas� � like�Oncology/Hematology,�Pulmonology,�Cardiovascular�

diseases,� Dermatology,� Gastroenterology,� Musculoskeletal� system,� � Neurology,� �

Metabolic� disorders,� � Endocrinology,� ENT,� Infectiology/� Clin� Immunology,�

Urology/Nephrology,�Opthalmology�and�Gynaecology.�Majority�of�our�experience� comes�

from� Oncology/� Hematology,� Neurology� and� Cardiovascular� diseases

General� Overview

of�Corporate's�Key

Contract� Services

Bioavailability� and� Bioequivalence� Services� (PK/PD)�

Our� end-to-end� service� comprises� regulatory� consulting,� IP� import� and� sample� export,�

protocol� design,� ethics� committee� submissions,� safety� screening� and� bio� analytical�

testing.�We� have� proven� expertise� in� clinical� study� management,� method� development�

and� validation.� � �

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General� Overview

of�Corporate's�Key

Contract� Services

Phase� I-IV�

Monitoring�

Our� CRAs� attend� in-house� education� courses� and� are� kept� up-to-date� with� the� latest�

information� on� current� and� upcoming� developments.� Project� � managers� and� CRA�

supervisors� discuss� site-specific� findings� and� provide� guidelines� on� what� and� how� to�

follow-up� consistently.� � �

Project� Management�

Project� teams� are� trained� for� each� study� in� advance�with� regard� to� the� study's�medical�

background,� study� goals.�Our�PMs� identify� study� challenges�upfront� and� implement� risk�

mitigation� plans.� � �

Regulatory� Consulting:�

We�obtain�authorization� to� conduct� studies� in�countries�within� individual� regions� for� the�

import�of� clinical� trial� supplies�and�export�of� samples.�We�provide�up� to�date�guidelines�

for� submission,� our� experts� are� also� invited� to� serve� on� industry� &� regulatory� advisory�

panels� bringing� credibility� to� the� submission.� We� have� in� depth� expertise� with�

requirements�of�US�FDA,�European�Regulators�and�Asian�Regulatory�Authorities,� related�

to� clinical� development.�

Clinical� Data� Management:�

Database� design� and� study� set-up,� CRF� design,� data� management� manual,� data� entry�

and� validation,� electronic� data� capture,� query� generation� and�discrepancy�management,�

non-CRF�data�handling,�use�of�CDISC�standards.�Our� team� is�experienced� in�working�on�

a� range� of� platforms,� including� Oracle®� Clinical,� Oracle®� RDC,� Oracle®� InForm,�

Medidata� Rave®� ,SAS®� .� We� are� CDISC� Registered� Solution� Provider.�

Biostatistics:�

Statistical� planning� and� sample� size� calculation,� statistical� analysis� plan,� statistical�

programming�and�analysis,� SAS�datasets�according� to�sponsor’s� specification,� integration�

of� databases,� electronic� data� transfer,� statistical� reports� and� summaries,� meta-analysis.�

Reports� and� Quality� Control:�

Standardised� and� customised� reports,� data� quality� assurance� and� audits.�

Pharmacovigilance:�

Periodic� safety�update� reports,� CIOMS�on�web,� literature� review� and�medical� narratives,�

signal� detection� and� trend� analysis,� medical� monitoring.� Medical�

Writing� &� Regulatory� Submissions:�

Protocol�preparation,� integrated� report�writing� (ICH�E3)�and�electronic� submissions,�data�

review� for� specialised� therapy� areas� by� clinicians,� sponsor-specific� formats� for� reporting,�

safety� summaries� and� narrative� writing,� scientific� publications� and� presentations.�

Central� Laboratory� Services:�

Central� Lab� testing� service� for� Clinicla� trials� Patients� Testing� including� molecular�

diagnostic� tests� Pharma� company� research� testing� including� biomarker� validation

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Contract� Service�

Capacity�

Affordable� by�

Service� Area

We�provide�end-to-end�clinical� research� services.�Our� flexibility� of� association�allows�our�clients� to�use�our�services� for� fulfilling�specific�needs�or�engage�us�as�an�across� the�board�partner� for� their� development� programs.�

Bioavailability� and� Bioequivalence� Services� (PK/PD)� -�Benchmarking�major� Frost� and� Sullivan�have� selected�us� as� ‘Partner� of�Choice’� for� BABE�studies� forquality�of� services.�State-of-the-art� facilities�with�116-Bed�CPU� in�Manipal� and�Mangalore� and� additional� 100� Bed� CPU� at� Chennai� through� our� partners.� All� our�facilities� are� self-identified� to� USFDA� Team� has�many� years� of� experience� in� conducting�studies� and� consists� of� MDs� in� clinic� and� Pharmacy� PhDs� in� lab..� � �

Phase� I� ­� IV�Our� team� comprises� of� Project�Managers�with� 6-8� yrs� experience,�Clinical� Team� leaders�with� 4-5� yrs� experience� and� CRAs� with� 2-3� yrs� of� experience.�

Regulatory� Consulting� -� � �Our� regulatory� experts� foster� effective� and� diplomatic� liaisons�with� regulatory� bodies� in�a� wide� variety� of� indications;� they� are� at� your� service� to� represent� and� support� you� in�meetings� with� regulatory� authorities.� � �

Data� Management� &� Biostatistics� -�Our� focus� is� to�expedite� the� process� and� shorten� timelines� through� � innovative� thinking�and�uncompromising�quality.�Our�Data�Management� team� comprises� of�Data�Manager,�Database�programmer,�Data�entry�associate�and�Database�administrator.�Our�Biostatistics�team� comprises� of� Biostatistian,� Statistical� programmer� and� Medical� writers/coders.�

Medical� and� Pharmacovigilance� Services� -� � �Our� team� of� dedicated,� professional� medical� writers� offers� a� comprehensive� suite� of�medical� writingservices.� The� medical� writing� team� consists� of� M.D.,� Ph.D.� and� master’s�level� writers.� Central� Laboratory� � ­� � � We� own� two� of� the� ten� CAP� accredited� � labs� in�India.� The� labs� are� situated� in� Whitefield,� Bangalore,� and� Kasturba� Hospital,� Manipal.�Our� labs�are�accredited�by� the�College�of�American�Pathologists� (CAP)�and� the�National�Accreditation�Board� for�Testing�Laboratories� (NABL)�of� the�governmental�Department�of�Science� &� Technology� pursuant� to� ISO� 15189.

Communication�

with� Clients

Dispositoion� of

Project� Manager

Responsible

Our� Project� Manager� is� the� single� point� of� contact� for� our� clients.�Qualification�of�our�PM� ranges� from�M.�Pharm� to�Phd.�and�average�experience� is�6-8�yrs.� PM� is� responsible� for�Risk�Mitigation,�planning�&� execution� of� the� project.� Management� with� every� department�included� in� scope� of� services� along� vendor� management�

Providing�

Realtime

Service� Delivery

Before� kick� start� of� the� project� we� provide� Project� Management�Plan� along� with� project� timelines� to� the� client� and� unanimously�decide� on� the� project� timelines�

Realtime

Feed-back

We� take� feedback� from� � our� clients� from� � time� to� time� � -�weekly/monthly/quarterly� basis� depending� on� the� length� of� the�project.� Formal� questionnaire� is� � shared�with� the� client� at� � the� end�of� the� project� asking� them� for� feedback.� Client� feedback� is� of�utmost� importance� to� us� as� it� helps� us� improvise� on� our� services.�

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4.� Corporate� Competitiveness

Corporate

Competitiveness

Cost� of� Service� ­� We� offer� value� proposition� to� our� clients� along� with� competitive�

rates.�

Planned� service� time-line� in� week� ­� We� understand� project� timelines� from� the� client�

and� work� accordingly�

Service� Certification� &� Regulatory� Approvals:�

-� Our� services� operations� are� certified� under� ISO� 9001� (Quality�Management� System �

­�QMS)�and� ISO�27001�(Information�Security�Management�System).�Our� laboratory�

operations� are� certified� by� ISO� 15189� (Particular� requirements� for� quality� and�

competence� of� Medical� Laboratories� QMS)� and� CAP� (College� of� American�

Pathologists).�

-� EA� team� is� experienced� in� handling� inspections� from� various� national� and�

international� competent� authorities� and�have� faced� several� inspections�globally.� So�

far� multiple� successful� inspections� have� been� executed� on� EA� offices� and�

EA-managed� clinical� trial� sites� in� three� different� continents� from�major� regulatory�

bodies� (USFDA,� EU� authorities,� ANVISA,�WHO,� Thai-FDA,� etc.)� and� sponsors� have�

obtained� marketing� authorizations� in� multiple� regions.�

In-house� Quality� Assurance� (QA)� and� Employee� Training:�

-� EA� has� a� global� independent� QA� group� directly� reporting� to� management� and� do�

not� involve� in� any� project� related� activities.� The� following� are� the� key� activities�

performed� in� addition� to� the� routine� activities:�

o� Plan� and� perform� internal� QA� audits� and� audit� of� Investigator� sites�

o� Perform� vendor� audits� to� qualify� vendors.�

o� Track� process� performance� by� critical� to� quality� measures.�

o� Conduct� management� review� meeetings� for� continual� improvements.�

-� EA� has� a� formal� qualification� and� training� programme� defined� for� employees.� The�

key� highlights� of� the� training� would� be� � �

o� An� Introduction� training� ­� for� all� new� EA� employees.

o� Internal� GCP� training� with� special� emphasis� on� job� specific� requirements� �

o� Web� based� GCP� &� SOP� tests.�

o� Internal� and� External� trainings� on� specific� topics.�

-� The� training� records� are� available� &� maintained� for� each� employees� which� contain�

company� CV,� Job� Description� and� other� training� records.� �

No.� of� Regulatory

Inspections

ClassificationFDA

(US)

FDA

(EU)

PMDA

(Japan)

CFDA

(China)

DCI

(India)Others

Pre-Clinical� Area

Clinical� Area 5 8 4 5

Manufacturing� Area

Others 10 17 16

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Current� Status� of

Accredited�

Certification

1.� � ISO� 9001� (QMS� -� Quality� Management� System)�

Ecron�AcuNova’s�global�offices�operating�under�a�unified�QMS�ensures� that� the�quality�

of� delivery� remains� consistent� independent� of� the� location� of� the� delivery.� The�

harmonized�set�of�procedures� for� all�key�processes�has�been� implemented�globally�and�

is� meant� to� comply� with� all� applicable� regulations� and� guidelines.�

2.� � ISO� 27001� (ISMS� ­� Information� Security� Management� System)�

Ensuring� customer� information� remains� confidential� is� of� paramount� importance� and�

hence� the� ISMS� implemented� ensures� that� the� information� remains� secure� in� both�

electronic� and� physical� formats� and� is� only� transmitted� on� need-to-know� basis.�

EA-India� was� the� first� CRO� in� India� to� get� ISO� accreditation� in� the� country� in� 2006.�

3.� � BVMA� ­� ICH� GCP� Compliance�

We� are� co-founder� (amongst� first� 8� CRO’s)� of� BVMA� (Bundesverband� Medizinischer�

Auftragsinstitut,� Federal� Association� of� Contract� Research� Organizations)� and� now�

there� are� more� than� 39� CROs� involved.� A� CRO� must� meet� the� high� quality�

prerequisites� set� by� the� BVMA� to� be� a�member.� In� order� to� ensure� that� these� quality�

standards� (relevant� national� and� international� requirements� and� standards,� and�

generally� accepted�good�practices)� are�met�and�maintained,�each�member�CRO�must�

undergo� an� independent� system� audit� carried� out� by� a� BVMA� appointed� external�

organization� before� acceptance� and� again� every� three� years.

4.� College� of� American� Pathologists� (CAP)�

With� a� goal� to� improve� patient� safety� and� to� ensure� our� laboratories� continue� to�

operate� at� international� standards;� our� medical� laboratories� participate� in� the�

well-recognized� CAP� accreditation� programme.� �

5.� ISO� 15189� (NABL)�

NABL� (National� Accreditation� Board� for� Testing� and� Calibration� Laboratories,� a�

national�autonomous�accreditation�body� in� India)� certifies�our�QMS�operational� in�our�

labs� is� compliant� to� particular� requirements� for� quality� and� competence� particular� to�

medical� laboratories� (ISO� 15189)�

6.� ANVISA� Accreditation� (Central� Lab)� � �

Data� for� regulatory� submissions� to� ANVISA� (Agência� Nacional� de� Vigilância� Sanitária� �

-� �National�Health�Surveillance�Agency,�Brazil)� from�our�qualified� central� laboratory�at�

Bangalore� provides� access� to� our� sponsors�who�wish� to� get� their� products� registered�

in� the� large� and� growing� Brazilian�

market.�

7.� EC� Accreditation� by� AAHRP� � �

The�Ethics�Committee�approving�and�monitoring�our�Bioequivalence� studies�has�been�

the� � first� in� the� country� � (India)� to� be� accredited� by� AAHRP� � (Association� for� the�

Accreditation� of� Human� Research� Protection� Programs,� Inc.).� The� certificate� was�

handed�over� from�Minister�of�Health;�Govt.�of� India�with�a�message� that�government�

is� happy� for� safe� conduct� of� research.�

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 235

Current� Status� of

Accredited�

Certification

8.� Lachman� Consultants,� USA�

The� quality� and� computers� systems� at� the� BA/BE� centres� have� been� audited�

independently� for� compliance� to� GCP,� GLP� and� 21� CFR� Part� 11� compliance� for� US�

FDA� inspection� readiness� and� the� auditors� (former� Director� in� Office� of� Compliance,�

US� FDA)� found� that� the� system� had� good� control.� � �

9.� Country� Consultants,� UK�

The� overall� conclusion� arrived� at� by� the� independent� Nigel� J� Dent� FRQA� of� Country�

Consultancy� Ltd�was� that� this� facility�was�operating� to�a� very�high�standard�of� science�

and�with�attention� to� the�welfare,� safety�and�wellbeing�of� the� volunteers.� The� facility�

is� operating� in� accordance� with� expected� standards� of� FDA,� EMEA� and� the�

international� community� for� the� conducting� of� BA/BE� studies.�

10.� Mike� Breese� Limited,� UK� (EMA� and� GLP� Compliance;� 2013)�

An� independent�auditor� from�UK�was�appointed� in�2013�by�EA’s�global�QA� team� for�

verifying� compliance� to� latest�EMA�and�GLP�guidelines.�The�auditor�has� confirmed�the�

compliance� based� on� report.

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5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� to

We� have� been� working� with� a� Stem� cell� specialist� CRO� based� out� from� India� since�

2008.� We� have� worked� on� a� FTE� based� model� for� 5� years� with� an� Israel� based� Big�

Pharma�and�are� currently�working�with� them�on�other�projects� .�We�are�also�currently�

working� with� a� Japan� based� Big� Pharma� on� registry� studies�

Asian� Clients'

Composition(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

39% 50% 11%

No.� of� Asian� Clients

in� recent� 3� years

We� have� worked� with� over� 25� Asian� clients.� We� have� a� long� standing� relationship�

with� them� and� repeat� business� from� them

Major� Service� Range

with� Asian�

Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D

Pre-Clinical Pre-clinical

Test� Sample

R&D� Strategy

&�

Management

Phase� I ○ Clinical� Trials

Phase� II ○Clinical� Test

Sample

Finished

Products

Regulatory

Affairs

Phase� III ○Finished

Product

Business

Development

Phase� IV ○Sales� &

Marketing

6.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

Product� registration� in� Asian� and� European� market.� Help� with� manufacturing� partners�

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 237

Corporate� Name Elezaby� Pharmacy

Head� Office� Address 6C,� Takseem� Asmaa� Fahmy� Division,� Ard� El� Golf� Heliopolis,� Cairo

Facilities� City� &� Country Egypt

Web-site� Address https://elezabypharmacy.com

Contact

(Korean�

Business)

E-mail [email protected]

Company� Description� &� Organization

[Vision]

To�become�the�MENA� region’s� leading�healthcare�provider�and�our�customers’�partner�of�choice�by�offering�

the� largest� range� of� premium� services� and� continuing� to� redefine� the� practice� of� pharmacy.

[Mission]

To� fulfill�our�purpose�of�helping�people�achieve�better�health�by�expanding�our�network,�driving� innovation,�

and� growing� our� partnerships.

[Goals]

As� a� leading� regional� provider� of� quality� health� and� personal� care� products�

and� services,� we� are� unwaveringly� committed� to:

Serve� Patients:� This� is� the� ultimate� bottom� line� of� the� profession� of� pharmacy.� Caring� for� patients,� helping�

them� achieve� better� outcomes,� and� improving� their� health� and� ellbeing� is� the� mainstay� of� our� existence.

Educate:�We�believe� that�we�have�a� social� responsibility� to�educate�and�empower�patientsto� take�better� care�

of� themselves.� By� providing� expert� advice,�we� educateour� customers� on�many� aspects� integral� to� a� healthy�

life.�

Invest:� We� are� committed� to� continuously� develop� the� skills� of� our� teams� to� ensure� they� remain� our�

customers’� reliable� providers� and� advisors� on� health� and� personal� care.�

Expand:�We� continue� toinvest� in� growing�our� network� to� help�more� patients,� customers� and� institutions� in�

Egypt� and� across� the� region,� thereby� strengthening� our� presence� and� leadership� as� the� go-to� resource� for�

all� health� products� and� services� within� our� mandate.�

Collaborate:� We� seek� to� build� rewarding� and� long� lasting� partnerships� with� all� our� stakeholders,from�

patients,suppliers�and�medical� institutions� to�government�and�community�organizations,Our�success� can�only�

be� achieved� and� maintained� by� collective� prosperity.

38. Elezaby Pharmacy

1.� Corporate� General� Information

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39. Emergent BioSolutions Inc.

1.� Corporate� General� Information

Corporate� Name Emergent� BioSolutions� Inc.

Corporate� Ownership Public� Company

Head� Office� AddressEmergent� BioSolutions� 400� Professional� Drive� Suite� 400� Gaithersburg,�Maryland� 20879

Facilities� City� &� CountryEmergent� BioSolutions� (Cangene� bioPharma)� 1111� South� Paca� Street�Baltimore,� Maryland� 21230-2591� USA

Web-site� Address www.emergentcontractmanufacturing.com

No.� of� EmployeesCorporate:� 1300� employees� (Full� Time)Manufacturing� Facility:� 137� employees

Financial� Status

Sales� Revenue� in�2014(US� K$)

Capital(US� K$) Dept-equity� Ratio(%)

450,380,000 313,979,000 .71

Contact(Korean�Business)

Name Patrick� DePalma� ­� Director� of� Business� Development

Address 1111� South� Paca� Street� Baltimore,� Maryland� 21230-2591� USA

Telephone 410-843-5000� ext� 2015

E-mail [email protected]

Company� History

Since� its� founding� in�1998,�Emergent’s�history�has�been�one�of� Innovation�and�Growth� focused�on�a�singular�mission� ­� To� Protect� and� Enhance� Life.From� its� beginnings� as� a�private� company�with�a� single� location� in� Lansing,�Michigan,� Emergent�has� grown�into� a� thriving� public� company� with� sites� around� the� world.1998� ­� September� 5th� 1st� Day� of� Business1998� ­� 2002:� EBSI� partnered� with� US� Gov’t� to� supply� Anthrax� Vaccine2002:� Commercial� distribution� of� Biothrax,� Approved� by� the� FDA2003� ­� 2005:� Multiple� acquisitions� (AntexBiologics,� MicroScience)2006:� Singapore� Office� opens,� Vivacs� acquired2007� ­� 2011:� Facility� upgrades� and� additional� acquisition� (Trubion),� Epic� Bio� partnership� established2012:� BARDA� and� EBSI� partnership2013:� Commercial� Rights� for� Pandemic� Influenza� Vaccine2014:� Cangene� Corporation� acquired2015:� Facility� upgrades� and� expansion,� mission� ongoing

Company� Description� &� Organization

Emergent� biosolutions� is� a� global� specialty� biopharmaceutical� company� seeking� to� protect� and� enhance� life�by� offering� specialized� products� to� healthcare� providers� and� governments� to� address� medical� needs� and�emerging� health� threats.� Emergent� biosolutions� also� provides� contract� manufacturing� services� to� a�worldwide� customer� base,� including� large,� small� and� virtual� pharmaceutical� and� biotechnology� companies.�Emergent� biosolutions� produces� products� that� are� distributed� in� over� 50� countries.Our�goal� is� to�pursue� innovative�ways� to�protect� life.�Whether� it� is�developing� specialized�products� that�can�make� life� better� for�millions� of� adults� and� children,� providing� the�world’s� only� FDA-licensed� anthrax� vaccine�to� protect� against� anthrax� disease� and� providing� contract� manufacturing� (fill/finish)� services� to� our� client’s�for� their� innovative� pipeline� of� therapeutics� that� target�diseases�worldwide.�We� are�passionate� in�pursuit� of�our� mission� ­� to� protect� and� enhance� life

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2.� Corporate� Service� &�Business� Area

Corporate� Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Central� &�

South�

America

Central� &�

South�

America

Central� &�

South�

America

Central� &�

South�

America

US US ○ US US

EU EU ○ EU EU

Asia Asia ○ Asia Asia

Russia� &�

CIS

Russia� &�

CIS○

Russia� &�

CIS

Russia� &�

CIS

ROW ROW ○ ROW ROW

Focusing� Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

ResearchAPI

APIs

R&D

Pre-Clinical

R&D� Strategy

&�

ManagementPre-clinical

Test� SamplePhase� I Clinical� Trials

Phase� II Clinical� Test

Sample○

Finished

Products

Regulatory

Affairs

Phase� IIIBusiness

DevelopmentFinished

Product○

Phase� IVSales� &

Marketing

Corporate� Product�

Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

○ ○ ○ ○

Generics APIs Devices Others

○ ○ ○

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3.� Corporate� Business�Overview

Clients'� Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

10 40 40 10

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

○ ○

Focusing� Therapeutic�

Area

Oncologics Lipid�RegulatorsRespiratory�

AgentsAnti-ulcerants

Angiotensin� II�

Antagonists

40 5 5 0 1

AntipsychoticsAutoimmune�

agentsAntidepressants Analgesics Others

0 20 0 0 29

Emergent� biosolutions� approach� is� to� achieve� balance� in� the� products� that� we�

develop� through� a� pipeline� comprising� innovative� vaccines� and� therapeutics� that�

target�diseases�worldwide.�Expanding�Emergent’s�product�pipeline�with�promising�

candidates� is� key� to� our� success.� Emergent� uses� multiple,� novel� technologies� to�

keep� at� the� forefront� of� scientific� development� and� new� product� discovery

Products� filled� at� EBSI’s� contract� manufacturing� facility� are� used� to� treat:

1.� Cancer� (many� types)

2.� Rare� Enzyme� Disorders

3.� Venomous� Snake� Bites

4.� Diabetes

5.� Infantile� Spasms

6.� Glaucoma

7.� Multiple� Sclerosis

8.� Arterial� Punctures

9.� Influenza

10.� Osteoporosis

11.� Cyanide� Poisoning

12.� Many,� many� others

General� Overview

of� Corporate's� Key

Contract� Services

Contract� Manufacturing� Services:

The�manufacturing� facility� is� focused�on�contract�manufacturing� services.� The� site�

provides� pharmaceutical�product� development�and� fill� services� (vials� and� syringes)�

for� injectable� and� other� sterile� products,� as� well� as� process� design,� technical�

transfer,� manufacturing� validations,� laboratory� support,� aseptic� filling,�

lyophilization,� terminal� sterilization,� final� packaging� and� accelerated� and� ongoing�

stability� studies� and� is� an� approved� manufacturing� facility� under� the� regulatory�

regimes� in� the� United� States,� Canada,� Japan,� Brazil,� the�Middle� East� and� several�

countries� in� the�European�Union.�The� facility� includes�warehousing�space�used� for�

cold� storage� and� freezer� capacity� to� support� product� distribution� and� storage� of�

all� related� equipment� and� accessories� for� our� contract� manufacturing� services.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 241

Contract� Service�Capacity� Affordable� by�

Service� Area

cGMP� Drug� Product� Manufacturing

Sterile� Fill/Finish

Liquid� or� Lyophilized� Products

Prefilled� Syringes� (0.5cc� ­� 20cc)

Vial� Sizes:

●� 3cc� ­� 125cc� (2� filling� lines)

●� 2cc� ­� 50cc� (1� filling� line)

Production� Lyophilizers

●� 216� sq� ft

●� 240� sq� ft

Lyophilization� Cycle� Development

●� Optimization� of� Critical� Cycle� Parameters

●� Material� Characterization

●� FDM/FTIR/DSC

●� Supporting� Stability

Laboratory� Services

●� Microbiology

●� Method� Development/Validation

●� ICH� Stability

Process� Development� &� Validation

Labeling,� Inspection� &� Packaging,� Distribution

Experience� with� Complex� Formulation� Types

●� Proteins

●� Plasmid� DNA

●� Liposomes

●� Monoclonal� Antibodies

Strong� Regulatory� History

●� 20+� Commercial� Products� (distributed� in� 50� countries)

●� 200� Clinical� Candidates� Supported

●� e-CTD� Filing

●� Experience� with� Government� Contracts

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Communication� with�Clients

Dispositoion� ofProject�ManagerResponsible

The� project� management� group� is� the� focal� point� for� all�activities� as� they� relate� to� the� client.� Primary� responsibilities�are�Primary� client� contact/interfaceProposal/Contract� oversightProject/Lot#� assignmentBatch� Record� requestsAdditional� sample� requestsClient� requested� deviationsProject� Invoice� requestsSample� shipment� schedulingFinal� Product� shipment� scheduling

Providing�Realtime

Service� Delivery

Proposed�method� for� communication�would�be�primarily�by�email,� telephone,� WEBEX,� FAX,� mail� (fedex� or� other�carriers)� and� in� person.

RealtimeFeed-back

Frequency� for� communication� can� be� set� up� with� the�assigned� project� manager.� Communication� with� your�project� manager� can� be� on� a� daily� basis.� Based� upon� the�need� for� information/discussion� with� a� group� of� key�members,� a� weekly� or� bi-weekly� meeting� can� be� set� up�during� the� initial� stages�of� the�project.� This�will� need� to�be�coordinated�with� the�assigned�project�manager.�The�project�manager� will� always� be� the� Primary� Client�Contact/Interface.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 243

CorporateCompetitiveness

1.� Cost� of� Service,� Planned� Service� Timeline:

Upon� receipt�of� client’s�project� scope,�a�project�proposal/quote� is�prepared�by�New�

Business� Development� containing� budget� cost� estimates,� Product� Information,�

Project� Activities,� Scheduling/Cancellation/Completion� Policies� and� Terms� and�

Conditions.� In� addition� a� Draft� Implementation� Plan/Timeline� is� prepared� based�

upon� the� client’s� needs.� These� cost� estimates,� plans� and� timelines� are� formalized�

once� contract� has� been� accepted� by� client.

2.� Service� Certification� or� Approval� from� Regulatory� Agencies:

EBSI’s� Regulatory� affairs� and� Quality� Assurance� will� be� available� to� support� the�

preparation� of� the� FDA� submission� or� other� agency� submissions� during� the� review�

process.� Audits� both� external� and� internal� are� performed� to� ensure� to� validate�

robustness�and� for�continuous� improvement�of�our�pharmaceutical�quality� systems.

3.� In-house� Quality� Assurance:

EBSI’s� pharmaceutical� quality� system� model� is� a� lifecycle� approach� enabled� by�

knowledge� management,� quality� risk� management,� lean� manufacturing� with� six�

sigma� principles,� employment� of� measurements� and� controls� and� continuous�

improvement� guided� by� our� mission� and� core� values.

4.� Training� and� Service� experience:

EBSI’s� training� program� is� an� innovative� method� of� transferring� knowledge� to�

promote� teamwork,�excellence�and�accountability� allowing�us� to�hold�patient� focus�

to� the� highest� standards� in� everything� we� do.

Training� is� based� on� both� the� requirements� identified� in� an� employee’s� job� set� as�

well� as� requirements� identified� in� the� responsibilities� of� the� affected� document�

when� available.� Training� is� continuous� and� ongoing� as� new� processes� are�

implemented� into� our� systems.

All�of�our�personnel�are�highly� skilled� individuals�with�many�years�of�pharmaceutical�

experience� and� knowledge.�

4.� Corporate� Competitiveness

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No.� of� RegulatoryInspections

Classification FDA(US) EMA(EU)PMDA(Japan)

Russia� &�CIS

Central� &�South�America

Others

Pre-Clinical� Area

Clinical� Area 6 5 1 4

Manufacturing�Area

6 5 1 4

Others

Current� Status� ofAccredited� Certification

FDA-CDER� and� CBER� do� not� provide� Certification,� but� routinely� audit� the� site� and�

the� site� is� Registered

HPRA� (Ireland)� ­� Nov.� 2014

MGCC� (Middle� East)� ­� Jun.� 2013

EMA� ­� IGZ� (Netherlands)� -� Mar.� 2013

Ministry� of� Health� (Belarus)� -� Feb.� 2013

BMGS� (Germany)� ­� Oct.� 2011

EMA-MPA� (Sweden)� ­� Mar.� 2013

Belarus� ­� Feb.� 2013

ANVISA� (Brazil)� -� Mar.� 2011

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 245

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� whichclients� belong� to

Japan,� South� Korea,� China

Asian� Clients'Composition(%)

Big� PharmasMid� or� Small-Size� Pharmas

BiotechCompanies

Start-ups

10 40 40 10

No.� of� Asian� Clientsin� recent� 3� years

3� Asian� Clients

Major� Service� Rangewith� Asian� Companies

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Research API

APIs

R&D

Pre-Clinical Pre-clinicalTest� Sample

R&D� Strategy&� Management

Phase� I Clinical� Trials

Phase� IIClinical� TestSample ○

FinishedProducts

RegulatoryAffairs

Phase� IIIFinishedProduct

BusinessDevelopment

○Phase� IV

Sales� &Marketing

6.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

Contract� Manufacturing� Services:

Emergent�provides�contract�manufacturing�services� to� third�party� customers.� The�majority�of� these� services�

are� performed� at� our� facility� located� in� Baltimore,� Maryland.� At� this� facility� we� perform� pharmaceutical�

product� development� and� filling� services� for� injectable� and� other� sterile� products,� as� well� as,� process�

design,� technical� transfer,�manufacturing�validations,� laboratory�support,� aseptic� filling,� lyophilization,� final�

packaging� and� accelerated� and�ongoing� stability� studies.�We�manufacture� both� vial� and� pre-filled� syringe�

formats� for�a�wide�variety�of�drug�products� ­� small�molecule�and�biological� ­� in�all� stages�of�development�

and�commercialization,� including�20� licensed�products�which�are� currently� sold� in�more� than�40�countries.�

This� facility� produces� finished� units� of� clinical� and� commercial� drugs� for� a� variety� of� customers� ranging�

from� small� biopharmaceutical� companies� to� major� multinationals.� The� facility� is� an� approved�

manufacturing� facility�under� the� regulatory� regimes� in� the�United�States,�Canada,� Japan,�Brazil,� the�Middle�

East� and� several� companies� in� the� European� Union.

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40. Encap drug delivery

1.� Corporate� General� Information

Corporate� Name Encap� drug� delivery

Corporate� Ownership Private� Company

Head� Office� AddressEncap� Drug� Delivery� Units4,5&6,� Oakbank� Park� Way� � Livingston,� West�

Lothian� United� Kingdom� EH530TH

Facilities� City� &� Country Livingston(UK)

Web-site� Address http://www.encapdrugdelivery.com

Company� History

Encap� was� established� in� Livingston,� Scotland� in� 1989� to� exploit� an� emerging� new� oral� drug� delivery�

technology.� �The�core�business� technology� is� in� the� liquid� filling�of� two-piece�hard� capsules�and�the�company�

has� grown� organically� and� steadily� over� the� years� and� has� made� significant� investments� in� people,�

equipment,� resources� and� moved� to� a� new� facility� in� 2005.�

Company� Description� &� Organization

For� 20� years� Encap� has� led� the� way� in� providing� solutions� for� oral� drug� delivery.

The� company�has� remained�as�a� specialist� company� focused�on� its� core� liquid� and� semi-solid� fill� technology�

.� Encap� works� with� companies� in� the� pharmaceutical� and� nutraceutical� industries� to� help� develop� and�

manufacture� their� products.

Liquid-fill� based� formulation� is� one� of� the� fastest� growing� sectors� of� the� drug� delivery� market,� increasing�

at�a� rate�of�30%�per�annum.�This� is�due� to� the�number�of�highly�potent� chemical� and�biological-based�drugs�

moving� through� development� pipelines� today� particularly� for� cancer� treatments.� To� meet� this� growing�

demand,� Encap� has� recently� expanded� the� size� of� its� facilities� by� nearly� 50%� to� provide� clients� with� high�

containment� manufacturing� capabilities.

Encap�has�also�been�a�pioneer� in� the�development�of�encapsulation� technology� to�produce�oral�Vancomycin.�

Vancomycin�capsules� release�antibiotic�directly� into� the�gastro-intestinal� tract� and�have�become� the� first� line�

treatment� for� life� threatening�diseases�associated�with� the�hospital� superbug�C.�Difficile,�which� is�becoming�

an� increasing� problem� in� Europe.� Encap� is� the� exclusive� manufacturing� facility� for� various� marketing�

authorizations� throughout� Europe� and� as� a� result,� Encap� supplies� 90%� of� the� European� market� with� this�

product.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 247

2.� Corporate� Service� &�Business� Area

Corporate� Main�Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

○ ○

GeographicalBusiness� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

US ○ US ○ US US

Canada ○ Canada ○ Canada Canada

EU ○ EU ○ EU EU

Asia ○ Asia ○ Asia Asia

Global Global Global Global

Other Other Other Other

Focusing� ContractService� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

ResearchAPI ○

APIs

R&D

Pre-ClinicalR&D� Strategy

&�ManagementPre-clinical

Test� SamplePhase� I Clinical� Trials

Phase� II Clinical� TestSample

FinishedProducts

RegulatoryAffairs

Phase� IIIBusiness

DevelopmentFinishedProduct

○Phase� IV

Sales� &Marketing

Corporate� Product�Area

New� DrugBiologics

HerbalMedicine

BiosimilarsNCE NME

○ ○

Generics APIs Devices Others

○ ○

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3.� Corporate� Business�Overview

Contract Service Capacity Affordable by

Service AreaEU,� Asia,� US

4.� Corporate� Competitiveness

No.� of� RegulatoryInspections

Classification FDA(US) EMA(EU) PMDA(Japan) Others

Pre-Clinical� Area

Clinical� Area

Manufacturing� Area ○ MHRA(UK)

Others

Current� Status� ofAccredited� Certification

3,113� GMP� batches

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� whichclients� belong� to

Major� pharma,� speciality� pharma,� biotechs,� generics,� nutraceutical� providers.�

Japan,� EU,� Asia

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 249

Corporate� Name Endopoint

Facilities� City� &� Country Israel

Web-site� Address www.endpoint.co.il

Contact

(Korean�

Business)

Telephone +972� 54� 7545065

E-mail [email protected]

Company� Description� &� Organization

Delivering� Quality� Since� 2005�

Endpoint� is� a� full� service� premium� contract� research� organization� (CRO),� experienced� in� performing� clinical�

development�activities� in�pharmaceutical� and�medical�devices�studies� in� Israel.�Endpoint�has�been�performing�

clinical� research� in� this� growing� and� dynamic� region� of� the� world� since� 2005.

� Endpoint� experience� of� working� across� a� large� number� of� companies� from� the� smallest� start-up� ventures,�

through� Biotech� and� Medical� Device� companies� to� large� CROs� and� drug� companies.� Since� established,�

Endpoint� successfully�completed�over�30� local� and� international�projects,� employ�3� full� time�CRA�and�2�CTA.�

Managed�by� Ilana� Fishman� (M.Sc.),� Senior�CRA� II� an� appreciated�professional�with�more� than� two�decades�

of� combined� industry� experience,� Endpoint� maximizes� the� benefits� of� the� region� with� a� complete�

understanding� of� international� research� standards.�

41. Endopoint

1.� Corporate� General� Information

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Corporate� Name ERA� Consulting� (Austrailia)� Pty� Ltd

Corporate� Ownership Private� Company

Head� Office� Address ERA� Consulting� GmbH� Postfach� 12� 49

Facilities� City� &� Country Walsrode� D-29652(GERMANY)

Web-site� Address http://www.eraconsulting.com

No.� of� Employees In� Australia:� 5� � Worldwide:� 32

Contact(Korean�Business)

Name GDFI� Co� Ltd

Address5FL.,� Yohyun� Bldg,� 242-29,� Nonhyun-dong,� Gangnam-gu,� Seoul,� 135-010,�

KOREA

Telephone +82-2-3445-0666

E-mail [email protected]

Financial� Status Private� and� Confidential Private� and� Confidential Private� and� Confidential

Company� History

The� ERA� Consulting� Group� is� an� international� biopharmaceutical� product� development� and� regulatory�

consultancy.� Founded� in� 1987� by� Dr� Christopher� Holloway� since� 1993,� ERA� has� evolved� into� a� leading�

independent� organisation� that� has�worked�with� over� 450�medicinal� products.� Our� offices� are� strategically�

located�near� the�EMA,�US�FDA�and�Asia-Pacific�Agencies� to�assist� clients�who� lack� representation� in� these�

jurisdictions.

Company� Description� &� Organization

The�ERA�Consulting�Group� (www.eraconsulting.com)�provides� regulatory�affairs� and�product�development�

consulting� services� for�biotechnology-derived�medicinal� products.�With�offices� in�Germany� (near�Hanover),�

UK� (London),�USA�(Washington�DC)�and�Australia� (Brisbane),�we�have�unrivalled�expertise,�a�proven� track�

record� and� over� 20� years’� experience,� covering� more� than� 450� biological/biotech� products.

42. ERA Consulting (Australia) Pty Ltd

1.� Corporatqe�General� Information

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 251

2.� Corporate� Service� &�Business� Area

Corporate�Main�

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

GeographicalBusiness� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

US US US US

Canada Canada Canada Canada

EU EU EU EU

Asia Asia Asia Asia

Global Global Global Global ○

Other Other Other Other

Focusing�Contract

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Research API

APIs

R&D

Pre-ClinicalPre-clinicalTest� Sample

R&D� Strategy&� Management

Phase� I Clinical� Trials ○

Phase� IIClinical� TestSample

FinishedProducts

RegulatoryAffairs

Phase� III

FinishedProduct

BusinessDevelopment

Phase� IVSales� &Marketing

Corporate�Product� Area

New� DrugBiologics

HerbalMedicine

BiosimilarsNCE NME

○ ○ ○ ○ ○

Generics APIs Devices Others

○ ○ ○

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3.� Corporate� Business�Overview

Clients'�Composition

(%)

Big� PharmasMid� or� Small-Size� Pharmas

BiotechCompanies

Start-ups

30% 30% 25% 15%

General� Overviewof� Corporate's� KeyContract� Services

ERA� offers� product� development� and� regulatory� strategy� advice� as� a� consultancy.

Contract� Service�Capacity� Affordable�by� Service� Area

ERA� specialises� in� product� development� and� regulatory� strategies,� especially� for�

innovative� technologies� andbiological� medicinal� products.�We� have� a� strong� scientific�

focus� with� a� profound� understanding� of� themedicines� development� process� and�

associated� regulatory� issues.� Combined� with� our� regulatory� expertise,� our� strength� in�

science� allows� us� to� identify� the� most� expeditious� developmental� and� regulatory�

pathways� for� our� clients.�

ERA�Consulting�has�extensive�experience�with�products� such�as�monoclonal�antibodies�

(both� novel� and� biosimilar),� peptides,� vaccines,� complex� drugs,� gene� therapies� and�

viable� cell� products.� In� addition,� ERA� has� also� significant� expertise� in� the� area� of�

innovative� small�molecules�and�"natural"�biologics,� including�blood�products�and�plant�

derivatives.� For� these� complex� products,� ERA� is� able� to� apply� appropriately� dynamic�

regulatory� strategies.�With�over� 35� full-time� staff� spread� throughout�ERA’s�offices,�we�

can�assist�with�every�aspect�of�product�development�and� regulatory� requirements.�ERA�

is� strategically� located�near� the�EMA,�US�FDA�and�Asia-Pacific�Agencies� to�assist�clients�

who� lack� representation� in� these� jurisdictions.�

Communication�with� Clients

Dispositoion� ofProject� ManagerResponsible

A� dedicated� ERA� Project� Manager� will� be� assigned� who� � will� act�

as� the� primary� point� of� contact� and:� �

§ Manage� the� budget� and� deadlines� �

§ Provide� consulting� support� and� allocate� tasks� to� ERA� staff� if�

additional� experience� or� capacity� is� required� �

Providing� RealtimeService� Delivery

ERA�provides� real-time� service� delivery,� and� is� available� to� provide�

regulatory� support� as� needed,� including� across� global� time� zones.�

RealtimeFeed-back

ERA� provides� real-time� feedback,� and� is� available� to� provide�

regulatory� support� as� needed,� including� across� global� time� zones.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 253

4.� Corporate� Competitiveness

CorporateCompetitiveness

ERA�holds�a�unique�position�globally� as� an� independent� consultancy�providing�both�

high� level�and�practical� advice�on�product�development�and� regulatory�pathways� to�

all� segments� of� the� industry.� � As� an� independent� group,� ERA� is� known� to� the�

regulatory�authorities� for�bringing� forward�clients�with�well-founded�programs�based�

on� scientific� data� and� rational� regulatory� strategies,� even� in� the� most� novel� and�

challenging� areas� of� medicine� development.�

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5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� whichclients� belong� to

Korea,� Taiwan

Asian� Clients'Composition(%)

Big� PharmasMid� or� Small-Size� Pharmas

BiotechCompanies

Start-ups

50% 25% 25% 0%

No.� of� Asian� Clientsin� recent� 3� years

5

Major� Service� Rangewith�Asian�Companies

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Research API

APIs

R&D

Pre-ClinicalPre-clinicalTest� Sample

R&D� Strategy&�Management

Phase� I Clinical� Trials ○

Phase� IIClinical� TestSample

FinishedProducts

RegulatoryAffairs

Phase� IIIFinishedProduct

BusinessDevelopment

Phase� IVSales� &Marketing

6.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

ü A� privately� owned� and� financially� stable� company� �

ü Relevant� expertise� ­� technical� and� regulatory� �

ü Extensive� interactions� with� regulatory� agencies� and� assessors� �

ü Optimal� team� size;� permanent� employees� �

ü Dedication� to� service� and� meeting� clients’� expectations� �

ü Dedicated� facilities� in� strategic� locations� �

ü Extensive� client� base� with� an� international� reputation� �

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 255

43. Estern Medical

1.� Corporate� General� Information

Corporate� Name Estern� Medical

Head� Office� Address

Insurgentes� Sur� No.1677

� Oficina� No.� 1106

� Col.� Guadalupe� Inn,�

� C.P.� 01020,�

� México� City,� Mexico

Facilities� City� &� Country Mexico

Web-site� Address www.esternmedical.com

Contact(Korean�Business)

E-mail [email protected]

Company� Description� &� Organization

The� ESTERN� Medical� CRO� Corporation� Group� is� one� of� the� world's� leading� global� full� Clinical� Research�

Organizations,�conducting�clinical� trials� in�US-North�America�and�the�Emerging�Markets�across�Latin�America.�

We� operate� in� two� continents,� in� North� America� and� South� America.� Our� corporate� office� is� located� in�

Boston� &� Cambridge,� USA� and� our� subsidiaries� regional� offices� are� spread� across� Mexico,� Colombia,� Chile�

&� Argentina.�

As� an� independent,� privately� corporation,� since� its� foundation� in� 2002� we� are� passionate� about� being� the�

preferred� full� service� CRO� partner� worldwide,� thus� contributing� to� people’s� health� and� quality� of� life.�

This� leadership� is� built� on� our� internal� skills� and� competencies,� and� is� complemented� by� collaboration�with�

external� partners� and� clients� that� include�Global� Pharmaceutical,� Biotechnology,�Medical�Device,� CROs,� and�

Academic� -� Government� Institutions.�

ESTERN� Medical� CRO� applies� innovative� dynamic� Clinical,� Operational� &� Regulatory� Development� and� a�

broad�track� record�of� therapeutic�expertise� to�our� clients.�We�emphasize�our� commitment� to�quality� to�help�

our� sponsors� and� partners� maximize� returns� on� their� R&D� investments� and� accelerate� the� delivery� of� safe�

and� effective� therapeutics� to� patients� globally.�

ESTERN�Medical� provides� outsourced� clinical� trial� services� across� all� phases,� through� its� years� of� experience,�

ESTERN� Medical� has� developed� the� operational� and� therapeutic� expertise� to� provide� high� quality,� global�

service� while� maintaining� our� differentiating� personal� interaction� element� of� commitment� to� excellence.

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44. ETHIC

1.� Corporate� General� Information

Corporate� Name ETHIC

Head� Office� Addressİmar� Limited� Sk.� No:23� Kat:2� Daire:2� 35817� Koşuyolu-Kadıköy-İSTANBUL/TURKEY

Facilities� City� &� Country Turkey

Web-site� Address www.ethic-cro.com

Contact(Korean�Business)

E-mail +90� 216� 545� 9103

Company� Description� &� Organization

[Mission]

� Our� mission� providing� high� quality� services� and� improving� professional� analysis� to� pharmaceuticals,�

investigator,� study� sites� etc.� adhere� strictly� to� international� standard,� local� regulations� and� medical� ethics�

about� all� types� of� clinical� research.

[Vision]

� Our� vision� is� to� be� top� leader� the� conducted�high�quality� study� in� Turkey�and�worldwide� cooperation�with�

national� and� international� companies� as� global� clinical� research� organizations.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 257

45. Eurotrials

1.� Corporate� General� Information

Corporate� Name Eurotrials

Head� Office� AddressAlameda� Santos,� 787� cj� 31

Cerqueira� César� 01419-001� São� Paulo,� BrasilFacilities� City� &� Country Brasil

Web-site� Address www.eurotrials.com

Contact(Korean�Business)

Telephone (55)� 11� 3842-6888

Company� Description� &� Organization

A� Eurotrials,� Consultores� Científicos,� é� uma� empresa� privada� fundada� em� Lisboa,� em� 1995,� por� membros�

do� meio� acadêmico,� da� comunidade� médica� e� da� indústria� farmacêutica.� Especializada� em� investigação�clínica� e� consultoria� científica� na� área� da� Saúde,� opera� actualmente� na� Europa� e� na� América� Latina,�

desenvolvendo� ainda� projectos� em� África.

A� forte� integração� da� Eurotrials� junto� das� instituições� médicas� e� regulamentares� constitui� um� factor�fundamental�para�o� seu�sucesso,� reconhecido�pelos�parceiros,�nomeadamente�a� indústria� farmacêutica�e�de�

biotecnologia� internacional,� as� CRO,� agências� regulamentares,� indústria� agro-alimentar,� universidades� e�

centros� de� investigação� clínica.

O� êxito� da� empresa� assenta� em� pilares� que� marcam� a� sua� personalidade� desde� a� fundação:� inovação� na�criação� de� soluções,� tecnologia� altamente� diferenciada,� expertise� própria� de� âmbito� multidisciplinar,�experiência� e� qualidade� consolidadas.� Em� qualquer� projecto� de� investigação� clínica,� translacional� ou�epidemiológica,� está� apta� a� intervir� em� todos� os� passos� do� processo,� desde� a� formulação� da� questão� de�investigação� até� ao� output� final.

Com� uma� equipa� de� mais� de� 120� colaboradores� jovens� e� motivados,� altamente� qualificados,� a� Eurotrials�

aposta� na� diversidade� e� interdisciplinaridade� para�melhor� responder� às� necessidades� dos� clientes.� A� equipa�

inclui� médicos,� biólogos,� farmacêuticos,� bioestatistas,� sociólogos,� nutricionistas,� químicos,� engenheiros,�

psicólogos� e� matemáticos,� entre� outros.

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46. Excel PharmaStudies Inc

1.� Corporate� General� Information

Corporate� Name Excel� PharmaStudies� Inc�

Corporate� Ownership Private� Company

Head� Office� AddressSuite�2003-2006,�North�Ring�Center,�No.18�Yumin�Road,�Xicheng�District,�

Beijing� 100029,� China

Web-site� Address www.excel-cro.com

Contact(Korean�Business)

Name -

AddressSuite�2003-2006,�North�Ring�Center,�No.18�Yumin�Road,�Xicheng�District,�

Beijing� 100029,� China

Telephone +86� 10� 8225� 0022�

E-mail [email protected]

Company� History

Excel,� a� leading� CRO� in� China,� was� founded� in� Beijing� in� 1999,� and� in� the� last� years� it� has� grown� into� a�

full� service� CRO� providing� comprehensive� regulatory,� clinical� research� and� quality� assurance� services� in� the�

areas� of� clinical� drug� development,� Phase� I~IV,� bioequivalence� studies,� clinical� monitoring,� project�

management,� patient� recruitment,� data� management,� biostatistics� analysis,� translation,� medical� report�

writing� and� other� related� services.

Company� Description� &� Organization

Excel's� headquarters� is� located� in� Beijing,� and� there� are� ten� satellite� offices� located� throughout� China� in�

Shanghai,�Guangzhou,�Nanjing,�Chengdu,�Chongqing,�Shenyang,�Nanning,�Wuhan,�XiAn�and�Harbin.�Excel�

has� established� business� offices� in� the� US� (Boston)� and� Europe� (Cologne,� Germany).

Excel� has� successfully� conducted� over� 125� clinical� trials� (phase� I� to� IV)� and� has� obtained� nearly� 200�

regulatory�approvals.�As�one�of� the� few�CROs� in�China�using�Oracle�and�SAS� for� clinical� data�management�

and� biostatistics� analysis,� its� biometrics� services� are� being� developed� to� comply� with� US� FDA� 21� CFR� Part�

11� requirements.

Its� clients� currently� include� many� of� the� top� international� pharmaceutical� companies� and� many� leading�

biotech� companies.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 259

Corporate� Name Exponent,� Inc.

Corporate� Ownership Public� Company

Head� Office� Address

149� Commonwealth� Drive

Menlo� Park,� CA� 94025

United� States

Facilities� City� &� Country Menlo� Park,� California,� United� States

Web-site� Address http://www.exponent.com

No.� of� Employees 938

Financial� Status

Sales� Revenue� in� 2010(US� K$)

Capital(US� K$) Dept-equity� Ratio(%)

267,130 580,310 0

Contact(Korean�Business)

Name Dokyoung� Yoon,� M.D.,� Ph.D.,� M.B.A.

Address 1150� Connecticut� Av.� NW,� Suite� 1100,� Washington,� DC� 20036,� USA

Telephone 202-772-4900,� 202-772-4933

E-mail [email protected]

Company� History

Exponent� started�as�a�consulting�business�called�Failure�Analysis�Associates®� (FaAA)� in�1967.� � It�went�public�

on� NASDAQ� (FAIL)� in� 1990� and� changed� its� name� to� Exponent� (EXPO)� in� 1998.� Exponent� acquired�

Environmental� Health� Strategies,� Performance� Technologies,� Inc.,� and� Novigen� Sciences,� Inc� to� expand� its�

service� to� health,� environmental� and� regulatory� support.� As� of� December� 31,� 2010,� the� company� operated�

23� practices� and� centers� in� the� area� of� failure� analysis� &� prevention,� environments,� health� sciences,� and�

technology� development.� Exponent� operates� 21� U.S.� offices� and� 5� international� offices.

Company� Description� &� Organization

47. Exponent, Inc.

1.� Corporate� General� Information

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Exponent� is� a� leading� science� and� engineering� consulting� firm� that� provides� solutions� to� complex� technical�

problems.� Our� multidisciplinary� team� of� scientists,� physicians,� engineers,� and� business� consultants� perform �

in-depth� research�and� analyses� in�more� than�90� technical� disciplines.�We�offer� clients� the� scientific� expertise�

needed� to� understand� important� issues� and�make� sound� strategic� decisions.� Our� clients� include� health� care�

providers,� pharmaceutical� companies,� manufacturers;� industry� associations;� insurers,� venture� capital�

companies,� government� agencies� and� law� firms.

Exponent’s� Health� Sciences� practice� includes� board-certified� physicians,� epidemiologists,� health� economists,�

toxicologists,� industrial� hygienists,� and� statisticians.� Exponent’s� health� care� professionals� apply� innovative�

techniques� to� help� clients� address� a� variety� of� issues,� including� health� economics� and� outcomes� research;�

pharmaceuticals,� medical� devices� and� biotechnology� products;� clinical� and� occupational� epidemiology;� and�

toxicology� and� human� health� risk� assessment.

At� Exponent,� we� pride� ourselves� on� the� high� quality� of� our� 900+� employees.� More� than� 700� are� degreed�

technical�professionals,� and�more� than�390�have�earned�an�M.D.�or�Ph.D.�Exponent�operates�21�U.S.�offices�

and� 5� international� locations,� and� is� publicly� traded� on� the� NASDAQ� exchange� under� the� symbol� EXPO.�

Exponent� is� certified� to� ISO� 9001.� More� information� can� be� found� on� our� website� at� www.exponent.com.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 261

2.� Corporate� Service� &�Business� Area

Corporate�Main�

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

〇 〇

GeographicalBusiness� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

US 〇 US US US 〇Canada Canada Canada Canada

EU 〇 EU EU EU 〇Asia 〇 Asia Asia Asia 〇Global 〇 Global Global Global 〇Other Other Other Other

Focusing�Contract

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Research 〇 API

APIs

R&D 〇Pre-Clinical

Pre-clinicalTest� Sample

R&D� Strategy&� Management

〇Phase� I Clinical� Trials 〇Phase� II

Clinical� TestSample

FinishedProducts

RegulatoryAffairs

Phase� IIIFinishedProduct

BusinessDevelopment

Phase� IVSales� &Marketing

Corporate�Product� Area

New� DrugBiologics

HerbalMedicine

BiosimilarsNCE NME

〇 〇 〇 〇 〇Generics APIs Devices Others

〇 〇

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3.� Corporate� Business�Overview

Clients'�Composition

(%)

Big� PharmasMid� or� Small-Size� Pharmas

BiotechCompanies

Start-ups

40% 20% 20% 20%

Focusing�Therapeutic� Area

Oncology/hematology,� Cardiovascular� disease,� Neurology,� Psychiatry,� Gastrointestinal�

disease,� Antibiotics,� AIDS,� Vaccines,� Pain� management/anesthesiology,�

Endocrinology/hormones,� Orthopedics,� Over-the-counter� (OTC)� medications

General� Overviewof� Corporate's� KeyContract� Services

Exponent’s�health� sciences�practice�combines� the�expertise�and�experience�of�M.D.s�and�

Ph.D.s� to� provide� a� comprehensive� perspective� on� human� health� issues� such� as�

occupational� and� environmental� health,� toxicology,� pharmaceuticals,� medical� devices,�

and� the�quality�of�health�care.� �We� respond�to�clients’�health�questions� in�a�wide�variety�

of� fields,� including�product� safety,� food� safety,� community�exposures,�health� risks� in� the�

workplace,� health� care� quality,� and� the� effects� of� pharmaceuticals� and�medical� devices.�

Exponent’s� consultants� are� well� known,� widely� published,� and� highly� respected.� �

Exponent� does� not� provide� direct� drug� development� contract� services.� � Exponent� also�

provides� support� related� to� issues� in� manufacturing;� product/process� control� issues;�

contamination;� regulatory� support;� risk� assessment� and� litigation� support.

Communication�with� Clients

Dispositoion� ofProject� ManagerResponsible

Exponent� assigns� a� project� manager� for� each� project.� However,�

client�has�access� to�all�members�of� the�project� team�on�an�on-going�

basis.

Providing� RealtimeService� Delivery

Exponent� prides� itself� in� both� its� quality� of� product� and� its�

responsiveness� to� client� requests.

RealtimeFeed-back

Exponent� operates� a� customer� satisfaction� program.� Feedback� is�

encouraged� and� solicited� during� the� project� lifecycle.� � Exponent’s�

Client� Services� VP� responds� to� all� client� requests� on� a� 24� hour,�

7-day� a� week� schedule.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 263

4.� Corporate� Competitiveness

CorporateCompetitiveness

Exponent's� solves� complex� problems� that� require� an� experienced,� multidisciplinary�

team� of� scientists,� engineers� and� regulatory� consultants.� Unlike� any� of� our�

competitors,� Exponent� has� one� of� the� foremost� health� sciences� consulting� practices�

in� the� United� States.� Our� Health� Sciences� practice� combines� the� expertise� and�

experience� of� M.D.s� and� Ph.D.s� to� provide� a� comprehensive� perspective� on� human�

health� issues� such� as� occupational� and� environmental� health,� toxicology,�

pharmaceuticals,� medical� devices,� and� the� quality� of� health� care.� Our� regulatory�

specialists� address� technical� issues� relating� to� the� impact� of� chemical� substances� on�

human� health� and� the� environment.� � Our� engineering� staff� has� over� 40� years� of�

providing� independent� third-party� design� reviews� of� products� being� subject� to� public�

or� regulatory� scrutiny.� We� respond� to� clients’� questions� in� a� wide� variety� of� fields,�

including� product� safety,� food� safety,� community� exposures,� health� risks� in� the�

workplace,� health� care� quality,� and� the� effects� of� pharmaceuticals� and� medical�

devices.� � Our� consultants� are� well� known,� widely� published,� and� highly� respected.

Current� Status� ofAccredited�Certification

Exponent� is� certified� to� ISO� 9001� and� is� authorized� by� the� General� Services�

Administration� (GSA)� to� provide� professional� engineering� services.

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264� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� whichclients� belong� to

USA,� EU,� Korea,� United� Kingdom,� China,� Japan

Asian� Clients'Composition(%)

Big� PharmasMid� or� Small-Size� Pharmas

BiotechCompanies

Start-ups

30% 20% 20% 30%

No.� of� Asian� Clientsin� recent� 3� years

10s

Major� Service� Rangewith�Asian�Companies

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Research 〇 API

APIs

R&D 〇

Pre-ClinicalR&D� Strategy&�Management

〇Pre-clinicalTest� Sample

Phase� I Clinical� Trials 〇

Phase� II Clinical� TestSample

FinishedProducts

RegulatoryAffairs

Phase� IIIBusiness

Development〇

FinishedProduct

Phase� IVSales� &Marketing

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 265

Corporate� Name FARMA� TEAM

Head� Office� AddressUğur� Mumcu� Caddesi� 82/4� Gaziosmanpaşa� 06700� ANKARA� TURKEY

Facilities� City� &� Country Turkey

Web-site� Address www.farmacro.com

Contact

(Korean�

Business)

Telephone +90� 312� 437� 80� 10

E-mail [email protected]

Company� Description� &� Organization

[Mission]

� Our�mission� is� to� contribute� to� the� pharmaceutical� and�other� health� sectors� by�quality� orientated�planning�

and� implementation,� with� a� scientific� and� ethical� approach,� and� in� compliance� with� national� and�

international� standards.

� Farma� team� pays� attention� to� details� in� providing� the� services.� We� are� commited� to� goal� oriantated�

cooperation� in� providing� rapid� service� with� absolute� confidentiality.� �

48. FARMA TEAM

1.� Corporate� General� Information

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Corporate� Name Farzan� Clinical� Research

Head� Office� AddressNo� 17,� Siami� Alley,� Satarkhan� Ave.,� Tohid� Sq.,� Tehran,� Iran� P.O.Box�

:13185-1678

Facilities� City� &� Country Iran

Web-site� Address cro.farzaninstitute.com

Contact

(Korean�

Business)

Telephone +9821-66439463

E-mail [email protected]

Company� Description� &� Organization

[Mission]

Our� mission� is� to� improve� both� quality� and� quantity� of� clinical� research� by� providing� excellent� research�

services� for� industry� and� investigators.

[Vision]

Our� vision� is� to�be�a�global�partner� in�health� research� services�and�a�pioneer� contract� research�organization�

in� the� region� to� improve� the� human� health.

49. FARZAN Clinical Research

1.� Corporate� General� Information

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50. Garphi Biosciences Pvt. Ltd.

1.� Corporate� General� Information

Corporate� Name Garphi� Biosciences� Pvt.� Ltd.

Corporate� Ownership Private� Company

Head� Office� Address No.4� Banjara� Basera� Road� no� 12,� Banjara� Hills� Hyderabad� ­� 500� 034

Web-site� Address www.garphi.com

No.� of� Employees8� ­� 10� permanent� staff� with� a� wide� network� of� partners,� associates� &�

professionals� across� the� globe

Financial� Status

Sales� Revenue� in� 2012(US� K$)

Capital(US� K$) Dept-equity� Ratio(%)

<� 5� million 500 Debt� free

Contact(Korean�Business)

Name Venkat� Kamalakar� Bundla

Address No.4� Banjara� Basera,� Road� no� 12,� Banjara� Hills� Hyderabad� ­� 500� 034,� India

Telephone +91� 40� 2332� 7046

E-mail [email protected]

Company� History

Garphi�Biosciences�was� founded� in�December�2007�by� industry�veterans�of�different�nationalities.�Over� the�

years� Garphi� has� grown,� offering� a� platform� of�wide� array� of� business� advisory� services� and� cutting� edge�

solutions� for� the� biopharmaceutical� industry.� With� a� cumulative� experience� of� over� 300� years,� the� cross�

functional� team�at�Garphi�comprises�of�experts�&� trail�blazers� in� their� respective� fields�with�proven� industry�

project� management� &� implementation� skills,� ensuring� a� competitive� edge� for� the� clients� by� augmenting�

their� business� development� capabilities,� helping� drive� significant� cost� savings,� delivering� faster� project�

execution� and� fueling� over� all� revenue� growth.

Company� Description� &� Organization

Garphi�Biosciences�Pvt.�Ltd� is�a�multi-disciplinary�pharma�&�biotech�business�advisory�consultancy� rendering�

strategic� consultancy� services� in� facilitation� of� Licensing� In� &� Out,� Tech-Transfer,� facilitation� of� Contract�

R&D,� Clinical� Development,� Drug� Development,� Contract� Manufacturing,� Alliance� Management,� Due�

Diligence,� Collaborative� Initiatives� such� as� setting� up� of� JVs� &� Partnerships,� Mergers� &� Acquisitions,� India�

entry,�Deal� Structuring,�Project�Management,�Divestments,�Growth�Capital,� Investee�Management�&�other�

Business� Advisory� services� etc.

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2.� Corporate� Service� &�Business� Area

Corporate�Main�

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

〇 〇 〇 〇

GeographicalBusiness� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

US 〇 US 〇 US 〇 US 〇Canada 〇 Canada 〇 Canada 〇 Canada 〇EU 〇 EU 〇 EU 〇 EU 〇Asia 〇 Asia 〇 Asia 〇 Asia 〇Global 〇 Global 〇 Global 〇 Global 〇Other 〇 Other 〇 Other 〇 Other 〇

Focusing�Contract

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Research 〇 API 〇APIs 〇

R&D 〇R&D� Strategy&� Management

〇Pre-Clinical 〇Pre-clinicalTest� Sample

Phase� I 〇 Clinical� Trials 〇Phase� II 〇 Clinical� Test

Sample

FinishedProducts

RegulatoryAffairs

Phase� III 〇FinishedProduct

〇Business

Development〇

Phase� IV 〇 Sales� &Marketing

Corporate�Product� Area

New� DrugBiologics

HerbalMedicine

BiosimilarsNCE NME

〇 〇 〇 〇 〇Generics APIs Devices Others

〇 〇 〇 NDDS,�

Neutraceuticals,� OTCs

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3.� Corporate� Business�Overview

Clients'�Composition

(%)

Big� PharmasMid� or� Small-Size� Pharmas

BiotechCompanies

Start-ups

15-20% 50-60% 15-20% 10-20%

General� Overviewof� Corporate's� KeyContract� Services

In-Licensing� ­� Garphi’s� in-licensing� services� are� built� on� a� partnership� concept� that�

develops� a� strong� understanding� between� two� firms.�We� help� companies� of� all� sizes�

identify,� evaluate� and� negotiate� in-licensing� opportunities� on� a� regional� or�worldwide�

basis,� at� every� phase� of� development� from� early-stage� to� market-ready� product� and�

some� real� cutting� edge� technologies.

Out-Licensing� -�Garphi�works�with� companies� to� successfully� out-license� technologies,�

compounds,�and�products�at�all�phases�of�development�and�product� life�cycle.�We�help�

develop� the�out-licensing�strategy�and�provide�guidance� in�maximizing� the�value�of� the�

compounds,� products,� and� technologies.

Contract�Manufacturing� -�Garphi� specializes� in� facilitation�of�outsourcing�your�contract�

manufacturing� needs� for� full� turn-key� projects,� from� clinical� trials� to� commercial�

production,� focusing� on� multiple� capabilities,� complex� processes,� laboratory� services,�

process� and� product� validation� right� through� to� regulatory� support.

Contract� R&D� -�Garphi� offers� consulting� expertise� and�development� resources� to� help�

you� set� the� pace� for� innovation� in� your� chosen� segments� of� Therapy� &� Delivery.� In�

cases,�where� research�capabilities� are� required,�but�not�available�within�your�company,�

we� have� the� ability� to� assist� you� in� the� development� of� these� capabilities� through�

tie-ups� with� third� parties

Clinical� Development� -� Garphi� partners� with� you� to� ensure� a� streamlined� process� to�

execute� and� assist� in� accelerating� your� clinical� trial� projects.� Garphi� provides� a� set� of�

solutions� that�allow�the�clients� to�utilize�globally-enabled� technology� that� leverage� their�

research� assets.� Our� clients� benefit� from� strategies� that� assist� the� flow� of�

business-critical� information� during� the� planning,� start-up� and� execution� of� clinical�

research� studies.�

Alliances,� JVs� &� Collaborations� -� The� initiation� of� a� transaction� is� influenced� by� the�

chosen� goals� and� the� scope� of� the� project� undertaken.� The� outcome� and� time� taken�

for� deal� negotiations� can� vary� widely� depending� on� the� need� of� the� acquirer,� the�

attractiveness� of� the� target� technology,� the� due� diligence� procedure� and� preferences�

for� value� distribution� by� the� parties.� Garphi’s� transaction� experts� use� project� specific�

transaction�processes� to� facilitate� faster� conclusion�of� the�deal�and�also�help�maximize�

value.

Strategy� &� Business� Development� -� Our� consultants� draw� upon� the� proprietary�

knowledge� repository,� industry�networks�and�contacts� to� identify,�analyze,�and�develop�

customized� strategies� for� effective� life� cycle� management,� geographic� expansions,�

newer� launches,� increasing� therapeutic� franchise� &� portfolio� restructuring� amongst�

others.

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Communication�with� Clients

Dispositoion� ofProject� ManagerResponsible

Exponent� assigns� a� project� manager� for� each� project.� However,�

client�has�access� to�all�members�of� the�project� team�on�an�on-going�

basis.

Providing� RealtimeService� Delivery

Exponent� prides� itself� in� both� its� quality� of� product� and� its�

responsiveness� to� client� requests.

RealtimeFeed-back

Exponent� operates� a� customer� satisfaction� program.� Feedback� is�

encouraged� and� solicited� during� the� project� lifecycle.� � Exponent’s�

Client� Services� VP� responds� to� all� client� requests� on� a� 24� hour,�

7-day� a� week� schedule.

4.� Corporate� Competitiveness

CorporateCompetitiveness

Garphi� ensures� a� competitive� edge� for� the� clients� by� augmenting� their� business�

development�capabilities�and�providing�business� support� through�the�entire� life�cycle�

of� business� processes.� In� addition,� Garphi� provides� the� strategic� insights,� strong�

techno-commercial� &� operational� expertise� to� help� speed-up� client� activities� and�

streamline� the�operational�processes.�The�process�expertise�at�Garphi�helps� to�attain�

faster,� quicker,� approvable� projects,� delivering� significant� cost� savings� with� faster�

project� execution� and� fueling� overall� revenue� growth� for� the� clients.� Garphi� thrives�

on� providing�

•� Seamless� Collaboration� to� clients� providing� intensive� dialogue� and� exchange� of�

information� that� is� built� on� clear-cut,� transparent� approach� matched� with�

commitment.

•� “Out�of� the�box”� thinking�combined�with� the�willingness� to� risk� is�an�added�value�

for� the� clients� and� partners.� 90%� of� the� revenues� are� success� fee� based� and�

sometimes� monetized� into� stake/� stock� options.

• More� than� 300� industry� years� of� cumulative� experience,� expertise� and�

competence� in� Pharma,� Biologics� and� medical� devices� coupled� with� unique�

hands� on� consulting� approach

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5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� whichclients� belong� to

Asia,� Europe,� Americas

Asian� Clients'Composition(%)

Big� PharmasMid� or� Small-Size� Pharmas

BiotechCompanies

Start-ups

15-20% 50-60% 15-20% 10-20%

No.� of� Asian� Clientsin� recent� 3� years

40-50

Major� Service� Rangewith�Asian�Companies

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Research 〇 API 〇

APIs 〇

R&D

Pre-Clinical 〇 R&D� Strategy&�Management

〇Pre-clinicalTest� Sample

Phase� I 〇Clinical� Trials 〇

Phase� II 〇 Clinical� TestSample

FinishedProducts

RegulatoryAffairs

Phase� III 〇 BusinessDevelopment

〇FinishedProduct

〇Phase� IV 〇 Sales� &

Marketing〇

6.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

•� Help� Korean� Companies� expand� into� US� &� Europe

•� Forge� alliances� with� European,� American� &� Indian� Companies

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51. Giant Med-Pharma Sercives, Inc.

1.� Corporate� General� Information

Corporate� Name Giant� Med-Pharma� Services,� Inc.

Corporate� Ownership Private� Company

Head� Office� AddressRm.2307,� Tower� 3,� Park� Avenue� International� Apartment,� No.16�

Jianguomenwai� Dajie,� Chaoyang� District,� Beijing� 100022,� China

Facilities� City� &� Country shanghai,� wuhan(CHINA)

Web-site� Address www.giantcro.com�

Contact

(Korean�

Business)

Name -

AddressRm.2307,� Tower� 3,� Park� Avenue� International� Apartment,� No.16�

Jianguomenwai� Dajie,� Chaoyang� District,� Beijing� 100022,� China

Telephone +86� 10� 5128� 1119�

E-mail [email protected]

Company� History

GIANT� CRO� is� a� Full� Service� contract� research� organization,� one� of� leading� CROs� in� China.� It� focuses� on�

providing� efficient� and� cost-effective� services� of� clinical� trial� monitoring� &� management,� regulatory� affairs�

consulting� and� healthcare� industry� research� to� its� clients.�

Founded� in� 2001� by� medical� doctors� and� statisticians,� Giant� is� growing� rapidly� and� steadily� with� its�

head-office� in� Beijing,� branch� office� in� Shanghai,� contact� offices� in� U.S.,� Europe,� Australia� and� Japan.

Company� Description� &� Organization

Giant� is� a� promising� contract� research� organization,� specializing� in� providing� drug� and� healthcare� products�

development� services� to� pharmaceutical,� biotechnology� and� healthcare� industry.�

We� are� technical� professionals� with� experience� of� broad� range� in� providing� expert� consulting� services� to�

health� care� industry� clients.� We� are� highly� qualified� in� regulatory� affairs,� clinical� and� preclinical� studies�

management,� data�management,� scientific� report� generation,� information� research,� technology� assessment,�

and� strategic� planning.�

We� take� pride� in� providing� innovative� resources� and� cost-effective� services.�Working� closely�with� our� clients�

to� understand� their� objectives,� our� project� teams� generate� solutions� tailored� to� address� their� issues� and�

goals.� Our� expertise� in� critical� evaluation� and� organization� of� relevant� research� data� provides� significant�

added� value.� We� are� committed� to� quality,� customized� service,� and� protection� of� client� confidentiality.

Our� CRAs� are� professional,� knowledgeable� and� experienced.� Experience� counts� and� shows-our� CRAs� have�

successfully�monitored� simplified� outpatient� studies� as�well� as� larger� complex� inpatient� studies.� From� Phase�

I� through�Phase� IV,� our�CRAs� bring� in�high-quality,� clean�data�quickly,� to�help�ensure�a� fast�database� close.�

Ongoing� training� ensures� that� our� CRAs� stay� on� top� of� changes� in� global� regulations� and� pharmaceutical�

practices.

The� Regulatory� Affairs� staff� assigned� to� your� dedicated� Project� Team� work� to� ensure� the� successful� and�

timely� submission� of� your� product� application.� We� become� part� of� your� team� from� onset� of� project� to�

completion� meeting� global� regulatory� requirements.� Our� standard� is� strict� adherence� to� regulatory�

requirements� to� facilitate�an�efficient�and�complete�product� submission� to� the�agencies�you� select-anywhere�

in� the� world.

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52. Global Engage Ltd.

1.� Corporate� General� Information

Corporate� Name Global� Engage� Ltd.

Corporate� Ownership Private� Company

Head� Office� Address Innovation� House,� Mill� Street,� Oxford,� Oxfordshire,� United� Kingdom

Web-site� Address http://www.globalengage.co.uk

No.� of� Employees 11

Contact(Korean�Business)

Name Steve� Hambrook

Address Innovation� House,� Mill� Street,� Oxford,� Oxfordshire,� United� Kingdom

Telephone Direct� :� +44(0)� 1865� 811189� or� Cell� :� +44(0)� 7949� 400� 917

E-mail [email protected]

Company� History

Global� Engage�was� formed� in� 2009� as� a� registered�UK� business� and� now�organises� over� fifteen� senior� level�

conferences� throughout� the� world.� Our� client� base� includes� leading� pharmaceutical� companies,� CROs� and�

other� industry� suppliers.�

A� separate�event�management�division�also�manages�events�on�behalf�of� clients,� researching�suitable� venues�

and� dealing� with� all� operational� and� logistical� aspects� of� conference� organisation

Company� Description� &� Organization

Global� Engage� is� an� international� events� company� specialising� in� the� pharmaceutical� industry�with� particular�

focus� in�outsourcing� clinical� trials� and� research�and�discovery.�We� research,�produce,� and�organise� senior� level�

summits� and� congresses� in� countries� such� as� Korea,� China,� United� Kingdom,�Germany,� Czech� Republic� and�

the� USA� bringing� together� leading� pharmaceutical� industry� executives� and� industry� suppliers� to� meet� and�

network� in� a� professional� atmosphere.

More� recently� Global� Engage� has� expanded� it’s� portfolio� of� events� to� include� topics� such� as� Good�

Manufacturing�Practice� (GMP),�Generic�Medicines,�Licensing�and� Intellectual�Property�Protection.�Our�unique�

conferences� offer� an� educational� conference� programme� given� by� leading� industry� experts� with� interactive�

panel�discussions�and� roundtables,�opportunities� to�exhibit�or� sponsor�and�prearranged�one� to�one�meetings�

between� your� company� and� attending� pharma� /� biotech� delegates.

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2.� Corporate� Service� &�Business� Area

Corporate�Main�

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

GeographicalBusiness� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

US US US US

Canada Canada Canada Canada

EU EU EU EU

Asia Asia Asia Asia

Global Global Global Global

Other Other Other Other 〇

3.� Corporate� Business�Overview

Clients'�Composition

(%)

Big� PharmasMid� or� Small-Size� Pharmas

BiotechCompanies

Start-ups

50% 40% 10% -

Focusing�Therapeutic� Area

Oncology,� Cardiovascular

General� Overviewof� Corporate's� KeyContract� Services

Global� Engage� is� a� global� conference� company� specializing� in� summits� and� congresses�

in� the� pharmaceutical� sector.

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4.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� whichclients� belong� to

Korea,� China,� Singapore,� Japan,� Vietnam,� Taiwan� and� India

Asian� Clients'Composition(%)

Big� PharmasMid� or� Small-Size� Pharmas

BiotechCompanies

Start-ups

60% 35% 5% -

5.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

Global�Engage� is�pleased� to�work�with�and�offer� assistance� to�Korean�pharmaceutical�and� supplier� companies�

either� through� our� conferences� or� on� specific� project� management.

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53. GUANGDONG BOHONG MEDICINE CO., LTD

1.� Corporate� General� Information

Corporate� Name GUANGDONG� BOHONG� MEDICINE� CO.,� LTD.

Corporate� Ownership Private� Company

Head� Office� Address 2nd� Floor,� #71� LeJia� Road,� BaiYun� District,� GuangZhou,� 510403,� China.

Web-site� Address www.gdbhyy.com

Contact(Korean�Business)

Name Ms.Lilian� Lo/Ms.Nancy� Zhong/Ms.Melody� Wang

Address 2nd� Floor,� #71� LeJia� Road,� BaiYun� District,� GuangZhou,� 510403,� China.

Telephone 0086-20-86342636/86337043

E-mail

[email protected],

[email protected],�

[email protected]

Company� History

BOHONG�was�established� in� 2002,�which� is�mainly� committed� to� introduction�of�new�pharmaceuticals� from �

abroad�and�exporting�pharmaceuticals� to� the�world,�as�well�as�developing�and�manufacturing�of�new�drugs.�

Our� goal� is� to� set� up� a� bridge� of� pharmaceuticals� between� China� and� the�world,� and� to� provide� affordable�

and� innovative� medicines� to� our� customers.

Company� Description� &� Organization

GUANGDONG� BOHONG�MEDICINE� CO.,� LTD� is� a� GSP� certified� company,� which� is� an� integrated� enterprise�

with�R&D,�manufacturing,�marketing,�distribution,� importation�&�exportation.� The�products� involve� in�Active�

Pharmaceutical� Ingredients,� Pharmaceutical� Intermediates,� Finished� Products,� Herbal� Extracts,� Excipients,�

Medical� Equipments� etc.

BoHong� has� established� an� extensive� relationship� with� a� majority� of� famous� international� pharmaceutical�

manufacturing� companies� and� local� manufacturers.� Currently,� our� marketing� network� covers� most� parts� of�

China,� with� more� than� 6000� sales� terminals,� and� Bohong� acts� as� an� agency� of� oversea� suppliers� with�

distribution�of�more� than�20� imported�APIs,� and�over� 10�products� are�pending� to� IDL� (Import�Drug� License)�

application.

We� have� two� branches,� one� is� JieYang� KangTe� Pharmaceutical� co.,� Ltd.� ,� the� other� is� GuangXi� KeLa�

Pharmaceutical� Technology�Co.,� Ltd.�And�ShanXi�NuoCheng�Pharmaceutical�Co.,�Ltd� is� a� joint� venture�of�our�

company.� Furthermore,� we� are� planning� to� set� up� a� new� API� factory� in� the� near� future.

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54. Guangzhou Boji Clinical Research Center

1.� Corporate� General� Information

Corporate� Name Guangzhou� Boji� Clinical� Research� Center�

Corporate� Ownership Private� Company

Head� Office� Address1707-1708,� Hui� Hua� Ge,� Huabiao� Plaza,� No.609,� Tianhe� Bei� Road,� Guangzhou,�

Guangdong� 510635,� China

Facilities� City� &� Country beijing(CHINA)

Web-site� Address www.gzboji.com

Contact(Korean�Business)

Name Mr.� Wang�

Address1707-1708,� Hui� Hua� Ge,� Huabiao� Plaza,� No.609,� Tianhe� Bei� Road,� Guangzhou,�

Guangdong� 510635,� China

Telephone +86� 20� 3847� 3208;� 3847� 3209�

E-mail [email protected];� [email protected]

Company� History

Guangzhou�Boji�Medical�Biotechnological�Co.,� Ltd.� is� a�high-tech�enterprise�providing�new�drug� research�and�

development� outsourcing� services.� Boji� is� a� leading� Contract� Research� Organization� (CRO)� in� China.� Our�

services� include� Pre-clinical� Study,� Clinical� Trial� (PhaseⅠ~Ⅳ),� Drug� Import� Registration,� In/out� license� and�

Technique� transfer� and� so� on.

Our� company� headquarters� in� Guangzhou.� We� have� 2� subsidiaries� in� Beijing� and� Shanghai� and� 25� offices�

around�China.�Our�pre-clinical� laboratory� (3200�m2)� is� in�Guangzhou�Science�Town.�Our� research� center� for�

Phase� I� clinical� trial�has�been� founded� in�2009,�which�was� certified�by�CFDA� in�China.�We�have�approx.�368�

employees,� in�which� there� are� 4� Post�doctorates,� 12� PhDs’�&�MBAs,� 66�Master�degrees� and�178�Graduates.�

Boji� has� been� started� in� 1998� and�officially� established� in� 2002.�We�have� serviced�up� to� 250� enterprises� for�

more� than� 700� projects.� Our� range� of� researches� relate� to� the� professional� fields� of� cardiovascular� system,�

oncology,�digestive�system,� respiratory� system,�urology,�neurology,� endocrinology,�psychiatry,�ophthalmology,�

otorhinolaryngology,� dermatology� etc.

Company� Description� &� Organization

The� center� is� specialized� in� clinical� research� organizations� and�preclinical� research,� offering� full� service� Phase�

I-IV� clinical� trials.� It� is� one� of� earliest� CRO� in� China,� which� is� a� subsidiary� of� Boji� Medicinal� Service� Group.�

It� has� 89� professional� technicians.� From� 1998,� it� has� successfully� conducted� about� 300� clinical� trials.

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Corporate� Name GVK� BIOSCIENCES� PVT.� LTD.

Corporate� Ownership Private� Company

Head� Office� Address GVK� Biosciences� Pvt.� Ltd.,� Plot� No.� 28� A,� IDA� Nacharam

Facilities� City� &� Country Hyderabad(India-� 500076)

Web-site� Address www.gvkbio.com

No.� of� Employees Over� 2000

Contact(Korean�Business)

Name Piyush� Chahar

AddressGVK� Biosciences� Pvt.� Ltd.,� Plot� No.� 28� A,� IDA� Nacharam,� Hyderabad,� India-�

500076

Telephone Mob-� +91-9550055544

E-mail [email protected]� /� [email protected]

Company� History

Founded� in� 2001,�GVK� Bio� is� supported� by� one� of� the� India’s� largest� business� houses,� the�GVK�Group�with�

Mr.� D.S.� Brar� as� Chairman� and� Mr.� G.V.� Sanjay� Reddy� serves� as� the� Vice� Chairman.�

Over� the� past� decade�we� have� added� varied� services� to� our� portfolio� of� offerings,� taking� into� consideration�

the� needs� of� our� diverse� client� base.� This� philosophy,� backed� by� client� delight,� has� helped� us� build� and�

consolidate� a� growing� client� base� in� the� life� sciences� industry.

GVK� Bio� enables� its� clients� to� address� their� drug� development� challenges� with� an� effective� combination� of�

science,� innovation� and� people.� Most� of� our� customers� are� repeat� customers� and� have� been� working� with�

us� for� almost� 8-9� years.

Company� Description� &� Organization

GVK� Biosciences� (GVK� BIO)� is� a� global� Contract� Research� Organization� (CRO)� and� a� preferred� partner� of�

choice� to�major� Pharma� and�Biotech� companies.� Spread� across� five� locations� in� India� and�head-quartered� in�

Hyderabad,� GVK� BIO� provides� its� customers� with� a� range� of� Collaborative/Integrated� services� (combined�

across� Analytical� Services,� Biology� Services,� Chemistry� Services,� Clinical� Pharmacology,� Clinical� Research,�

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55. GVK BIOSCIENCES PVT. LTD.

1.� Corporate� General� Information

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Informatics� and� Process� R&D�and�Contract�Manufacturing)�with� flexible� business�models� to� suit� client� needs�

at� various� levels.� Best-in-class� science� and� innovation� ably� supported� by� state-of-the-art� infrastructure� have�

helped� GVK� BIO� significantly� accelerate� research� decisions� for� its� clients.

GVK� BIO� works� with� a� large� and� diverse� set� of� customers� from� leading� pharmaceutical� companies,�

biotechnology�organizations,� and�virtual� companies� to� research� institutions�&�universities� throughout� the�R&D�

value� chain.

Our� scientists� possess� outstanding� academic� credentials,� immense� capabilities� and� problem� solving� skills�

backed� by� years� of� global� and� industry� experience.�We� attract,� retain� and�motivate� our� employees� through�

various� employee� engagement,� learning� &� development� initiatives.� GVK� BIO� employs� over� 2000� people.�

We�at�GVK�BIO� fully� comprehend� the� importance�of� safeguarding� the�clients� Intellectual�Property.�We�ensure�

that�our� client’s� interests�are�protected� through�our�water� tight� systems�encompassing�people,�processes,�and�

policies.� Our� clients� trust� us� completely� with� their� proprietary� information.�

GVK� BIO� operates� on� the� following� business� models:�

-� Full� Time� Equivalent� (FTE)

-� Fee� For� Service� (FFS)

-� Risk� Sharing

-� Milestone� Based

-� Integrated� Services

부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 279

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2.� Corporate� Service� &�Business� Area

Corporate�Main�

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

○ ○

GeographicalBusiness� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

US ○ US ○ US US

Canada ○ Canada ○ Canada Canada

EU ○ EU ○ EU EU

Asia ○ Asia ○ Asia Asia

Global ○ Global ○ Global Global

Other Other Other Other

Focusing�Contract

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Research ○ API ○

APIs

R&D

Pre-Clinical ○Pre-clinicalTest� Sample

R&D� Strategy&� Management

Phase� I * Clinical� Trials

Phase� II ○Clinical� TestSample

FinishedProducts

RegulatoryAffairs

Phase� III ○FinishedProduct

BusinessDevelopment

Phase� IV ○Sales� &Marketing

Corporate�Product� Area

New� DrugBiologics

HerbalMedicine

BiosimilarsNCE NME

Generics APIs Devices Others

* can take it up, if the NCE is discovered in India. For others we can assist through our partners.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 281

3.� Corporate� Business�Overview

Clients'�Composition

GVK� BIO� enjoys� a� client� base� from� the� world’s� largest� pharmaceutical,� biotechnology,�

agri-bio,� cosmetics,� fine� chemicals,� and� electronic� chemicals� companies� and� leading�

academic� &� research� institutions� to� small� and� start-up� organizations.

In-house� Facilities

Research� &Development

Preclinical ClinicalCustom

ManufacturingCustom� Sales

○ ○ ○ ○

Focusing�Therapeutic� Area

Pain,� Inflammation,� Cardiovascular,� CNS,� Oncology,� and� Metabolic� Diseases

General� Overviewof� Corporate's� KeyContract� Services

1.� Analytical� Services-� from� Discovery� to� Commercial� Phase� III

2.� Biology� Services-� Integrated� and� Standalone� full� services

3.� Chemistry� Services-� Organic/� Medicinal� Chemistry,� Libraries,� Parallel� Chemistry

4.� Clinical� Pharmacology-� Large� centres� compliant� with� global� regulatory� requirements

5.� Clinical� Research� Services-� Integrated� or� Standalone� full� service� contract� research�

support� for� Phase� II� to� Phase� IV� clinical� trials

6.� Informatics� Services-� Bio� and� Chemo-informatics,� Custom� Services,� Databases�

7.� Process� R&D� and� Contract�Manufacturing� Services-� Quality,� cost-effective� and� timely�

delivery� for� Process� � Research� and� Contract� Manufacturing�

Collaborative� Research-� Preferred� partners-� sharing� risks� and� rewards,� generating� IP�

without� conflict

Contract� Service�Capacity� Affordable�by� Service� Area

-� Analytical� Services-� SFC� (3)� upto� 500� g/wk,� Preparative� LC� (12)� 50� gms/day,� Flash�

Chromatography� (8)� 50� gms/day,� MPLC� (2)� 30� gms/day

-� Biology� Services-� 13,000� sq� ft� lab� area� with� over� 100� experienced� scientists.

-� HTS� Services-� can� screen� upto� 3000� compounds� a� day.

-� Chemistry� Services-� synthesis� of� 600-700� compounds� per� month� by� PMC,� can� purify�

and� characterize� upto� 20,000� compounds� annually� by� HTS,�

-� Isotope�Labeling-�AERB�Certified,�1000�sq.� ft.,�GLP�Compliant� lab,� can�undergo� isotope�

labeling� using� Deuterium� (2H),Tritium(3H),13Cand14Cstableisotopes.

-� Clinical� Pharmacology� Services-� supports� Generic� and� NCE� Drug� Development,�

conducting� Bioequivalence/Bioavailability/Phase� I� studies.� Have� completed� 1000+�

studies� for� global� regulatory� submissions.

-� Clinical� Research� Services-� experienced� in� pain� management,� urology,� vaccines,� bone�

disease,� CV,� dermatology,� endocrinology,� GI,� gynaecology,� dermatology,� oncology,�

infectious� diseases,� musculoskeletal� and� ophthalmology� studies.

-� Informatics� Services-� Over� 500� scientists,� GOSTAR� (largest� manually� curated� SAR�

database,� 13�mn� SAR� data� points� and� 5.6� mn� unique� structures),� GOBIOM�&� CTOD�

Database.�

-� Process�R&D�and�Contract�Manufacturing�Services-�cGMP�manufacturing,� total� reaction�

volume� of� 1,18,000� L,� CMC� support,� KFDA,� PMDA,� and� WHO� audited.

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Communication�with� Clients

Dispositoion� ofProject� ManagerResponsible

•Single� point� contact� for� a� project� being� executed

•Details� of� the� project� known� to� the� respective� Project�

Managers� only

•Restricted� computer� access� (incl.� USB� drives)-� 21� CFR�

compliant� IT� systems

•Experiments� are� recorded�by� chemists� in� dedicated� Lab� books,�

ultimately� shipped� to� the� clients�

•Project� managers� visiting� Client� sites

•Weekly� reports� and� final� reports� ­� standard� or� customized�

formats

•CDA� signed� with� each� employee

•‘Review� of� Performance� Matrices’� unique� to� GVK� Bio-�

� � -� Number� of� steps/chemist� /� quarter� or� month

� � -� Number� of� Compounds� shipped,� Quality� and� Quantity� of�

Deliverable

Providing� RealtimeService� Delivery

GVK�BIO� follows� a� standard� format� for� reporting/�measuring� the�

project.� We� measure� both� productivity� and� quality� of� our�

projects� on� weekly� basis.� We� also� hold� bimonthly�

teleconferences�with� the� client� so� that� the� client� can�understand�

the� status� of� the� project.� We� take� into� consideration� client�

feedback,� project� status� and� review� the� performance� metrics�

while� reporting� to� the� client.

However,� at� GVK� BIO� we� are� open� to� any� particular� format� in�

which� the� customer� expects� the� reporting/� measurement.

RealtimeFeed-back

•Data� transfer� through� e-room,� FTP� or� SFTP�

•Ease� in� feedback� and� tracking�due� to� dedicated� team� for� each�

project

•Online,� real-time� engagement�management� systems� for� clients

•Monitoring� compound� delivery� within� promised� timelines

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 283

4.� Corporate� Competitiveness

CorporateCompetitiveness

GVK�BIO�does�not�have�any� in�house�proprietary� research�and�development.�We�give�

utmost� priority� to� maintaining� client� confidentiality� and� the� Project� in� Charge� will�

enforce� stringent� confidentiality� protection� procedures.� As� part� of� our� current�

corporate�practices,�we�have�all� scientists�and� support� staff�working�on�collaboration;�

sign�a�Non�­�Disclosure�Agreement� (NDA)�with� the� company.�We�emphasize�on�hiring�

and�retention� thereby�maintaining�a� low�employee� turnover.�Besides�we�are�also�a� full�

service� CRO� and� offer� complete� spectrum� from� discovery� to� development� and� mg�

scale� to� tons.� Our� effective� project� management� is� one� of� our� important� features� in�

contrast� to�other� service�providers.�We�have�some�of� the�best�practices�of� the� industry�

which� coupled�with� knowledge� resource� forms� our� strength� and� gives� us� advantage�

over� other� providers.

Current� Status� ofAccredited�Certification

KFDA� Audited/� GLP/� GMP/� ISO� 9001-2008/� AAALAC/� CPCSEA/� IBSC/� OLAW� (PHS)/�

PMDA/� AERB/� MHRA/� ANVISA/� AFSSAPS/USFDA/� DCGI/� NABL/� MOH-� Turkey

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� whichclients� belong� to

South� Korea,� India,� Taiwan,� Thailand,� Israel,� Japan,� and� Singapore� etc.

No.� of� Asian� Clientsin� recent� 3� years

Over� 50� Asian� Clients

Major� Service� Rangewith�Asian�Companies

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Research ○ API ○

APIs

R&D

Pre-Clinical ○ Pre-clinicalTest� Sample

R&D� Strategy&�Management

Phase� I * Clinical� Trials

Phase� II ○Clinical� TestSample

FinishedProducts

RegulatoryAffairs

Phase� III ○FinishedProduct

BusinessDevelopment

Phase� IV ○Sales� &Marketing

* For Indian studies we can take it up, if the NCE is discovered in India. For others we can assist through our partners.

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6.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

•Burgeoning� R&D� costs,� risks� related� to� discovery� and� development,� and� advantage� in� reduced� cycle� times�

have�made� outsourcing� in� pharma� R&D� the� need� of� the� hour.� This� is� where� GVK� BIO� steps� in.�We� have�

skillfully� forward�and�upward� integrated�our�service�portfolio,� in� sync�with� the�changing�Pharma�&�biotech�

environment.�

•As�a�purely� service�oriented� company�we�do�not�pursue�any� internal/proprietary� research�programmes� thus�

we� do� not� pose� any� conflict� over� your� IP.

•Our� Contract� Manufacturing� facility� has� recently� been� audited� by� Korean� Food� and� Drug� Administration�

(KFDA).�

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 285

56. Harlan Korea Laboratories, Ltd.

1.� Corporate� General� Information

Corporate� Name Harlan� Korea� Laboratories,� Ltd.

Corporate� Ownership Private� Company� -� Genstar,� Public� Company� -� Harlan� Laboratories

Head� Office� AddressHarlan� Laboratories,� Inc.� 8520� Allison� Pointe� Blvd.,� Suite� 400,� Indianapolis,� IN �

46250

Facilities� City� &� CountryIndianapolis� -� US,� Itingen� -� Swiss,� Barcelona� -� Spain,� Frankfurt� -� Germany,� Derby�

-� UK

Korean� Business� OfficeHarlan� Korea� Laboratories,� Ltd.� 30thfloor,� ASEMtower� 159-1,� Samsung-dong,�

Kangnam-Gu,� Seoul,� 135-798

Web-site� Address http://www.harlan.com

No.� of� Employees Over� 3,500

Financial� Status

Sales� Revenue� in� 2010(US�K$)

Capital(US� K$) Dept-equity� Ratio(%)

600� Billion� USD� - -

Contact(Korean�Business)

Name 송승우

Address 서울특별시 강남구 삼성동 아셈타워 30층 Harlan� Korea

Telephone +82-2-6001-3092

E-mail [email protected]

Company� History

1981년:� 52명의 규모로 런칭.�

1987년:� Pharmaceutical,� Agrochemical,� Industrial� Chemicals� and� Food� Addictives� 분야에 RCC� (Registration�

and� Consulting� Company)� Ltd,� 는 이름의 회사를 건립.

1989년:� 로슈가 운영하던 BRL� (Biological� Research� Laboratories)� Ltd.을 인수.

2002년:� RCC� 본사가 Swiss� Itingen에 설립.

2005년:� 스페인 CIDAL� (Monkey� study� Lab)� 합병.

2007년:� 영국 CRO� Safepharm� 합병

2008년:� 미국 Harlan� 사와 합병하여 브랜드 명 Harlan� Laboratories.로 통합

2009년:� Harlan� Laboratories,.� 한국 현지 법인 설립.

Harlan� Korea� Laboratories� :� 2005� 년 현지 법인 설립 후,� 한국에서의 10년 경험보유.

Company� Description� &� Organization

Harlan� is� a� leading� provider� of� essential,� pre-clinical� and� non-clinical� contract� research,� research�models,� lab�

animal� diets,� and� services.� Our� focus� is� on� providing� customers� with� products� and� services� to� optimize� the�

discovery� and� safety� of� new� medicines� and� compounds.� Harlan� Laboratories� is� in� 12� countries� with� over�

3,500� employees

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2.� Corporate� Service� &�Business� Area

Corporate�Main�

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

GeographicalBusiness� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

US US US US ○

Canada Canada Canada Canada

EU EU EU EU ○

Asia Asia Asia Asia ○

Global ○ Global Global Global

Other Other Other Other

Focusing�Contract

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Research API

APIs

R&D

Pre-Clinical ○Pre-clinicalTest� Sample

R&D� Strategy&� Management

Phase� I Clinical� Trials ○

Phase� IIClinical� TestSample

FinishedProducts

RegulatoryAffairs

Phase� IIIFinishedProduct

BusinessDevelopment

Phase� IVSales� &Marketing

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 287

3.� Corporate� Business�Overview

Clients'�Composition

(%)

Big� PharmasMid� or� Small-Size� Pharmas

BiotechCompanies

Start-ups

50% 30% 20%

In-house� Facilities

Research� &Development

Preclinical ClinicalCustom

ManufacturingCustom� Sales

Focusing�Therapeutic� Area

Oncology,� Inhalation,� high� quality� of� Histopathology-techniques,� Bio-molecule

General� Overviewof� Corporate's� KeyContract� Services

할란 레이버 토리스는 70년 경험을 바탕으로 세계 각국에 Lab� Facility를 보유하고 있으며,�세계

수준의 GLP�인증 기관으로서,�숙련된 Study�Director�와 다양한 경험을 바탕으로 한 노하우를 통

해 최고 수준의 실험 동물 Service� 및 동물 독성 시험 Service� 를 제공하고 있습니다.

Contract� Service�Capacity� Affordable�by� Service� Area

▶� Pharma� /� Agrochemical� /� Industrial� 의 모든 시험 가능.

▶� Capacity

� � � -� Housing� capacity� of� NHP(Monkeys)� :� 300� Animal.�

� � � -� Housing� capacity� of� Dogs� :� 900� Animal.

� � � -� 6� Carcinogenicity� study� can� be� conducted� in� same� time.

Communication�with� Clients

Dispositoion� ofProject� ManagerResponsible

▶� Dr.� Paolo� Marinelli� (Project� Manager)

� :� 18� years� in� Serono� (Tox� team� leader)� /� more� than� 30� years�

experience

▶� Prof.� Rüdiger� Häcker� (Dr.� med.)

� :� Regulation� Affair� /� Consulting,� over� 40� years� experience.

Providing� RealtimeService� Delivery

▶� Harlan� Korea에 의한 프로젝트 관리 (communication)� � .� �

� :�Agent가�아닌 현지 법인 (Harlan�Korea)이 국내에서 follow� -�up�본사

의 PM과 끊임없는 당일 communication.

▶� 2009년부터 스위스 현지에 상주하는 한국인 직원

� :�Sponsor�에서 Harlan�본사 방문 시,�보다 편리한 inspection�가능,�한국

프로젝트들에 대한 지속적인 관심의 표현

RealtimeFeed-back

본사의 Location� 이 EU� (7~8�시간 차)�에 위치해 있어,�당일 response� /�

communication� 가능.

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4.� Corporate� Competitiveness

CorporateCompetitiveness

-� 30� 여년에 걸친 다양한 molecular에 대한 풍부한 경험

-� 현재 국내에서 가장 많은 프로젝트에 대한 경험

-�한국 담당 PM� (Project�Manager)의 프로젝트 관리 :� PM은 전임상 프로젝트의 quotation�

단계부터 involve되어 물질에 따라,�적용증에 따라,� target� 국가에 따라 알맞은 전임상시험

design에 해당하는 quotation�항목 작성.�이후,� IND� /� IMPD�작성 후,�submission까지 다양

한 분야에서 discussion� 가능

-� Back� data가� 풍부한 실험 동물 자체 공급

-� 전임상의 tox� 시험 뿐만 아니라,� 전임상을 진행하는데 필요한 consulting� 협조

-� 미국/유럽 임상 1상을 내부 계열사 (PRA� International)를 통한 빠른 연계

No.� of� RegulatoryInspections

Classification FDA(US) EMA(EU) PMDA(Japan) Others

Pre-Clinical� Area ◯ ◯

Clinical� Area

Manufacturing� Area

Others

Current� Status� ofAccredited�Certification

GLP� /� GMP� /� ISO� /� AAALAC

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 289

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� whichclients� belong� to

Korea� /� Japan� /� India

Asian� Clients'Composition(%)

Big� PharmasMid� or� Small-Size� Pharmas

BiotechCompanies

Start-ups

70% 20% 10% -

No.� of� Asian� Clientsin� recent� 3� years

50� company

Major� Service� Rangewith�Asian�Companies

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Research API

APIs

R&D ◌

Pre-Clinical ◯Pre-clinicalTest� Sample

R&D� Strategy&�Management

Phase� I ◯ Clinical� Trials ◌

Phase� IIClinical� TestSample

FinishedProducts

RegulatoryAffairs

Phase� III

FinishedProduct

BusinessDevelopment

Phase� IVSales� &Marketing

6.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

미국/유럽 임상 1상을 내부 계열사 (PRA� International)를 통한 빠른 연계

-� 짧은 시간 (IND� reviewing� period)� 안에 유럽 에서 임상 가능.

-� 전임상 시험의 result� 가� 나오는 시점에서부터,� Clinical� study� 논의 가능.

-� 현재 국내 3� project� 가� Harlan� /� PRA� 를 통해 전임상 /� 임상이 단계별로 진행 중.

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290� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

57. HCM Enterprise LLC

1.� Corporate� General� Information

Corporate� Name HCM� Enterprise� LLC

Corporate� Ownership Private� Company

Head� Office� Address 63� Woodside� Ln,� New� Hope,� PA� 18938

No.� of� Employees 20

Contact(Korean�Business)

Name Jinna� Kim

Address 63� Woodside� Ln,� New� Hope,� PA� 18938

Telephone 347-479-5542

E-mail [email protected]

Company� History

HCM� is� a� young� company�with� focuses� to� commercialize� pharmaceutical� and�diagnostic� products� in� the�US.� �

Our� leadership� team�has�extensive�and�diverse�experiences� in� the�healthcare�market;�our�expertise�covers� FDA�

regulatory� evaluation� &� filing,� sales� &� marketing,� reimbursement,� and� distribution.

Company� Description� &� Organization

HCM�Helps�Establish�and�Grow�Commercial�Capabilities� in� the�drug�business� in� the�US�and�across� the�globe.

•Business/brand� plan� development

� � ­Market� situation� analysis,� strategic� planning,� and� business� plan� development� and� budgeting

•Distribution� and� Sales� execution

� � ­With�our�extensive� connections�with� the�major�distributors�and� sales�experiences�with� large�accounts,�we�

can� help� your� products� break� into� the� distribution� channel�

•Temporary� staffing� your� marketing� and� sales� positions�

� � ­HCM’s� experienced� staff� fill� your� positions� to� ensure� quick� starting� and� business� continuity

•Business� development� needs

� ­Licensing,� JV,� M&A,� cross� border� transaction,� and� negotiation

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 291

2.� Corporate� Service� &�Business� Area

Corporate�Main�

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

〇 〇

GeographicalBusiness� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

US US US 〇 US

Canada Canada Canada 〇 Canada

EU EU EU EU

Asia Asia Asia Asia

Global Global Global Global 〇Other Other Other Other

Focusing�Contract

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Research API

APIs

R&D

Pre-ClinicalPre-clinicalTest� Sample

R&D� Strategy&� Management

Phase� I Clinical� Trials

Phase� IIClinical� TestSample

FinishedProducts

RegulatoryAffairs

Phase� IIIFinishedProduct

BusinessDevelopment

Phase� IVSales� &Marketing

Corporate�Product� Area

New� DrugBiologics

HerbalMedicine

BiosimilarsNCE NME

〇 〇 〇 〇 〇Generics APIs Devices Others

〇 〇

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292� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

3.� Corporate� Business�Overview

In-house� Facilities

Research� &Development

Preclinical ClinicalCustom

ManufacturingCustom� Sales

Focusing�Therapeutic� Area

•CNS� � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � •Oncology

•Central� Nervous� System� � � � � � � � � � � � � � � � � •Dermatology

•Endocrinology� � � � � � � � � � � � � � � � � � � � � � � � � � � •OC� Markets

•Gastroenterology� � � � � � � � � � � � � � � � � � � � � � � � •Cardiovascular

•Ophthalmology� � � � � � � � � � � � � � � � � � � � � � � � � � •Pediatrics

•Podiatry� � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � •Respiratory

•HIV� � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � •Infectious� Disease

•Pain� Medications� � � � � � � � � � � � � � � � � � � � � � � � •Women’s� Health

General� Overviewof� Corporate's� KeyContract� Services

•Business/brand� plan� development

� ­Market� situation� analysis,� strategic� planning,� and� business� plan� development� and�

budgeting

•Distribution� and� Sales� execution

� ­With�our�extensive� connections�with� the�major�distributors�and� sales�experiences�with�

large� accounts,� we� can� help� your� products� break� into� the� distribution� channel�

•Temporary� staffing� your� marketing� and� sales� positions�

� ­HCM’s� experienced� staff� fill� your� positions� to� ensure� quick� starting� and� business�

continuity

•Business� development� needs

� ­Licensing,� JV,� M&A,� cross� border� transaction,� and� negotiation

4.� Corporate� Competitiveness

CorporateCompetitiveness

Our� Commercial� Team� bring

•A� proven� and� successful� strategic� approach

•Unparalleled� expertise� of� sales,� marketing� and� account� managing� experiences

� � ­Our� Team� has� successfully� commercialized� Over� 50� Pharmaceutical� Products

•Each� member� has� 15+� years� of� hands� on� experiences� in� selling,� marketing� and�

distributing� pharmaceutical� and� diagnostic� products

� � ­Relationships� and� Access� to� Key� Decision� Makers

•Fully� Dedicated� National� Account� team� Committed� to� your� Company’s� Success

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 293

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Major� Service� Rangewith�Asian�Companies

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Research API

APIs

R&D

Pre-ClinicalPre-clinicalTest� Sample

R&D� Strategy&�Management

Phase� I Clinical� Trials

Phase� IIClinical� TestSample

FinishedProducts

RegulatoryAffairs

Phase� III

FinishedProduct

BusinessDevelopment

Phase� IVSales� &Marketing

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294� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name HD� Biosciences� (China)� Co.,� Ltd.�

Corporate� Ownership Private� Company

Head� Office� Address590� Ruiqing� Road,� Zhangjiang�High-tech� Park� East� Campus,� Pudong,� Shanghai�

201201,� P.R.� China

Facilities� City� &� Country Shanghai(CHINA)

Web-site� Address http://www.hdbiosciences.com

No.� of� Employees Total� 250� employees� and� the� number� is� growing

Financial� Status

Sales� Revenue� in� 2012(US� K$)

Capital(US� K$) Dept-equity� Ratio(%)

15,000 14,000 9

Contact(Korean�Business)

Name 유켐(U� Chem)� /� David� Kwon(HoYoung,� Kwon)

Address 경기도 안양시 동안구 시민대로 277,� 1502

Telephone 070-8718-1830

E-mail [email protected],� [email protected]

Company� History

HD�Biosciences� (HDB)�was�established� in�2002�as�a�drug�discovery� company�devoted� to�discovery�of�novel�

drug� candidate� from� Chinese� traditional� medicine� (TCM).� In� 2005,� the� company� transformed� into� a� CRO�

company� providing� full� line� of� preclinical� drug� discovery� services.� In� 2006,� HDB� signed� the� first� biology�

service� contract� in� China� with� Organon� International.� In� the� next� years,� HDB� started� collaborations� with�

Pfizer,� Johnson&Johnson,� Roche,� etc.� In� 2008,� the� company�was� awarded� “Top� Research� Service� Partner”�

by�Pfizer.� Till� today,� eight� out�of� ten� big� pharmaceutical� companies�having� collaborations�with�HDB,� so�as�

many� other� mid-sized� pharmaceutical� and� biotech� companies� and� small� start-up� companies� around� the�

world.� HDB� has� been� recognized� as� one� of� the� leading� biology-focused� CRO� company� by� global�

pharmaceutical� industry.� The� company� ranks� No.� 12� in� 2011� Deloitte� technology� fast� 50� China.

58. HD Biosciences (China) Co., Ltd.

1.� Corporate� General� Information

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 295

Company� Description� &� Organization

HD�Biosciences� (HDB)� is�a� Shanghai-based�and�biology� focused�preclinical�drug�discovery�contract� research�

organization.� The� company� offers� comprehensive� technology� platforms� and� expertise� around� target�

validation,� hit� to� lead� and� lead� discovery� in� preclinical� drug� discovery� and� development,� which� includes�

biology� assays/assay� development,� compound� profiling,� high� throughput� screening,� therapeutic� antibody�

discovery,� medicinal� chemistry,� DMPK,� in� vivo� pharmacology,� drug� efficacy� and� safety,� as� well� as� natural�

product� based� lead� compound� discovery.� The� company� currently� collaborates� with� eight� out� of� ten� big�

pharmaceutical� companies,� and� is� strategic� partner� for� several� major� pharmaceutical� clients� in� hit�

identification/HTS,� target� validation� and� therapeutic� antibody� discovery.� The� strong� expertise� and� high�

quality� deliveries� have� earned� the� company� a�great� reputation� in� the� industry� and�helped� the� company� to�

build� its� widely� recognized� leadership� in� contract� research� services.

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2.� Corporate� Service� &�Business� Area

Corporate�Main�

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

GeographicalBusiness� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

US 〇 US US US

Canada 〇 Canada Canada Canada

EU 〇 EU EU EU

Asia 〇 Asia Asia Asia

Global 〇 Global Global Global

Other 〇 Other Other Other

Focusing�Contract

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Research 〇 API

APIs

R&D

Pre-Clinical 〇Pre-clinicalTest� Sample

R&D� Strategy&� Management

Phase� I Clinical� Trials

Phase� IIClinical� TestSample

Phase� IIIFinishedProduct

Phase� IV

Corporate�Product� Area

New� DrugBiologics

HerbalMedicine

BiosimilarsNCE NME

Generics APIs Devices Others

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 297

3.� Corporate� Business�Overview

Clients'�Composition(%)

Big� PharmasMid� or� Small-size�

PharmasBiotechCompanies

Start-ups

60 25 10 5

In-house� Facilities

Research� &Development

Preclinical ClinicalCustom

ManufacturingCustom� Sales

〇 〇

General� Overviewof� Corporate's� KeyContract� Services

The� company� offers� comprehensive� technology� platforms� and� expertise� around�Hit� to�

Lead�and�Lead�Discovery� in�preclinical�drug�discovery�and�development,�which� includes�

target� validation,� plate-based� pharmacology� (biology� assays/assay� development,�

compound� profiling,� HTS/SAR� screening),� DMPKT/Bioanalysis,� in� vivo� pharmacology,�

drug� efficacy� and� safety,� medicinal� chemistry� and� natural� product� based� lead�

compound� discovery.

The� following� service� areas� are� HDB’s� core� competences-

ØTarget�Discovery:�HDB�has�built�up�strong�platform�for� target�validation�with�support�

of� advanced� gene� manipulation� technologies� for� both� in� vitro� and� in� vivo� target�

validation,� target� engagement� and� MOA� studies.� The� company� currently� has�

collaborations� with� multiple� pharmaceutical� clients� on� FTE� structure� to� provide�

focused� and� knowledge-based� services;� and� therefore� assists� our� clients� in� their�

decision� for� go� or� no� go� on� target� of� their� interest.�

ØPlate-based� pharmacology:� HDB� has� set� up� the� most� comprehensive� assays� &�

screening� platform.� Assay� formats� are� much� diversified,� including� biochemical,�

cellular,� radiometric,� LC/MS,� multiplex� and� high� content� assays� for� various�

therapeutic� targets� like� GPRs,� NHRs,� enzymes,� transporters,� ion� channels,� etc� with�

panels� of� phenotypic� and� functional� assays� using� primary� cells� and� tissues� in�

supporting� compound� evaluations� and� MOA� studies.� The� company� averagely�

delivered� ~200� assays� each� year� to� our� clients� in� last� three� years�with� large� percent�

of� de� novo� assay� development� and� a� small� portion� of� assay� transfer� from� client� to�

support� HTS/SAR� screening.� HDB� is� designated� partner� for� one� of� big� pharma’s�

HitID/HTS� center.� With� full� setup� of� infrastructure� from� compound� management,�

assay� execution� to� data� processing,� HDB� provides� the� most� high� quality� services� in�

HTS/SAR� screening.�

ØTherapeutic� antibody� discovery:� HDB� antibody� discovery� program� is� based� on�phage�

display� technology� and� has� built� diversified� phage� libraries� to� support� client’s�

antibody� discovery� effort.� The� company� is� the� first� CRO� company� in� China� that�

formed� strategic� partnership� with� major� pharmas� in� novel� therapeutic� antibody�

discovery.�

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General� Overviewof� Corporate's� KeyContract� Services

ØLead� discovery� for� infectious� disease:� HDB� is� one� of� the� only� CRO� that� owns� both�

PL2/PL3� in� vitro� labs� and� PL2-animal� facility� in� supporting� our� clients’� integrated�

anti-infective�drug�discoveries.�The�company�provides� services� in�varieties�of� anti-viral�

and�anti-bacterial�assays,�plus� target� validation,�HTS� for�hit� identification� to�SAR� lead�

optimization� in� both� target-based� and� cell-based� setup.�We� also� offer� anti-infective�

MOA� research� services,� drug� resistance� studies,� compound� profiling� etc.� The� clients�

could� access� our� viral,� bacterial� strain� banks� that� include� standard� lab� adapted� virus�

and� bacterial� strains,� clinical� isolates,� ATCC� QC� strains,� as� well� as� clinical� drug�

resistant� strains.� All� Stains� are� well� characterized� with� quality� control� records.�

ØAdvanced� gene� manipulation� (AGMTM):� Advanced� Gene� Manipulation� (AGM™)�

technology� and� platform� provide� comprehensive� solutions� to� our� clients� for� their�

gene�manipulations� of� knock-down,� knock-out,� knock-in� and� over-expression,� so� to�

understand� the� gene� of� interest� in� functional� impact� and� mechanism� of� actions.�

Various� types� of� genetic� manipulation� including� AAVs-based� vectors,� proprietary�

genome�editing,�and� transgenic� technology�offer�cell�models�and�animal�models�with�

region� specific,� tissue� specific� and� cell� type� specific,� in� supporting� target� discovery�

and� target�engagement� in� the�context�of�diseases�and� the� impact�of�drug� treatment.�

Integration� of� AGM™� with� in� vitro,� in� vivo� pharmacology,� biomarkers,� and�

bioinformatics� enables� HDB� to� grow� into� a� leader� in� the� services� around� target�

discovery,� validation,� translational� sciences� and� lead� discoveries.�

Contract� Service�Capacity� Affordable�by� Service� Area

HDB�currently�has� sufficient�capacity� to�accommodate�more�projects� from�clients.� Last�

year,� the� company� set�up� a� second� facility� and� there� is� still� plenty� of� space� remaining�

for� expansion.� The� company� is� continuing� recruiting� new� talents� and� enhancing� the�

infrastructure.

Communication�with� Clients

Dispositoion� ofProject� ManagerResponsible

Project� communication� mostly� would� lead� by� project� leader� at�

HDB.� Project� leader� will� be� assigned� before� the� initiation� of� the�

study,� who�manage� daily� project� activities,� have� regular� TCs� with�

clients� for�project�update�and�scientific�discussions.�Besides� regular�

TC,� email� exchanges� or� phone� calls� are�most� often� used� for� daily�

information� exchange� and� discussions.� �

HDB� also� assigns� a� designated� project� manager� for� each� project.�

The� project� manager� will� support� the� project� on� related�

operational� matters,� including� reagent� logistics,� notebooks,� SOPs,�

invoicing,� etc.� The� project�manager�will� also�monitor� the� progress�

and� QA/QC� issues,� IP,� EHS� compliance� issues,� will� have� regular�

communications� with� his/her� counterparts� from� client� to�

coordinate� these� activities.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 299

Communication�with� Clients

Providing� RealtimeService� Delivery

HDB� strictly� follows� established� industry� compliant� processes� and�

SOP� guided� QA/QC� process� to� deliver� fully� validated� data� to� our�

clients.� Our� project� leaders� will� keep� our� clients� posted� on� a�

regular� basis� for� project� progress� and� ensure� the� service� delivery�

would� be�within� the� expected� timeline.� � Besides� regular� TC,� email�

exchanges�or�phone�calls�are�most�often�used� for�daily� information�

exchange� and� discussions.

RealtimeFeed-back

HDB� project� leader� and� project� manager� work� together� to�

streamline� all� the� project� processes� and� follow-ups.� Upon� study�

initiates,� a� kick� off� teleconference� (TC)� will� be� scheduled� with�

client� to�go�over� the�study�plan�and� timeline�projection.�After� that,�

project�update�TC�will�be�held�weekly�or�bi-weekly� to�close� follow�

up� the� progress� and� address� any� issues� in� the� studies.� Email� and�

phone� calls� can� be� taken� whenever� there� is� a� need.� Periodical�

face-to-face�meeting�would� also�be� necessary.�On-site� instructions�

and� communications� usually� lead� to� improvement� in� efficiency.

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300� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

4.� Corporate� Competitiveness

CorporateCompetitiveness

1.� Excellent� track� record:�

HDB� has� collaborations� with� almost� all� top� 10� big� phamas� in� all� research� and�

development� areas.� Especially,� HDB� is� strategic� partner� with� several� pharma� clients�

in� plate-based� pharmacology,� target� validation� and� therapeutic� antibody� discovery.�

HDB’s� high�quality� service� has�been�well� recognized�as� one� of� the� leader� in�biology�

CRO� services.�

2.� Strong� talent� pool:�

With� a� total� ~250� employees,� HDB� has� over� 25%� scientists� and� leaders� who� are�

returnees� from�US� and� EU� pharmas� and� biotechs� and�with� educational� trainings� in�

PhD�and�postdocs.�Their�extensive�experience� from�academia�and� industry�gives�our�

team�culture�and� language�advantage� in�client�communication�and� relationship.�The�

strong�scientific�background�and� industrial�experience�also�make�HDB�team�standing�

out� from� the� industry� for� our� knowledge� input� and� problem-solving� capability,�

therefore,� ensures� the� successful� and� high� quality� delivery� of� projects� and� high�

recognition.�

3.� Complete� infrastructure� and� SOP� guided� process:�

HDB�has�built� strong� infrastructure� to�support�our� in�vitro�and� in�vivo�pharmacology�

services.� HDB� has� inserted� and� established� the� comprehensive� and� proprietary�

systems� for� compound� and� data� management� to� support� a� full� line� plate-based�

pharmacology� services� from� compound� receiving/tracking,� assay� development,� HTS�

operation,� SAR� compound� screening� to� data� analysis� and� QC.� Additionally,� an�

instrument� backup�plan� has�been� fully� implemented� to�ensure� there�are�no�hiccups�

during� project� execution.� A� streamlined� work� flow� is� also� supported� by� project�

management� on� sample� logistics,� progress� tracking� and� SOP/notebook� compliance,�

etc.� All� processes� are� guided� by� our� SOPs� to� ensure� the� smooth� delivery� of� project�

and� data� integrity� and� quality.�

4.� Rich� biology� assets:�

Over� the� past� 10+� years� in� the� business,� HDB� has� accumulated� a� large� asset� of�

variety� of� assays,� cell� lines,� disease� models,� as� well� as� technology� platforms.� Our�

diversified� assays� include� biochemical,� cellular,� radiometric,� LC/MS,� multiplex� and�

high� content� assays� for� various� therapeutic� targets� like� GPRs,� NHRs,� enzymes,�

transporters,� ion� channels,�etc,�and�with�panels�of�phenotypic�and� functional�assays�

using� primary� cells� and� tissues� in� supporting� compound� evaluations� and� MOA�

studies.�Currently�HDB�has� developed�over� 200� recombinant� cell� lines� in� house�and�

banked� ~400� tumor� cell� lines.�

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 301

CorporateCompetitiveness

5.� Strong� scientific� input� and� expertise:

HDB� emphasizes� on� knowledge� exchange� and� innovations.� Our� scientific� team� can�

provide� strong� scientific� input� to� client’s� programs� and� facilitate� clients� to� drive� the�

project� forward� quickly.� The� company� also� has� alliance� with� several� biotech�

companies� for� utilizing� proprietary� technology� platforms� to� drug� candidate�

screening,� therefore� provides� unique� solutions� for� client� programs.�

6.� Flexible� business� models:�

HDB�provides� flexible�business�models� to�accommodate�different�client’s�preference.�

Two�most� common�models� are� FTE� and� Fee-for-Service.�We� are�willing� to�adapt� to�

clients’�business�practice� to�propose�most�cost-effective�models� for� the�collaboration.

Current� Status� ofAccredited�Certification

ISO90001,� AAALAC� accreditations

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5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� whichclients� belong� to

Local� China,� India,� Japan,� Korea,� Singapore,� Israel

Asian� Clients'Composition(%)

Big� PharmasMid� or� Small-Size� Pharmas

BiotechCompanies

Start-ups

30% 40% 15% 15%

No.� of� Asian� Clientsin� recent� 3� years

~50

Major� Service� Rangewith�Asian�Companies

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Research 〇 API

APIs

R&D

Pre-Clinical 〇Pre-clinicalTest� Sample

R&D� Strategy&�Management

Phase� I Clinical� Trials

Phase� IIClinical� TestSample

FinishedProducts

RegulatoryAffairs

Phase� III

FinishedProduct

BusinessDevelopment

Phase� IVSales� &Marketing

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 303

Corporate� Name Henan� Purui� Pharmaceutical� Co.,� Ltd.

Corporate� Ownership Private� Company

Head� Office� AddressHigh-tech� Industrial� Development� Zone,� Zhengzhou� City,� Cuizhu� Street,� No.� 6�

863� Central� Software� Park,� Building� 9,� Room� 601,605

Web-site� Address http://www.puruipharm.com

No.� of� Employees 300

Contact(Korean�Business)

Name Alice� Su

Address

Telephone +86-13619849381

E-mail [email protected]

Company� Description� &� Organization

Henan�Purui�Pharmaceutical�Co.,�Ltd.� is� located� in�Xihua� town�of�Henan�Province,�covers�an�area�of�20,000�

square�meters,� based�on� raw�materials� tablets,� troche,� capsules� products,� is� an� integrated� pharmaceutical�

company.

The� company� has� more� than� 300� employees,� 72� professional� and� technical� personnel� (middle� rank� and�

senior),� fixed� assets� of� 30�million� yuan,� the� company� has� strong� technical� strength,� advanced� production�

technology,� sophisticated� equipment,� all� kinds� of� testing� equipment,� strictly� in� accordance� with� the�

"Chinese�Pharmacopoeia"� for�production�and�GMP� standards� for� scientific�management.�The�main�products�

are� racemic� anisodamine� raw�materials� drug,� atropine� sulfate�drug� and� racemic� anisodamine� tablets,�with�

four� automated� tablet� capsule� production� lines,� the� present� value� of� more� than� 40� million,� taxes� of� five�

million� yuan

Our� corporation� adhere� to� the� "quality� first,� people-oriented"� management� principles,� advance� with�

times,Pioneering� for� progress� entrepreneurial� spirit,� to� establish� credibility� PURUI� image.

59 Henan Purui Pharmaceutical Co., Ltd

1.� Corporate� General� Information

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304� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name Huntingdon� Life� Sciences

Corporate� Ownership Private� Company

Head� Office� Address

Huntingdon� Life� Sciences� Ltd.,� Woolley� Road,� Alconbury,� Huntingdon,�

Cambridgeshire,� PE28� 4HS,� UK.

Huntingdon� Life� Sciences� Inc.,� PO� Box� 2360,� Mettlers� Road,� East� Millstone,� NJ�

08875-2360,� USA

Facilities� City� &� Country Huntingdon(UK),� East� Millstone(USA)

Korean� Business� OfficeIesung� International,�2nd�FL.,� iLbok�Bldg.1602-4,� Seocho-dong,�Seocho-gu,�Seoul,�

137-070,� Korea

Web-site� Address www.huntingdon.com

No.� of� Employees Globally� 1,532� represented� by� 1,230� in� the� UK,� 12� in� Japan,� 290� in� USA

Financial� Status

Sales� Revenue� in� 2011(US� K$)

Capital(US� K$) Dept-equity� Ratio(%)

$208,553K $121,475K 71%

Contact(Korean�Business)

Name Myung-Ryul� Jang

AddressIesung� International,�2nd�FL.,� iLbok�Bldg.1602-4,� Seocho-dong,�Seocho-gu,�Seoul,�

137-070,� Korea

Telephone +82� 2� 521� 0501~4

E-mail [email protected],� [email protected]

Company� History

1951� Huntingdon� Life� Sciences� founded.� Originally� known� as� Nutritional� Research� Institute� and� based� in�

Huntingdon,� Cambridgeshire,� UK.

1963� Moved� to� current� site� at� Alconbury,� 4� miles� from� Huntingdon.

1988� Shares� traded� on� London� Stock� Exchange.

1995�Acquisition�of� toxicology�business�of�APBI� -� included�Eye�Research�Centre� (UK)�and�Princeton�Research�

Centre� (US)� sites.

2002� Life� Sciences� Research� (LSR)� Inc� launched� to� acquire� all� Huntingdon� Life� Sciences� shares.� Company�

re-domiciled� in� the� US.

2006� LSR� shares� traded� on� NYSE� Arca.

2008� LSR� acquired� Gregory� Fryer� Associates� Ltd.� This� broadened� HLS’� capability� in� clinical� consultancy� and�

regulatory� services.

2009� LSR� became� a� private� company.

60. Huntingdon Life Sciences

1.� Corporate� General� Information

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 305

Company� Description� &� Organization

Huntingdon� Life� Sciences� is� a� private� contract� research� organisation,� originally� founded� in� England� in� 1951.�

Huntingdon�Life�Sciences� is�one�of� the�world's� leading�Contract�Research�Organisations,�providing�non-clinical�

and�clinical� safety�evaluation� research�services� for�new�chemical� entities� (NCE)�and�new�biologic�entities� (NBE)�

to� the� world's� leading� pharmaceutical,� biotechnology,� agrochemical� and� industrial� chemical� companies.�

Services� are� designed� to� meet� the� regulatory� requirements� of� governments� around� the� world,� and� are� an�

indispensable� part� of� safely� developing� new� drugs� to�manage� and� improve�mankind’s� health.� The� Company�

has� a� professional� staff� of� over� 1,500� working� in� facilities� near� Princeton� (NJ),� and� Huntingdon� and� Eye,�

England.

Main� research� locations� are� based� on� 3� sites� in� the� UK� and� the� US:

1.� Huntingdon� Life� Sciences� Ltd

� � -� Huntingdon� Research� Centre� (HRC� -� corporate� headquarters),� Cambridgeshire� UK.

� � -� Eye� Research� Centre� (ERC),� Suffolk� UK.

2.� Huntingdon� Life� Sciences� Inc.

� � -� Princeton� Research� Center� (PRC),� New� Jersey� USA.

3.� Huntingdon� Life� Sciences� Co.,� Ltd.

� � -� Business� office� (HLSKK),� Tokyo,� Japan.

4.� Collaborative� arrangements� with� Chinese� and� Korean� providers

� � � Local� client� support� offices,� alliance� laboratories� and� field� stations:

� � -� Ely,� UK� Regulatory� and� clinical� consultancy

� � -� Denmark,� France,� USA,� Canada� Client� support

� � -� Spain� Field� station

� � -� Germany� Field� trials� and� client� support

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2.� Corporate� Service� &�Business� Area

Corporate�Main�

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

○ ○

GeographicalBusiness� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

US ○ US US US ○

Canada ○ Canada Canada Canada ○

EU ○ EU EU EU ○

Asia ○ Asia Asia Asia ○

Global ○ Global Global Global ○

Other ○ Other Other Other ○

Focusing�Contract

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Research ○ API

APIs

R&D ○

Pre-Clinical ○Pre-clinicalTest� Sample

R&D� Strategy&� Management

Phase� I○

(1,2)Clinical� Trials ○

Phase� II○

(1,2)

Clinical� TestSample

FinishedProducts

RegulatoryAffairs

Phase� III○

(1) FinishedProduct

BusinessDevelopment

Phase� IV○

(1)

Sales� &Marketing

Corporate�Product� Area

New� DrugBiologics

HerbalMedicine

BiosimilarsNCE NME

○ ○ ○ ○ ○

Generics APIs Devices Others

○ ○ ○ ○

1 Analytical support2 Monitoring of clinical trials (Phase 1, II)

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 307

Clients'�Composition

(%)

Big� PharmasMid� or� Small-Size� Pharmas

BiotechCompanies

Start-ups

40 17 16 4

※� The� remaining� balance� (23%)� is� combination� of� agrochemical,� chemicals,� food� &�

veterinary� products

In-house� Facilities

Research� &Development

Preclinical ClinicalCustom

ManufacturingCustom� Sales

○ ○ ○(1,2)

1� Analytical� support

2� Monitoring� of� clinical� trials� (Phase� 1,� II)

Focusing�Therapeutic� Area

(%)

Oncologics Lipid� RegulatorsRespiratory�Agents

Anti-ulcerantsAngiotensin� � � II�Antagonists

50 <1 5 <1 6

AntipsychoticsAutoimmune�agents

Antidepressants Analgesics Others

2 4 6 5 22

General� Overviewof� Corporate's� KeyContract� Services

HLS�offers�a� full� complement�of� services� to� take� your� compound� from� lead�optimization�

to� clinical� proof-ofconcept.� Customers� can� access� our� capabilities� flexibly;� from� a� study�

by� study�basis� to�managed�end�to�end�program.�We�work�with�a�variety�of� test�materials�

including� NCEs,� vaccines,� monoclonal� antibodies,� replacement� proteins,� peptides� and�

advanced� therapies� delivered� through� a� variety� of� routes� and� devices.� Our� services�

include:

•Safety� Assessment:� Models� utilize� multiple� rodent� and� non-rodent� species� including�

the�primate,�minipig�and�dog.�We�have�worked�with�a� variety�of�unusual� animals�and�

transgenic� strains� where� niche�models�may� be�more� appropriate� and� relevant� to� the�

clinical� situation.� Studies� include�general� toxicology,� safety�pharmacology,� reproductive�

and� developmental� toxicology� and� juvenile� toxicology.� This� is� supported� by� multiple�

in� vitro� testing� methods,� both� for� genetic� toxicology� assessment� and� innovative�

replacement� of� animal� models� where� possible.

•DMPK:� Drug� metabolism� offers� a� full� fit-for-purpose� ADME� service� to� support� our�

customers� from� candidate� selection� to� regulatory� submission.�We�work� with� in� vitro,�

in� vivo� and� clinical� models� using� test� materials� and� synthesized� radiolabels.� Studies�

3.� Corporate� Business�Overview

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include� in� vitro� transporter� and� adsorption,� dermal� absorption,� plasma� protein�

binding,� cross-species� comparative� metabolism,� CYP� induction� and� inhibition,� CYP�

identification,� pharmacokinetics,� mass� balance,� biliary� excretion,� hepatic� circulation,�

QWBA,�microautoradiography,� quantitative� tissue� distribution,� placental� transfer,�milk�

secretion,� metabolite� profiling,� metabolite� identification.

•Chemistries:� Analytical� support� including� preparation� and� validation� of� dose�

formulations� within� pharmacy� and� analytical� endpoints� on� preclinical� and� clinical�

studies.� We� have� a� variety� of� platforms� to� assay� small� and� large� molecule�

pharmacokinetics;� neutralising� and� non-neutralising� antibodies;� and� multiple�

apparatus� for� pharmacodynamic� analysis� of� analytes� in� fluid� matrices,� internal� and�

external� cell� markers� and� genomics.� Our� translational� scientists� progress� these�

endpoints� from� preclinical� to� clinical� proof-ofconcept.

•CMC� Services:� Assay� support� from� preclinical� development� to� validation� and�

commercial� launch.� Lot� release� and� stability� trials� of� small� and� large� molecules,�

medical� devices� to� ICH� guidelines� in� our� GMP� facility.� With� our� qualified� person� we�

release� batches� of� non-EU� products� into� the� European� Union.

•Regulatory� and� Clinical� Consultancy:� Scientific� and� regulatory� advice� to� progress�

pharmaceuticals� from� early� concept� and� into� the� clinic� and� ultimately� marketing�

authorization.� Also� provide� impartial� and� confidential� due� diligence.� We� implement�

quality� systems,� conduct� clinical� trial� feasibility,� site� selection� and� monitoring� and�

pharmacovigilence.

•Project� and� Program� Management:� Provision� of� a� focal� point� for� contact� with� the�

customer� to� provide� scientific� and� financial� management� of� your� program.� The�

program�manger�appointed�will� have�specific� experience� in� your� therapeutic�area�and�

stage� of� drug� development.

•Environmental� Sciences:� Environmental� Risk�Assessment� (ERA)� of� your� pharmaceutical�

to� fulfill� the� regulatory�criteria� for�marketing� in�Europe.�Provide� consultancy�and�OECD�

impact� working� with� you� through� the� initial� risk� assessment� to� the� potential�

ecotoxicological� and� environmental� fate� studies� your� compound� may� trigger.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 309

Contract� Service�Capacity� Affordable�by� Service� Area

a� -� Excludes�office� areas�within� animal� and� laboratory�areas.� Includes� conference� rooms

b� -� Excludes� small� stock� holding� areas� within� animal� areas� and� laboratories�

c� -� Includes� restaurants,� site� maintenance� and� ancillary� services

d� -� The� total� PRC�building�area� includes� building� capacity�of� new�adjacent� site,� but� this�

is� not� reflected� in� the� individual� building� splits� as� there� are� currently� no� services� in�

the� new� facility.

Communication�with� Clients

Dispositoion� ofProject� ManagerResponsible

Highly� efficient� integrated� development� services� from� late� stage�

discovery� through� to� proof� of� concept� in� patients.� Dedicated�

project/program� management� through� a� single� point� of� contact�

ensuring� seamless� integration� of� science,� scheduling,� timelines,�

delivery.�Expertise� in�Biologics�and�NCEs.�Clinical-�we�have�an�expert�

team� providing� skilled� organisation� and� management� of� Phase� I,�

Phase� II� trials� in� Europe� and� the� US.

Providing� RealtimeService� Delivery

Huntingdon� Life� Sciences� (HLS)� do� not� currently� have� realtime�

service�delivery.�Secure�&� instantaneous�document�exchange�offered�

using� the� HLS� Extranet,� a� private� website� offering� flexibility� and�

security�compared� to�e-mail/fax/post.�Any� file� type� can�be�easily� and�

securely� uploaded� to� the� Extranet� into� predefined,�

intuitively-structured� folder� areas.

RealtimeFeed-back

Status�updates�can�be� supplied�at� a� frequency� suitable� for� the�client�

and� in� a� convenient� format� (e.g.� Excel,� Project� etc)

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4.� Corporate� Competitiveness

CorporateCompetitiveness

The� focus� at� Huntingdon� Life� Sciences� is� on� the

-� Financial� stability� -� so� that� we� can� continue� to� invest� in� our� people,� facilities� and�

services

-� Services� and� strategic� marketing� -� ensuring� we� adopt� and� promote� the� right�

technologies� to� provide� the� services� our� customers� need

-� Operating� efficiency� ­� continually� improve� quality,� consistency� and� reduce� timelines�

to� increase� value

-� Personnel� ­� attract,� develop� and� retain� the� right� people� to� deliver� the� right� skills,�

experience� and� consistency� of� performance.

-� The� needs� of� our� customers� in� all� that� we� do�

Quality,� training,� expertise� and� experience:

-� Regulatory� GLP,� GMP� and� GCP� certification� and� animal� welfare� AAALAC�

accreditation.

-� QA� departments� with� 55� staff� globally� The� UK� and� USA� Directors� of� Quality�

Assurance� are� respectively� responsible� for� the� documented� Quality� Assurance�

Program� in� the� UK� and� USA.� The� QA� function� reports� to� senior� management,�

independent� of� the� staff� who� conduct� the� studies.� Senior� QA� staff� have� extensive�

industry�experience�and�are�engaged� in� industry� related�committees� such�as�BARQA�

or� SQA.

-� Huntingdon� Life� Sciences� ensures� that� all� personnel� employed� in� the� conduct� of�

studies� (whether� GLP,� GMP� or� GCP� related)� have� an� appropriate� combination� of�

qualifications,� training�and�experience� to�enable� them� to�perform�the� role�assigned�

to� them.� Integral� to� this,� the� objective� of� training� is� to� ensure� that� staff� have� the�

specific� knowledge� and� skills� to� enable� them� to� undertake� the� tasks� assigned� to�

them� competently� and� confidently.� The� personal� training� programs� are� reviewed�

and�up-dated� regularly� as� individuals� progress,� to� ensure� that� they� remain� relevant�

and� contemporary.

-� Industry� reknowned� scientists.�Many�are�on� industry� related�committees,�attend�and�

present� posters� and� papers� at� scientific� meetings.

-� High� retention� of� staff� and� low� turnover� rates� ensuring� continuity� and� depth� of�

experience.

No.� of� RegulatoryInspections

Classification FDA(US) EMA(EU) PMDA(Japan) Others

Pre-Clinical� Area15�

(2� FDA� in� UK)37

Clinical� Area4�

(GCP� for� labs)

Manufacturing� Area5�

(FDA� in� UK)6(GMP)

Others 3(US� EPA)

Current� Status� ofAccredited�Certification

Full� compliance� with� the� following

HLSUK:� GLP,� GMP,� GCP,� AAALAC

HLSUS:� GLP,� CLIA,� AAALAC

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 311

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� whichclients� belong� to

Korea,� China,� Japan,� Taiwan,� HongKong,� Singapore,� India,� Thailand.

Asian� Clients'Composition(%)

Big� PharmasMid� or� Small-Size� Pharmas

BiotechCompanies

Start-ups

3 52 45 0

No.� of� Asian� Clientsin� recent� 3� years

181� companies� 2010� ­.� 2012� (Oct)

Major� Service� Rangewith�Asian�Companies

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Research ○ API

APIs

R&D

Pre-Clinical ○

Pre-clinicalTest� Sample

R&D� Strategy&�Management

Phase� I○

(1,2)Clinical� Trials

Phase� II○

(1,2)

Clinical� TestSample

FinishedProducts

RegulatoryAffairs

Phase� III○

(1) FinishedProduct

BusinessDevelopment

Phase� IV○

(1)

Sales� &Marketing

1 Analytical support2 Monitoring of clinical trials (Phase 1, II)

6.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

As� a� Company,� Huntingdon� Life� Sciences� globally� develop� partnerships� and� alliances� with� pharmaceutical�

and� non-pharmaceutical� companies� although� we� are� not� able� to� disclose� their� details� for� confidentiality�

reasons.� Approximately� fifty� percent� of� our� business� revenue� comes� from� strategic� relationships� and� the�

remainder� split� fairly� equally� between� transactional� and� tactical� relationships.

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312� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

61. ICON plc

1.� Corporate� General� Information

Corporate� Name ICON� plc

Corporate� Ownership Public� Company

Head� Office� Address South� County� Business� Park,� Leopardstown,� Dublin18,� Ireland

Facilities� City� &� Country Dublin(Ireland)

Korean� Business� OfficeICON� Clinical� Research� Korea� Ltd� 18/F� Capital� Tower,� 736-1,� Yeoksam-dong,�

Kangnam-gu,� Seoul,Korea135-9024

Web-site� Address www.iconplc.com

No.� of� Employees over� 8,500

Financial� Status

Sales� Revenue� in� 2011(US� K$)

Capital(US� K$) Dept-equity� Ratio(%)

ICON’s� revenue� for� FY�

ending�31�December�2011�

was� US$946� million

- -

Contact(Korean�Business)

Name Mr.� Jae� Wook� Lee,� Associate� Director,� Business� Development

Address 18/F�Capital� Tower,� 736-1,�Yeoksam-dong,� Kangnam-gu,� Seoul,� Korea� 135-9024

Telephone +82� 2� 520� 5283

E-mail [email protected]

Company� History

From� a� small� team� of� 5� people� in� 1990,� ICON� now� employs� over� 8,300� people� across� 79� offices� in� 38�

countries.�We�have�mainly� grown�organically,� but� have� bolstered�our�growth� through�a� number� of� strategic�

acquisitions� which� have� broadened� our� service� portfolio� and� have� added� scale� to� existing� services.

Company� Description� &� Organization

ICON� plc� is� a� global� provider� of� outsourced� development� services� to� the� pharmaceutical,� biotechnology� and�

medical� device� industries.� The� Company� specialises� in� the� strategic� development,� management� and� analysis�

of� programs� that� support� clinical� development� -� from� compound� selection� to� Phase� I-IV� clinical� studies.�

With� headquarters� in� Dublin,� Ireland,� ICON� currently� operates� from� 79� locations� in� 38� countries� and� has�

approximately� 8,500� employees.� Over� 1,400� of� these� employees� are� based� in� 13� different� countries�

throughout� Asia� Pacific.� ICON� Clinical� Research� specialises� in� the� planning� management,� execution� and�

analysis� of� Phase� IIb� ­� IV� clinical� trials,� ranging� from� small� studies� to� complex,� multinational� projects.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 313

2.� Corporate� Service� &�Business� Area

Corporate�Main�

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

GeographicalBusiness� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

US ○ US US US

Canada ○ Canada Canada Canada

EU ○ EU EU EU

Asia ○ Asia Asia Asia

Global ○ Global Global Global

Other ○ Other Other Other

Focusing�Contract

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Research API

APIs

R&D

Pre-ClinicalPre-clinicalTest� Sample

R&D� Strategy&� Management

Phase� I ○ Clinical� Trials

Phase� II ○Clinical� TestSample

FinishedProducts

RegulatoryAffairs

Phase� III ○FinishedProduct

BusinessDevelopment

Phase� IV ○Sales� &Marketing

Corporate�Product� Area

New� DrugBiologics

HerbalMedicine

BiosimilarsNCE NME

○ ○ ○

Generics APIs Devices Others

○ ○

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Clients'�Composition

(%)

Big� PharmasMid� or� Small-Size� Pharmas

BiotechCompanies

Start-ups

60 12 28 0

In-house� Facilities

Research� &Development

Preclinical ClinicalCustom

ManufacturingCustom� Sales

Focusing�Therapeutic� Area

Oncology,� CNS,� Biosimilars,� cardiovascular,� endocrine� &� metabolic� disorders,�

gastrointestinal,� etc� � �

General� Overviewof� Corporate's� KeyContract� Services

ICON�offers�a�broad�range�of� specialised�services� to�assist�pharmaceutical,�biotechnology�

and� medical� device� companies� to� bring� new� drugs� and� devices� to� market� faster.� Our�

services� span� the� entire� lifecycle� of� product� development� and� can� be� adapted� to� suit�

small� local� trials� or� large� global� programs.

-� Preclinical/Phase� I�

-� Phase� II� ­� IIIb

-� Late� Phase� &� Outcome� Research

-� Laboratories

-� Imaging

-� Resourcing� Solutions

Contract� Service�Capacity� Affordable�by� Service� Area

3.� Corporate� Business�Overview

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 315

Communication�with� Clients

Dispositoion� ofProject� ManagerResponsible

­Serve� as� the� primary� (not� only)� project� point� of� contact� and�

communications� manager� for� the� Sponsor

Providing� RealtimeService� Delivery

­Serve� as� the� cross­functional,�multi-service� project� lead� responsible�

for� the� execution� and� delivery� of� a� project

­have� ownership� and� accountability� of� the� budget� and� contract

­Develop� full� scale� cross� functional� project� plans,� including� team�

requirements� (in� conjunction� with� functional� leads)

RealtimeFeed-back

­Ensure� all� functional� project� elements� are�managed� in� compliance�

with�all� regulatory� requirements,�&� standard�operating�procedures

­Actively�manage�project� financials� and� efficient� resource� allocation

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Corporate

Competitiveness

ICON� is� a� global� provider� of� outsourced� development� services� to� the� pharmaceutical,�

biotechnology� and� medical� device� industries.� We� specialise� in� the� strategic�

development,� management� and� analysis� of� programs� that� support� clinical�

development� -� from� compound� selection� to� Phase� I-IV� clinical� studies.

Our� goal� is� to� provide� flexible,� superior� quality,� global� pharmaceutical� development�

services,� that� enable� clients� to� expedite� development,� reduce� costs,� and� establish� the�

benefits� of� treatments� that� enhance� people’s� lives

We� have� the� operational� flexibility� to� provide� development� services� on� a� stand-alone�

basis,� functional� service�provision�or�as�part�of�an� integrated� “full� service”� solution.�We�

work� in� close� collaboration� with� our� clients� to� fully� understand� the� unique�

requirements� of� each� study� and� match� these� requirements� with� tailored� resourcing�

models� and� we� have� the� experience� and� knowledge� (scientific,� therapeutic� and�

regulatory)� to� solve� the� challenges� that� arise� during� any� development� project.

We�believe�our�project�management�governance� structure�with� strong�oversight� from�

ICON� senior� management� sets� us� apart� from� other� service� providers.� � Our� use� of�

strong� collaborative� tools,� processes� and� systems� is� also� a� critical� component� in�

providing� a� quality� service� to� our� pharma� and� biotech� clients.

No.� of� Regulatory

Inspections

Classification FDA(US) EMA(EU) PMDA(Japan) Others

Pre-Clinical� Area

Due� to� client� confidentiality,�we� are� not� able� to� provide� the�

answer

Clinical� Area

Manufacturing� Area

Others

Current� Status� of

Accredited�

Certification

Quality� Assurance� Services

In� addition� to� providing� in-house� Quality� Assurance� auditing� for� all� clinical� trials,� the�

Quality� Assurance� department� provides� stand� alone� services� to� support� companies� to�

develop,� implement� and�maintain� quality�management� systems� to� assure� the� highest�

standard�of� conformance� to�GCP,�GMP�and�GLP� regulations� and� to� ISO�9000�quality�

standards.

ICON�has� the� resources� to�meet� all� your� auditing� requirements� of�Phase� I� -� IV� clinical�

trials.� With� QA� personnel� located� across� Europe� and� the� US,� Asia-Pacific,� Latin�

4.� Corporate� Competitiveness

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 317

America�and� Japan,� the� ICON�QA� team� is� flexible�enough� to�provide�an� individual�and�

personalised� service� for� locally� managed� projects.

•Phase� I� -� IV� GCP� audits�

•Clinical� laboratories� (GCP,� GLP)�

•Database� and� Statistical� tables�

•Computer� validation�

•Clinical� trial� reports�

•Technical� and� operational� vendor� audits�

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318� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� whichclients� belong� to

Due� to� client� confidentiality,� we� are� not� able� to� provide� the� answer

No.� of� Asian� Clientsin� recent� 3� years

Due� to� client� confidentiality,� we� are� not� able� toq� provide� the� answer

Major� Service� Rangewith�Asian�Companies

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Research API

APIs

R&D

Pre-ClinicalR&D� Strategy&�ManagementPre-clinical

Test� SamplePhase� I ○ Clinical� Trials

Phase� II ○ Clinical� TestSample

FinishedProducts

RegulatoryAffairs

Phase� III ○Business

DevelopmentFinishedProduct

Phase� IV ○Sales� &Marketing

6.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

Due� to� client� confidentiality,� we� are� not� able� to� provide� the� answer

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 319

62. ICR

1.� Corporate� General� Information

Corporate� Name ICR

Facilities� City� &� Country Mexico

Web-site� Address www.infiniteresearch.com.mx

Contact(Korean�Business)

E-mail [email protected]

Company� Description� &� Organization

ICR� is� a� Mexican� Full� Service� CRO� (Clinical� Research� Company� Contract),� dedicated� to� enhance� the� quality�

and�development�of�Clinical�Research� in�Mexico�and�Latin�America.� ICR� is�a�100�%�Mexican� institution�with�

more� than� 12� � years� working� experience� in� top� level� companies,� offering� service� under� the� needs� of� each�

of� our� customers� allowing� us� to� go� from� the� phases� of� clinical� research� of� a� new� drug.

ICR� offers� its� services� integrally� to� meet� the� specifications� of� each� of� our� customers,� allowing� us� to� cover�

all� your� needs� and� requirements� of� clinical� research.� The� services� that� ICR� offers� are:� monitoring� clinical�

phase� II� to� phase� IV,� drug� registration� in� basic� table,� protocol� design,� consulting,� personnel� training,�

Pharmacovigilance,� pharmacoeconomics,� management,� ethics� committees� and� clinical� material� store.

*Each�one�of�our�services� can�be�added�as�a�module� to� your�contract� in�order� to�meet�your� corporate�needs.

ICR´s� headquarters� are� located� in� Mexico� City,� it´s� known� as� a� leader� for� its� expertise� in� regulatory� affairs�

and� it´s� a� Clinical� Research� Organization� benchmark� for� clinical� trials� in� Mexico� and� Latin� America.� Our�

Quality� standards,� our� broad�portfolio� of� services� and�unique� flexibility� in� the�market,� allow�us� to� offer� you�

a� professional� and� personalized� service� that� we� are� sure� will� meet� your� expectations.

OUR� MISSION

Assist� in� the� development� ,� creation� and� research� of� new� drugs� towards� improving� the� health� and� quality�

of� human� life.

OUR� VISION

Be�the� leader� in�outsourcing�services� for� the�pharmaceutical� industry�within� the� region�encompassing�Mexico�

and� Latin� America.

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320� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

63. INC Research

1.� Corporate� General� Information

Corporate� Name INC� Research

Head� Office� Address Raleigh,�North�Carolina�3201�Beechleaf�Court� Suite�600�Raleigh,�NC�27604-1547

Korean� Business� Office20F,� Korea� First� Bank� Building� 100� Gongpyung-Dong� Chongno-Gu� Seoul,�

110-702

Web-site� Address http://www.incresearch.com/

No.� of� Employees Nearly� 5,000

Contact(Korean�Business)

Name -

Address20F,� Korea� First� Bank� Building� 100� Gongpyung-Dong� Chongno-Gu� Seoul,�

110-702

Telephone -

E-mail -

Company� History

INC�Research�has�a�deep-rooted�history�of� therapeutic�expertise�and�technological� innovation.� Founded�more�

than� two�decades�ago�as�an�academic� research�organization� focused�on�CNS� research,�we've� translated� that�

expertise� into�a�global�organization�with� the�added�specialties�of� cardiovascular,�endocrinology,� immunology,�

infectious� diseases,� oncology,� pediatrics,� respiratory� and� women’s� health,� as� well� as� full� data� services� and�

regulatory� capabilities.

Company� Description� &� Organization

We� are� a� therapeutically� focused� contract� research� organization� with� a� high� performance� reputation� for�

conducting� global� clinical� development� programs� of� the� highest� integrity.� Pharmaceutical� and�biotechnology�

companies� look� to� INC� Research� for� a� complete� range� of� customized� Phase� I� -� Phase� IV� programs� in�

therapeutic� areas� of� specialty,� and� in� innovative� pediatric� and� women’s� health� trials.� Our� Trusted� Process® �

methodology� and� therapeutic� foresight� leads� our� customers� to� more� confident,� better-informed� drug� and�

device� development� decisions.�

Our� Mission� Statement

We� are� an� organization� composed� of� therapeutically-focused� high� performance� teams� led� by� world-class�

project� managers� and� leaders,� dedicated� to� helping� our� customers� bring� products� to� market� in� order� to�

improve� world� health.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 321

2.� Corporate� Service� &�Business� Area

Corporate�Main�

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

GeographicalBusiness� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

US 〇 US US US

Canada 〇 Canada Canada Canada

EU 〇 EU EU EU

Asia 〇 Asia Asia Asia

Global 〇 Global Global Global

Other 〇 Other Other Other

Focusing�Contract

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Research API

APIs

R&D

Pre-ClinicalPre-clinicalTest� Sample

R&D� Strategy&� Management

Phase� I 〇 Clinical� Trials

Phase� II 〇 Clinical� TestSample

FinishedProducts

RegulatoryAffairs

Phase� III 〇FinishedProduct

BusinessDevelopment

Phase� IV 〇 Sales� &Marketing

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322� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

3.� Corporate� Business�Overview

Focusing�Therapeutic� Area

•Cardiovascular� � � � � � � � � � � � � � � � � � � � � •Central� Nervous� System� (CNS)

•Endocrinology� � � � � � � � � � � � � � � � � � � � � � •Immunology

•Infectious� Diseases� � � � � � � � � � � � � � � � •Oncology

•Pediatrics� � � � � � � � � � � � � � � � � � � � � � � � � � •Respiratory�

•Women's� Health�

General� Overviewof� Corporate's� KeyContract� Services

INC� Research� is� a� contract� research� organization� (CRO)� offering� a� comprehensive� suite�

of� global� services� to� support� your�drug�development�process,�with�a�particular� focus�on�

Phase� I� -� Phase� IV� clinical� trials.�

As� the�drug�development� industry�becomes� truly�global,� contract� research�organizations�

must�not�only� keep�up,�but�set� the�pace� in� the�drug�development�process.� INC�Research�

provides� full� service� CRO� support� across� six� continents.

From� small� biotech� start-ups� looking� to� stretch� their� cash� and�design� a� clinical� program�

that� supports� out-licensing� of� their� lead� product,� to� international� pharmaceutical�

companies� looking� to� increase� efficiency� across� multiple� clinical� trials� for� a� given�

compound�or� indication,� INC�Research�offers� solutions�at�every�stage�of� the� clinical�drug�

development� process.

As� a� full� service� CRO,� we� provide� experienced,� process� experts� in� the� areas� of:

•Alliance� Partnerships� � � � � � � � � � � � � � � � � •AVOS� Consulting

•Data� Services� � � � � � � � � � � � � � � � � � � � � � � •Functional� Services�

•Medical� Devices� � � � � � � � � � � � � � � � � � � � � •Strategic� and� Regulatory� Consulting

•Trial� Services

Using� our� proven� Trusted� Process� and� therapeutic� expertise,� we� are� a� leading� contract�

research� organization� in� clinical� trial� outsourcing� services� and� consulting� for� Phase� I� -�

Phase� IV� studies.

Our� concentrated� experience� in� these� areas� enables� us� to� provide� an� unsurpassed� level�

of� investigative� site� support� and� unmatched� deliverables� to� clinical� trial� sponsors.

With� a� focus� on� Phase� I� -� Phase� IV� trials,� INC� Research� is� a� leading� contract� research�

organization� that� offers� unparalleled� therapeutic� foresight� and� expertise� to� support� the�

drug�development� process.�Our� full� service�CRO� capabilities� and�proven�Trusted� Process�

makes� us� an� ideal� partner� for� drug� developers� looking� for� dependable� outcomes� and�

actionable� results� from� a� contract� research� organization.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 323

64. iNovacia AB

1.� Corporate� General� Information

Corporate� Name iNovacia� AB

Corporate� Ownership Public� Company

Head� Office� Address Banvaktsvagen� 22,� 17148� Solna,� Sweden

Facilities� City� &� Country Stockholm,� Sweden

Web-site� Address www.inovacia.se

No.� of� Employees 20

Contact(Korean�Business)

Name Markus� Thor

Address Banvaktsvagen� 22,� 171� 48� Solna,� Sweden

Telephone -

E-mail [email protected]

Company� History

The� company� was� founded� in� 2006� and� the� organization� with� resources� and� expertise� originates� and� was�

spun� out� from� Biovitrum/Pharmacia.�

Company� Description� &� Organization

iNovacia�AB� is�an�established�pharmaceutical�discovery�provider�with�a�strong�track-record� in�generating�high�

quality� small�molecule� lead� series.� Long� industrial� experience,� a� diverse� and� novel� compound� collection� and�

lead�generation�and�optimization�operations�of�highest� standard�have�made� iNovacia�an�appreciated�partner�

for� pharmaceutical� companies� in� the� US� and� Europe.� iNovacia� has� fully� equipped� laboratories� and� strong�

expertise� which� covers� e.g.� assay� development,� high-throughput� screening,� fragment-based� screening,�

pharmacology,�medicinal�chemistry� and�ADMET.�The� iNovacia� client-base�contains�high�profile�pharmaceutical�

and� biotech� customers.

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2.� Corporate� Service� &�Business� Area

Corporate�Main�

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

GeographicalBusiness� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

US ○ US US US

Canada ○ Canada Canada Canada

EU ○ EU EU EU

Asia ○ Asia Asia Asia

Global ○ Global Global Global

Other Other Other Other

Focusing�Contract

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Research ○ API

APIs

R&D

Pre-Clinical ○Pre-clinicalTest� Sample

R&D� Strategy&� Management

Phase� I Clinical� Trials

Phase� IIClinical� TestSample

FinishedProducts

RegulatoryAffairs

Phase� IIIFinishedProduct

BusinessDevelopment

Phase� IVSales� &Marketing

Corporate�Product� Area

New� DrugBiologics

HerbalMedicine

BiosimilarsNCE NME

Generics APIs Devices Others

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3.� Corporate� Business�Overview

Clients'�Composition

(%)

Big� PharmasMid� or� Small-Size� Pharmas

BiotechCompanies

Start-ups

30% 20% 50% -

In-house� Facilities

Research� &Development

Preclinical ClinicalCustom

ManufacturingCustom� Sales

○ ○

Focusing�Therapeutic� Area

All� major� areas

General� Overviewof� Corporate's� KeyContract� Services

All� aspects� of� small� molecule� lead� compound� generation.� Main� focus� on� quality�

high-throughput� screening� (HTS)� and� Fragment� Based� Screenin� (FBS),� supported� by�

world� class� screening� libraries.

4.� Corporate� Competitiveness

CorporateCompetitiveness

Very� experienced� personnel� supported� by� state-of-the-art� laboratories.� Compound�

collection� with� excellent� track-record� which� has� successfully� delivered� over� 35�

screening� projects� to� pharmaceutical� and� biotech� clients� internationally.

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5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� whichclients� belong� to

Currently�clients�only� in�Europe�and� the�US.� iNovacia� is� seeking�pharma�clients� in�Asia.

Major� Service� Rangewith�Asian�Companies

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Research ○ API

APIs

R&D

Pre-Clinical ○Pre-clinicalTest� Sample

R&D� Strategy&�Management

Phase� I Clinical� Trials

Phase� IIClinical� TestSample

FinishedProducts

RegulatoryAffairs

Phase� III

FinishedProduct

BusinessDevelopment

Phase� IVSales� &Marketing

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 327

Corporate� Name International� Pharmaceutical� Research� center� (IPRC)�

Head� Office� Address P.O.Box� 963166� Amman,� 11196,� Jordan

Facilities� City� &� Country Jordan

Web-site� Address www.iprc.com.jo�

Contact

(Korean�

Business)

Telephone +962� 6� 56� 27� 651

E-mail [email protected]

Company� Description� &� Organization

IPRC� is� a� privately� owned� leading� Clinical� Research� Organization� (CRO),� established� by� Prof.� Naji� Najib� in�

1997� to� provide� clinical� &� bioanalytical� services� for� the� pharmaceutical� industry.

IPRC�has� successfully�passed�numerous� inspections� by�US-FDA,� EMA,�WHO�and� is� accredited�by� the� Turkish�

MOH.� � IPRC� is� approved� by� the� Jordan� Food� and� Drug� Administration� as� well� by� the� Gulf� Cooperation�

Council� (GCC).�

IPRC� has� a� fully-equipped� clinic� and� bioanalytical� facilities� under� the� same� roof.� With� 60� beds,� the� main�

facility� is� well-suited� for� mid-sized� BE� studies.� The� Bioanalytical� laboratory� has� processed� hundreds� of�

thousands� of� samples� and� is� complete�with� state-of-the-art� LCMSMS� stations�managed�by�Watson� LIMSTM�

adhring� to� international� standards.

In� accordance� with� ICH-GCP� regulations,� IPRC� provides� quality� research� services:

-� Phase� I� bioavailability/bioequivalence/pharmacokinetics� studies

-� Clinical� trials� management,� phase� II-IV� throughout� the� MENA� region

-� Bioanalysis

-� Data� management,� PK,� statistics� &� medical� writing

� With�more� than�100�professionals,� IPRC�has� conducted�more� than�1000�bioequivalence,�bioavailability�and�

pharmacokinetics� studies� catered� to� US,� EU,� AU,� India� and�MENA�markets.� IPRC’s� reports� are� accepted� by�

US-FDA,� EMA� and� other� Regulatory� Authorities� worldwide.

65. International Pharmaceutical Research Center (IPRC)

1.� Corporate� General� Information

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66. Intrials

1.� Corporate� General� Information

Corporate� Name Intrials

Head� Office� AddressRua� Joaquim� Floriano,� 913� -� 2º� andar� -� Itaim� -� São� Paulo� -� SP� -� Brazil� -�04534-013

Facilities� City� &� Country Brazil

Web-site� Address www.intrials.com.br

Contact(Korean�Business)

Telephone (+55� 11)� 3073-6770

Company� History

1999� -� INTRIALS� was� founded� in� São� Paulo,� Brazil.�2001� -� the� INTRIALS�Continuing�Education�Program,�a� series�of�open-house� courses� in�Clinical�Research�was�

launched� to� develop� a� high-performance� team� with� highly� qualified,� competent� and� client-driven�

professionals.

2003� -� as� a� result� of� our� client-driven� strategy,� business� was� significantly� expanded.�

2004� -� INTRIALS� moved� to� larger� facilities,� in� a� 2,500� square� feet� intelligent� and� secure� building� in� São�Paulo.

2006� ­� INTRIALS� gives� the� first� steps� in� the� direction� of� expansion� to� Latin� America.�

2007� ­� INTRIALS� initiates� operations� in� Chile.�

2008� ­� INTRIALS� Mexico� and� Argentina� offices� are� opened.�

2010� ­� NTRIALS� initiates� Colombia� operations.�

2012� ­� INTRIALS� operations� in� Peru� are� initiated.�

2013� ­� INTRIALS� celebrates� its� 13th� anniversary�

2015� ­� INTRIALS� consolidates� a� strategy� for� continuous� development� as� the� regional� CRO� of� excellence� in�

Latin� America.�

Company� Description� &� Organization

6Mission

Our� mission� is� to� serve� our� clients,� acting� as� an� extension� of� their� organization,� focusing� on� success,�

exceeding� their�expectations,�always� in� compliance�with�all� ethical�aspects�and� the�highest�quality� standards

Vision

INTRIALS´vision� is� to� be� known� as� a� reference� in� clinical� research� in� Latin� America� for� its� ethical�work�with�

quality,� effectiveness,� innovation,� reliability� and� focusing� on� results� through� the� development� of� new�

treatments� for� the� society.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 329

67. inVentive Health Inc.

1.� Corporate� General� Information

Corporate� Name inVentive� Health� Inc.

Corporate� Ownership Private� Company

Head� Office� Address 1� Van� de� Graaff� Drive,� Burlington,� MA� 01803

Facilities� City� &� Country London&Europe,� Tokyo&Japan,� Shanghai&China� etc.

Korean� Business� Office 13� Fr.� Kangnam� Finance� Center,� Yeoksamdong,� Gangnamgu,� Seoul,� Korea

Web-site� Address www.inventivhealth.com

No.� of� Employees 13,000

Contact(Korean�Business)

Name -

Address 13� Fr.� Kangnam� Finance� Center,� Yeoksamdong,� Gangnamgu,� Seoul,� Korea

Telephone 02-6206-1613

E-mail -

Company� Description� &� Organization

We're� a� best-in-class� team� of� global� healthcare� experts� 13,000� employees� in� 40� countries.

We�are� clinicians,� researchers,� educators,� sales�professionals,� scientists,�Web�developers,�marketers,� and�more.�

We’re� dedicated,� flexible,� and� ready� for� the� challenges� of� a� rapidly� evolving� healthcare� environment.�

We� are� inVentiv� Health,� and� we're� here� to� help.

-� As� a� global� company,� there's� always� something� happening� at� inVentiv� Health.� Read� about� it� in� our�

Newsroom.�

-� Our� constant� striving� for� excellence� has� paid� off—check� out� our� Awards� and� Recognition.�

-� Get� to� know� the� minds� behind� inVentiv� Health:� the� Leadership� Team.�

-� Wherever� in� the� world� you� are,� inVentiv� Health� is� there.� Find� Our� Locations.�

-� We� are� part� of� the� global� community—to� find� out� more,� see� our� Corporate� Citizenship� section.�

-� inVentiv� Health� is� a� privately� held� company.� Learn� more� in� Investor� Relations.�

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2.� Corporate� Service� &�Business� Area

Corporate�Main�

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

◯ ◯ ◯

GeographicalBusiness� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

US ◯ US US ◯ US ◯

Canada ◯ Canada Canada ◯ Canada ◯

EU ◯ EU EU ◯ EU ◯

Asia ◯ Asia Asia ◯ Asia ◯

Global ◯ Global Global ◯ Global ◯

Other ◯ Other Other ◯ Other ◯

Focusing�Contract

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Research API

APIs

R&D

Pre-ClinicalPre-clinicalTest� Sample

R&D� Strategy&� Management

Phase� I ◯ Clinical� Trials ◯

Phase� II ◯Clinical� TestSample

FinishedProducts

RegulatoryAffairs

Phase� IIIFinishedProduct

BusinessDevelopment

Phase� IVSales� &Marketing

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 331

68. JOINN LABORATORIES., Ltd

1.� Corporate� General� Information

Corporate� Name JOINN� LABORATORIES.,� Ltd

Corporate� Ownership Private� Company

Head� Office� Address No.5� Rongjingdong� St.� Beijing� Economic-Technological� Development� Area�

Facilities� City� &� Country Beijing,� China

Web-site� Address www.joinn-lab.com,� www.joinnlaboratories.com

No.� of� Employees 366

Contact(Korean�Business)

Name CAI� XI

Address No.5� Rongjingdong� St.� Beijing� Economic-Technological� Development� Area

Telephone 86-10-67869966� ext� 1090

E-mail [email protected]� or� [email protected]

Company� History

In� 1995,� Beijing� Joinn� Laboratories� was� established;

In� 2004,� the� facility� located� in� Beijing� economic� and� technological� development� area� was� finished�

construction� and� put� into� use;

In� 2005,� Joinn� achieved� GLP� certification� from� SFDA;

In� 2008,� Joinn� Laboratories� USA,� Inc.� started� operation;

In� 2009,� Joinn� achieved� AAALAC� accreditation;�

In� 2009,� Joinn� received� U.S.� FDA� GLP� inspection;

In� 2011,� JOINN’s� one� million� square� feet� new� facility� near� Shanghai� (the� Heptagon)� started� operation� .

Company� Description� &� Organization

JOINN� LABORATORIES� is� a� leading� privately� held� preclinical� CRO� founded� in� 1995.� JOINN�was�GLP� certified�

by� SFDA� in� 2005,� accredited� by� AAALAC� in� 2008,� and� inspected� by� US� FDA� in� 2009.� JOINN’s� headquarters�

and�research� facilities� in�Beijing�are�housed� in�a�50,000-square-foot,� state-of-the-art� facility� in� full� compliance�

with� international� GLP� regulations.� JOINN’s� USA� office� in� Germantown� MD,� founded� in� 2008� and� headed�

by�a� former�FDA�reviewer,�provides�direct� customer� service� to�western� clients.� JOINN’s�one�million� square� feet�

new� facility� near� Shanghai(theHeptagon)� started� operationin� May,� 2011.

Since� GLP� certified� by� SFDA� in� 2005,� JOINN� evaluated� more� than� 400� compounds� including� 200� biologics,�

210� chemicals,� and� 16� botanicals.� Eight� of� them� were� evaluated� for� overseas� companies.� We� prepare�

protocols� and� reports� in� English.� Our� study� reports� submitted� in� IND� packages� have� been� accepted� by� both�

Chinese� and� US� FDA� to� support� clinical� trials� in� China� and� US.

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2.� Corporate� Service� &�Business� Area

Corporate�Main�

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

○ ○

GeographicalBusiness� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

US ○ US US US ○

Canada ○ Canada Canada Canada

EU ○ EU EU EU

Asia ○ Asia Asia Asia ○

Global ○ Global Global Global

Other Other Other Other

Focusing�Contract

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Research ○ API

APIs

R&D ○

Pre-Clinical ○Pre-clinicalTest� Sample

R&D� Strategy&� Management

Phase� I ○ Clinical� Trials

Phase� IIClinical� TestSample

FinishedProducts

RegulatoryAffairs

Phase� IIIFinishedProduct

BusinessDevelopment

Phase� IVSales� &Marketing

Corporate�Product� Area

New� DrugBiologics

HerbalMedicine

BiosimilarsNCE NME

○ ○

Generics APIs Devices Others

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 333

3.� Corporate� Business�Overview

Clients'�Composition

(%)

Big� PharmasMid� or� Small-Size� Pharmas

BiotechCompanies

Start-ups

15% 50% 30% 5%

In-house� Facilities

Research� &Development

Preclinical ClinicalCustom

ManufacturingCustom� Sales

○ ○ ○

Focusing�Therapeutic� Area

Conduct� contract� research� in� all� therapeutic� areas

General� Overviewof� Corporate's� KeyContract� Services

We� can� provide� the� following� preclinical� service:

Drug� Discovery:� Pharmacology� Efficacy� Models� (in� vitro� and� in� vivo);� Plasma� Biomarker�

Analysis.

Pharmacodynamic:� in� vivo� models� in� both� small� and� large� animals.

Safety� Pharmacology:� Central� Nervous� System;� Cardiovascular� System;� Respiratory�

System;� Renal/Urinary� System;� Gastrointestinal� System.

Toxicology:�General� Toxicology� (single-� and� repeated-dose� toxicity� studies� in�mice,rats,�

rabbits,�dogs,�monkeys�and�others�as� required);Genetic�Toxicology� (Ames,� chromosomal�

aberration� and� micronucleus� assays);Carcinogenesis� (Rodent� life-time� bioassays� and�

transgenic� mice� study);Developmental� and� Reproductive� Toxicology� (Three�

segments);Special� Toxicity� (Immunogenicity� study,� hemolysis� test,� topical� and� local�

toxicity� tests).

Pharmacokinetics� and� Toxicokinetics:� Drug� Exposure� (AUC);� PK� and� TK� Parameters;

Bioequivalence/Bioavailability;� In� Vivo� CYP� Induction;� Formulation� Assessment.

Pathology� Services:� Toxicologic� Pathology;� Immunohistochemistry;� Histomorphometry.

Contract� Service�Capacity� Affordable�by� Service� Area

JOINN's�animal� facility�was�accredited�by�AAALAC�on�October�2008.� It� started�operations�

at� current� location� in� September� 2004� and,� a� month� later,� was� authorized� the� Beijing�

Municipal� Science� and� Technology� Commission� since� October� 2004.

Our� animal� facilities� are� designed� to� house� several� species:� mouse,� rat,� rabbit,� guinea�

pig,� canine� and� monkey.� All� animal� rooms� are� equipped� with� monitoring� devices� that�

automatically� report� pressure,� temperature,� and� humidity� and� automatically� adjust� the�

temperature� and� humidity� for� each� room.� The� animal� lab� also� features� a� video�

monitoring� and� recording� system.

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4.� Corporate� Competitiveness

CorporateCompetitiveness

Track� Record:� �

Since� 1995� we've� completed� 1100� studies� for� � 500� customers.� In� the� last�

three� years� we� have� evaluated� more� than400� drugs� including� biologics,�

chemicals,� and� botanicals.�

Confidentiality� and� IP� issues:�

As� a� privately� held� company,� we� take� the� protection� of� our� customers'� IP�

and�confidentiality� very� seriously.� �Our� IP�protection� system� is�comparable� to�

Western� CROs.�

Qualified� personnel:�

More� than� 80%� of� our� employees� have� both� advanced� degrees� and�

extensive� experience� in� performing� contracted� studies.

Accreditations:� �

JOINN� Laboratories� is� AAALAC-accredited� and� SFDA-certified� and� USFDA�

inspected� GLP� facility.�

U.S.� Branch:� �

The� overseas� office,� located� in� the� Washington� DC-area� and� next� to� the�

FDA,� provides� direct� services� convenient� to� our� western� clients.

Fast� Turnaround:

Time� is�money.�We�work�with� you�together� to�meet�or�beat� your�deadlines.�

Competitive� Price:

We� provide� competitive� pricing� with� low-cost� and� efficient� operations.�

Reliable� NHP� Supply:

We�have�a� reliable�NHP� supply� that� can� respond� to�demanding�client�needs�

on� short� notice

No.� of� RegulatoryInspections

Classification FDA(US) EMA(EU)PMDA(Japan)

Others

Pre-Clinical� Area 1 2

Clinical� Area

Manufacturing� Area

Others

Current� Status� ofAccredited� Certification

GLP/AAALAC

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 335

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� whichclients� belong� to

China,� Japan;� South� Korea;� Pakistan

Asian� Clients'Composition(%)

Big� PharmasMid� or� Small-Size� Pharmas

BiotechCompanies

Start-ups

60% 20% 20% -

No.� of� Asian� Clientsin� recent� 3� years

200

Major� Service� Rangewith�Asian�Companies

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Research ◌ API

APIs

R&D

Pre-Clinical ◌Pre-clinicalTest� Sample

R&D� Strategy&�Management

Phase� I ◌ Clinical� Trials

Phase� IIClinical� TestSample

FinishedProducts

RegulatoryAffairs

Phase� III

FinishedProduct

BusinessDevelopment

Phase� IVSales� &Marketing

6.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

Based�on� the�good�business� co-operation�with�Korean�pharmaceutical� companies,�we�hope�we�have�more�

business� contact� with� yours� in� the� future.

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Corporate� Name KCR,� SA

Corporate� Ownership Private� Company

Head� Office� Address

KCR� S.A.

6� Postepu� Str.

02-676� Warsaw,� Poland

Phone:� +48� 22� 313� 13� 13

Fax:� +48� 22� 313� 13� 14

Facilities� City� &� Country

Facilities� in� 14� countries� (Bulgaria,� Croatia,� Czech� Republic,� Estonia,� Hungary,�

Latvia,� Lithuania,� oland,� Romania,� Russia,� Serbia,� Slovakia,� Slovenia,Ukraine)

Business� Development� Representation� in:� USA

Web-site� Address http://www.kcrcro.com

No.� of� Employees 223

Financial� Status

Sales� Revenue� in� 2010(US� K$)

Capital(US� K$) Dept-equity� Ratio(%)

Private Shared� capital� 211� K$ To�be�disclosed�upon�CDA

Contact(Korean�Business)

Name Marek� Kiecana

Address 6� Postepu,� str.� 02-676� Warsaw� Poland

Telephonephone� +48� 22� 313-13-13

fax� +48� 22� 313-13-14

E-mail [email protected]

Company� History

The� Company� has� 12� branches� across� Europe� and� has� operational� coverage� for� all� Western� Europe� and�

Central/Eastern� Europe.

Since� 1995� KCR� has� carried� more� than� 300� trials� treating� nearly� 300,000� patients� at� over� 7,500� sites.� We�

are�proud� to� that�we�are�working�with�most�of�prestigious� clinical� research� institution�and�key�opinion� leaders�

across� Europe.

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69. KCR, SA

1.� Corporate� General� Information

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Company� Description� &� Organization

KCR� is� a� leading� Central� and� Eastern� European� CRO,� with� offices� and� experienced� staff� in� 14� countries�

throughout�Central� and�Eastern�Europe,�and�Russia.�We�offer� clinical� research� services� from�Phase� I� to�Phase�

IV� within� a� broad� range� of� therapeutic� areas.� We� have� carried� out� more� than� 300� trials� in� over� 300,000�

patients� in� more� than� 7,500� research� sites.�

KCR� has� maintained� a� customer� focused� culture� while� managing� quality� studies� during� our� 15� years� of�

experience� in� conducting� clinical� trials� for� pharmaceutical,� biotechnology,� and� medical� device� companies�

throughout�Central� and�Eastern�Europe.�Our� long-term� relationships�with� leading� investigators�and� site�staff,�

at� all� levels� throughout� the� region,� facilitate� accurate,� meaningful� feasibility� and� patient� recruitment�

commitments.� This�proactive� intelligence�combined�with�proven� start-up�strategies�ensures� that�we�meet�your�

recruitment� goals.� KCR’s� stable� project� teams,� including� project� management� staff� comprised� of� MDs� and�

PhDs,� experienced� and� efficient� site�monitoring� teams,� and� in-country� regulatory� expertise,� deliver� excellent�

results.

Our� aim� is� simple,� using� our� in-depth� knowledge� of� the� health� care� systems� in� our� region,� to� provide� you�

with� the� patients� that� your� trials� demand,� in� a� timely� and� cost-effective� manner.

부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 337

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2.� Corporate� Service� &�Business� Area

Corporate�Main�

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

〇 〇

GeographicalBusiness� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

US US US US

Canada Canada Canada Canada

EU EU EU EU

Asia Asia Asia Asia

Global 〇 Global Global Global 〇Other Other Other Other

Focusing�Contract

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Research API

APIs

R&D

Pre-ClinicalPre-clinicalTest� Sample

R&D� Strategy&� Management

Phase� I Clinical� Trials 〇Phase� II 〇 Clinical� Test

Sample

FinishedProducts

RegulatoryAffairs

Phase� III 〇FinishedProduct

BusinessDevelopment

Phase� IV 〇 Sales� &Marketing

Corporate�Product� Area

New� DrugBiologics

HerbalMedicine

BiosimilarsNCE NME

〇 〇 〇 〇Generics APIs Devices Others

〇 〇 〇

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3.� Corporate� Business�Overview

Clients'�Composition

(%)

Big� PharmasMid� or� Small-Size� Pharmas

BiotechCompanies

Start-ups

30% 40% 30% -

In-house� Facilities

Research� &Development

Preclinical ClinicalCustom

ManufacturingCustom� Sales

Focusing�Therapeutic� Area

Cardiovascular,� Dermatology,� Endocrinology/Metabolics,� Gastrointestinal,� Gynecology,�

Hematology,� Immunology,� Infectious� Diseases,� Nephrology,� Neurology,� Oncology,�

Orthopedics,� Otorhinolaryngology,� Psychiatry,� Respiratory,� Rheumatology,� Surgery,�

Transplantology,� Urology

General� Overviewof� Corporate's� KeyContract� Services

•Feasibility� and� Study� Site� Selection

•Clinical� Monitoring� &� Site� management

•Clinical� Project� Management

•Patient� Recruitment� and� Retention� Strategies

•Regulatory� Services

•Sub-contracted� services:� Pharmacovigilance� and�Medical�Monitoring,�Medical�Writing,�

Protocol� Development� and� ICF,� Data� Management,� Biostatistics.

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4.� Corporate� Competitiveness

CorporateCompetitiveness

KCR� has� run� over� 300� studies� that� involved� more� than� 7,200� centers� in� various�

therapeutic� areas.�We� have� successfully� recruited� patients� from� a� single� centre� Phase�

I� up� to� multi-country� trials� of� 220,000� patients.

Our� most� extensive� experience� lies� in� the� areas� of:� Neurology,� Psychiatry,� Internal�

Medicine,� Pulmonology,� Cardiology,� Gastrology,� Oncology,� Endocrinology,� Infectious�

diseases� and� Dermatology.

All� our� studies� have� been� conducted� with� strict� adherence� to� ICH� GCP.

No.� of� RegulatoryInspections

Classification FDA(US) EMA(EU) PMDA(Japan) Others

Pre-Clinical� Area

Clinical� Area

Regulatory�

Inspection� in�

Latvia� in� 2010�

year

Manufacturing� Area

Others

Current� Status� ofAccredited�Certification

ISO� CERTIFICATION

KCR� has� been� certified� EN� ISO� 9001-2000� since� February� 2007.� We� are� annually�

audited� by� ISO� external� auditors� who� verify� that� our� QA� System� is� adequately�

organized.� Here� is� the� 2009� audit� conclusion:�

"the� internal� organization,� procedures,� experience� and� qualification� of� personnel,�

observed�during� the�audit,�prove� that�Quality�Assurance�system�meets� ISO�9001-2000�

requirements".

CIR� ACCREDITATION

KCR� is�accredited�by� French�Ministry�of�Education� (Ministère�de� l'Éducation�Nationale)�

with� «� Le� crédit� d'impôt� recherche� ».

RESEARCH� &� DEVELOPMENT� STATUS

KCR� has� been� granted� status� of� a� Research� &� Development� Company� by� Polish�

Government.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 341

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Major� Service� Rangewith�Asian�Companies

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Research API

APIs

R&D

Pre-ClinicalPre-clinicalTest� Sample

R&D� Strategy&�Management

Phase� I Clinical� Trials 〇

Phase� II 〇 Clinical� TestSample

FinishedProducts

RegulatoryAffairs

Phase� III 〇FinishedProduct

BusinessDevelopment

Phase� IV 〇 Sales� &Marketing

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70. KEOSYS Medical Imaging

1.� Corporate� General� Information

Corporate� Name KEOSYS� Medical� Imaging

Corporate� Ownership Private� Company

Head� Office� Address1,� impasse� Augustin� Fresnel� ZA� du� Moulin� Neuf� BP� 60227� 44815� SAINT�

HERBLAIN� Cedex� FRANCE

Facilities� City� &� CountrySingapore(SINGAPORE)

Philadelphia� (in� January� 2014)� (USA)

Korean� Business� Office Service� coverage� in� Korea� but� no� Korean� business� office� at� the� moment

Web-site� Address www.keosys.com

No.� of� Employees 33

Financial� Status

Sales� Revenue� in� 2012(US� K$)

Capital(US� K$) Dept-equity� Ratio(%)

3,200Shareholders'� equity� :�

1,400� US� K$

Contact(Korean�Business)

Name Olivier� A� LO

Address 50� Tagore� Lane,� Unit� 03-10� K,� 787494� SINGAPORE

Telephone +65� 9622� 3920

E-mail [email protected]

Company� History

2001-2004:� Launch

2001:� Inception

2002:� 1st� research� programs,� Positoscope� for� medical� imaging� data� exchange� in� clinical� routine� and�

diagnosis2004:� Presentation� of� Positoscope� solution� at� SPIE� Medical� Imaging� meeting

2004-2007:� Nuclear� Medicine� Development

2006:�Additional� research�program,�Ethot;�partnership�with� the�French�society�of�Nuclear�Medicine� (SFMN)�

for� a� multisite� solution.

2007:� Implementation� of� the� Visio+� range� complementary� to� Positoscope� (renamed� Visio+� Duo)

2007-2010:� Strategic� shift,� Imaging� CRO

2009:� Launch� of� Keosys� Web� imaging� management� system:� IMAGYS� platform

2010-2014:� International� Expansion

2011:� Imagys�Community;�Patent� filed�on� technology�developed� to�access�diagnosis� interpretation�software�

in� the� cloud.

2012:� Opening� of� office� in� Singapore

2014:� Opening� of� office� in� the� USA

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Company� Description� &� Organization

Keosys� is� an� innovative� developer� of� imaging� data� management� cloud� solutions� and� provider� of� central�

reading� services� for� clinical� trials.� Keosys� is� composed� of� a� team� of� experts� in� medical� imaging,� IT� and�

telecommunications.

Our�headquarters�are� located� in�France.�We�also�have�an�office� in�Singapore�since� July�2012�and�will� open�

a� subsidiary� in� the� USA� in� January� 2014.

After� 10� years� of� scientific� and� academic� collaboration� within� clinical� research� in� nuclear� medicine� and�

radiology,� Keosys� has� become� a� key� player� establishing� 10� international� partnerships� with� renowned�

institutions� such� as� the� EORTC� (European� Organization� for� Research� and� Treatment� of� Cancer),� LYSARC�

(The� Lymphoma� Academic� Research� Organization),� SNM� (American� Society� of� Nuclear� Medicine� and�

Molecular� Imaging),� SFMN� (French� Society� of� Nuclear� Medicine),� UNICANCER� (French� Comprehensive�

Cancer� Centers� group),� and� VUmc� (VU� University�medical� center)…� Those� partnerships� are� based� on� the�

supply� of� Imagys,� medical� imaging� cloud� services� for� exam� centralization� of� patients� enrolled� in� clinical�

studies� (phase� I-II).�

Keosys� extended� all� activities� positioning� Keosys� as� a� challenger� of� the� historical� IT� actors� of� this� market�

for� phase� III� and� IV.� Beside� Keosys� IT� services,� Keosys� provides� imaging� core� lab� activities� through� a� team�

of� medical� experts� (radiologists,� nuclear� physician,� neurologists,� cardiologists,� gastro-enterologists....),�

located� in� Europe,� USA� and�Asia.� Keosys’�medical� team� is� composed� of�medical� directors,� central� readers�

and� technologists.

Keosys� now� offers� full� medical� imaging� services� for� academic� and� phases� I-II-III-IV� clinical� trials� to�

Pharmaceutical,� Biotechnology� and� Medical� Device� companies.

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2.� Corporate� Service� &�Business� Area

Corporate�Main�

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

○ ○

GeographicalBusiness� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

US ○ US US US

Canada ○ Canada Canada Canada

EU ○ EU EU EU

Asia ○ Asia Asia Asia

Global ○ Global Global Global

Other ○ Other Other Other

Focusing�Contract

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Research API

APIs

R&D

Pre-ClinicalPre-clinicalTest� Sample

R&D� Strategy&� Management

Phase� I ○ Clinical� Trials ○

Phase� II ○Clinical� TestSample

FinishedProducts

RegulatoryAffairs

Phase� III ○FinishedProduct

BusinessDevelopment

Phase� IV ○Sales� &Marketing

Corporate�Product� Area

New� DrugBiologics

HerbalMedicine

Biosimilars

NCE NME

Generics APIs Devices Others

○ ○

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 345

3.� Corporate� Business�Overview

Clients'�Composition

(%)

Big� PharmasMid� or� Small-Size� Pharmas

BiotechCompanies

Start-ups

18% 32% 40% 10%

In-house� Facilities

Research� &Development

Preclinical ClinicalCustom

ManufacturingCustom� Sales

Focusing�Therapeutic� Area

Research� &Development

Preclinical ClinicalCustom

ManufacturingCustom� Sales

70 2 2 5

Research� &Development

Preclinical ClinicalCustom

ManufacturingCustom� Sales

8 13

Our� imaging� technologies� and� services� can� be� used� to�manage� imaging� trials� in� every�

therapeutic� area� that� use� medical� images,� in� particular:

§ Digital� Pathology

§ Cardiology

­� Coronary� Artery� Disease

­� Arterial� Hypertension

­� Heart� failure

­� Peripheral� vascular� disease

§ Gastroenterology

§ Hepatology

§ Infectious� diseases

§ Neurology

­� Alzheimer’s� disease

­� Multiple� sclerosis

­� Parkinson’s� disease

§ Neurophysiology

§ Oncology

­� Solid� Tumor� Malignancies� (Breast,� Brain,� Cervix� Uteri,� Digestive,� Lung,� Ovary,�

Pancreas,� Prostate,� Kidney,� Thyroid,� Bladder…)

­� Hematological� Malignancies:� Lymphoma,� leukemia,� myeloma

§ Rheumatology

§ Orthopedics

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Focusing�Therapeutic� Area

We� also� provide� imaging� endpoint� analysis� ­� read� analysis� ­� inclusion� /� exclusion�

assessment� for� a� wide� range� of� criteria.� In� particular,� for� oncology� studies� we� cover�

the� following� criteria:

§ 5-point� scale� criteria

§ Choi

§ Hallek

§ IHP� /� Cheson

§ JUWEID

§ PCWG2

§ PERCIST� /� SUV

§ RANO� and� MacDonald

§ RECIST� 1.0� and� 1.1

§ Volumetric� assessment

§ WHO� Methodology

General� Overviewof� Corporate's� KeyContract� Services

Keosys� provides� innovative� imaging� solutions� to� clinical� trial� sponsors� and� other�

organizations� involved� in� clinical� research:

•�We�draw�on� state-of-the-art� technology�with� the� development� of� a�global� imaging�

infrastructure� for� clinical� trials,� the� IMAGYS� platform.� This� cloud-based� platform�

optimizes� centralization,� visualization� and� assessment� of� imaging� data� during�

multicenter� clinical� trials.� It� is� compatible� with� every� medical� imaging� modality.� It�

can� be� used� for� every� therapeutic� area� that� involves� medical� imaging:� oncology,�

cardiology,� neurology� etc.�

•�Besides� IMAGYS,�Keosys�provides�Quality�Control�and�Central�Reading� services�with�

its� international� network� of� medical� experts:� radiologists,� nuclear� medicine�

physicians,� etc.� from� Europe,� Asia� and� the� USA.

For� clinical� trials� that� involve� medical� images� we� provide� the� following� services:

§ Configuration� and� roll-out� of� cloud� platforms� for� imaging� data� management;

§ Project� management� services�

§ Quality� Control� and� Central� reading� services� including� qualification� (intra-variability�

assessments� and� longitudinal� audits),� training,� follow-up� &� coordination

§ Writing� of� imaging� manuals� for� clinical� trials� (Core� Imaging� Laboratory� manuals,�

central� imaging� review� charters,� image� acquisition� guidelines)

§ Consulting� services.

Keosys� thus� enables� the� management� of� the� whole� imaging� process� during� clinical�

trials� thanks� to� its� innovative� IMAGYS�technology�and� its� international�medical�experts.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 347

Contract� Service�Capacity� Affordable�by� Service� Area

Our� IMAGYS� cloud� solution� can� be� used� for� any� clinical� trial� that� involves� medical�

imaging,� regardless�of� the�number�of� images� to�be�centralized,� the�number�of�patients,�

the� number� of� sites� and� the� study� duration.

More� than�90�central�experts� (quality�controllers�and�central� readers)� are�dedicated� to�

Keosys’� clinical� trial� projects.

Keosys� is� currently� involved� in� 42� clinical� trial� studies� including� Phase� II� studies,� Phase�

III� studies,� Medical� Device� studies� and� Academic� studies.� However,� we� have� the�

capacity� to� provide� full� central� services� (IMAGYS� platform� and� central� expertise)� for�

100� clinical� trials.

Thanks� to� our� technological� and� competitive� intelligence� policies,� we� are� able� to�

anticipate� customer� needs� and� adjust� our� contract� service� capacity� in� advance.�

Communication�with� Clients

Communication�with� Clients

A� senior�Clinical� Project�Manager�with�a� PhD�and� several� years� of�

experience� in�clinical� trials’�project�management,�possessing�a�GCP�

certification� will� be� assigned� to� clinical� projects� organized� by�

potential� Korean� partners� and� clinical� sponsors.� The� selected�

profile� will� have� already� managed� studies� in� the� dedicated�

therapeutic� areas.� The� clinical� project� manager� will� supervise� and�

coordinate� the�overall� study�management� from�startup� to�closeout.�

He/she� will� be� the� sponsors'� team� main� contact� and� will� be�

accountable� for� ensuring� that� all� project� deliverables� meet� the�

sponsor's� expectations� as� well� as� Keosys� standards.� He/she� will�

collaborate� with� major� functional� areas� to� identify� and� evaluate�

fundamental� issues� on� the� project,� interpret� data,� make� good�

decisions� and� ensure� the� implementation� of� timely� solutions.

Providing� RealtimeService� Delivery

We� have� 24/7� turnaround� capabilities� and� provide�Multilanguage�

support.� IMAGYS� technologies� enable� the�exam�to�be�available�as�

soon�as� the�exam� is� centralized.�Our� imaging� readers�network�has�

been� built� up� to� provide� a� 24/7� turnaround� capability.� Central�

reading� can� then� be� performed� within� hours� or� 24h� after� QC�

validation,� if� needed.

We� have� got� a� network� of� readers� in� different� regions� of� the�

world:� Europe,� United� States� and� Asia

Keosys� also� provides� 24/7� support� to� sites� and� customers� thanks�

through� Keosys� IT� engineers� based� in� the� USA,� Europe� and� Asia.

RealtimeFeed-back

Issues�at� sites� are�usually� solved�within�hours� /� days� after� they�are�

reported� to� Keosys.

Keosys’� support� team� is� dedicated� to� handling� Site� feedback� on� a�

24/7� basis.� Handling� sites’� requests� is� part� of� our� Quality�

Management� System’s� After� Sales� process

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4.� Corporate� Competitiveness

CorporateCompetitiveness

A� provider� of� medical� imaging� innovation� for� clinical� trials:

§ Company� representative� selected� by� the� Korean� Health� Industry� Development�

Institute� (KHIDI)� for� the� Global� Pharma� Key� Opinion� Leader� program.

§ Company� representative� selected� by� the� U.S.� Quantitative� Imaging� Biomarkers�

Association� for� his� expertise� in� managing� PET� and� CT/MRI� modalities.�

§ Member� company� of� the� Atlanpole� biocluster� in� France.� Atlanpole� ‘s� partner�

network�with�other�bioclusters� from�Europe,�America�and�Asia�has�allowed�Keosys�

to� efficiently� identify� potential� collaborators� at� the� global� scale.

§ Highly� performing� teams� of� project� managers,� support� engineers� and� medical�

experts� dedicated� to� patients’� and� customers’� satisfaction.

§ A� Quality-oriented� company� with� ISO� 9001,� ISO� 13485,� CE� certificates� and� FDA�

510(k)� clearance.

§ An� international� team� for� an� international� market.

IT� Solutions� for� enhanced� time� optimization� and� cost� control� during� clinical� trials:

§ Cloud-based� imaging� data� management� solutions:�

­� Advanced� and� secure� internet� technologies.

­� Optimized� and� timely� data� communication� between� clinical� trial� sites.

­� No� logistics/hardware-software� related� issues.

­� Online� Viewer� software� with� volume� segmentation� tools.

­� Automated� processes� that� reduce� human� errors.

§ Full� management� of� the� entire� imaging� data� workflow� during� clinical� trials:�

­� Centralization� &� Archiving.

­� Investigation.

­� De-identification� &� Quality� Assurance.

­� Quality� Control.

­� Central� Reading.

­� Adjudication.

­� Study� supervision.

§ Customizable� imaging� solutions;� compatible� with� any� imaging� modality� and�

format,� including� enhanced�DICOM�and�Raw�data;� suitable� for� every� therapeutic�

area� that� involves� medical� imaging.

Support� and� medical� services� for� international� clinical� trial� professionals� and�

sponsors:

§ Multi-language� and� 24/7� support.

§ Wide� range� of� assessment� criteria� covered� by� our� central� readers

§ In-depth� training� in� imaging� data� management� and� assessment� provided� to�

customers� and� users.

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No.� of� RegulatoryInspections

ClassificationFDA(US)

EMA(EU)

PMDA(Japan)

CFDA(China)

DCI(India)

Others

Pre-Clinical� Area

Clinical� Area 1 1�per� year 5

Manufacturing� Area

Others 1�per� year

Current� Status� ofAccredited�Certification

The�Keosys�quality�management� system� is� certified� ISO�9001:2000�(GMED)�and� ISO�

13485:2003� (GMED)� for� the� “Design,� manufacturing� and� sales� of� software� and�

hardware� solutions� for�medical� imaging� applications.� Servicing:� installation,� release,�

training� and� technical� assistance”.

Keosys� IMAGYSTM� Web� solution� is� Medical� Device� EC� certified� (Approval� of� full�

quality� assurance� system,�annex� II� section�3�directive�93/42/EEC�concerning�medical�

devices)� and� FDA� 510� (k)� cleared� for� its� Web� based� Medical� Imaging� Data�

Management� for� clinical� trials.

These� certifications� ensure� secure� medical� imaging� data:� upload,� transfer,�

management,� viewing,� reviewing,� printing,� storage� and� archiving.� IMAGYSTM� can�

thus� support� the� management� of� the� imaging� parts� of� a� clinical� trial� workflow�

including� the� following� steps:� Quality� Control,� data� processing� and� audit� trail.

The� entire� Keosys� IMAGYSTM� process� is� 21� CFR� Part� 11� compliant.

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5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� whichclients� belong� to

Our� clients� (clinical� trial� sponsors� or� CROs)� are� based� in� France,� the� USA,� Belgium,�

the� Netherlands,� Spain,� Switzerland,� Italia,� Poland,� Norway,� Ireland,� UK,� Singapore�

and� Japan.

Our� solutions’� users� (clinical� trial� professionals)� are� based� in� 28� countries:

Australia,� Austria,� Belgium,� Canada,� Chile,� China,� Czech� Republic,� Finland,� France,�

Germany,� Hungary,� India,� Indonesia,� Israel,� Italy,� Korea,� Malaysia,� the� Netherlands,�

New�Zealand,�Philippines,� Singapore,� Spain,� Sweden,� Switzerland,� Taiwan,� Thailand,�

the� UK,� the� USA.

Asian� Clients'Composition(%)

Big� PharmasMid� or� Small-Size� � Pharmas

BiotechCompanies

Start-ups Academia

35% 30% - - 35%

No.� of� Asian� Clients�in� recent� 3� years

3� Asian� clients� since� July� 2012.

Keosys� opened� its� Asian� office� and� started� to� provide� services� to� Asian� sponsors� in�

July� 2012.

Major� Service� Rangewith�Asian�Companies

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Research API

APIs

R&D

Pre-ClinicalPre-clinicalTest� Sample

R&D� Strategy&�Management

Phase� I Clinical� Trials

Phase� II ○Clinical� TestSample

FinishedProducts

RegulatoryAffairs

Phase� III ○

FinishedProduct

BusinessDevelopment

Phase� IVSales� &Marketing

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 351

71. Key-Obs

1.� Corporate� General� Information

Corporate� Name Key-Obs

Corporate� Ownership Private� Company

Head� Office� Address 13� avenue� Buffon� 45100� Orléans� -� France

Facilities� City� &� Country Orléans,� France

Web-site� Address www.key-obs.com

No.� of� Employees 15

Financial� Status

Sales� Revenue� in� 2010

(US� K$)Capital(US� K$) Dept-equity� Ratio(%)

664 150 24.1

Contact(Korean�Business)

Name Trovero� fabrice

Address -

Telephone +33� 238� 646� 068

E-mail [email protected]

Company� History

Since� 12� years� Key-obs� offers� a� range� of� highly� specialized� in� vivo� tests� for� preclinical� research� in� CNS�

disorders.

•A� scientific� team� of� highly� qualified� people

•More� than� 330� preclinical� studies� conducted

•More� than� 60� customers� (pharma,� biopharma,� food� industry,� academic� institutes…)�

•Repeated� business

•Phenotyping� platform� :� more� than� 80� transgenic� strains� analysed.�

� � A� new� laboratory� in� 2011� :� new� staff,� new� services,� new� preclinical� models….

Company� Description� &� Organization

Key-Obs� is� a� preclinical� contract� research� company� specialized� in� CNS.� Key-Obs� conducts�

invivoresearchinvariousfields:Screening,Telemetry,Memory,� Learning,� Aging,� Alzheimer� disease,� Depression,�

Anxiety,� Psychosis,� Drug� abuse,� Pharmacodependence,� Vigilance,� Attention,� Impulsivity,� Parkinson� and�

Huntington� diseases,� Pain,� Inflammation,� Immunology.� Key-Obs� has� developed� specific� targeted� tests:�

pharmacodependence,�neuroprotective�drugs,�antidepressants,�behavioral�phenotyping�of� transgenic�animals,�

ADHD� (attention� deficit� hyperactivity� disorder).

The� services� of� preclinical� research� are� offered� to� pharmaceutical� groups� or� biopharmaceutical� companies.�

They� are� also� involved� in� academic� research� program.� The� small� size� of� the� company� allows� to� stay� close� to�

the�sponsor,� and� to�adapt�our� capabilities� to� the�specific�needs�of� the�projects.� The� company� is� internationally�

recognized� as� a� relevant� platform� for� drug� discovery.

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2.� Corporate� Service� &�Business� Area

Corporate�Main�

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

GeographicalBusiness� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

US ○ US US US

Canada Canada Canada Canada

EU ○ EU EU EU

Asia Asia Asia Asia

Global ○ Global Global Global

Other Other Other Other

Focusing�Contract

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Research ○ API

APIs

R&D

Pre-Clinical ○R&D� Strategy&� ManagementPre-clinical

Test� SamplePhase� I Clinical� Trials

Phase� II Clinical� TestSample

FinishedProducts

RegulatoryAffairs

Phase� IIIBusiness

DevelopmentFinishedProduct

Phase� IVSales� &Marketing

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 353

3.� Corporate� Business�Overview

Clients'�Composition

(%)

Big� PharmasMid� or� Small-Size� Pharmas

BiotechCompanies

Start-ups

25% 75%

In-house� Facilities

Research� &Development

Preclinical ClinicalCustom

ManufacturingCustom� Sales

○ ○

Focusing�Therapeutic� Area

•Aging,� Alzheimer� disease…

•Depression,� Anxiety,� Psychosis

•Drug� abuse,� Pharmacodependence

•Attention� Deficit/Hyperactivity� Disorder

•Motor� disorders� :� Parkinson� and� Huntington� diseases

•Genetics� disease

General� Overviewof� Corporate's� KeyContract� Services

Large� platform� for� in� vivo� preclinical� studies� on� mouse� and� rat�

•Molecule� screening� (in� vivo� validation)

•Telemetry� (in� vivo� physiological� monitoring� during� treatments)

•Tests� for� Memory,� learning:� Aging,� Alzheimer� disease

•Models� of� Depression,� Anxiety

•Various� tests� for� Schizphrenia

•Drug� abuse,� Pharmacodependence

•Vigilance,� Attention,� Impulsivity

•Attention� Deficit/Hyperactivity� Disorder

•Motor� disorders� :� Parkinson� and� Huntington� diseases

•Pain,� inflammation

•Necropsy,� tissue� sampling,� Histology

Contract� Service�Capacity� Affordable�by� Service� Area

Animal� facilities� 8000� mice,� 3000� rats.�

Currently,� and� for�example,�our� capabilities� (place�and� staff)� in� the� following� fields�allow�

us� to� establish� the� in� vivo� screening� of� :

-� 150� molecules/year� in� stress/anxiety

-� 50-100� molecules/year� in� memory

-� 50� molecules/year� in� ADHD

-� 50-100� molecules/year� in� schizphrenia

A� follow-up� of� studies,� a� precise� time-table� of� studies� and� of� results� delivery.

Communication�with� Clients

Dispositoion� ofProject� ManagerResponsible

studies� are� conducted� with� the� sponsor� with� a� follow-up� on-line.�

Study� director� available� everyday� (mail� or� phone).

Providing� RealtimeService� Delivery

1�month�average�delay� from�contact� to�design�and�starting�a�study.�

A� study� is� around�2� to� 4�weeks�duration� time.� Results� are� available�

in� realtime.� Delay� of� report� delivery� 2� weeks.

RealtimeFeed-back

Average� time� for� a� drug� study� :� between� 1� and� 3� months

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4.� Corporate� Competitiveness

CorporateCompetitiveness

-� specialized� research� services� :� specific� models,� publications

-� strongly� validated� tests� and� models� :� various� reference� compounds,� data� bank� on�

several� mouse� strains.� Expert� background� for� results� analysis.�

­competitive�price�according� to�great�quality� and�great�expertise� in� the� field.�Price�are�

provided� per� animal,� in� order� to� facilitate� the� design� of� the� study� by� the� sponsor.�

According� to� the� model,� prices� comprised� between� 5� and� 40� K$� to� establish�

efficacy� of� a� candidate� drug.� No� delay� for� delivery� of� information� regarding�

protocols,� planning� availability…studies� are� planned� with� the� sponsor,� with�

expected� deliverables� .� Expriments� conducted� by� well� trained� technicians� and�

managed� by� expert� researchers,� authors� of� recognized� publications� in� the� field.�

No.� of� RegulatoryInspections

Classification FDA(US) EMA(EU) PMDA(Japan) Others

Pre-Clinical� Area

Veterinary�

services�

(animal�

experimentati

on)

Ministry� of�

research:� �

transgenic�

animals

Clinical� Area

Manufacturing� Area

Others

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 355

72. Kinesis Pharma B.V.

1.� Corporate� General� Information

Corporate� Name Kinesis� Pharma� B.V.

Corporate� Ownership Private� Company

Head� Office� Address Kinesis� Pharma� B.V.� Lage� Mosten� 29,� 4822� NK

Facilities� City� &� Country Breda,� The� Netherlands

Web-site� Address www.kinesis-pharma.com

No.� of� Employees 60

Contact(Korean�Business)

Name Kees� Bol,� PhD

Address 56� Namly� Drive,� 267464� Singapore

Telephone +65� 6649� 7612� (office)� /� +65� 9007� 2290� (HP)

E-mail [email protected]

Company� History

Founded� in� 1997� by� Kees� Groen,� PhD,� in� Breda,� The�Netherlands.� In� 2010� a� regional� office�was� opened� in�

Singapore.

Company� Description� &� Organization

Kinesis� Pharma� is� an� internationally� operating,� independent,� drug� development� consulting� company� with�

headquarters� in� the� Netherlands� (1997)� and� a� regional� office� in� Singapore� (2010).� Kinesis� offers� strategic�

advice,�management�consultancy�and�contract� research�services� for� the�development�and�registration�of� small�

molecules,�biologics,�herbal�medicines�and�nutraceuticals.�Kinesis�workforce�consists�of� about�60�professionals�

with� hands-on� experience� in� drug� development� and� registration.

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2.� Corporate� Service� &�Business� Area

Corporate�Main�

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

○ ○

GeographicalBusiness� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

US ○ US US US ○

Canada ○ Canada Canada Canada ○

EU ○ EU EU EU ○

Asia ○ Asia Asia Asia ○

Global ○ Global Global Global ○

Other Other Other Other

Focusing�Contract

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Research ○ API

APIs

R&D ○

Pre-Clinical ○Pre-clinicalTest� Sample

R&D� Strategy&� Management

Phase� I ○ Clinical� Trials ○

Phase� II ○Clinical� TestSample

FinishedProducts

RegulatoryAffairs

Phase� IIIFinishedProduct

BusinessDevelopment

Phase� IV ○Sales� &Marketing

Corporate�Product� Area

New� DrugBiologics

HerbalMedicine

BiosimilarsNCE NME

○ ○ ○ ○ ○

Generics APIs Devices Others

○ ○

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 357

3.� Corporate� Business�Overview

Clients'�Composition

(%)

Big� PharmasMid� or� Small-Size� Pharmas

BiotechCompanies

Start-ups

20% 35% 25% 20%

Focusing�Therapeutic� Area

All� therapeutic� areas� are� covered� by� Kinesis.

General� Overviewof� Corporate's� KeyContract� Services

Kinesis� services� include:�

•Technical� Due� Diligence�

•Strategic� Advice� (Design� of� a� cost-effective� drug� development� strategy� (“road� map”)�

that� outlines� the� minimal� required� preclinical� and� clinical� studies,� the� timelines,� risks�

and� costs� that� are� associated� with� the� development� of� the� project� up� to� a� certain�

milestone)�

•Candidate� Selection� (Tailor-made� program� to� select� drug� candidate� from� promising�

leads)�

•Formulation� Development� and� Production� (CMC,� small� molecules� and� biologics)�

•Non-clinical� Development� (including� IND-package� preparation,� determination� of� safe�

starting� dose� for� first-in-human� study)�

•Clinical� Development� (with� focus� on� phase� I� and� proof-of-concept,� adaptive� designs�

to� accelerate� drug� development)�

•Pharmacokinetic� and� Pharmacodynamic� (PK/PD)� evaluation�

•Regulatory� Affairs� (FDA� and� EU,� preparation� and� attending� meetings)�

•Project� Management� (From� leading� multi-disciplinary� teams� to� coordination� of�

individual� studies)�

•Quality� Assurance� (including� audits� and� setting� up� GLP,� GCP� and� GMP� systems).

Communication�with� Clients

Dispositoion� ofProject� ManagerResponsible

One�Project�Manager� is� assigned�per�project� assuring�a� single�point�

of� contact� and� efficient� communication

Providing� RealtimeService� Delivery

Presence� in� Singapore� allows� communication� in� same� time� zone

RealtimeFeed-back

Swift� feedback� by� phone� or� email.

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4.� Corporate� Competitiveness

No.� of� RegulatoryInspections

Classification FDA(US) EMA(EU) PMDA(Japan) Others

Pre-Clinical� Area 4

Clinical� Area 3

Manufacturing� Area

Others

Current� Status� ofAccredited�Certification

Kinesis� has� OECD� GLP� accreditation� for� toxicokinetics� analysis

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� whichclients� belong� to

China,� Taiwan,� Thailand,� Singapore,� Korea,� Japan,� India

Major� Service� Rangewith�Asian�Companies

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Research ○ API

APIs

R&D ○

Pre-Clinical ○Pre-clinicalTest� Sample

R&D� Strategy&�Management

Phase� I ○ Clinical� Trials ○

Phase� IIClinical� TestSample

FinishedProducts

RegulatoryAffairs

Phase� III

FinishedProduct

BusinessDevelopment

Phase� IVSales� &Marketing

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 359

73. Kinexum Services

1.� Corporate� General� Information

Corporate� Name Kinexum� Services

Corporate� Ownership Private� Company

Head� Office� Address Home� office:� PO� Box� 1260,� 550� East� Ridge� Street

Facilities� City� &� Country Harpers� Ferry,� West� Virginia

Web-site� Address www.kinexum.com

No.� of� Employees 0� ­� 2� partners� and� all� others� are� subcontractors

Financial� Status

Sales� Revenue� in� 2010(US� K$)

Capital(US� K$) Dept-equity� Ratio(%)

$1.4� million - -

Contact(Korean�Business)

Name Chris� Yun

Address -

Telephone 404-547-7291

E-mail [email protected]

Company� History

Kinexum� was� established� in� 2003.� We� have� a� consistent� track� record� of� providing� strategic� guidance,�

regulatory� submissions,� and� project� management� support� for� more� than� 100� development� programs.� Our�

network� is� global,� coordinated� from� business� operations� in� Minneapolis,� MN� with� an� office� strategically�

located� near� Washington� DC.

Company� Description� &� Organization

Pharmaceutical� Drug� Development� Consulting� Practice

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2.� Corporate� Service� &�Business� Area

Corporate�Main�

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

○ ○

GeographicalBusiness� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

US ○ US US US ○

Canada ○ Canada Canada Canada ○

EU ○ EU EU EU ○

Asia ○ Asia Asia Asia ○

Global ○ Global Global Global ○

Other Other Other Other

Focusing�Contract

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Research API

APIs

R&D

R&D� Strategy&� Management

Pre-Clinical ○Pre-clinicalTest� Sample

Phase� I ○ Clinical� Trials ○

Phase� II ○ Clinical� TestSample

FinishedProducts

RegulatoryAffairs

BusinessDevelopment

○Phase� III ○

FinishedProduct

Phase� IV ○ Sales� &Marketing

Corporate�Product� Area

New� DrugBiologics

HerbalMedicine

BiosimilarsNCE NME

○ ○ ○ ○ ○

Generics APIs Devices Others

○ ○ ○

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 361

3.� Corporate� Business�Overview

Clients'�Composition

(%)

Big� PharmasMid� or� Small-Size� Pharmas

BiotechCompanies

Start-ups

20% 30% 30% 20%

Focusing�Therapeutic� Area

Diabetes,� Oncology,� endocrine� and� metabolism,� Cardiovascular

General� Overviewof� Corporate's� KeyContract� Services

Kinexum� is� an� international� consulting� group� specializing� in� regulatory� strategy� and�

clinical� development.� Kinexum’s� team� includes� senior� level� FDA� experienced� consultants�

with�broad�expertise� in� regulatory,�nonclinical,�clinical,� and�manufacturing.�Kinexum�has�

helped� more� than� 200� companies� over� the� past� 10� years� to� expedite� successful�

commercial-value� milestones.� Kinexum� has� provided� strategic� services� to� companies�

based� in� Europe,� Asia,� and� North� and� South� America.� Kinexum� is� known� for� its� high�

value,� high� impact� solutions� for� complex� regulatory� issues� in� a� broad� range� of�

therapeutic� areas.� Our� in-house� medical� expertise� in� diabetes/metabolism/�

cardiometabolic� and� immunology/oncology� has� experience� in� a� full� range� of

product� development� strategies� including� pharmaceutical,� biosimilars,� botanicals,�

nutraceuticals,� dietary� supplements,� generics,� device,� and� diagnostics.� Combined� with�

access� to�a�global�network�of�professionals� in� clinical/regulatory�strategy,�pharmacology,�

toxicology,� chemistry� &� manufacturing,� biostatistics,� project� management,� contract�

research� services,� and� global� regulatory� /� FDA� interactions� and� compliance.

Contract� Service�Capacity� Affordable�by� Service� Area

See� above.

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4.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� whichclients� belong� to

India,� Hong� Kong,� China

Asian� Clients'Composition(%)

Big� PharmasMid� or� Small-Size� Pharmas

BiotechCompanies

Start-ups

30% 30% 40%

No.� of� Asian� Clientsin� recent� 3� years

6

Major� Service� Rangewith�Asian�Companies

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Research API

APIs

R&D ◌

Pre-ClinicalPre-clinicalTest� Sample

R&D� Strategy&�Management

Phase� I Clinical� Trials ◌

Phase� IIClinical� TestSample

FinishedProducts

RegulatoryAffairs

Phase� III

FinishedProduct

BusinessDevelopment

Phase� IVSales� &Marketing

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 363

Corporate� Name Klinar� CRO

Head� Office� Address Mustafa� Kemal� Mah� 2127.� Sk.� 38� /4� Çankaya� /� ANKARA� TURKEY

Facilities� City� &� Country Turkey

Web-site� Address www.klinar-cro.com

Contact

(Korean�

Business)

Telephone (+90)� (312)� 231� 76� 46

E-mail [email protected]

Company� Description� &� Organization

Klinar� CRO� established� in� January� 2009� as� an� Optimum� CRO� enterprise� for� the� international� clinical� trials�

conducted� in� Turkey.

Klinar�CRO�and� its� team�has�a�deep�experience�over� the�clinical� trials�of�different�phases�and�post�marketing�

surveillance� studies.

Optimum� CRO� /� Klinar� CRO� has� more� than� 60� employees� (including� CRAs,� PMs,� QC,� SCs� and� data�

management� units)� are� located� in� the� main� office� based� in� Ankara,� the� capital� city� of� Turkey.

With� its�high�development� rate,�Klinar�CRO� is�one�of� the� leading�and�experienced� foundations� for� conduct,�

organization� and� improvement� of� clinical� researches� in� Turkey.

Currently,� Klinar� CRO� has� become� one� of� the� first� certified� CRO� to� be� approved� by� the�Ministry� of� Health�

in� Turkey,� working� in� compliance� with� the� principles� of� “Guideline� For� Good� Clinical� Practices”.

74. Klinar CRO

1.� Corporate� General� Information

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75. KLIXAR

1.� Corporate� General� Information

Corporate� Name KLIXAR

Head� Office� AddressCiudad� de� la� Paz� 1887� 1º� B� ­� C1428CPC� ­�Ciudad�Autónoma� de�Buenos�

Aires,� Argentina� |� (54� 11)� 4788-9191

Facilities� City� &� Country Argentina

Web-site� Address www.klixar.com

Company� Description� &� Organization

Mission

KLIXAR's�mission� is� to�provide� flexible� clinical� research� services� to� the�pharmaceutical,�biotechnology,�medical�

device� companies� and� CROs� with� no� local� presence� in� the� region� for� the� development� of� pharmaceutical�

products� throughout� Latin� America.� Our� dedicated� and� experienced� professionals� deliver� timely,� accurate�

data�at�high�quality� standards,�while�maintaining� low�costs� for�our�customers.� It� is�KLIXAR's�aim� to�establish�

communication� channels� that� know� no� boundaries.� Our� employees� are� very� important� to� us� and� the�

organization� is� committed� for� their� well� being.

Vision

KLIXAR� envisions� being� a� leader� contract� research� organization� in� Latin� America,� assisting� the�

pharmaceutical,� biotechnology� and� medical� devices� industries� in� product� development.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 365

Corporate� Name Laboratorios� Silanes� S.A.� de� C.V.

Corporate� Ownership Private� Company

Head� Office� Address Amores� #� 1304� Col.� Del� Valle,� Delegación� Benito� Juárez,� C.P.� 03100

Facilities� City� &� Country Site� Toluca(Mexico),� Madrid(Spain)

Web-site� Address www.silanes.com.mx

No.� of� Employees 800

Financial� Status

Sales� Revenue� in�2014(US� K$)

Capital(US� K$) Dept-equity� Ratio(%)

79,665 60,539 2.24%

Contact(Korean�Business)

Name Paulina� Oteiza

AddressAmores� 1304,� Colonia� del� Valle,� Delegación� Benito� Juárez,� México� D.F.�

03100

Telephone (+52)-55-5488-3700

E-mail [email protected]

Company� History

In� 1943� the� World� was� suffering� from� the� Second� World� War� and� the� recently� created� pharmaceutical�

Industry� in� Mexico� was� in� crisis.� Against� this� background,� Don� Antonio� López� de� Silanes� Senior� created� a�

pharmaceutical� laboratory� that� could� satisfy� the� market� demands.�

From� its�beginning,�Laboratorios�Silanes� increased� rapidly� their� sales�of� vitamins�and�pain� treatment�products.�

In�1959� the� first� combined�product� to� treat�diabetes�was� launched,� currently� the�antidiabetics� are� the�main�

product� family� in� the� company.�

Antonio�Silanes�Senior�was�also� concerned�about�creating�a� close� relationship�with�Health�Ministries,�medical�

and� research� centers� and� physicians,� tradition� that� is� currently� kept� to� encompass� other� countries� and�

continents.�

When� the� company’s� founder� passed� away� the� Company� was� passed� to� his� wife� and� six� progeny� who�

76. Laboratorios Silanes S.A. de C.V.

1.� Corporate� General� Information

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faithfully� preserve� his� legacy.� In� 1995,� Antonio� López� de� Silanes� Son� took� control� of� the� Company�

establishing� new� strategies.� The� antidiabetics’� family� was� promoted� as� well� as� the� concept� of�

pharmacoeconomy,� considering� the� benefit� of� the� patients� with� chronic� diseases.

When� the� XXI� Century� started,� Silances� opened� their� Manufacturing� site� in� Toluca� and� is� currently� in� a�

globalization,� innovation� and� institutionalization,� looking� forward� to� growing� in� competitiveness� and�

productivity.

Company� Description� &� Organization

Silanes� with� more� than� 70� years� of� history� is� currently� a� solid� Company� that� has� been� able� to� evolve�

according� to� the�quality� and� innovation� criterion�and�at� the� same�time�keeps�a� trust�and�comitment� tradition�

with�different�groups� such�as�physicians,�public�health�members,�workers,� customers,� researchers,� suppliers,�

authorities,� etc.,� motivated� to� bring� every� day� better� health� solutions.�

We� set� aside� 10%� of� our� sales� to� Research� and� Development,� generating� patents� and� colaboration�

agreements� with� the� academy.� We� are� aware� of� the� challenges� that� the� globalized� World� arises� and� we�

are� looking� to� expand� our� coverage� to� other� countries� through� our� subsidiary� in� Spain.�

Our� product� portfolio� conists� on� more� than� 80� pharmaceutical� products� with� a� recognized� family� of�

antidiabetic� products.� Instituto� Bioclon� the� biotechnology� división�manufactures� antivenoms� and� is� the� first�

Latinamerican� Company� to� get� approval� from� the� Food� and� Drug� Administration� to� commercialize� an�

antivenom� in� the� United� States.�We� also� have� differentiated� products� at� the� diagnostics� and� nutraceuticals�

área.�

Silanes�has�a� tradition�of� social� responsibility� in� the�health� sector,� supporting�Young�phisicans�and�donating�

drugs.� Currently� is� a� signatory� of� the� Global� Compact.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 367

2.� Corporate� Service� &�Business� Area

Corporate� Main�Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

GeographicalBusiness� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Central� &�South�America

Central� &�South�America

Central� &�South�America

○Central� &�South�America

US US US ○ US

EU EU EU ○ EU

Asia Asia Asia Asia

Russia� &�CIS

Russia� &�CIS

Russia� &�CIS

Russia� &�CIS

ROW ROW ROW ROW

Focusing� ContractService� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Research API

APIs

R&D

Pre-ClinicalR&D� Strategy

&�Management

Pre-clinicalTest� Sample

Phase� I Clinical� Trials

Phase� II Clinical� TestSample

FinishedProducts

RegulatoryAffairs

Phase� IIIBusiness

DevelopmentFinishedProduct

Phase� IVSales� &Marketing

Corporate� Product�Area

New� DrugBiologics

HerbalMedicine

BiosimilarsNCE NME

○ ○ ○

Generics APIs Devices Others

○ ○

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3.� Corporate� Business�Overview

Clients'� Composition(%)

Big� PharmasMid� or� Small-Size� Pharmas

BiotechCompanies

Start-ups

80 20 - -

In-house� Facilities

Research� &Development

Preclinical ClinicalCustom

ManufacturingCustom� Sales

○ ○ ○

General� Overviewof� Corporate's� KeyContract� Services

Silanes� has� developed� commercialization� channels� through� Mexico� and� Latin�

America� through�well-established� partnership�models�with� local� companies.�We�

are� looking� to� increase� our� product� portfolio� through� internal� Research� and�

Development� and� external� alliances�with� foreign� companies,� consolidating� joint�

ventures� and� licensing� agreements.� With� our� R&D� infrastructure,� our�

multidisciplinary� working� group� and� our� international� regulatory� expertise,� the�

required� phases� of� the� product� development,� such� as� clinical� trials� and� local�

registration� can�be� completed� to�ensure�commercial� success� in�countries� such�as�

Mexico,� Ecuador,� Colombia� and� Costa� Rica.� We� have� coverage� for� both�

pharmaceutical� and� biological� or� biotechnological� products.�

Bioclon� Silanes� is� the� first� Latin-American� company� that� has� obtained� approval�

from� the� Food� and� Drug� Administration� in� the� United� States� to� commercialize�

an� antivenom� to� treat� envenomation� caused� by� scorpion� sting.� Two� more�

products� for� snake� and� spider� bite� are� under� registration� process.

Contract� Service� Capacity�Affordable� by� Service� Area

Silanes� doesn’t� provide� or� hire� this� Service

Communication� with�Clients

Dispositoion� ofProject� ManagerResponsible

A�project� leader� is� assigned� for�every�project� and� leaders� from�

different� áreas� (clinical,� R&D,� commercial)� are� dedicated� to�

the� project� as� needed.

Providing�Realtime

Service� Delivery

We�have�developed�a� supply� chain� for� international� customers�

that�allows�us� to� take� into�account� the�needs�of� the� countries�

where� our� products� are� sold,� facilitating� the� supply� the�

products� in� real� time.

RealtimeFeed-back

Our� project� leaders� are� dedicated� to� our� customers’� needs,�

procedures� can� be� created� to� establish� the� communication�

channels� to� provide� real� time� feedback.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 369

4.� Corporate� Competitiveness

CorporateCompetitiveness

Our� service� cost� is� established�on�a�case�basis�and�depends�on� the� type�of�contract.�

Once� the� contract� is� signed,� a� project�manager� is� assigned� to� follow-up�on� all� the�

activities� and�milestones� of� the� project.� If� needed,�we� can� prepare� clinical� dossiers�

to� submit� to� local� Ethics� Committees� and� technical� dossiers� to� request�

commercialization� licenses� in� different� countries.� We� can� also� manage� the� brands�

and� intellectual� property.� Our� personnel� is� in� constant� training� to� assure� process�

efficiency� and� consistency,� work� teams� consist� of� specialists� on� every� needed� area�

who�have� regular� follow-up�meetings� in�order� to� fulfill� the�objectives�of� the�project.�

We� are� the� only� company� in� Latin� America� that� has� fully� developed� a� product�

approved� by� the� Food� and� Drug� Administration.�Our�manufacturing� site� has�GMP�

certificates� from� several� Health� Ministries� such� as� Colombia,� Brasil,� Mexico,� EMA.�

We� have� three� pilot� plants,� one� for� pharmaceuticals,� one� for� biologicals� and� one�

for� recombinant� proteins� that� work� with� the� New� Product� Development�

department.� Our� manufacturing� plant� for� diagnostics� produces� tests� that� are� sold�

at� pharmacies� and� clinical� laboratories.� Our� Board� of� Directors� consists� of� Key�

Opinion� Leaders� on� their� fields� with� several� years� of� experience� and� a� business�

driven� vision� of� the� developments� and� services� that� Silanes� provides.� Our� Business�

Development�department� is�devoted� to� finding�new�opportunities� and� increase� the�

product� and� service� portfolio� of� the� company.

No.� of� RegulatoryInspections

Classification FDA(US) EMA(EU)PMDA(Japan)

Russia� &�CIS

Central� &�South�America

Others

Pre-Clinical� Area

Clinical� Area ○

Manufacturing�Area

○ ○ ○

Others

Current� Status� ofAccredited� Certification

GMP

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5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� whichclients� belong� to

We� currently� have� no� clients� in� Asia

No.� of� Asian� Clientsin� recent� 3� years

We� currently� have� no� clients� in� Asia

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 371

77. Lal Clinica

1.� Corporate� General� Information

Corporate� Name Lal� Clinica

Head� Office� AddressRua� General� Osório,� 507� -� Vila� Martina

Cep.� 13271-130� -� Valinhos/SP�

Facilities� City� &� Country Brazil

Web-site� Address www.lalclinica.com.br

Contact(Korean�Business)

Telephone 55� (19)� 3829-6160

E-mail [email protected]

Company� Description� &� Organization

LAL� Group� is� one� of� the� most� complete� clinical� research� companies� in� Brazil,� acting� as� a� CRO� (Contract�

Research� Organization)� and� producing� Phase� I� and� Bioequivalence� (BE)� tests,� Phase� II,� III� and� IV,� offering�

services� compliant� with� the� strictest� international� standards.� It� is� divided� into� three� business� units,� meeting�

the� needs� of� the� pharmaceutical,� cosmetic,� food� and� health� product� industry.� Our� business� ensures� the�

efficacy� and� safety� of� the� items� that� require� national� and� international� health� regulation� with� expertise� in�

all� steps� of� this� process.�

LAL�was� founded� in� 1999,� fully� compliant�with� the� international� legislation� and� the� new�ANVISA�proposal,�

under� the� management� of� two� health� professionals:� the� physician� Dr.� Alexandre� Frederico� and� the�

pharmacist� Dr.� Luciana� Bortolassi� Ferrara.�

LAL�Group�has� little�paperwork�and�ensures�quick� feasibility�of� the� start�of�projects,� thanks� to� the�gathered�

experience� when� dealing� with� the� Brazilian� legislation� and� continuous� adaptation� to� all� technical�

requirements.� We� also� work� in� all� Latin� America� in� association� to� local� partners,� who� follow� the� strictest�

quality� standards� as� well.

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78. LBBM

1.� Corporate� General� Information

Corporate� Name LBBM

Facilities� City� &� Country Argentina

Web-site� Address www.lbbmresearch.com

Contact(Korean�Business)

E-mail [email protected]

Company� History

Today,�we� are� proud� of� being� a�CRO�which� keeps� growing,� being� able� however� to� keep� the� flexibility� and�

dynamics� of� a� small� group� given� that� LBBM� seeks� for� fluid� and� collaborating�working� solutions� within� our�

professional� staff.� We� assign� each� trial� as� a� personal� project� to� a� selected� group� of� our� staff,� keeping�

everyone� committed�with� the� project,� and� involved� with� the� study� outcome� and� final� results.�We� have� an�

excellent� relationship� with� the� investigators� we� work� with.� We� are� well� known� by� the� evaluators� of� the�

regulatory�authorities,� through�the� seriousness�and�quality�of�our�work�and�how�personal�we� take�our�work.�

We� are� always� available:� we� talk� to� the� sponsor/client� on� a� regular� basis� in� order� to� solve� urgent� issues,�

no�matter� if� it� is� office� time�or� not,�we� try� to� be� always� available� because�we� really� believe� that� this� is� the�

best� way� to� have� the� best� results� of� a� trial.�

-� More� than� 25� clinical� trials,� phase� I� to� IV,� proof� of� concept,� toxicology� preclinical� assays

-� More� than� 450� Healthy� volunteers

-� More� than� 150� HIV-1� infected� patients

-� Setup� of� a� clinical� oncology� site� coordinating� 8� trials

-� Large� experience� in� cardiology� research

-� Network� of� psychiatry� specialized� units� and� investigators

LBBM� started� its� activities� in� 2002,� focused� on� the� organization� and�management� of� bioequivalence� trials,�

in� an� academic� environment� (CAECE� University,� school� of� sciences).� In� 2005� we� moved� our� headquarters�

to� the� school� of�Medicine� "Fundación� H.A.Barceló"� with� the� aim� of� having� close� contact� to� the�medical�community�which�would� facilitate�and�enrich�our�network.� Finally,� thanks� to�our�growth,� in�2007�we�moved�

to� our� own� offices� in�Olivos,� the� north� suburbs� of� Buenos� Aires,� in� a� very� residential� environment,� near� to�

the� river.�

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 373

79. LEPING SAFELY PHARMACEUTICAL CO., LTD

1.� Corporate� General� Information

Corporate� Name LEPING� SAFELY� PHARMACEUTICAL� CO.,� LTD.

Corporate� Ownership Private� Company

Head� Office� Address Tashan� Industry� Park,� Leping,Jiangxi,� China

Web-site� Address www.safelypharm.com

Contact(Korean�Business)

Name James� Tao

Address Tashan� Industry� Park,� Leping,Jiangxi,� China

Telephone +86-798-6703456�

E-mail [email protected]

Company� Description� &� Organization

Le� ping� Safely� Pharmaceutical� Co.,� Ltd.� Lotcated� in� Tashan� Chemical� Zone,� Le� ping� City,� Jiangxi� Province,�

is� the� production� base� of� Taizhou� Shanyu� Chemical� Co.,� td.

The� company�was� established� in� 2006,� covering� 40,000m2� ,the� building� area� is� 25,000m2� .� The� company�

is� a� specialized� manufactrer� of� anti-viral� (anti-HBV,� anti-HIV)� pharmaceutical� intermediates.� (� Adefovir�

intermediate� ,� Tenofovir� intermediate� ,� Nevirapine� intermediate� ,� ect.).

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80. Marin Biologic Laboratories

1.� Corporate� General� Information

Corporate� Name Marin� Biologic� Laboratories

Corporate� Ownership Private� Company

Head� Office� Address 378� Bel� Marin� Keys� Blvd.

Facilities� City� &� Country Novato,� CA� 94949,� USA

Web-site� Address http://www.Marinbio.com

No.� of� Employees 22

Contact(Korean�Business)

Name Peter� Ralph,� Ph.D.,� VP� Science� and� Technology

Address 378� Bel� Marin� Keys� Blvd.,� Novato,� CA� 94949� USA

Telephone 415� 883-8000

E-mail [email protected]

Company� History

17� years� old.� � CRO� (Contract� Research� Organization),� bioanalytical� services,� no� proprietary� programs.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 375

2.� Corporate� Service� &�Business� Area

Corporate�Main�

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

○ ○

GeographicalBusiness� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

US ○ US ○ US US

Canada ○ Canada ○ Canada Canada

EU ○ EU ○ EU EU

Asia ○ Asia ○ Asia Asia

Global ○ Global ○ Global Global

Other Other Other Other

Focusing�Contract

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Research 20% API 7%

APIs

R&D

R&D� Strategy&� Management

Pre-Clinical 10%Pre-clinicalTest� Sample

8%Phase� I 15% Clinical� Trials

Phase� II 15%Clinical� TestSample

7%

FinishedProducts

RegulatoryAffairs

Phase� III 10%Business

DevelopmentFinishedProduct

8%

Phase� IV 5%Sales� &Marketing

Corporate�Product� Area

New� DrugBiologics

HerbalMedicine

BiosimilarsNCE NME

○ ○ ○ ○ ○

Generics APIs Devices Others

○ ○ ○

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In-house� Facilities

Research� &Development

Preclinical ClinicalCustom

ManufacturingCustom� Sales

11,000� square�

feet

Focusing�Therapeutic� Area

all

General� Overviewof� Corporate's� KeyContract� Services

CRO� (Contract� Research� Organization),� bioanalytical� services,� no� proprietary� programs.�

Marin� Biologic� develops,� validates,� and� performs� a� variety� of� assays� for� lot� release�

potency,� PK� and� PD� studies,� immunogenicity� (Anti-Drug�Antibodies),� bioassays� for� drug�

bioactivity,� and� humoral� and� cellular� immunity� assays.� �We� also� offer�molecular� biology�

services,� and� protein� production,� purification� and� analysis.� � Marin� Biologic� Laboratories�

is� FDA� inspected� and� can� perform� these� tests� with� or� without� GLP/GMP� conditions.� �

Marin� Biologic� Laboratories� is� a� contract� laboratory� for� pharmaceutical� and� biotech�

industries.� We� have� been� operating� for� 16� years� and� we� take� pride� in� our� science� as�

well� as� the� quality� of� our� communication.�We� specialize� in� development� and� validation�

of� cell� based� assays� and� immunoassays� as� well� as� enzyme� assays,� protein� and� RNA�

expression,� transfections,� protein� purification,� and� radioactivity� methods.� �

We�have�developed�and�performed�a�variety�of�human�and�murine�cellular� immunology�

assays� ex� vivo,� macrophage/monocyte� activation,� lymphocyte� proliferation� and� cytokine�

production� and� cell� surface�markers� (FACS� analysis),� NK,� ADCC,� cytotoxic� T� lymphocyte� �

(CTL),� complement�killing,�etc.� �Our�niche� is� to� take�projects�encompassing� several� fields�

such� as� biochemistry,� molecular� and� cell� biology� and� bring� them� to� a� rapid� and�

successful� conclusion.� �Companies�with� seemingly� intractable�problems�of� imprecision� in�

bioassays,� detecting� low� levels� of� protein� analytes,� or� interference� by� blood� and� other�

biological� matrices� have� turned� to� us� for� solutions.�

Our� staff� has� developed� and� validated� ELISA� and� bioassays� for� numerous� Ab� projects,�

plus� some� related� candidates� (Fab,� Fab2,�PEG�conjugates).� � This� included�potency�assays�

for� drug� (ELISA� at� IND,� bio�at� Phase� III),� for� PK� in�animals� and�humans,� host� antibodies�

to� the� product,� free� vs� bound� drug� in� plasma,� endogenous� plasma� target� proteins,�

tox/PD/efficacy�markers,� etc.� �Marin� Biologic� has� developed,� qualified,� validated,� run� or�

transferred� over� 50� ELISA� and� bioassays� in� the� past� 3� years,� some� were� GLP� or� GMP.� �

We�perform�traditional� colorimetric,� fluorometric�and� luminescent�ELISAs,� time-resolved,�

and� on� the� MesoScaleDiscovery� (MSD)� � platform� for� higher� sensitivity,� much� wider�

dynamic� range� and� less� matrix� interference.

3.� Corporate� Business�Overview

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 377

Communication�with� Clients

Dispositoion� ofProject� ManagerResponsible

PhD� assigned� to� project,� directly� available� to� client

Providing� RealtimeService� Delivery

Each�experiment� is� communicated� to� client� informally,� in�addition� to�

final� report

RealtimeFeed-back

Each�experiment� is� communicated� to� client� informally,� in�addition� to�

final� report

4.� Corporate� Competitiveness

CorporateCompetitiveness

Full� GLP/GMP.2

No.� of� RegulatoryInspections

Classification FDA(US) EMA(EU) PMDA(Japan) Others

Pre-Clinical� Area 2

Clinical� Area 2

Manufacturing� Area 1

Others

Current� Status� ofAccredited�Certification

Registered� and� inspected� by� US� FDA

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� whichclients� belong� to

Japan,� Republic� of� China� (Taiwan),� Australia,� India

No.� of� Asian� Clientsin� recent� 3� years

4

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Corporate� Name McGuireWoods� LLP

Corporate� Ownership Private� Company

Head� Office� Address One� James� Center,� 901� East� Cary� Street,� Richmond,� Virginia� 23219-4030�

Facilities� City� &� Country U.K.� 외 다수나라 다수지역

Korean� Business� Office None

Web-site� Address www.mcguirewoods.com

No.� of� Employees

As� of� November� 28,� 2011,� McGuireWoods� had� 437� partners� and� 1557� others�

(including� non-partner� attorneys� as� well� as� administrative� staff� firmwide).� � These�

numbers� include� subsidiaries� McGuireWoods� Consulting,� and� McGuireWoods�

Capital� Group.

Financial� Status

Sales� Revenue� in� 2010(US� K$)

Capital(US� K$) Dept-equity� Ratio(%)

As� an� AmLaw� 100� firm� with� a� long� and� remarkable� history,� McGuireWoods� is�

strong� and� financially� viable.�We� are� a� privately� held� organization� and� therefore�

our� policy� is� not� to� disclose� financial� information.

Contact(Korean�Business)

Name Joe� McMenamin

Address McGuireWoods� LLP,� One� James� Center,� 901� East� Cary� St.� Richmond,� VA� 23219

Telephone 804.775.1015

E-mail [email protected]

Company� History

Tracing� the� firm's� roots� back� to� 1834,� McGuireWoods� has� a� long� history� of� growth� through� mergers� with�

predecessor� firms� in� existing�markets,� as�well� as� client-centered� expansion� into� new�markets.� On� January� 1,�

2011,�we�combined�operations�with� the�Texas-based� firm�Nickens�Keeton�Lawless�Farrell�&� Flack�LLP,� adding�

12� attorneys� with� experience� in� the� insurance� and� energy� industries.� Previously,� we� merged� with�

81. McGuireWoods LLP

1.� Corporate� General� Information

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 379

London-based� Grundberg� Mocatta� Rakison� LLP� (2009)� and� the� 145-attorney� North� Carolina� firm� Helms�

Mulliss�&�Wicker,�PLLC� (2008).� In�2006,�we�expanded�our�U.S.� footprint�by�merging�with� Los�Angeles-based�

Van�Etten�Suzumoto�&�Becket� LLP,�and�added� the�boutique� capabilities�of�Chicago-based�Gordon�&�Glickson�

LLC,� known� throughout� the� U.S.� for� their� specialization� in� IT� outsourcing,� technology� and� IP� legal� practice�

areas.

Company� Description� &� Organization

With� approximately� 950� lawyers� in� 19� strategically� located� offices� worldwide,�McGuireWoods� serves� public,�

private,� government� and� nonprofit� clients� from� many� industries� including� energy� resources,� automotive,�

manufacturing,� healthcare,� technology� and� transportation,� to� name� just� a� few,� thus� meeting� clients’� needs�

from� virtually� any� area� of� law.�

To� complement� our� legal� services,� we� offer� a� number� of� solutions� outside� the� legal� realm,� such� as� those�

provided�by�our�subsidiary�McGuireWoods�Consulting� LLC.�Thisgroup�offers� a�wide� range�of�government�and�

public� relations� services,� business� advisory� services,� and� other� non-legal� consulting� services� including� public�

affairs,� strategic� and� grassroots� communications,� and� economic� and� infrastructure� development� services� in�

the� United� States� as� well� as� central� and� eastern� Europe.�

McGuireWoods� is� organized� as� a� limited� liability� partnership.

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2.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� whichclients� belong� to

Our� clients� include� companies� and� organizations� from� Singapore,� Malaysia,� China,�

Thailand,� Japan,� South� Korea,� Taiwan,� Hong� Kong,� Sri� Lanka,� Laos�

No.� of� Asian� Clientsin� recent� 3� years

We� have� represented� a� wide� array� of� Asian� clients� in� the� last� three� years.� Some� of�

our� representations� include:�

McGuireWoodsKorea's� seventh-largest� bank� in� its� acquisition� by� Citigroup� Inc.� for�

$2.6� billion.� � The� merger� created� South� Korea's� fifth-largest� bank.� � On� behalf� of� a�

Korean� automobile� manufacturer,� we� closed� a� landmark� sponsorship� and� marketing�

deal� with� the� top� North� American� men's� professional� basketball� league.� � The� deal�

makes� our� client� the� exclusive� automotive� sponsor� of� various� league� performance�

awards;� it� is� a� companion� to� the� 20� separate� league� team� sponsorship� deals�

McGuireWoods� had� closed� for� the� client� in� the� previous� three� years.� � We� are�

representingKorean� company� in� connection� with� a� series� of� joint� ventures� forthe�

development�of�mixed�use� commercial� and� residential�properties� in� the�U.S.� �We�also�

handled� the� sale�of� a� controlling� interest�by�a�U.S.� investor� in�a�privately�held�Korean�

company� whose� main� assets� are� real� estate� investments� and� a� Lexus� dealership� in�

Seoul.� � We� have� also� done� corporate� work� for� Kia�Motors� America,� the� U.S.� sub� of�

the� Korean� manufacturer.� �

In� litigation� and� risk�management,�we�defendedKorean� shipping� company,� in�a� claim �

related� to� a� large� oil� spill.� � A� little� more� recently,� we� advisedlarge� Korean� car�

manufacturer�on�how� to�avoid�product� liability� in� the�United�States.� �We� represented�

a� Korean� bank� in� a�major� US� bankruptcy� case.� �We� also� represented� theof� a� Korean�

company� doing� business� in�Mexico� in� a� personal� injury� and� property� damage� border�

crossing� matter� against� the� U.S.� government.�

3.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

McGuireWoods� is� approaching� its� third� century�of�providing� sound� advice�and� legal� assistance� to� companies�

big� and� small.We� take�pride� in� our� flexibility� and� scope�of�practice,�which�permit�us� to� cost-effectively� serve�

businesses� of� all� sizes� -� from� smallstart-ups� searching� for� investment� dollars� to� large� multinationals� doing�

mergers�and�acquisitions.�Although�we� represent� companies� in� every� sector�of� the�economy,�we� cherish� our�

deep� heritage� of� partnering� with� life� sciences� companies� making� pharmaceuticals,� biologics,� and� medical�

devices.Ably� led� by�Melissa� Gilmore,� MW's� FDA� practice� is� experienced� and� skilled� in� handlingissues� whose�

resolution�will� determine�whether�a� company's�product�may�be� lawfully�marketed�here� in� the�US.As�a� large,�

general�practice� law� firm,�McGuireWoods�also�has�extensive� contacts�with�domesticand�health�care�providers,�

whose� decisions� will� determine� market� penetration� for� the� products� of� Korean� companies.And� as� an�

international� legal� services� provider,� we� are� attuned� to� the� cultural,� language,� and� legal� barriers� that�

companies�based�abroad�must� clearwhen� seeking� to�do�business� in� the�U.S.,� and� in�part� for� that� reasonstaff�

includes� Korean� language� speakers.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 381

Corporate� Name mediSMART

Head� Office� AddressEkinciler� Cad.� Muhtar� Sokak� no:5� Kat:2� � 34810� Kavacık� Beykoz� İstanbul�Turkey

Facilities� City� &� Country Turkey

Web-site� Address www.medismart.com.tr

Contact

(Korean�

Business)

Telephone 0090216� 404� 10� 88

E-mail [email protected]

Company� Description� &� Organization

[Mission]

� Increasing� our� quality� standards� continuously� � as� well� as� extending� our� service� network� beside� providing�

strategic� direction� and� insight� which� help� pharmaceutical� companies� perform� effective� clinical� researches.

[Vision]

� Becoming� a� full-service� and� international� CRO�as�we�believe� that� our� values�will�make�us� reach�our� vision.

82. mediSMART

1.� Corporate� General� Information

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Corporate� Name Medpace,� Inc

Corporate� Ownership Private� Company

Head� Office� Address 5375� Medpace� Way

Facilities� City� &� Country Cincinnati,� OH� 45227,� USA

Korean� Business� Office Opening� 2012

Web-site� Address http://www.medpace.com

No.� of� Employees 1,100

Financial� Status

Sales� Revenue� in� 2010(US� K$)

Capital(US� K$) Dept-equity� Ratio(%)

US$180,230,000 US$68,378,000 0.84

Contact(Korean�Business)

Name Nicholas� Allen

Address 5375� Medpace� Way,� Cincinnati,� OH� 45227USA

Telephone +1-919-651-9012

E-mail [email protected]

Company� History

Medpace� was� founded� in� 1992� providing� support� services� to� Medical� Research� Services� a� central� clinical�

laboratory� in�Cincinnati�becoming�an� independent� company� in�1997.�Since� the�organization�has�grown�both�

in� the� US� and� globally� to� have� offices� in� all� the� major� regions� of� the� world,� Latin� America,� Eastern� and�

Western�Europe,�South�Africa�and�Asia�Pacific.� The�company�had�grown�organically�with�only�a� few� strategic�

acquisitions� to� expand� expertise� and� service� offerings.

In� 2008� Medpace� built� its� state-of-the-art� 64-bed� Clinical� Pharmacology� Unit� and� added� a� bioanalytical�

laboratory� (Medpace� Bioanalytical� Laboratory� -MBL)� to� provide� bioanalytical� services� and� support� phase� I�

studies.� In�2009�central� laboratory� locations�were�added� in�Beijing,�China�and�Mumbai,� India� to� support� the�

growing� number� of� clinical� studies� in� the� Asia-Pacific� region.� In� 2010� Medpace� acquired� a� medical� device�

CRO� that� is� now� known� as� Medpace� Medical� Device.

83. Medpace, Inc

1.� Corporate� General� Information

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Company� Description� &� Organization

Medpace� is� a� leading� global� full-service� Contract� Research� Organization� (CRO)� providing� Phase� I-IV�

development� services� for� biopharmaceutical� and� device� clinical� trials.� Medpace� has� medical,� regulatory� and�

operational� expertise� in� multiple� therapeutic� areas� to� provide� complete� and� seamless� drug� development�

services.

The� company� has� a� global� reach�with�more� than� 1,100� employees� in� 40� countries� and� can� support� clinical�

trials� from� program� planning� and� execution� to� product� approval.� In� addition� to� clinical� staff� Medpace� has�

a� central� laboratory�with� locations� in� the� US,� Europe,� China� and� India� to� support� studies�wherever� they� are�

conducted.

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2.� Corporate� Service� &�Business� Area

Corporate�Main�

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

〇 〇

GeographicalBusiness� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

US 〇 US US US 〇Canada 〇 Canada Canada Canada 〇EU 〇 EU EU EU 〇Asia 〇 Asia Asia Asia 〇Global 〇 Global Global Global 〇

Other

Latin�

America,�

South�

Africa

Other Other Other

Focusing�Contract

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Research 〇 API

APIs

R&D 〇Pre-Clinical

Pre-clinicalTest� Sample

R&D� Strategy&� Management

〇Phase� I 〇 Clinical� Trials 〇Phase� II 〇 Clinical� Test

Sample

FinishedProducts

RegulatoryAffairs

Phase� III 〇FinishedProduct

BusinessDevelopment

Phase� IV 〇 Sales� &Marketing

Corporate�Product� Area

New� DrugBiologics

HerbalMedicine

BiosimilarsNCE NME

〇 〇 〇 〇Generics APIs Devices Others

〇 〇

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 385

Clients'�Composition

(%)

Big� PharmasMid� or� Small-Size� Pharmas

BiotechCompanies

Start-ups

12% 20% 60% 8%

In-house� Facilities

Research� &Development

Preclinical ClinicalCustom

ManufacturingCustom� Sales

•Medpace�

CRO

•Central�

Reference�

Laboratories

•64� Bed�

Clinical�

Pharmacolo

gy� Unit

•Bioanalytical�

Laboratory

•Core�

Imaging�

Laboratory

•Medical�

Device

Phase� I� -� IV

Focusing�Therapeutic� Area

Oncology,� Metabolism,� Cardiovascular,� CNS,� Infectious� Disease,� Nephrology,� Medical�

Device

General� Overviewof� Corporate's� KeyContract� Services

•Clinical� Operations� � � � � � � � � � � � � � � � � •Medical� Writing

•Biometrics� � � � � � � � � � � � � � � � � � � � � � � � � •Regulatory� Affairs

•Quality� Assurance� � � � � � � � � � � � � � � � � � •Pharmacovigilance

•Cardiovascular� Core� Laboratory� � � � � •Pharmacokinetics

•Electronic� Adjudication� Services� � � � •Clinical� Pharmacology

•Bioanalytical� Services� � � � � � � � � � � � � � •Core� Imaging� Services

•Central� Laboratory� Services

Medical� Device� Development

Contract� Service�Capacity� Affordable�by� Service� Area

Medpace�offers�drug�and�device�development�services� for�all� stages�of�development�and�

has� the� supporting� services� to� seamless� integrate� the� service� offerings� creating�

efficiencies� of� time.� The� clinical� team� has� strong� support� in�medical� writing,� regulatory�

affairs,� clinical� safety,� medical� monitoring,� data� management� and� statistical� analysis.� In�

addition� the� central� laboratory,� bioanalytical� laboratory,� imaging� capabilities� and�

3.� Corporate� Business�Overview

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cardiovascular� core� laboratory� are� valuable� additions� to� the� core� contract� research�

services.

Communication�with� Clients

Dispositoion� ofProject� ManagerResponsible

The� Clinical� Trial� Manager� is� the� central� point� of� contact� and�

responsible� for� all� aspects� of� a� program.� S/he� establishes� timelines�

is� responsible� for�deliverables�and�coordinates� the� internal� resources�

required� to� execute� a� program.

Providing� RealtimeService� Delivery

Medpace� has� its� own� custom-built� and� maintained� clinical� trial�

management� system� ClinTrak®� that� provides� real-time� information�

through� a� secured� web� portal.� It� provides� key� information� on� the�

progress� of� study� and� can� be� used� to� print� out� status� reports� and�

graphics.�

RealtimeFeed-back

ClinTrak®� provides� feedback� in� a� customizable� format.

4.� Corporate� Competitiveness

CorporateCompetitiveness

Medpace�has�a� successful� track� record�of� regulatory�marketing�applications� in�Europe�

and� the� US� and�has� successfully� completed� 27�New�Drug�Applications� (NDAs)� in� the�

US.� In� addition� Medpace� has� obtained� regulatory� approval� to� begin� clinical� trials� in�

over�40� countries� including�Korea�and�China.� The� company’s� regulatory� focus� together�

with� its� strong�expertise� in�both�medical�and� scientific� areas�has�proven� the� company’s�

competitive� advantage� for� almost� 20� years.

No.� of� RegulatoryInspections

Classification FDA(US) EMA(EU) PMDA(Japan) Others

Pre-Clinical� Area

Clinical� Area 〇 〇Manufacturing� Area

Others

Current� Status� ofAccredited�Certification

GLP,� GCP,� ICH,� CAP

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 387

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� whichclients� belong� to

China,� Japan,� Korea,� Taiwan,� Hong� Kong,� Singapore

Asian� Clients'Composition(%)

Big� PharmasMid� or� Small-Size� Pharmas

BiotechCompanies

Start-ups

60% 20% 20%

No.� of� Asian� Clientsin� recent� 3� years

22

Major� Service� Rangewith�Asian�Companies

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Research 〇 API

APIs

R&D

Pre-ClinicalR&D� Strategy&�ManagementPre-clinical

Test� Sample

Phase� I 〇 Clinical� Trials 〇

Phase� II 〇 Clinical� TestSample

FinishedProducts

RegulatoryAffairs

Phase� III 〇 BusinessDevelopment

FinishedProduct

Phase� IV 〇 Sales� &Marketing

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Corporate� Name meneresearch

Head� Office� Address

GOSB� Teknopark

� Kemal� Nehrozoglu� Cad.

� Uretim� Binasi:� 2-3� Unite:� 1-6

� 41480,Gebze-Kocaeli,� TURKEY

Facilities� City� &� Country Turkey

Web-site� Address www.meneresearch.com

Contact

(Korean�

Business)

Telephone +90� 262� 751� 39� 80

E-mail [email protected]

Company� Description� &� Organization

[Mission]

Our�mission,� is� to� deliver� best� value� to� the� benefit� of� patients,� clients,� employees� and� government� through�

innovation,� trust,� speed,�quality,�global�orientation,� sound�business�management�and�dedication� to�excellent�

service.

[Vision]

� Our� vision,� is� to� primarily� provide� clinical� monitoring� and� supporting� services� and� to� design,� develop� and�

market� new� patented� software� products� in� the� clinical� research� field.� with� them� to� facilitate� the� efficient�

management� of� their� projects� and� the� success� of� our� business� partnerships.�

84. Meneresearch

1.� Corporate� General� Information

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 389

85. Midas Pharma

1.� Corporate� General� Information

Corporate� Name Midas� Pharma

Corporate� Ownership Private� Company

Head� Office� Address Rheinstrasse� 49� 55218Ingelheim/Germany

Web-site� Address http://www.midas-pharma.com

No.� of� Employees 150� employees� worldwide

Contact(Korean�Business)

Name Michael� Suess

AddressOffice� 4O,� Hongqiao� Business� Center� 2272,� Hongqiao� Road� 20� 03� 36� Shanghai,�

People`s� Republic� of� China

Telephone +86.21.62� 37� 69� 92�

E-mail [email protected]

Company� History

Since� being� established� almost� 25� years� ago,� Midas� Pharma� has� grown� into� a� global� business� while�

expanding� its� services.

April� 1988� :� Midas� Pharmachemie� GmbH� was� founded.

May� 1996:� Midas� Chimie� Fine� in� France� was� established.

May� 1998:� The� company� made� its� first� sales� of� finished� pharmaceutical� products.

January� 1999:� A� liaison� office� in� Beijing,� China� was� opened.

August� 2001:� Midas� Pharmaceuticals,� Inc.� in� the� USA� was� founded.

March� 2002:� Midas� Pharmakemi� Skandinavien� was� established� in� Copenhagen.

October� 2002:�An� import� licence� for� finished�pharmaceutical�products� from�non-EU�markets�was�granted� to�

the� company.

August� 2005:� Midas� Pharma� Polska� Sp.� z� o.o.� in� Warsaw,� Poland� was� founded.

September� 2006:� Midas� Pharma� Italia� S.r.l.� in� Gallarate� (VA),� Italy� was� established.

January� 2007:� The� company� entered� the� Japanese� market� through� an� exclusive� consultancy.

April� 2009:� A� liaison� office� in� Hyderabad,� India� was� opened.

Company� Description� &� Organization

Providing� products� and� services� across� the� full� industry� value� chain,� Midas� Pharma� is� a� mid-sized�

pharmaceutical� company� that� provides� a� wealth� of� expertise� while� connecting� companies,� people� and�

knowledge.� As� a� catalyst� for� collaboration,�we�have� been� helping� our� clients� and� partners� unlock� untapped�

potential� for� almost� 25� years.� Active� in� all� major� pharmaceutical� markets,� our� affiliates� serve� as� points� of�

contact� for� our� local� customers� as� well� as� development� and� supply� partners.� They� also� provide� local�

competence� and� networks.

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390� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

2.� Corporate� Service� &�Business� Area

Corporate�Main�

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

○ ○ ○

GeographicalBusiness� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

US ○ US ○ US US ○

Canada ○ Canada ○ Canada Canada ○

EU ○ EU ○ EU EU ○

Asia ○ Asia ○ Asia Asia ○

Global ○ Global ○ Global Global ○

Other ○ Other ○ Other Other ○

Focusing�Contract

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Research API ○

APIs

R&D

Pre-ClinicalPre-clinicalTest� Sample

R&D� Strategy&� Management

Phase� I Clinical� Trials

Phase� IIClinical� TestSample

FinishedProducts

RegulatoryAffairs

Phase� IIIFinishedProduct

BusinessDevelopment

Phase� IVSales� &Marketing

Corporate�Product� Area

New� DrugBiologics

HerbalMedicine

BiosimilarsNCE NME

Generics APIs Devices Others

○ ○

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 391

3.� Corporate� Business�Overview

General� Overviewof� Corporate's� KeyContract� Services

Midas� is� active� in� sourcing,� supplying� and� developing� finished� products,� active�

ingredients� and� intermediates.� In� addition,� we� offer� services� in:

•Custom� synthesis

•Biotechnology

•Finished� product� development

•Finished� product� manufacturing

•Regulatory� affairs

•Quality� management

•Patents� and� intellectual� property

•Business� development� and� licensing.

4.� Corporate� Competitiveness

CorporateCompetitiveness

We� offer� our� services� on� an� exclusive� basis� and� all� information� is� treated� strictly�

confidential.� In� working� with� our� customers� and� partners,� we� believe� in� full�

transparency� and� open� communication.� You� are� directly� involved� in� discussions� with�

our� partners� and� are� always� fully� aware� of� the� activities� and� progress.� You�will� gain�

access� to�our� integrated,�global�network�of�partners�and�pool�of� special� technologies,�

as� well� as� the� knowledge� gained� from� our� years� of� experience� and� that� of� our�

industry-leading� partners.

The� specialist� teams� at�Midas� cover� all� stages� of� the� pharmaceutical� value� chain� and�

are� able� to� provide� complete� solutions� to�meet� the� specific� needs� of� each� customer.

As� well� as� custom� synthesis� and� API� manufacturing,� we� offer� a� range� of�

complementary� services.

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392� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name Monitor

Head� Office� AddressCumhuriyet�Mh.�Ergenekon�Cd.Ahmetbey� Plaza�No:10�Kat:2�Pangaltı�Şişli�-� Istanbul� /� TURKEY

Facilities� City� &� Country Turkey

Web-site� Address www.monitorcro.com

Contact

(Korean�

Business)

Telephone +90� (212)� 234-1260

E-mail [email protected]

Company� Description� &� Organization

[WHAT� WE� DO]

MonitorCRO� provides� a� comprehensive� service� package� at� all� stages� of� medical� research� from� designing�

projects� and� getting� approval� from� the� legal� authorities� up� to� statistical� analysis� and� final� report�writing� to�

reach� to� a� required� outcome� for� successful� product� development.

[MISSION]

We� intend� to� run� operations� smoothly.�Our� attention� to� detail� and� experience� enable� us� to� solve� problems�

before� they� arise� so� that� our� sponsors� can� concentrate� on� their� core� businesses.

[VALUE]

We�aim� the�highest�ethical� standards�placing� the� safety�and�care�of�patients�at� the� centre�of�our� core� values.

86. Monitor

1.� Corporate� General� Information

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 393

87. Myoderm

1.� Corporate� General� Information

Corporate� Name Myoderm

Corporate� Ownership Private� Company

Head� Office� Address 330� DeKalb� Street,� Norristown,� PA� 19401� USA

Facilities� City� &� Country Norristown,� PA(USA),� Worcestshire(UK)

Web-site� Address www.myoderm.com

No.� of� Employees 28� between� US� and� UK

Financial� Status

Sales� Revenue� in� 2011(US�K$)

Capital(US� K$) Dept-equity� Ratio(%)

$165� Million private private

Contact(Korean�Business)

Name Michael� Cohen

Address 330� DeKalb� Street,� Norristown,� PA� 19401

Telephone 610-233-3302

E-mail [email protected]

Company� History

Company� has� been� involved� with� supplying� comparator� medications� for� 25� years.� � Our� company� grew� out�

of� a� retail� pharmacy� that� has� been� in� business� for� 80� years.

UK� office� opened� in� January� 2011.

Company� Description� &� Organization

Supplier� of� Commercial� medications� for� use� in� clinical� trials.� � Specifically� used� as� rescue,� concomitant,�

standard� of� care,� and� comparator� medications.

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394� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

2.� Corporate� Service� &�Business� Area

Corporate�Main�

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Supply� of

Comparator

Medications

GeographicalBusiness� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

US US US US ○

Canada Canada Canada Canada ○

EU EU EU EU ○

Asia Asia Asia Asia ○

Global Global Global Global ○

Other Other Other Other

Focusing�Contract

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Research API

APIs

R&D

Pre-ClinicalPre-clinicalTest� Sample

R&D� Strategy&� Management

Phase� I Clinical� Trials ○

Phase� IIClinical� TestSample

FinishedProducts

RegulatoryAffairs

Phase� IIIFinishedProduct

BusinessDevelopment

Phase� IVSales� &Marketing

Corporate�Product� Area

New� DrugBiologics

HerbalMedicine

BiosimilarsNCE NME

○ ○

Generics APIs Devices Others

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 395

3.� Corporate� Business�Overview

Clients'�Composition

(%)

Big� PharmasMid� or� Small-Size� Pharmas

BiotechCompanies

Start-ups

50 30 20 0

4.� Corporate� Competitiveness

CorporateCompetitiveness

Our� company� specializes� in� the� planning� and� execution� of� strategies� for� comparator�

drug� supply.� �We�have� contacts� in� the�US�and�UK,� an�ability� to� supply�products� from�

almost� anywhere� in� the�World,� have� GMP�warehouses� in� the� US� and� UK,� and� have�

a� wealth� of� experience� with� drug� supply,� clinical� supplies,� and� clinical� project�

management.

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396� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� whichclients� belong� to

Confidential

Asian� Clients'Composition(%)

Big� PharmasMid� or� Small-Size� Pharmas

BiotechCompanies

Start-ups

50% 25% 25% -

No.� of� Asian� Clientsin� recent� 3� years

8

Major� Service� Rangewith�Asian�Companies

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Research API

APIs

R&D

Pre-ClinicalPre-clinicalTest� Sample

R&D� Strategy&�Management

Phase� I Clinical� Trials ○

Phase� IIClinical� TestSample

FinishedProducts

RegulatoryAffairs

Phase� III

FinishedProduct

BusinessDevelopment

Phase� IVSales� &Marketing

6.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

We�have� significant� expertise� in� providing� innovator� products� for� Biosimilar� research.� �We� can� supply� for� all�

stages,� from�analytical� (helping� to�build�a� library�of� lots� for� a�particular�product)� to� large�Phase�3� trials.� �We�

collaborate�with�our� customers� in�advance� to�advise� regarding� sourcing� strategy� for� these� innovator�products.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 397

Corporate� Name Nagy� Research

Head� Office� Address Building� 63,� Road� 104,� Maadi,� Cairo,� Egypt.

Facilities� City� &� Country Egypt

Web-site� Address www.nagyresearch.com

Contact

(Korean�

Business)

Telephone +20-2-25275071

E-mail [email protected]

Company� Description� &� Organization

[Mission]

Client� satisfaction� through�providing�highest� quality� research� services� at� best� prices�within� agreed� timelines.

[Vision]

To� be� a� leading,� well-known� service� research� organization� worldwide.

88. Nagy Research

1.� Corporate� General� Information

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398� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name NOVA� TRIALS

Head� Office� Address Israel

Facilities� City� &� Country novatrials.com

Web-site� Address +972-77-2052400

Contact

(Korean�

Business)

Telephone [email protected]

E-mail [email protected]

Company� Description� &� Organization

NovaTrials� is� a� privately� owned� Contract� Research� Organization� with� a� great� experience� within� the� Israeli�

pharmaceutical,� medical� device� and� health� care� industry.� NovaTrials� offers� her� clients� with� clinical� research�

services� in�all�aspects�of� study�monitoring�and�centre�management,� from�set�up� to� centre�closure,� according�

to� current� GCP� requirements.� � Our� reliable� and� efficient� support� is� based� on� well� established� experience�

performing� phase� II-IV� studies� in� a� global� team� environment� in� multiple� therapeutic� areas.

Managed�by�Noga�Brunicki,�NovaTrials� is�committed� to�provide�personalized�service,� fast� response� times�and�

the� ability� to� custom� design� a� strategy� that� will� fit� to� each� of� our� clients� based� on� their� individual� needs.�

NovaTrials� is� an�expanding� leading�company�who�demonstrated�an�outstanding�ability� to�work� to�deadlines�

and�drive� recruitment�at�centers�while�delivering�quality�work,� together�with� flexibility� and�capability� to�work�

closely� with� a� cross� functional� team.

89. NOVA TRIALS

1.� Corporate� General� Information

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 399

Corporate� Name NOVAGENIX

Head� Office� AddressNovagenix� Bioanalytical� Drug� R&D� Centre,�Özal� Blv.� (Esenboğa� Yolu)� 25.�km� 06970� Akyurt� /� ANKARA� -� TURKEY�

Facilities� City� &� Country Turkey

Web-site� Address www.novagenix.com

Contact

(Korean�

Business)

Telephone +90� (312)� 398� 10� 81�

E-mail [email protected]

Company� Description� &� Organization

Novagenix� Bioanalytical� R&D� Centre� has� been� established� as� a� result� of� the� need� for� a� center� of�

Bioavailability� /� Bioequivalence� (BA� /� BE)� to� analyse� the� effectiveness� of� drugs� in� our� country,� thus�

determining� the� quality� with� accredited� certifying� organisation� in� an� international� level.� Nowadays,� in-vitro�

dissolution� analysis� and� quantification� of� active� compound� analysis� are� being� done.In� addition,� Novagenix�

provides�services� in� the� fields�of� analysis�of�herbal�products�and� intermediates,�phase� studies�and� registration�

dossiers� in� CTD� format.�

90. NOVAGENIX

1.� Corporate� General� Information

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400� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name Novotech

Corporate� Ownership Private� Company

Head� Office� Address Level� 3,� 235� Pyrmont� Street,� Pyrmont,� NSW� 2009

Facilities� City� &� Country Sydney(Australia)

Korean� Business� Office #601,�City�Air� Tower,�Samsung-dong�159-9,�Seoul,�Gangnam-gu,�135-090,�Korea

Web-site� Address http://www.novotech-cro.com

No.� of� Employees 158

Financial� Status

Sales� Revenue� in� 2011

(US� K$)Capital(US� K$) Dept-equity� Ratio(%)

$18M Confidential 0

Contact(Korean�Business)

Name Juhn,� Jeong,� Country� Manager� Korea

Address #601,�City�Air� Tower,�Samsung-dong�159-9,�Seoul,�Gangnam-gu,�135-090,�Korea

Telephone +82� 70� 7727� 0761

E-mail [email protected]

Company� History

In� 1996,� Novotech� establishes� operations� in� Sydney,� Australia.� Initial� service� offering:� regulatory� affairs.� In�

1997,� data� management� and� clinical� research� services� were� added.� In� 1999,� Novotech� obtains� ISO� 9000�

accreditation.� In�2002,�New�Zealand� subsidiary�was�established.� In�2003�and�2004,�Melbourne� and�Brisbane�

offices� were� opened.� In� 2006� and� 2008,� Novotech� was� awarded� inaugural� Australian� CRO� of� the� Year� by�

Frost� &� Sullivan.� In� 2007,� Novotech� initiated� operations� in� India� and� South� Korea.� In� 2009,� Novotech�

operations�established� in�Malaysia�and�Singapore.� In�2010,�operations� in�Thailand�were�established.� In�2011,�

Novotech’s� Asian� operations� expanded� to� Taiwan.

91. Novotech

1.� Corporate� General� Information

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 401

Company� Description� &� Organization

Established� in� 1996,� and�with� operations� across� Asia,� Novotech� is� the� largest� clinical� CRO� headquartered� in�

Australia.� With� operations� in� Australia,� New� Zealand,� India,� South� Korea,� Taiwan,� Thailand,� Malaysia� and�

Singapore,�Novotech’s� service� offering� has� come� to� be� recognized� for� its� quality� both� by� our� clients,� as�well�

as� industry� analyst� groups.� Engaged� primarily� to� manage� clinical� trials� for� FDA� and� EMA� registration,�

Novotech’s� track� record� includes� hundreds� of� phase� I-III� clinical� trials� for� biotechnology,� pharmaceutical� and�

medical� device� developers.� �We� operate� across� a� broad� therapeutic� range� including� oncology,� dermatology,�

cardiovascular,� CNS,� as� well� as� biosimilars� to� name� a� few.� � A� large� proportion� of� Novotech’s� clients� are� US�

based�drug�and�device�development� firms,�who�are�engaged� in� large� international� trials� in�Asia�and�Australia�

to� speed� up� product� development� in� a� cost� effective� manner.� �

In�addition,� through�key� strategic�partnerships�we�offer�worldwide� reach� to�our�Asian�clients,� including�North�

America,� eastern� and� western� Europe,� and� Latin� America.�

Novotech� Sydney� is� the� only� Australian� CRO� with� ISO9001� certification.� � Our� services� include� clinical� trial�

management,� data� management� including� EDC,� biostatistics,� regulatory� affairs� consulting� and� medical�

writing.

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402� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

2.� Corporate� Service� &�Business� Area

Corporate�Main�

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

○ ○

GeographicalBusiness� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

US US US US

Canada Canada Canada Canada

EU EU EU EU

Asia Asia Asia Asia

Global Global Global Global

Other

Australia�&�

New�

Zealand

Other Other Other

Australia�&�

New�

Zealand

Focusing�Contract

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Research API

APIs

R&D

Pre-ClinicalPre-clinicalTest� Sample

R&D� Strategy&� Management

Phase� I ○ Clinical� Trials ○

Phase� II ○Clinical� TestSample

FinishedProducts

RegulatoryAffairs

Phase� III ○FinishedProduct

BusinessDevelopment

Phase� IV ○Sales� &Marketing

Corporate�Product� Area

New� DrugBiologics

HerbalMedicine

BiosimilarsNCE NME

○ ○ ○ ○

Generics APIs Devices Others

○ ○

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 403

Clients'�Composition

(%)

Big� PharmasMid� or� Small-Size� Pharmas

BiotechCompanies

Start-ups

10% 40% 40% 10%

Focusing�Therapeutic� Area

(%)

Oncologics Lipid� RegulatorsRespiratory�Agents

Anti-ulcerantsAngiotensin� � � II�Antagonists

22 4 12 0 4

AntipsychoticsAutoimmune�agents

Antidepressants Analgesics Others

0 2 0 7 49

Therapeutic� area� experience� includes� the� following:

Analgesia� -� pain� management

Anti-infectives� ­� antivirals,� novel� antibiotics,� vaccines

Cardiovascular� -� acute� coronary� syndromes,� CAD,� CHF,� chronic� angina

CNS� -� ADHD,� Alzheimer's,� epilepsy,� migraine,� MS,� sleep� disorders,� stroke

Dermatology� -� actinic� keratosis,� basal� cell� carcinoma,� hyperhidrosis,� tinea

Endocrinology� -� diabetes� type� I� and� II,� HRT,� obesity,� osteoporosis

Haematology� -� CTCL,� DVT,� leukaemia,� lymphoma,� myeloma,� PTCL

Infectious� Diseases� -� genital� herpes,� influenza,� pneumonia,� sepsis

Gastroenterology� -� Crohn's� disease,� haemorrhoids,� IBD

Oncology� -� a� range� of� indications� including:� breast,� colorectal,� glioma,� head� &

neck,� hepatic,� melanoma,� NSCLC,� ovarian,� pancreatic,� prostate

Ophthalmology� -� glaucoma,� macular� degeneration

Psychiatry� ­� bipolar� disease,� depression,� schizophrenia

Respiratory� &� Allergy� -� asthma,� bronchitis,� emphysema,� pneumonia,� rhinitis

Rheumatology� -� OA,� RA

We� also� have� experience� in� studies� involving� the� following� devices:

Cardiovascular,� CNS,� Infectious� Disease,� Gastroenterology,� Respiratory� &� Allergy

General� Overviewof� Corporate's� KeyContract� Services

Novotech’s� services� cover� the� full� spectrum� of� clinical� drug� development� requirements.� �

This� includes� protocol� concept� and� design,� regulatory� advice� and� submissions,� ethics�

committee� submissions,� feasibility� assessment,� site� identification� and� selection,� patient�

recruitment� initiatives,� laboratory� management,� site� monitoring� to� ICH� GCP,� vendor�

selection� and� management� (including� quality� assurance� audits),� data� management�

3.� Corporate� Business�Overview

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404� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

(including� safety),� biostatistics� and� report� writing.� These� services� are� available� in�

Australia,� New� Zealand,� South� Korea,� India,� Taiwan,� Thailand,�Malaysia� and� Singapore.� �

In� each� of� these� countries,� locally� based� Novotech� staff� with� expertise� in� the� local�

environment� apply� a� common� process� in� service� delivery,� and� are� subject� to� the� same�

rigorous� quality� assurance� and� auditing� requirements� throughout� the� region.

Contract� Service�Capacity� Affordable�by� Service� Area

Novotech’s� costs� are� presented� in� a� clear� and� transparent�manner� to� clients� before� any�

work� is� undertaken.� � Feasibility� for� new� projects� is� typically� carried� out� free� of� charge.� �

For� the� rest�of�our� services,�costs�are�calculated�based�on�service� requirements�of� clients,�

ensuring� regulatory�compliance�at�all� times,� and�based�on� time� requirements� to�perform �

the� required� tasks.� � Quotes� are� usually� provided�on� a� fixed� price� basis�with� any� change�

in� scope� requiring� the� approval� of� both� the� client� and� Novotech.� � When� required�

Novotech� is� able� to� substantially� add� to� its� capacity� to� service� larger� projects� drawing�

on� our� pool� of� experienced� personnel� throughout� the� region.

Communication�with� Clients

Dispositoion� ofProject� ManagerResponsible

All� Project� Managers� undergo� rigorous� training� on� all� aspects� of�

projects� they� are� assigned� to� manage.� � Novotech� will� maintain�

regular� communication� with� clients� regarding� the� progress� of�

studies.�Novotech�will� be� available� to�attend�meetings�as� requested�

by� clients� either� via� teleconference� or� in� person.

Providing� RealtimeService� Delivery

A� Project� Plan� is� developed� by� the� Project�Manager,� detailing� tasks�

that� require�consideration�and�management� throughout� the�project.�

This� plan� is� approved� by� the� client� prior� to� implementation� and�

includes:

-� a� communication� plan

-� a� recruitment� plan

-� a� clinical� monitoring� plan

-� a� risk� management� plan

RealtimeFeed-back

Novotech�provides� regular� status� reports� to� clients,�with� the�Project�

Manager� having� responsibility� for� notifying� clients� of� all� important�

issues� as� they� arise.� Novotech� can� also� make� available� real� time�

reporting� via� its� Oracle� Siebel� Clinical� Trial� Management� System �

(CTMS)� giving� clients� direct� access� to� key� metrics� regarding� their�

projects.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 405

4.� Corporate� Competitiveness

CorporateCompetitiveness

Amongst�smaller� international�CROs,�Novotech�has� the�widest� footprint� in� the� industry�

for� ability� to� deliver� clinical� outsourced� services� across� the� Asia� Pacific.� � This� makes�

Novotech�uniquely�placed� to�service� the� requirements�of�biotechnology� companies,� as�

well� as� small� to� midsize� pharmaceutical� companies.� � Our� track� record� includes�

hundreds� of� clinical� trials� across� most� therapeutic� areas,� with� currently� 8� NMEs�

approved� by� FDA� and� marketed� internationally� based� on� data� from� clinical� trials�

managed� by� Novotech.� �

To� date,�Novotech�has� been� audited� 33� times�by,� FDA,� EMA,� Sponsors� and�CROs,�all�

with�no�critical� findings.� � In�addition,�Novotech� is�one�of� very� few�CROs� in� the� industry�

to� have� achieved� ISO� 9000� quality� certification� for� clinical� and� data� management�

services.

Being� headquartered� in� the� region� means� Novotech� is� highly� focused� on� services� in�

the� region,� even� if� our� client� base� is� global.� � Our� local� environment� knowledge� and�

expertise� is� a� major� reason� behind� our� 80%+� repeat� business� rate,� as� is� the� wide�

range� of� our� services� which� allows� us� to� provide� a� turnkey� solution� to� most� clinical�

trial� outsourcing� needs.

No.� of� RegulatoryInspections

Classification FDA(US) EMA(EU) PMDA(Japan) Others

Pre-Clinical� Area

Clinical� Area 2 2

29�(clients�and�

other� CRO� �

partners)

Manufacturing� Area

Others

Current� Status� ofAccredited�Certification

ISO� 9001� certification

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5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� whichclients� belong� to

Australia,� France,� Germany,� Japan,� Malaysia,� New� Zealand,� South� Korea,� Taiwan,�

Thailand,� United� Kingdom,� United� States.

Asian� Clients'Composition(%)

Big� PharmasMid� or� Small-Size� Pharmas

BiotechCompanies

Start-ups

2 49 49 0

No.� of� Asian� Clientsin� recent� 3� years

18� Asian� clients� (65� in� total)

Major� Service� Rangewith�Asian�Companies

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Research API

APIs

R&D

Pre-ClinicalPre-clinicalTest� Sample

R&D� Strategy&�Management

Phase� I ○ Clinical� Trials ○

Phase� II ○Clinical� TestSample

FinishedProducts

RegulatoryAffairs

Phase� III ○

FinishedProduct

BusinessDevelopment

Phase� IV ○Sales� &Marketing

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 407

Corporate� Name Ocimum� Biosolutions� Ltd

Corporate� Ownership Private� Company

Head� Office� AddressRoyal� Demeure,� Plot� No.� 12/2,� Sector-1� HUDA� Techno� Enclave,� Madhapur�

Hyderabad-500� 081,� A.P.,� India

Facilities� City� &� Country HYDERABAD(INDIA),� HUSTON(TX),� JAPAN,� GERMANY

Web-site� Address www.ocimumbio.com

No.� of� Employees 150

Financial� Status

Sales� Revenue� in� 2012

(US� K$)Capital(US� K$) Dept-equity� Ratio(%)

99,621.92$ 0.54

Contact

(Korean�

Business)

Name Ms.� Priya� /� Mrs.� Geethanjali� Tanikella�

AddressRoyal� Demeure,� Plot� No.� 12/2,� Sector-1� HUDA� Techno� Enclave,� Madhapur�

Hyderabad-500� 081,� A.P.,� India

Telephone +91� 40-� 66986700

E-mail [email protected]� &� [email protected]

Company� History

Ocimum� Biosolutions,� with� resounding� history� in� the� arena� of� providing� LIMS� solutions� to� biorepository�

industry,�understands� this�need�of� the�scientific�community�and�have�developed�a�core�product�with�built-in�

solution� that� provide� as� much� application� specific� functionality� as� possible� out-of-the-box� to� meet� the�

particular� needs�of� the� biorepository� as� yours.�Our� growth�plan�and� strategy�has� been� envisioned� to� cater�

the� changing� and� growing� needs� of� the� research� community.� Our� acquisition� of� Gene� Logic’s� genomic�

division�makes� us� to� stand� as� the� �most� experienced� commercial� microarray� facility.�We� are� indebted� our�

growing� list� of� global� customers,� in� terms� of� being� trustworthy� and� being� referred� � as� partners� in� their�

R&D� efforts.�Majority� of� them� revert� and� have� chosen� us� as� their� long� term� outsourcing� partner� for� their�

ongoing�programs.� This� has� helped� us� continuously� in� expanding� our� portfolio� and�offering� unique� range�

of� integrated� solutions.

Company� Description� &� Organization

Ocimum� Biosolutions� is� a� global� “Integrated� Life� Science� Informatics”� company,� providing� the� Information�

Solutions� to� Pharma,� Life� Science,� Health� Care,� Agro� Bio,� CROs,� Diagnostics,� Government� and� Academic�

research.� Our� products� and� consulting� services� have� been� used� by� top� scientists,� analysts� and� managers� �

globally� for� over� 12� years.

92. Ocimum Biosolutions Ltd

1.� Corporate� General� Information

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408� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

2.� Corporate� Service� &�Business� Area

Corporate�Main�

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

○ ○ ○

GeographicalBusiness� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

US ○ US US ○ US ○

Canada ○ Canada Canada ○ Canada ○

EU ○ EU EU ○ EU ○

Asia ○ Asia Asia ○ Asia ○

Global ○ Global Global ○ Global ○

Other ○ Other Other ○ Other ○

Focusing�Contract

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Research ○ API

APIs

R&D ○

Pre-Clinical ○Pre-clinicalTest� Sample

R&D� Strategy&� Management

Phase� I ○ Clinical� Trials ○

Phase� II ○Clinical� TestSample

FinishedProducts

RegulatoryAffairs

Phase� III ○FinishedProduct

BusinessDevelopment

Phase� IV ○Sales� &Marketing

Corporate�Product� Area

New� DrugBiologics

HerbalMedicine

BiosimilarsNCE NME

Generics APIs Devices Others

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 409

Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

50 20 20 10

In-housse� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

○ ○ ○ ○

Focusing�

Therapeutic� Area

(%)

Oncologics Lipid� RegulatorsRespiratory�

AgentsAnti-ulcerants

Angiotensin� � � II�

Antagonists

30 5 10 5 15

AntipsychoticsAutoimmune�

agentsAntidepressants Analgesics Others

10 15 10 5 5

Our� product� BioExpress®� -� a� commercial� gene� expression� database� offers� datasets� in�

various� therapeutic� areas� like� ­� Oncology� ,� Inflammation,� Cardiovascular,� Central�

nervous� systems� and�Metabolic� disorders..� Our� specialty� lab� information�management�

solutions� � (LIMS)� solution,� Biotracker™� caters� to� the� growing� needs� of� labs� in� global�

companies� and� research� working� in� varied� therapeutic� areas.� centers.

General� Overview

of� Corporate's� Key

Contract� Services

Ocimum� Biosolutions� is� a� leading� genomics� company� providing,� comprehensive�

genomic� reference� databases,� -� LIMS,� Softwares� andBio-IT� consulting� services� .� ..� Our�

solutions� span� across� key� priority� areas� including� BioPharmaceutical,� Diagnostics,�

Agriculture,� Food� &� Nutrition.�

Our� products� in� Brief� ­�

BioExpress®� System� -� A� comprehensive� genome-wide� gene� expression� database�with�

histopathology,� clinical� chemistry,� hematology,� treatment,� follow-up� and� many� other�

clinical� details� for� over� 22,000� clinically-defined� tissue,� blood,� and� cell� samples� from�

human� clinical� studies� and� complementary� animal� models.

ToxExpress®� Program� -� A� toxicity-based� gene� expression� database� coupled� with�

classical� toxicology� endpoints� to� lead� optimization� and� drug� safety� studies.

ASCENTA®�System�-�Provides� � fast,�easy,�and�affordable�way� to�assess,�prioritize,� and�

qualify� gene� targets� and� potential� biomarkers.�

Genowiz™� -� A� gene� expression� analysis� program� that� has� been� designed� to� store,�

process� and� visualize� gene� expression� data� efficiently.�

Genchek™� -� � A� � comprehensive,� multi-platform,� sequence� analysis� software� package.�

It� facilitates� analysis� of� Expressed� Sequence� Tags� (ESTs),� Complete�Genome,� and� SNP�

(Single� Nucleotide� Polymorphism)� data.

iRNAchek™� � -� It� provides� a� comprehensive� and� intuitively� designed� environment� for�

3.� Corporate� Business�Overview

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organization� of� sequence� data,� design� of� siRNAs,� and� tracking� and� analysis� of�

successful� templates.

OptGene™� -�A�novel�Gene�Optimizing� tool� that�optimizes�naturally�occurring�genes� to�

achieve�higher�productivity,�at� the�same�time�giving�higher� flexibility� for�protein�design.

Biotracker� LIMS� (BTrnx)­� A� next� gene� version� offered� as� a� on� premise� solutions.

Biotracker� LIMS�Enterprise�Edition� (BTREE)� ­�A� �web�based�application�offered�as� “Saas”�

and� “on� premise”� solutions

Facility�Tracker� ­�A� fully�web�based�solutions�designed� for�core� facilties�and�basic� LIMS�

functions

Contract� Service�

Capacity� Affordable�

by� Service� Area

Contract� services� offered� by� us�

1)� ToxExpress� ­� Toxicity� screening� of� drugs� for� lead� optimization�

2)�BIO-� IT� consulting�­�NGS�data�analysis,�Gene�expression�and�genotyping�analysis�and�

also� Genome� wide� association� studies� (GWAS)

3)�Preclinical� services� ­Sample� Isolation� ,�DNA/RNA�extraction,�Gene,�Exon�and�miRNA�

Expression,� Sequencing,� qRT-� PCR,� cloning� services,� genotyping� and� copy� number.

4)� Research� Xcelerator� -� A� framework� for� integrated� genomic� and� proteomic� data�

analysis� designed� for� Biologists� and� Bioinformaticians� and� is� conveniently� deployed�

on� public-private� cloud/cluster.� Apart� from� facilitating� high� throughput� jobs� on�

multiple� workflows�within� a� single� framework� it� can� also� be� used� in� customizable�

environment

Communication�

with� Clients

Dispositoion� of

Project� Manager

Responsible

Ocimum�displays�high�sense�of�methodology�while� figuring�out� the�

project� plan.� Responsibilities� being� aligned� with� the� project�

manager�get� the�maximum�space� in� terms�of�word�exchange,�kick�

up� meetings� and� design� discussion.� With� the� processing� of� User�

Requirement� � � Specifications� (URS)� and� Functional� Requirement�

Specifications� (FRS)� the� metrics� deployment� schemes� do� take� a�

well� proved� step� for� delivering� any� project� on� a� specific� length.

Providing� Realtime

Service� Delivery

Ocimum�believes� in�affording� less� time� for� support� and�delivery�of�

service� to� its� customers.� It� follows� up� with� the� severity� in� issues�

and� their�possible�delivery�on� time.�With� the�cropping�of�each�new�

issue�or�blocker,� there� is� fair�play�of� time�management�with� regard�

to� analysis,� evaluation� and� delivery.� It� is� always� been� an� effective�

methodology� on� the� part� of� Ocimum� to� display� tasks� on� a� more�

managerial� front.

Realtime

Feed-back

Ocimum�has�a�dedicated�and�well� trained� technical�and� functional�

support� team� which� address� the� production� issues� within� an�

average� span�of� 2hours� to� 48hours� depending�upon� the� criticality�

and� prioritization.� Right� from� issue� reporting,� addressing,� fix� plan,�

fix� solution� to� production� roll� out-� the� complete� life� cycle� of� issue�

will�be�handled�using�an�online� ticket�mechanism�straight� from�the�

LIMS� application� and� Ocimum� corporate� website.� �

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 411

4.� Corporate� Competitiveness

CorporateCompetitiveness

Innovation

The� emergence� of� genomic� technologies� in� 1990’s� had� a� tremendous� impact� on�

global� pharmaceutical� and� biotech� organizations,� as� these� technologies� found� wide�

ranging� application� in� their� in-house� research.� We� have� been� a� key� innovator� and�

through� our� subsidiary,� Gene� Logic,� � are� pioneers� as� industry� adopters� of� genomic�

technologies,� knowledge� databases,� discovery� platforms.� This� has� helped� us� to�

develop� the� infrastructure� and� expertise� -� in� providing� � the�widest� range� of� genomic�

services� which� we� now� offer� to� global� pharmaceutical,� biotech� and� research�

organizations.

Flexibility

Ocimum�has� built� processes� and� systems� that� help� us� deliver� the� highest-quality� and�

reproducible�dataOur� internal� research�programs�challenged� the� lab�with�new�sample�

types� and� limited� RNA� amounts.� Samples� were� provided� from� multiple� sites� under�

timelines� that� kept� changing.� We� built� our� system� to� handle� these� issues.� We� have�

an�on-site�biorepository;�We�understand� that�our� customers’� requirements� are�unique�

and� design� customized� and� flexible� solutions� for� them.�

Quality

We� are� the� acknowledged� leader� in� providing� high� quality� genomic� data.� Major�

pharmaceutical� companies�and�Federal�Drug�Agency� (FDA)�uses�our�data�as� reference�

standards.� Our� Quality� Assurance� Programs� validated� the� established� procedures� and�

protocols� and� QC�metrics� �was� � determined.� New�methods� undergo� rigorous� testing�

and� their� results� are� compared� to� previous� work,� prior� to� method� certification.�

Experience

Our� subsidiary,� Gene� Logic� started� running� genomic� platforms� over� 12� years� ago� for�

our�own� target�discovery�and�biomarker�development�programs.� .�We�have�completed�

hundreds�of�data�analysis�projects� for�our�clients.�We�are�GLP�compliant�and�have� run�

many� successful� clinical� trials.� External� audits� by� clients� have� confirmed� our�

compliance.

Cost-� Effectiveness� ­� We� offer� quality� service� at� competitive� price.

Multi-location� ­� Our� presence� in�multiple� locations� around� the� globe� helps� clients� to�

gain�better�access� to�our� services�and�products.� It� eases� the� coordination�and�reduces�

the� time� gap� in� communicating� essential� issues.

Current� Status� ofAccredited�Certification

GLP/GCP/GMP

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5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� whichclients� belong� to

Across� the� Clobe

Asian� Clients'Composition(%)

Big� PharmasMid� or� Small-Size� Pharmas

BiotechCompanies

Start-ups

60 15 15 10

No.� of� Asian� Clientsin� recent� 3� years

356� clients� form� Asia

Major� Service� Rangewith�Asian�Companies

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Research ○ API

APIs

R&D ○

Pre-Clinical ○Pre-clinicalTest� Sample

R&D� Strategy&�Management

Phase� I ○ Clinical� Trials ○

Phase� II ○Clinical� TestSample

FinishedProducts

RegulatoryAffairs

Phase� III ○

FinishedProduct

BusinessDevelopment

Phase� IV ○Sales� &Marketing

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 413

6.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

Ocimum�Biosolutions� has� got� vast� experience� in� gene� expression� profiling� services� and�has� also� developed�unique� and� � curated� gene� expression� database.The� BioExpress®� System� offers� in� a� single� platform,� phenotypic,� clinical� and� experimental� information�coupled�seamlessly�with�high-quality�Affymetrix�GeneChip®�microarray�data.�Unique�software�analysis� tools�enable� researchers� to� maximize� the� benefit� of� the� BioExpress®� System� data� to� to� reach� conclusions.You� can� access� the� BioExpress®� System� through� flexible� subscription� terms� that� take� into� account� your�specific�needs.�You�can�choose�a� full� subscription� to� the�entire�BioExpress®�System�or� select� specific� sample�subsets� relevant� to�your� therapeutic�area�of� research.� In�addition� to�accessing� the�human�and�animal� tissues�and�cell� line�samples,� subscriptions�also� include�on-site� training�and�use�of� the�Genesis�Enterprise�System®�Software� for� enterprise-wide,� rigorous,� open-ended� data� mining� and� analysis.The� BioExpress®� System� offers� data� sets� in� therapeutic� areas� that� accelerate� today’s� most� compelling�research� needs:

Oncology� Suite�

The�BioExpress®�Oncology�Suite�contains�gene�expression�data� from�primary,�metastatic�and�benign� tumor�samples� and� normal� samples,� including� matched� adjacent� controls.� The� suite� includes� valuable�hematological� malignancy� samples� for� many� well-known� cancers.�

Inflammation� Suite

The� BioExpress®� Inflammation� Suite� contains� gene� expression� profiles� for� both� autoimmune� and�inflammatory�diseases.�Due� to� the� complex�nature�of� inflammatory�processes,� targeted�diseases� represented�in� the�BioExpress®� Inflammation�Suite� include�a� combination�of�human�clinical� samples,� animal�models�of�disease� development� and� cellular� systems.�

Cardiovascular� Suite

The�BioExpress®�Cardiovascular� Suite� is� a� large-scale,�comprehensive� reference�data�set� consisting�of�gene�expression� profiles,� clinical� annotations� and� histopathology� information� derived� from� the� analysis� of� our�collection� of� human� tissues� and� complementary� animal�models� related� to� cardiac� and� vascular� diseases…

Central� Nervous� System� Suite

The� BioExpress®� Central� Nervous� System� (CNS)� Suite� is� a� large� scale,� comprehensive� reference� data� set�consisting� of� gene� expression� profiles,� clinical� annotations� and�pathological� information� data� derived� from�our� collection� of� high-quality,� well-documented� psychiatric� and� neurodegenerative� diseased� human� brain�tissues� and� complementary� animal� models.

ToxExpress

Toxicogenomic� profiling� can� accelerate� the� pace� of� uncovering� critical� information� before� making�investments� into� preclinical� studies.� The� use� of� microarrays� to� examine� gene� expression� profiles� of�compounds� in� animal� systems,� when� benchmarked� to� large� reference� data� sets,� helps� establish� accurate�predictive�methods� that� identify� potential� toxic� liabilities,� even� in� the� absence� of� overt� injury.� In� addition,�Gene� Logic’s� ToxExpress®� Program� helps� to� streamline,� focus� and� augment� subsequent� classical� studies�through�specialized�applications� that� support�key� research�areas�of�predictive,� investigative�and�mechanistic�toxicology� as� well� as� safety� biomarker� discovery.

The�products�and�services� that�comprise�our�ToxExpress®�Program�can� transform�and�augment�your�critical�Preclinical� toxicological� programs.� With� one� service� provider,� you� have� direct� access� to� the� full� spectrum�of� compound� safety� assessment� technologies,� providing� powerful,� innovative� ways� of� resolving� drug�development� questions� and� enabling� targeted� compound� decisions.

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93. OnCall LLC.

1.� Corporate� General� Information

Corporate� Name OnCall� LLC.

Corporate� Ownership Private� Company

Head� Office� Address 114� Fifth� Avenue,� New� York,� NY� 10011

Facilities� City� &� Country Cincinnati,� Carlsbad� &� US

Web-site� Address http://www.oncall-llc.com

Contact(Korean�Business)

Name -

Address -

Telephone 888-795-5598

E-mail [email protected]

Company� History

In� September� 2004,� OnCall� became� a� wholly-owned� subsidiary� of� WPP,� one� of� the� largest� global�

communications�companies.�As�part�of�WPP,�we�are�able� to�offer� the�most� comprehensive�array�of� innovative�

sales� solutions� to� clients� in� the� US� and� globally.�

OnCall� has� enjoyed� successful� contracts� with� some� of� the� biggest� names� in� the� industry.� Together,� OnCall�

and�WPP�will� continue� to�grow�and� respond� to� the�needs�of� the�marketplace,�offering� the�most�progressive�

range� of� commercialization� solutions� including� contract� sales,� pharma� contract� sales,� biotech� contract� sales,�

dental� contract� sales,� outsourced� sales� force,� recruiting� pharmaceutical� sales� representatives,� trade� relations�

management,� marketing� communications,� e-detailing,� and� telesales.� OnCall� also� has� a� leading� edge� sales�

force� automation� tool� called� OnCall� SFA.� This� application� is� touted� as� the� pharma� SFA� and� biotech� SFA� of�

choice�by�many� leading�pharmaceutical�and�biotech�companies.�OnCall�has�established� itself� among� the�most�

sophisticated� contract� sales� organizations� in� the� US.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 415

2.� Corporate� Service� &�Business� Area

Corporate�Main�

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

GeographicalBusiness� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

US US US ◯ US

Canada Canada Canada Canada

EU EU EU EU

Asia Asia Asia Asia

Global Global Global Global

Other Other Other Other

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416� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name Optimum

Head� Office� Address Mustafa� Kemal� Mah� 2127.� Sk.� 38� /4� Çankaya� /� ANKARA� TURKEY

Facilities� City� &� Country Turkey

Web-site� Address www.optimum-cro.com

Contact

(Korean�

Business)

Telephone (+90)� (312)� 231� 76� 46�

E-mail [email protected]

Company� Description� &� Organization

OPTIMUM�CRO�was� established� in�September� 2000� as� one�of� the� first� CROs� in�Turkey.� Beginning� from� this�

date,�many� projects� have� been� conducted,� varying� from� international� phase� III� and� local� phase� II� studies� to�

post-marketing� trials.�More� than�20� employees� (including�CRAs,� PMs,�QC� and�data�management� units)� are�

located� in� the� main� office� based� in� Ankara,� the� capital� city� of� Turkey.

With� its�high�development� rate,�OPTIMUM�CRO� is�one�of� the� leading� foundations� for�conduct,�organization�

and� improvement� of� clinical� researches� in�Turkey.�Our�main� concern� is� to�provide�high�quality� standards� for�

all� the� local� and� international� trials� starting� from� the� design�phase� through� statistical� analysis� report,�which�

constitutes� our� mission� as� well.� Our� vision� is� to� be� a� leader� in� providing� high� quality� in� all� our� services�

including� clinical� researches� originating� from� Turkey� expanding� worldwide.

94. Optimum

1.� Corporate� General� Information

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 417

Corporate� Name Optimumclintrial

Head� Office� Address Optimum� ClinTrial� Nigeria,� 9,� Fola� Daniel� Close,� � Lekki� Phase� 1,� Lagos

Facilities� City� &� Country Nigeria

Web-site� Address optimumclintrial.com

Contact

(Korean�

Business)

Telephone +234� 814� 013� 9672

E-mail [email protected]

Company� Description� &� Organization

Optimum�ClinTrial� Limited� is� an� independently� run�Site�Management�Organisation� (SMO)�based� in�Lagos�but�

managing� a� network� of� Sites� across� Nigeria.

We� have� assembled� a� team� of� experienced� and� highly� qualified� Homeexpertise� in� the� field� of� Clinical�

Research� to� fulfil� the� emerging� needs� of� Pharmaceutical� � � and� Healthcare� Industry.

Our� aim� is� to� improve� the� quality�of� Patient/Investigator� interface�and�also� Sponsor/Investigator� interface� in�

other� to� improve� clinical� trial� efficiency� in� Nigeria� to� ensure� that� clinical� trials� are� conducted� in� accordance�

with� Good� Clinical� Practice� (GCP)� in� an� ethical,� cost� effective� and� systematic� method.

95. Optimumclintrial

1.� Corporate� General� Information

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96. Pacific BioLabs

1.� Corporate� General� Information

Corporate� Name Pacific� BioLabs

Corporate� Ownership Private� Company

Head� Office� Address 551� Linus� Pauling� Dr

Facilities� City� &� Country Hercules,� Unites� States

Web-site� Address www.pacificbiolabs.com

No.� of� Employees 65

Contact(Korean�Business)

Name Aaron� Burke

Address -

Telephone +1� 510-964-9000

E-mail [email protected]

Company� History

Founded� in� 1982� as� Northview� Pacific� Labs� and� renamed� Pacific� BioLabs� in� 2005.� Pacific� BioLabs� has� been�

serving� the� biotech,� pharmaceutical,� and� medical� device� industries� with� preclinical� testing� and� lot� release�

testing� for� many� years.

Company� Description� &� Organization

Pacific� BioLabs� is� a� contract� research� organization� (CRO)� offering� testing� and� research� support� services�

primarily� focused� on� supporting� the� pharmaceutical,� biotech,� and� medical� device� industries.� Specializing� in�

the�biological� sciences,�PBL� is� committed� to�helping� its�clients�deliver� lifesaving�medicines�and�medical�devices�

to� physicians� and� patients� who� need� them.�

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 419

2.� Corporate� Service� &�Business� Area

Corporate�Main�

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

○ ○

GeographicalBusiness� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

US ○ US US US

Canada ○ Canada Canada Canada

EU ○ EU EU EU

Asia ○ Asia Asia Asia

Global ○ Global Global Global ○

Other Other Other Other

Focusing�Contract

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Research API

APIs

R&D

Pre-Clinical ○Pre-clinicalTest� Sample

R&D� Strategy&� Management

Phase� I Clinical� Trials

Phase� IIClinical� TestSample

FinishedProducts

RegulatoryAffairs

Phase� IIIFinishedProduct

BusinessDevelopment

Phase� IVSales� &Marketing

Corporate�Product� Area

New� DrugBiologics

HerbalMedicine

BiosimilarsNCE NME

○ ○

Generics APIs Devices Others

○ ○

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420� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

3.� Corporate� Business�Overview

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

General� Overview

of� Corporate's� Key

Contract� Services

We� provide� in� vivo� testing� services� including� PK� and� radiolabeled� ADME.� We� perform �

biocompatibility� testing�on�medical�devices,�and�perform�bioassays� for� insulin,�glucagon,�

tetracosactide,� and�botulinum� toxin.�We�also�perform� stability� testing,� and�microbiology�

including� sterility� testing.

4.� Corporate� Competitiveness

Corporate

Competitiveness

We� have� been� inspected� by� the� US� FDA� 7� times� with� 5� years� with� no� Form� 483s�

issued,� and� have� excellent� quality� systems.�We� are� one� of� the� only� labs� in� the�world�

that� can� perform� the� bioassays� that� we� do.

Current� Status� of

Accredited�

Certification

GLP/GMP/AAALAC/ISO� 13485:2003/ISO� 9001:2008

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� toTaiwan,� Japan

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 421

Corporate� Name PAREXEL� INTERNATIONAL� LLC.

Corporate� Ownership Public� Company

Head� Office� Address195� West� Street,� Waltham,� Massachusetts,� 02451-1163,� USA(Tel:�

1-781-487-9900,� Fax:� 1-781-768-5512)

Facilities� City� &� Country 67� offices,� 52� countries

Korean� Business� Office18F.� HaesungBuilding,� 942,� Daechi-Dong,� Gangnam-Gu

Seoul� 135-725(Tel:� +82� 2� 3453� 8838,� Fax:� +82� 2� 3453� 8839

Web-site� Address www.PAREXEL.com

No.� of� Employees

Headquartered� near� Boston,� Massachusetts,� PAREXEL� operatesin� 67� locations�

throughout� 52� countries� around� the� world,� and� has� approximately� 10,850�

employees.

Financial� Status

Sales� Revenue� in� 2010

(US� K$)Capital(US� K$) Dept-equity� Ratio(%)

US� $� 1,212,099 US� $� 317,298 1.52

Contact

(Korean�

Business)

Name Minyoung� Kim� /� Randy� Hur

Address18F.� HaesungBuilding,� 942,� Daechi-Dong,� Gangnam-Gu

Seoul� 135-725

Telephone +82� 2� 3453� 8838

E-mail [email protected]

Company� History

PAREXEL� has� been� in� business� for� 29� years.� PAREXEL� was� founded� in� 1982� and� incorporated� in� 1983.�

PAREXEL� is� a� public� company� traded� on� the� NASDAQ� under� the� symbol� “PRXL”.

Founded�by� Josef�H.� von�Rickenbach,� PAREXEL’s� current�Chairman� and�CEO,� PAREXEL� International� is� today�

one� of� the� largest� contract� research� organizations� (CROs)� in� the�world.� � The� company� takes� its� name� from�

Paracelsus,� the�Swiss� physician,� scientist� and�natural� philosopher,�who� is� celebrated� as� the� father�of�modern�

empirical� chemistry.

97. PAREXEL INTERNATIONAL LLC.

1.� Corporate� General� Information

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PAREXEL’s� strong� presence� in� the� Asia/Pacific� region� includes� offices� in� China,� Japan,� Australia,� Indonesia,�

Malaysia,� the�Philippines,� Singapore,�South�Korea,� Taiwan,�and�Thailand.�Our�wide�geographic� coverage�and�

extensive� local� knowledge� give� us� the� resources� to� successfully� support� any� aspect� of� clinical� development�

and� market� expansion� throughout� the� region.� Equally� important,� our� regulatory� experts� work� closely� with�

government� officials� in� each� country,� giving� us� a� thorough� understanding� of� steadily� improving� regulatory�

environment� for� clinical� development� and� product� marketing.

Company� Description� &� Organization

As�a�global� and� international� contract� research�organization,�PAREXEL�has�developed� significant�expertise� to�

assist� clients� in� the� worldwide� pharmaceutical,� biotechnology� and� medical� device� industries� with� the�

development� and� launch� of� their� products� in� order� to� bring� safe� and� effective� treatments� to� the� global�

marketplace� for� the�patients�who�need� them.�Headquartered�near�Boston,�Massachusetts,� PAREXEL�operates�

in� 67� locations� throughout� 52� countries� around� the� world,� and� has� approximately� 10,850� employees.

We� are� a� leading� global� bio/pharmaceutical� services� organization� that� helps� clients� expedite� time-to-market�

through� our� development� and� launch� services.� These� include� a� broad� range� of� clinical� development�

capabilities,� integrated� advanced� technologies,� regulatory� affairs� consulting,� and� commercialization� services.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 423

2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

○ ○

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US ○ US US US ○

Canada ○ Canada Canada Canada ○

EU ○ EU EU EU ○

Asia ○ Asia Asia Asia ○

Global ○ Global Global Global ○

Other ○ Other Other Other ○

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D ○

Pre-ClinicalPre-clinical

Test� Sample

R&D� Strategy

&� Management○

Phase� I ○ Clinical� Trials ○

Phase� II ○Clinical� Test

Sample

Finished

Products

Regulatory

Affairs○

Phase� III ○

Finished

Product

Business

Development○

Phase� IV ○Sales� &

Marketing○

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3.� Corporate� Business�Overview

Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

This� is� confidential.� � In� Fiscal� Year� 2010,� our� five� largest� clients� accounted� for� 27%,� of�

our� consolidated� service� revenue.� No� single� client� accounted� for� 10%� or� more� of�

consolidated� service� revenue.� However,�we� expect� that� client� concentrations�will� rise� in�

the� future� in� conjunction� with� our� increasing� number� of� strategic� partnerships

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

Focusing�

Therapeutic� Area

As� a� global� CRO,� PAREXEL� has� experience� in� all� major� therapeutic� areas.� � Patricianly,�

PAREXEL� has� established� Therapeutic� Area� Teams� in� five� key� therapeutic� areas,�

Oncology,� Cardiovascular� and� Endocrine/Metabolism,� Infectious� Disease,� CNS,� and�

Rheumatology/Immunology,� Those� cross-functionally� integrated� teams,� our� expert�

community,� provide� comprehensive� strategy� and� overview� to� meet� operational� and�

research� objectives.

General� Overview

of� Corporate's� Key

Contract� Services

PAREXEL� is� a� leading� global� bio/pharmaceutical� services� organization� that� helps� clients�

expedite� time-to-market� through�our� development� and� launch� services.� These� include� a�

broad� range� of� clinical� development� capabilities,� integrated� advanced� technologies,�

regulatory� affairs� consulting,� and� commercialization� services.

PAREXEL�offers� a� broad� range� of� services� -� from� strategy� to� commercialization� -� to� the�

biopharmaceutical� industry.� With� extensive� experience� in� biopharmaceutical� product�

development� and� regulatory� affairs,� our� team� of� professionals� can� help� accelerate� the�

transition� from� Drug� Discovery� to� Clinical� Proof-of-Concept� through� to� Clinical�

Development.� Partnering� with� client� senior� management� provides� the� opportunity� to�

integrate� drug� development� and� commercialization� strategy� with� business� objectives.�

PAREXEL�has� four�divisions:�Clinical�Research�Services,�Medical� Communication�Services,�

PAREXEL� Consulting,� and� Perceptive� Informatics.�

For� small� and� medium� companies� requiring� deep� capabilities� and� experience� in� global�

bio/pharmaceutical� and� medical� device� development� and� commercialization,� PAREXEL�

International� helps� develop� the� product� with� the� right� quality� standards� for� the� right�

patient� population,� and� successful� interaction� with� regulatory� agencies,� through� our�

combined� scientific,� clinical� and� regulatory� expertise.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 425

Contract� Service�

Capacity� Affordable�

by� Service� Area

With� over� 29� years� of� experience,� PAREXEL� is� one� of� the� world’s� largest� CROs,� with�

approximately� 10,850� employees� in� 67� offices� throughout� 52� countries.�

Global� Pharmaceutical� Product� Development� Services

Every� biopharmaceutical� company� needs� strategic� partners� to� meet� the� demands� of�

today’s� complex� global� marketplace� ­� partners� than� can� help� you� accelerate�

pharmaceutical� product� development…� reduce� overhead� costs…expand� into� new�

markets� to�maximize� product� value…make�better� “Go/No-Go”� decisions…mitigate� risk…

reduce� regulatory� delays…improve� quality…or� leverage� advanced� technology� for� greater�

operational� efficiency.

For� all� of� your� biopharmaceutical� services,� PAREXEL� is� right� where� you� need� us,�

delivering�proven� solutions�based�on�more� than�25�years�of�global�clinical�and�consulting�

experience.� � We� have� helped� companies� of� all� sizes� overcome� the� challenges� of�

biopharmaceutical� development� and� bring� their� products� to� market� for� the� benefit� of�

patients� around� the� world.

What� does� “right� where� you� need� us”� mean� for� you?

-�Biopharmaceutical� services�wherever� you�need� them,�across� the�Americas,�Europe,� the�

Middle� East,� Africa,� and� the� Asia/Pacificregion

-� A� full� range� of� clinical� services� across� every� phase� of� development� ­� from� pre-clinical�

and� Phase� I� trials� through� large� Phase� IV� post-marketing� studies� and� medical�

communications�

-� Scientific� and� medical� expertise� across� all� major� therapeutic� areas�

- Advanced� clinical� and� imaging� technologies� to� support� every� aspect� of�

biopharmaceutical� development�

-� Integrated� consulting� expertise� encompassing� the� complete� development� cycle,�

including� strategic� partnering� and� licensing;� product� pipeline� optimization;� strategic�

compliance;� reimbursement� and� market� access;� and� development� of� leading-edge�

products� such� as� biologics,� biosimilars,� and� therapeutic� vaccines�

Most� important,� “right�where�you�need�us”�means� that�PAREXEL�has� the�experience�and�

flexibility� to� provide� the� right� combination� of� biopharmaceutical� services� to� fit� your�

specific� product� development� requirements� ­� making� us� the� right� strategic� partner� to�

help� you� succeed� in� a� difficult� global� environment.

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Communication�

with� Clients

Dispositoion� of

Project� Manager

Responsible

PAREXEL� provides� project� management� services,� which� entail�

providing�overall� leadership� to�our�project� team,�acting�as� the�main�

client� liaison,� project� planning,� managing� progress� against� study�

goals� and� deliverables,� budget� management,� progress� and� metrics�

reporting,� and� issue� resolution.� These� project�management� services�

are� offered� on� all� types� of� trials� ­� single-service,� multi-service,� or�

full-service.

Providing� Realtime

Service� Delivery

It� is� quite� critical� for� PAREXEL� and� sponsor� to� develop� the� rrealistic�

project� plan� /� timeline� including� key� assumptions� around� patient�

enrolment� projections.� Furthermore,� PAREXEL� employees� will� be�

well� trained� to�understand�the� importance�of�delivering� the� services�

within� the� projected� timeline� in� the� efficient�way� and� timely� report�

the� task� status� if� they� meet� any� challenges� or� difficulty� on� the�

project� delivery.� � �

Realtime

Feed-back

When� initiating� one� project,� PAREXEL� will� establish� the�

communication� plan� based� on� sponsor’s� needs� and� project�

requirement� to� ensure� the� efficient� running� of� discussion� and�

updates� with� the� sponsor� externally� and� within� PAREXEL� project�

team� internally.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 427

Corporate

Competitiveness

To� meet� the� demands� of� a� challenging� global� marketplace,� biopharmaceutical�

companies� of� all� sizes� are� embracing� strategic� partnerships� to� create� a� cost-efficient�

blend� of� internal� and� external� resources� that� helps� them� optimize� their� development�

programs� and� product� portfolios.� � This� new� approach� allows� biopharmaceutical�

companies� to� reduce�oversight�costs� and�concentrate�on� their�highest�priorities� ­� such�

as� research,� product� acquisition,� and� market� expansion.� The� benefits� can� include�

significant� cost� savings,� accelerated�product�development,�higher�quality,� and�reduced�

risk.� � To� capitalize� on� those� benefits,� however,� a� biopharmaceutical� company� must�

choose� the� right� partner� ­� one� with� in-depth� experience,� proven� processes,� a� global�

infrastructure,� and� a� complete� range� of� biopharmaceutical� services� that� are� fully�

enabled� by� technology.

A� unique� combination� of� expertise,� resources� and� technology

PAREXEL� is� the� only� biopharmaceutical� services� provider� offering� a� comprehensive�

global� network� of� expertise,� clinical� resources,� and� technology� within� a� single�

organization� ­� a� unique� combination� that� maximizes� your� product� development�

efficiency.� � Whatever� your� requirements,� PAREXEL� is� right� where� you� need� us,�

delivering� proven,� integrated� solutions� across� every� phase� of� the� product� lifecycle… �

every� therapeutic� area…�and�every�geographic� region.� �Our�unsurpassed�qualifications�

include:

-� Conducting� studies� in� more� than� 100� countries� �

-� Full� range� of� services� in� every� phase� of� development� �

-� Scientific� and� medical� expertise� across� all� major� therapeutic� areas�

-� Advanced� proprietary� eClinical� technologies� �

-� Clinical� and� regulatory� strategists� encompassing� the� complete� development� cycle�

-� Access� to� emerging� markets�

As� an� innovator� in� the� biopharmaceutical� services� industry,� PAREXEL� continues� to�

create� new� models� of� operating� excellence� and� best� practices� to� help� our� industry�

partners� address� key� product� development� challenges.� The� proven� benefits� of�

PAREXEL’s� integrated� approach� include:

Cost� savings� ­� Reduced� sponsor� oversight,� faster� study� start-up� and� closeout,� and�

improved� study� management

Accelerated�development� times� ­� Faster�patient� recruitment,� better� site� selection,� and�

integrated� technology

Risk� mitigation� ­� Improved� data� reliability,� proven� protocols,� and� greater� focus� on�

first-cycle� approvals

Quality� optimization� ­Standardized� processes,� improved� training,� and� reduced� data�

redundancy

These� benefits� can� cut� the� cost� of� a� typical� Phase� III� trial� by� 10-15� percent� ­� savings�

4.� Corporate� Competitiveness

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that� are� worth� millions� of� dollars� at� a� time� when� cost� reductions� and� accelerated�

development� times� are� absolutely� vital� for� success� in� the� biopharmaceutical�

marketplace.

PAREXEL� ­� The� right� choice

By� selecting� PAREXEL� as� your� strategic� partner,� your� company� can� leverage� our�

dedication,� expertise,� innovative� technology,� and� global� infrastructure� to� accelerate�

the� completion� of� key� development� milestones,� increase� efficiency,� and� reduce� the�

cost� of� bringing� new� products� to� market.� � Most� important,� only� PAREXEL� has� the�

experience,� flexibility� and� resources� to� provide� the� right� combination� of�

biopharmaceutical� services� and� technology� for� any� product� development� requirement�

­� making� us� the� right� partner� for� today’s� difficult� global� environment.

No.� of� Regulatory

Inspections

Classification FDA(US) EMA(EU) PMDA(Japan) Others

Pre-Clinical� Area

(TBC:� this� is� quite� confidential,� not� sure� if� it� can� be� shared�

to� the� public)

Clinical� Area

Manufacturing� Area

Others

Current� Status� of

Accredited�

Certification

PAREXEL� as� an� organization�has� not� undergone� ISO�certification,� but� some� individual�

business� units� applied� for� and� achieved� appropriate� ISO� certification� where� this� was�

found� desirable.� � PAREXEL� FARMOVS� Bioanalytical� Services� in� Bloemfontein,�

SouthAfrica,� has� aquality� system�according� to�OECD�GLP�guidelines� and� ISO17025� in�

place.� The� laboratory�has�been� ISO17025�accredited� since�April� 2002�and� received� its�

GLP� accreditation� in� July� 2006� by� the� South� African� health� authorities(SANAS).

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 429

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� to

As� PAREXEL� is� an� international� company�with� large� geographic� coverage� around� the�

global,� our� clients� are� from�a� numbers� of� countries,�when� they� need� the� professional�

supports� on� clinical� research� and� development

Asian� Clients'

Composition(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

This� is� confidential.� � In� Fiscal�Year�2010,�our� five� largest� clients� accounted� for�27%,�

of�our�consolidated� service� revenue.�No�single� client� accounted� for�10%�or�more�of�

consolidated�service� revenue.�However,�we�expect� that�client�concentrations�will� rise�

in� the� future� in� conjunction� with� our� increasing� number� of� strategic� partnerships.�

No.� of� Asian� Clients

in� recent� 3� years

This� is� confidential.�

PAREXEL� has� coordinated� projects/services� for� each� of� the� top� 50� pharmaceutical�

companies� and� the� top� 10� biopharmaceutical� companies.� � (This� information� is� based�

on� Med� Ad� News'� Top� Pharmaceutical� Company� Rankings� by� consolidated� revenue�

(Sept� 2009)� and� Med� Ad� News'� Top� Biotechnology� Company� Rankings� by� revenue�

(June� 2009)

PAREXEL’s� overall� revenue� is� well� distributed� between� the� large,� mid-sized� and� small�

pharmaceutical� sectors.� � So� far,� PAREXEL� has� assisted� a� lot� of� Asian� pharmaceutical�

and� biotech� companies� to� conduct� the� clinical� research� activities.

Major� Service� Range

with�Asian�Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D ◌

Pre-ClinicalR&D� Strategy

&�Management◌

Pre-clinical

Test� SamplePhase� I ○ Clinical� Trials ◌

Phase� II ○Clinical� Test

Sample

Finished

Products

Regulatory

Affairs◌

Phase� III ○Business

Development◌

Finished

ProductPhase� IV ○

Sales� &

Marketing◌

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Corporate� Name Parthys� Reverse� Informatics� Analytic� Solutions� Private� Limited

Corporate� Ownership Private� Company

Head� Office� Address IIT� Madras� Research� Park� ­� 8C,� Kanagam� Road,� Taramani

Facilities� City� &� Country Chennai(INDIA)

Web-site� Address www.reverseinformatics.com

No.� of� Employees 93

Financial� Status

Sales� Revenue� in� 2012

(US� K$)Capital(US� K$) Dept-equity� Ratio(%)

US� $� 2,247 184

Contact

(Korean�

Business)

Name Dr.� Parthiban� Srinivasan

AddressIIT� Madras� Research� Park� ­� 8C,� Kanagam� Road,� Taramani,� Chennai� ­� 600113,�

Tamil� Nadu,� India

Telephone +91-44-4281� 8333

E-mail [email protected]

Company� History

Parthys� Reverse� Informatics� is� the� brainchild� of� Parthiban� Srinivasan,� who� is� a� computational� chemist� by�

training.� The� idea� of� Reverse� Informatics�was� initiated� in� 2007� and� the� company�was� established� in� April�

2008.� The� company� is� located� in�Chennai,� India.�As� the� name� suggests,� Reverse� Informatics� is� innovative,�

understands� the� fundamentals� of� life� sciences� and� chemistry,� accumulates� the� scientific� information� with�

accuracy� and� reconfigures� this� amorphous� and� diversely� distributed� information� to� regenerate� perfectly�

formatted� information�customized� to�generate�new�knowledge.�Analogous� to� in�vivo,� in�vitro,� in� silico,�our�

technology�contributes� towards� “in� litero”:�A�Literature�Driven�Drug�Discovery�approach.�We�are�one�of� the�

leading� information� research� providers� in� data� harvesting,� text�mining� and� literature� processing� services� in�

many� scientific� disciplines,� including� biomedical� sciences,� chemistry,� engineering,� materials� science,�

agricultural� science,� and� more!

Company� Description� &� Organization

Parthys� Reverse� Informatics� is� one� of� the� leading� Information� Research� organizations� which� serve� three�

main� verticals� being� custom� curation,� patent� analytics� and� thought/opinion� leaders’� research.� Custom�

curation� is� performed� across� Life� Sciences� and� Chemistry,� patent� analytics� across� Biotech� and� High-tech�

industries,�and� thought� leaders� for�Pharma� industries.�We�deliver� a�complete,�comprehensive�and� in-depth�

actionable� data� for� your� research.

98. Parthys Reverse Informatics Analytic Solutions Private Limited

1.� Corporate� General� Information

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 431

2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

○ ○

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US ○ US US US ○

Canada Canada Canada Canada

EU ○ EU EU EU ○

Asia ○ Asia Asia Asia ○

Global ○ Global Global Global ○

Other Other Other Other ○

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research ○ API

APIs

R&D ○

Pre-Clinical Pre-clinical

Test� Sample

R&D� Strategy

&� Management○

Phase� I Clinical� Trials

Phase� IIClinical� Test

Sample

Finished

Products

Regulatory

Affairs

Phase� IIIFinished

Product

Business

Development

Phase� IVSales� &

Marketing

Corporate�

Product� Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

Generics APIs Devices Others

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3.� Corporate� Business�Overview

Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

70% 20% 10% 0%

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

Focusing�

Therapeutic� Area

Oncologics Lipid� RegulatorsRespiratory�

AgentsAnti-ulcerants

Angiotensin� � � II�

Antagonists

30 5

AntipsychoticsAutoimmune�

agentsAntidepressants Analgesics Others

65

Researchers� at� Reverse� Informatics� (RI)�have�a� strong� scientific� background� in� cell� and�

molecular�biology� and� an�experience� in�mining�and� curating� large�data� sets� can� assist�

you� in� creating� customized� solutions� for� your�Cancer� informatics�needs.�We�can� assist�

you� in� the� development� of� centralized,� integrated� databases� and� build� associated�

data-mining� tools� to� help� reveal�molecular�markers� for� commercial� exploitation� in� the�

field� of� cancer� diagnosis,� prognosis� and� treatment.�

Neuroinformatics� solution� offered� by� RI� integrates� and� analyzes� neuroscience� data�

from�various� sources�and� improves�accessibility�of� the�data� for� the� research�users.�We�

provide� user� friendly� features� which� enable� data� mining� using� custom� queries� and�

numerous� predefined� search� criteria,� simplifying� data� retrieval� and� analysis.� By�

facilitating� the� consolidation� of� relevant� information� in� a� common� platform� and�

providing� simple� but� powerful� tools� to� analyze� the� available� information� in� diverse�

ways,� we� aim� to� further� the� cause� of� the� neuroscience� research� community� in�

translating� the� discoveries� made� on� the� bench� into� new� therapies� for� neurological�

diseases.�

RI� facilitates� the� integration� of� chemistry� and� biology� space� to� address� the� areas� of�

chemical� biology/chemogenomics� and� tackle� target� hopping� and� scaffold� morphing�

challenges� in� Cheminformatics.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 433

General� Overview

of� Corporate's� Key

Contract� Services

Parthys� Reverse� Informatics� is� one� of� the� leading� Information� Research� organizations�

which� serve� three� main� verticals� being� custom� curation,� patent� analytics� and�

thought/opinion� leaders’� research.� Reverse� Informatics� specialize� in� creating� these�

knowledge�networks�which�are� comprehensive,�accurate,�and�up-to-date�picture�of� the�

current� biological� knowledge.� This� network� of� information� provides� researchers� with�

easy�access� to�detailed�and�highly�cross-linked� information� that� is� traceable�back� to� its�

source.

We� are� experts� in� various� Literature� Curation� Services:

•� Indexing

•� Abstraction

•� Annotation

•� Ontology� development

•� Customized� biological� information� research

Patent� analytics� is� performed� by� Parthys� IP� Services,� a� sub� unit� of� Parthys� IP� Services�

is� one� of� the� leading� information� providers� specializing� in� Patent� Searches,� Market�

Analytics,�Generics� IP�and�Periodic�alert.�Our�customized�Patent�Searches,� ranging� from�

Prior� Art� Search� to� Infringement� Study,� Patent� Portfolio� Management,� Claim� Chart�

Mapping� and� Landscape� Analysis� are� tailor-made� to� meet� your� needs.

Reverse� Informatics�are�experts� in�pinpointing�and�mapping� the�key�opinion� leaders�on�

local,� regional,�and�national� level.�KOL� identification�and�profiling�aides� in� the�planning�

process� of� product� commercialization� by� supplying� the� company� with� business�

intelligence� from� the� key� opinion� leaders� and� their� peers.� We� can� expertly� build�

catalogues� of� key� opinion� leaders� which� will� have� data� in� an� easily� navigable,�

retrievable� and� computable� format.

Contract� Service�

Capacity� Affordable�

by� Service� Area

We�are�a� strong� team�of�93�members�and� this�number� can�be�easily� scaled�up�as�per�

the� project� requirement.� We� are� located� at� IIT� Madras� Research� Park� which� is� the�

knowledge� powerhouse� of� India.� We� have� an� easy� access� to� the� best� student� and�

eminent� professors� for� various� fields� of� technology.� Our� service� capacity� is� highly�

scalable.

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Corporate

Competitiveness

Reverse� Informatics� prides� itself� on� being� a� team� of� knowledgeable,� talented,� and�

highly� experienced�professionals.�We� firmly� believe� the�only�way� to�excel� is� through�

experience.�Each�member�has�years�of�hands-on�experience�with� the�kind�of�project�

associated,� for�a� seamless�development�of�daily�activities.�We�understand�our�clients�

need� and� wholeheartedly� agree� to� it.

Our� in� litero� services:� a� literature� driven� drug� discovery� services� enables� you� to:

Save� time� and� money;� Accelerate� your� R&D� pipeline:� Avoid� duplicating� research�

effort;� Stay� current�with� the� latest� research;�Make�more� informed� decisions;� Follow�

emerging� ideas� and� worldwide� trends;� Monitor� competitors’� activities.

No.� of� Regulatory

Inspections

ClassificationFDA

(US)

EMA

(EU)

PMDA

(Japan)

CFDA

(China)

DCI

(India)Others

Pre-Clinical� Area

Clinical� Area

Manufacturing� Area

Others DSIR

Current� Status� of

Accredited�

Certification

Company� has� a� Department� of� Scientific� and� Industrial� Research� (DSIR)� certification�

for� its� in-house� R&D� unit.

Communication�

with� Clients

Dispositoion� of

Project� Manager

Responsible

The� project� manager� is� responsible� to� end� the� operation� of� the�

project� in� a� planned,� orderly� manner� and� to� ensure� that� the�

project� components� and� data� are� properly� archived� or�

incorporated� into� other� systems.�

Providing� Realtime

Service� Delivery

We�make� informed�decisions�and�we�provide� insights� that�help� the�

management� and� client� know� the� real� status� of� the� project� and�

assure� service� levels� and� optimize� performance� of� business-critical�

services.

Realtime

Feed-back

Reverse� Informatics�works�with� the�client�while�we�work� for� them.�

We� encourage� our� clients� to� give� us� a� feedback� which� allows� us�

to� improve� our�quality� and�understanding�of� the� project� in-depth.�

We� actively� implement� the� feedbacks� and� improve� our� process.

4.� Corporate� Competitiveness

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 435

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� toIndia

Asian� Clients'

Composition(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

100

No.� of� Asian� Clients

in� recent� 3� years1

Major� Service� Range

with�Asian�Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research ○ API

APIs

R&D ◌

Pre-Clinical Pre-clinical

Test� Sample

R&D� Strategy

&�Management

Phase� I Clinical� Trials

Phase� IIClinical� Test

Sample

Finished

Products

Regulatory

Affairs

Phase� IIIFinished

Product

Business

Development

Phase� IVSales� &

Marketing

6.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

If� you� have� an� idea� for� a� concept,� Parthys� Reverse� Informatics� has� the� process,� expertise� and� resources� to�

envision�and�co-create�a�great�product.�We�create�products�based�on�your� focus� like�gene�variants,�pathway�

curation� or� ADME� information�which� is� curated� and� customized� to� your� needs,� budget� and� time� line.�May�

be� you� would� like� to� know� the� list� of� in� force� patents� on� kinase� inhibitors,� or� need� to� know� the� list� of�

compounds� that� are� reported� to� be� interacting� with� GPCRs,� or� interested� in� the� bioactivity,� synthetic�

methodology,� pharmacology� and� toxicology/metabolism� collections� generally� derived� from� the� primary�

literature,� journals�and�patents.�We�make� it�easier� for�you�to�find�the� information� in�the�context�of�your�work.

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99. PDI Inc.

1.� Corporate� General� Information

Corporate� Name PDI� Inc.

Corporate� Ownership Private� Company

Head� Office� AddressMorris� Corporate� Center� 1,� Building� A� ,� 300� Interpace� Parkway,� Parsippany,� NJ�

07054

Web-site� Address www.pdi-inc.com

Contact

(Korean�

Business)

Name -

AddressMorris� Corporate� Center� 1,� Building� A� ,� 300� Interpace� Parkway,� Parsippany,� NJ�

07054

Telephone 1.862.207.7800

E-mail -

Company� Description� &� Organization

PDI,� Inc.� is� your� partner� for� sales� success� in� the� increasingly� competitive� and� cost-constrained�

biopharmaceutical� industry.� As� one� of� the� first� Contract� Services� Organizations� (CSO)� to� provide� sales� and�

marketing� support� to� both� established� and� emerging� U.S.-based� biopharmaceutical� companies,� PDI� offers� a�

track� record� of�more� than� twenty� years� of� accomplishment� and� innovation.� Today,� as� a� recognized� industry�

pioneer� and� leader,� PDI� builds� on� this� extensive� experience� to� design� and� execute� customized,� integrated�

solutions� that� achieve� superior� results.

2.� Corporate� Service� &�Business� Area

Corporate� Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 437

100. Penn Pharma

1.� Corporate� General� Information

Corporate� Name Penn� Pharma

Corporate� Ownership Private� Company

Head� Office� AddressPenn�Pharma�23-24� Tafarnaubach� Industrial� Estate�Tredegar,�Gwent,� SouthWales�

NP223AA,� UnitedKingdom

Web-site� Address http://www.pennpharm.co.uk/

Company� History

1979� Company� founded� in� the� village� of� Penn,� Buckinghamshire,� England

1986� Obtained� manufacturing� licence� from� MHRA

1986� Company� moved� to� its� current� site� at� Tredegar,� South� Wales

1986� Obtained� 'Specials'� manufacturing� licence� from� MHRA

1990� Established� Clinical� Trial� Supplies� department

1995� Established� Analytical� Development� laboratory� and� Formulation� Development� department

1997� First� successful� NDA� application� support� for� FDA� licensed� product

2001� Construction� of� 16� room� GMP� manufacturing� facility

2003� Achieved� IiP� and� Queens� Award� for� Enterprise:� International� Trade� Category

2004� Obtained� manufacturing� licence� for� IMPs� (Investigational� Medicinal� Products)

2005� Awarded� ISO� 14001� and� Green� Dragon� Level� 5� environmental� standards

2006� IiP� re-accreditation� and� Environmental� Gold� Standard� Award

2007� Establishment� of� US� subsidiary� and� US� based� business� development� team

2008� Opening� of� new� high� containment� manufacturing� facility� (Jan� 2008)

Company� Description� &� Organization

As� one� of� the� longest� established� pharmaceutical� services� companies,� Penn� Pharma� has� 30� years� of�

experience� in� providing� integrated� drug� development,� clinical� trial� supply� and�manufacturing� services� to� the�

international� healthcare� industry.� Penn� Pharma� is� privately� owned� and� operates� from� a� single� site� facility� in�

South� Wales,� UK� where� we� employ� over� 280� highly� skilled� staff.

Our� flexible�and�customised�approach�provides�our�clients�with�a�unique� service�enhanced�by� the�co-location�

of� our� operational� and� project� management� teams�which� facilitates� clear� communication� and� rapid� project�

decisions.� Clients� can� choose� to� utilise� Penn� as� a� complete� development� partner� and� benefit� from� our� full�

range� of� services� and� experience� or� choose� any� of� our� core� services� as� a� stand-alone� offering.� lt� is� this�

flexibility� and� personal� approach� that� differentiates� us� from� our� competitors.�

Penn� is� rare� amongst� service� providers� in� having� core� capability� in� both� human� and� veterinary� products� at�

both� investigational� and� commercial� scale

This� in� depth� knowledge� has� enabled� us� to� become� the� trusted� European� partner� for� many� of� the� world's�

top� companies� and� our� reputation� for� providing� secure,� reliable� and� trustworthy� advice� on� the� importation�

and� distribution� of� clinical� trial� and� commercial� products� continues� to� grow.�

With� global� reach� through� our� international� sales� force,� distribution� network� and� strategic� alliances,� many�

international� companies� already� trust� us� to� get� their� products� to� clinic� and� market.

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2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

○ ○ ○

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US ○ US ○ US US

Canada Canada Canada Canada

EU ○ EU ○ EU EU

Asia ○ Asia ○ Asia Asia

Global Global Global Global

Other Other Other Other

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research ○ API ○

APIs

R&D

Pre-Clinical Pre-clinical

Test� Sample

R&D� Strategy

&� Management

Phase� I Clinical� Trials ○

Phase� IIClinical� Test

Sample

Finished

Products

Regulatory

Affairs

Phase� IIIFinished

Product

Business

Development

Phase� IVSales� &

Marketing

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 439

3.� Corporate� Business�Overview

General� Overview

of� Corporate's� Key

Contract� Services

Central� to� Penn's� integrated� service�offering� is�our� capability� to�manufacture�a� range�of�

dosage� forms� in� compliance� with� GMP.� Our� facilities� have� been� designed� to� allow�

flexibility� in� processing� technology� and� are� approved� by� MHRA� for� the� manufacture� of�

investigational� and� commercial� products� for� both� human� and� veterinary� use.� We� also�

have� UK� Home� Office� approval� for� the� storage� and� processing� of� Controlled� Drugs�

(Narcotics).

This� combination� of�manufacturing� capability� coordinated�with� a� full� service� offering� in�

Pharmaceutical� Development� is� a� strength� of� Penn's� business� model.� Our� long� and�

successful� track� record�with� FDA� inspections� is� clearly� a� factor� in�maintaining�our�strong�

export� success� which� has� been� recognised� through� two� Queen's� Awards� for�

International� Trade� in� 2003� and� 2010.

We� focus� our� expertise� in� the� manufacture� of� three�main� dose� types:� Solid� Oral� Dose,�

Oral� Liquids�and�Topical�Products.�We�have�extensive�expertise�and�a�growing�capability�

to� produce� dosage� forms� containing� highly� potent� active� pharmaceutical� ingredients.

Contract� Service�

Capacity� Affordable�

by� Service� Area

EU,� US,� Asia

4.� Corporate� Competitiveness

No.� of� Regulatory

Inspections

Classification FDA(US) EMA(EU) PMDA(Japan) Others

Pre-Clinical� Area

Clinical� Area

Manufacturing� Area ○ MHRA

Others

Current� Status� of

Accredited�

Certification

ISO� 14001� and� Green� Dragon� Level� 5� environmental� standards,� GMP

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440� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name Perfection-CRO

Head� Office� Address 10� Plaut� St.� Rehovot� Science� Park� Rehovot� 7670609,� ISRAEL

Facilities� City� &� Country Israel

Web-site� Address www.perfection-cro.com

Contact

(Korean�

Business)

Telephone +972-89-316330

E-mail [email protected]

Company� Description� &� Organization

[Mission]

Aristotle� said� that� Pleasure� in� the� job� puts� perfection� in� the� work.�

We� at� Perfection-CRO� enjoy� the� work� all� the� way� to� perfect� completion!

•� We� are� driven� by� the� knowledge� that� what� we� do� every� day� can� significantly� affect� the� lives� and�

well-being� of� the� customers� we� serve,� the� patients� and� their� care� givers,� and� the� providers� we�work�with.

•� Perfection-CRO� approaches� every� project,� may� it� be� large,� medium� or� small,� with� high� motivation� and�

full� commitment� with� one� aim;� to� succeed� in� achieving� your� project� to� your� satisfaction� and� beyond.

•� Our� teams� are� small� and� competent.� We� do� not� burden� you� with� hierarchies.� All� it� takes� is� a� team� of�

CTA,� CRA� and� a� project� manager� that� are� experienced� and� well-coordinated.

•�We� listen� to� you� and� always� look� for� proactive,� sensible� solutions� to� ensure� smooth� and� right� resolution�

to� each� obstacle.

•�We� are� flexible� and� can�bend� time.�We� are� available� at� short� notice� and�will� not� tire� out� until�we� reach�

resolution.

•� We� commit� to� quality� every� time,� everywhere,� in� everything� we� do.

101. Perfection-CRO

1.� Corporate� General� Information

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 441

102. PHARMA TRADE

1.� Corporate� General� Information

Corporate� Name PHARMA� TRADE�

Corporate� Ownership Private� Company

Head� Office� Address Zona� Ind.� Le� ­� Loc.� Punta� Penna� 66053

Facilities� City� &� Country VASTO� (CH)(Italy)

Web-site� Address www.pharma-trade.it

No.� of� Employees 45

Contact

(Korean�

Business)

Name Roberto� Falleti

Address Zona� Ind.� Le� ­� Loc.� Punta� Penna� 66053

Telephone +39� 0832� 936312

E-mail [email protected]

Company� History

Pharma�Trade�has�been�established� in�Vasto� in�2003.�Since�August�2009�we�belong�to�Guala�Closures�Group�

spa.� The� Guala� Closures� is� a� multinational� company� leader� in� spirits� and� beverage� packaging.

Company� Description� &� Organization

Pharma� Trade� who� is� a� leader� in� the� production� of� packaging� for� the� pharmaceutical� industry.

Pharma�Trade�supplies�a� large� range�of� sealing,� capsules� for�drinkable�and� injectable�products�and� is� the� first�

producer� of� capsules� “A� LEVA”.� Since� August� 2009� we� belong� to� Guala� Closures� Group� spa.� The� Guala�

Closures� is� a� multinational� company� � � leader� in� spirits� and� beverage� packaging.

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442� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US US US US

Canada Canada Canada Canada

EU 〇 EU EU EU

Asia 〇 Asia Asia Asia

Global 〇 Global Global Global

Other 〇 Other Other Other

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D

Pre-Clinical Pre-clinical

Test� Sample

R&D� Strategy

&� Management

Phase� I Clinical� Trials

Phase� IIClinical� Test

Sample

Finished

Products

Regulatory

Affairs

Phase� IIIFinished

Product

Business

Development

Phase� IVSales� &

Marketing

Corporate�

Product� Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

Generics APIs Devices Others

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 443

Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

15 75 10 0

3.� Corporate� Business�Overview

4.� Corporate� Competitiveness

Corporate

Competitiveness

Flexibility,� service� and� cost� of� service,� planned� service� time-line� in� week,� service�

certification� or� approval� from� regulatory� agencies,� in-house� quality� assurance,�

periodical� in-house� employees� training

No.� of� Regulatory

Inspections

ClassificationFDA

(US)

EMA

(EU)

PMDA

(Japan)Others

Pre-Clinical� Area

Clinical� Area

Manufacturing� Area ○ ○ ○

Others

Current� Status� of

Accredited�

Certification

ISO� 9001,� GMP� 15378

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444� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

103. Pharmaceutical Advisors

1.� Corporate� General� Information

Corporate� Name Pharmaceutical� Advisors

Corporate� Ownership Private� Company

Head� Office� Address 316� Wall� Street,� Second� Floor

Facilities� City� &� Country Princeton,� NJ,� USA

Web-site� Address http://www.pharmadvisors.com

Contact

(Korean�

Business)

Name Minwoo� Kim

Address 316� Wall� Street,� Second� Floor,� Princeton,� NJ� 08540

Telephone (609)� 688-1330

E-mail [email protected]

Company� History

Since� 2001,� we� have� offered� an� innovative� approach� to� accessing� a� broad� and� deep� network� of� expertise�

to�support�our� clients’�drug�development,�commercialization,� technology�and�opportunity� assessment�needs.�

Our� clients� range� from� those�moving� from� discovery� into� development� to� those�with� commercial� products�

but� more� projects� than� they� can� resource.�

Our�approach� to�provides�unique�and�customized�Product�Development�Planning,� Implementation�and� Issue�

Resolution,� Technical,� Operational� and� "Manufacturability"� Due� Diligence,� Strategy� and� Operational�

Improvement,�Market�Opportunity�Assessment,�product�Valuation�and�Commercialization� support� for� clients�

in� various� Life� Sciences� industries.

Company� Description� &� Organization

We�offer� an� innovative�approach� to�accessing�a�broad�and�deep�network�of�expertise� to�support�our� clients’�

drug� development,� commercialization,� technology� and� opportunity� assessment� needs.� We� address� specific�

technical� issues;� help� manage� product� development� programs� as� well� as� support� strategy� &� portfolio�

management.� Our� resources� and� approach� have� become� a� critical� resource� to� help� companies� effectively�

progress� their� programs� while� navigating� the� challenges� of� outsourcing� to� CROs� and� CMOs.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 445

2.� Corporate� Service� &�Business� Area

Corporate� Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US US US US 〇Canada Canada Canada Canada

EU EU EU EU

Asia Asia Asia Asia

Global Global Global Global

Other Other Other Other

Focusing� Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D

Pre-Clinical

R&D� Strategy

&�

Management

〇Pre-clinical

Test� Sample

Phase� I Clinical� Trials

Phase� IIClinical� Test

Sample

Finished

Products

Regulatory

Affairs

Phase� IIIBusiness

Development〇

Finished

ProductPhase� IV

Sales� &

Marketing〇

Corporate� Product�

Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

〇Generics APIs Devices Others

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446� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

3.� Corporate� Business�Overview

Focusing� Therapeutic�

Area

Human�&�Animal� Pharmaceuticals,�Medical� Devices,� Diagnostics,� Chemicals�&�

related� technology� (� catalysis� etc),� Animal� Health� &� Food,� Nutriceuticals,�

Service� Providers,� Investors

General� Overview

of� Corporate's� Key

Contract� Services

Integrated� development,� project� &� portfolio� decisions,� virtual� expert� panel�

reviews,� resolve� issues,� build� skills,� regulatory� advice,� scale-up� and� sourcing�

decisions,� capital� planning

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 447

104. Pharmaceutical Regulatory Services, Inc.

1.� Corporate� General� Information

Corporate� NamePharmaceutical� Regulatory� Services,� Inc.

PRS� Clinical� Ltd

Corporate� Ownership Private� Company

Head� Office� Address 103� Carnegie� Center,� Suite� 103

Facilities� City� &� Country Princeton,� NJ,� USA

Korean� Business� Office Seoul� based� consultant

Web-site� Addresshttp://www.pharmregservices.com

http://www.prs-clinical.com

No.� of� Employees 22,� and� >200� networked� consultants,� 14� CROs

Contact

(Korean�

Business)

Name Synex� Consulting� Ltd.

Address

3F� Daejong� Building�

143-48� Samsung-dong,� Kangnam-ku

Seoul� 135-527,� Korea

Telephone +82-2-6202-3341

E-mail [email protected]

Company� History

We� are� a� US� corporation,� established� in� June� 2000.� In� later� years,� we� established� subsidiaries� in� Malaysia,�

Singapore,� Hong� Kong,� and� the� Netherlands.� In� 2005,� we� added� a� small� clinical� CRO� in� Ireland,� with�

subsidiaries� in� Russia,� Romania,� Belgium,� and� the� US.

Company� Description� &� Organization

We� are� a� provider� of� expert� regulatory� support� of� all� phases� of� global� drug� development.� We� currently�

provide� regulatory� consulting� and� services� in� around� 90� countries� on� all� continents.� We� work� primarily� via�

PRS� owned� legal� entities� and� employees,� and� in� addition�we� operate� a� network� of� experienced� consultants�

and� partners� in� countries� where� we� do� not� have� our� corporate� presence.� � We� support� new� chemical� and�

biologic�entity�development,�provide� regulatory� support�of�global�clinical� trials,� safety�and�pharmacovigilance�

services,� and� administer� regulatory� maintenance� of� marketed� products.� We� also� provide� regulatory� due�

diligence� assessments� of� in-licensing� or� out-licensing� candidates,� as� well� as� regulatory� activities� related� to�

mergers� and� acquisitions.

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2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

〇 〇

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US US US US

Canada Canada Canada Canada

EU EU EU EU

Asia Asia Asia Asia

Global 〇 Global Global Global 〇Other Other Other Other

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D 〇Pre-Clinical Pre-clinical

Test� Sample

R&D� Strategy

&� Management〇

Phase� I 〇 Clinical� Trials 〇Phase� II 〇 Clinical� Test

Sample

Finished

Products

Regulatory

Affairs〇

Phase� III 〇Finished

Product

Business

Development〇

Phase� IV 〇 Sales� &

Marketing

Corporate�

Product� Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

〇 〇 〇 〇Generics APIs Devices Others

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 449

3.� Corporate� Business�Overview

Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

10% 55% 30% 5%

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

〇 〇Focusing�

Therapeutic� AreaOncology,� cardiovascular,� metabolic,� dermatology,� CNS,� anti-infective,� other

General� Overview

of� Corporate's� Key

Contract� Services

Our� main� services� are� in� the� general� area� of� regulatory� affairs� ­� includes� consulting,�

regulatory� and� general� drug� development� global� strategy,� preparation� and� writing� of�

regulatory� documents,� safety� and� pharmacovigilance� services,� CMC,� compliance�

activities,� liaison� with� authorities� (approx.� 90),� regulatory� maintenance� of� marketed�

products.� We� also� provide� consulting,� organization,� start,� project� management,�

oversight,� monitoring,� and� analysis� of� clinical� trials,� as� needed.

Contract� Service�

Capacity� Affordable�

by� Service� Area

Capacity� is�project� specific� and�will�be�assessed� for�each�project.�Our�business�model�was�

designed� to� offer� the� flexibility� of� offering� our� support� to� very� small� companies� with�

small� projects,� but� also� expand� and� provide� full� development� support� for� major�

multinational� projects� by� tapping� into� our� network� of� over� 200� individual� consultants,�

as�well� as�14�CROs� (some�of� them� large�CROs).� In� this�way,� the� capacity�of� services�can�

be� fine-tuned� to� each� project� and� is� not� really� a� limiting� factor.�

Communication�

with� Clients

Dispositoion� of

Project� Manager

Responsible

With� every� contracted� project,� we� will� assign� a� Project� Manager�

who� serves� as� the� main� liaison� between� PRS� and� the� client

Providing� Realtime

Service� Delivery

Given� our� flexible� business� model,� we� can� assign� experienced�

personnel� to� the� contracted� projects� which� helps� quick� turnaround�

and� high� quality� delivery� of� all� services

Realtime

Feed-back

One� of� the� main� duties� of� the� Project� Manager� is� to� provide�

frequent� and� real� time� feedback� to� the� client� as� requested� and�

determined� in� the� statement� of� Work

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4.� Corporate� Competitiveness

Corporate

Competitiveness

Each�PRS�member�has�on�average�over�20�years�of� experience� in�big�pharma�and�big�

CRO� companies,� and� has� been� involved� with� development� and� registrations� of�

numerous� well-known� pharmaceutical� products.� In� addition,� our� flexible� business�

approach� and� geographic� outreach� to� around� 90� countries� makes� us� a� unique�

one-stop,� cost-efficient� expert� contractor� for� all� regulatory� needs� in� global� drug�

development.

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� toKorea,� Malaysia,� Indonesia,� Singapore,� Hong� Kong

Asian� Clients'

Composition(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

20% 70% 10%

No.� of� Asian� Clients

in� recent� 3� years10

Major� Service� Range

with�Asian�Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D

Pre-ClinicalR&D� Strategy

&�Management〇

Pre-clinical

Test� SamplePhase� I Clinical� Trials

Phase� IIClinical� Test

Sample

Finished

Products

Regulatory

Affairs〇

Phase� IIIBusiness

DevelopmentFinished

ProductPhase� IV

Sales� &

Marketing

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 451

6.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

We�can�consult� and� support�Korean�companies�develop�and�market� their�products� in� the�major�markets� (US,�

European�Union,�Canada,�Australia,�etc),� as�well�as� in� smaller� countries�of�Latin�America�and�CEE.� In�addition,�

we� can� offer� appropriate� contacts� and� provide� regulatory� due� diligence� support� of� in-licensing� or�

out-licensing� candidates.� Finally,� we� can� offer� GMP� consulting� services� to� help� Korean� manufacturing�

companies� meet� the� demand� of� US� FDA,� EMA,� and� other� major� agency� GMP� inspections� for� importing�

Korean-manufactured� pharmaceutical� and� biotech� products� into� new� markets.

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Corporate� Name Pharmaceutical� Research� Associates,� Inc

Corporate� Ownership Public� Company

Head� Office� Address 4130� ParkLake� Avenue� Suite� 400� Raleigh,� NC� 27612� US

Facilities� City� &� Country 11F,� GS� Tower� 508� Nonhyeon-ro� Gangnam-gu� Seoul,� 135-985,� Korea

Web-site� Address www.prahs.com

No.� of� EmployeesPRA� currently� has� 12,777� employees� (11,610� full-time,� 783� part-time,� and� 384�

contractors)

Financial� Status

Sales� Revenue� in� 2012

(US� K$)Capital(US� K$) Dept-equity� Ratio(%)

Please� refer� to� http://prahs.com/investors/sec-filings/� for� PRA's�most� recent� filing�

documents,� including� financial� information.

Contact

(Korean�

Business)

Name Lance� Eminger,� Director� ­� Business� Development

Address 21� Biopolis� Road� #02-06� Nucleos� North� Tower� Singapore� 138567

Telephone +65� 9758� 3879

E-mail [email protected]

Company� History

Founded� in� 1976� as� the� ANTI-INFLAMMATORY� DRUG� STUDY� GROUP,� services� expanded� to� clinical� trial�

management� in�1991�with�hiring�of� the� first�clinical�operations�staff.�PRA�was�acquired� in�2013�by�Kohlberg�

Kravis� Roberts� &� Co,� LP� (KKR),� a� private� equity� group� with� more� than� 78� billion� dollars� in� assets.� KKR� has�

committed� considerable� resources� to� supporting� PRA’s� growth.� This� has� allowed� us� to� expand� our� global�

footprint� and� scope�of� services.� In� 2014,� as� the� culmination�of� a�multi-year� strategic� initiative,� the� company�

was� re-named� to� PRA� Health� Sciences.� An� IPO� made� us� a� publically� traded� stock� on� NASDAQ.

Company� Description� &� Organization

PRA� is� one� of� the�world's� leading� global� contract� research� organizations,� by� revenue,� providing� outsourced�

clinical� development� services� to� the� biotechnology� and� pharmaceutical� industries.� PRA’s� global� clinical�

development� platform� includes� 71� offices� in� North� America,� Europe,� Asia,� Latin� America,� South� Africa,�

Australia� and� the� Middle� East,� and� approximately� 12,000� employees� worldwide.� Since� 2000,� PRA� has�

performed� more� than� 3300� clinical� trials� worldwide� and� has� worked� on� more� than� 100� marketed� drugs�

across� several� therapeutic� areas.� In� addition,� PRA� has� participated� in� the� pivotal� or� supportive� trials� that� led�

to� US� Food� and� Drug� Administration� or� international� regulatory� approval� of� more� than� 60� drugs.

105. Pharmaceutical Research Associates, Inc

1.� Corporate� General� Information

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 453

2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

○ ○

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US ○ US US US ○

Canada ○ Canada Canada Canada ○

EU ○ EU EU EU ○

Asia ○ Asia Asia Asia ○

Global ○ Global Global Global ○

Other ○ Other Other Other ○

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research ○ API

APIs

R&D ○

Pre-Clinical ○ Pre-clinical

Test� Sample

R&D� Strategy

&� Management○

Phase� I ○ Clinical� Trials ○

Phase� II ○Clinical� Test

Sample

Finished

Products

Regulatory

Affairs○

Phase� III ○Finished

Product

Business

Development

Phase� IV ○Sales� &

Marketing

Corporate�

Product� Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

○ ○ ○ ○

Generics APIs Devices Others

○ ○ ○ ○

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3.� Corporate� Business�Overview

Clients'�Composition

(%)

Big� PharmasMid� or� Small-Size� Pharmas

BiotechCompanies

Start-ups

19 24 23 34

In-house� Facilities

Research� &Development

Preclinical ClinicalCustom

ManufacturingCustom� Sales

Focusing�Therapeutic� Area

Oncologics Lipid� RegulatorsRespiratory�Agents

Anti-ulcerantsAngiotensin� � � II�Antagonists

16 1 5 2 1

AntipsychoticsAutoimmune�agents

Antidepressants Analgesics Others

7 7 5 10 46

NOTE:� We� do� not� track� specific� drug� classifications;� therefore� we� have� provided� the�percentages� for� the� most� relevant� therapeutic� areas� and� indications.Oncologics� =� oncology� (solid� tumors)� and� hematological� malignancies;� Lipid� Regulators�=� select� cardiovascular� indications� (hyperlipidemia� and� others);� Respiratory� Agents� =�respiratory;� Anti-ulcerants� =� gastroenterology;� Angiotensin� II� Antagonists� =� select�cardiovascular� indications� (hypertension� and� others);� Antipsychotics� =� schizophrenia,�bipolar� disorder,� and� acute�mania;�Autoimmune� agents�=� immunology;�Antidepressants�=� depression� and� anxiety� disorders;� Analgesics� =� pain“Other”� includes� the� therapeutic� areas� of� dermatology,� endocrinology,� genitourinary,�hepatology,� infectious�diseases,�musculoskeletal,�ophthalmology,� and�surgical,� as�well� as�non-malignant� hematology,� other� cardio-metabolic� (arrhythmia,� type� 2� diabetes,� PAD,�PAH,� VTE),� and� other� CNS� (ADHD,� dementia,� Parkinson's� disease,� multiple� sclerosis,�seizure,� substance� use� disorders)

In� the�past�5�years,�PRA�has�worked�on�1641�clinical� studies�across� the� therapeutic� areas�noted� below.We� have� also� provided� consulting� services� for� stand-alone� services� (eg,� biostatistics,�medical� writing,regulatory,� feasibility).

•� Anesthesiology:� 15� (1%)•� Cardio-Metabolic:� 96� (6%)•� Endocrinology:� 44� (3%)•� Gastroenterology:� 36� (2%)•� Genitourinary:� 40� (2%)•� Hematology:� 79� (5%)•� Hepatology:� 18� (1%)•� Immunology:� 114� (7%)

•� Infectious� Diseases:� 162� (10%)•� Musculoskeletal:� 14� (1%)•� Neurology:� 306� (19%)•� Oncology:� 200� (12%)•� Psychiatry:� 231� (14%)•� Respiratory:� 72� (4%)•� Functional� Services*:� 193� (12%)•� Other**:� 21� (1%)

*�“Functional�Services”� for� clinical� studies� indicates�an�EDS� study�where� the�drug�specifics�are� not� yet� determined� by� the� sponsor� tobe� allocated� to� the� level� of� therapeutic� area/indication.**� “Other”� includes� Dermatology,� Hereditary� Disorders,� Injury� &� Poisoning,�Ophthalmology,� Otology,� and� Surgical

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 455

General� Overview

of� Corporate's� Key

Contract� Services

PRA� provides� its� clients� with� one� of� the� most� flexible� clinical� development� service�

offerings,� which� includes� both� traditional,� project-based� Phase� I� through� Phase� IV�

services� as� well� as� embedded� and� functional� outsourcing� services.

PRA's� Product� Registration� Services� group� has� been� instrumental� in� helping� our� clients�

conduct� complex,� global,� multi-center� trials� and� has� supported� our� clients� in� achieving�

over� 65� drug� approvals� across� a� range� of� therapeutic� areas.

PRA's�Early�Development�Services�group�provides�comprehensive� services� for�Phase� I� and�

Phase� IIa� clinical� research,� bioanalytical� research,� and� data� support.

PRA’s� Late� Phase� Services� group� supports� global� and� regional� post-approval� studies,�

assisting� clients� with� the� post-marketing� process� by� planning� and� conducting�

safety-surveillance� studies,� large� simple� trials,� registries,� retrospective� studies,� and�

restricted� access� programs.

PRA’s� Strategic�Solutions�Division� is� a�pioneer�of� the�Embedded�Solutions� staffing�model.�

Our� custom� solutions� allow� companies� with� limited� resources/infrastructure� to� leverage�

PRA’s� substantial� staffing� and� logistics� to� increase� their� scope� to� meet� short-� or�

long-term� demands.

Contract� Service�

Capacity� Affordable�

by� Service� Area

PRA� has� over� 12,000� staff,� including� 11,610� full-time� employees,� 783� part-time�

employees,� and� 384� contractors.

Product� Registration:� 6440

•� Clinical� Operations:� 2,973

•� Project� Management:� 553

•� Biometrics� -� Biostatistics:� 44

•� Biometrics� -� Data� Operations:� 295

•� Biometrics� -� Medical� Writing:� 50

•� Biometrics� -� Programming:� 214

•� Biometrics� Project/Portfolio� Management:� 65

•� Document� Management:� 145

•� Investigator� Contracts:� 243

•� Quality� Assurance:� 80

•� Regulatory� Affairs:� 262

•� Safety� &� Risk� Management:� 249

•� Therapeutic� Expertise:� 226

•� Corporate� Services:� 1,041

Early� Development� Services� (Phase� I-IIa):� 1074

Late� Phase� Services� (Phase� IIIb-IV):� 130

Strategic� Solutions� Division� (embedded� staff):� 5133

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Communication�

with� Clients

Dispositoion� of

Project� Manager

Responsible

The� project� manager� (or� project� director)� is� the� primary� client�

contact;� they� lead� cross-functional� teams� (including� vendors),� plan�

and�measure� the�progress�of�each�deliverable,�and�manage/escalate�

potential� risks� and� issues.� They� are� responsible� for� implementing�

solutions� based� on� consultation� with� the� sponsor.

Providing� Realtime

Service� Delivery

PRA� offers� JReview,� a� Web-enabled� application,� which� provides� a�

fully� integrated� and� interactive� data� review� and� reporting� tool.� The�

software� supports� standard� and� customized� reports� for� quick� and�

effective�data� review,�powerful�data�manipulation,�multidimensional�

analysis,� and� dynamic� graphical� and� statistical� modeling� on� near�

real-time� clinical� data.

Realtime

Feed-back

PRA� recognizes� that� providing� our� clients�with� visibility� of� real-time�

study� data� enables� them� to� make� key� decisions� throughout� the�

study.� PRA� offers� our� secure�Web� portal� application� that� facilitates�

information� sharing.� Sponsors,� investigators,� vendors,� and� project�

teams�use� the�portal� to�access� information�critical� to� study� conduct.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 457

Corporate

Competitiveness

PRA�provides� services� for� all� phases�of�biopharmaceutical�drug�development.�We�have�

the� depth� of� therapeutic� expertise� and� operational� diversity� to� offer� high-quality,�

full-service� support� as� well� as� embedded� staffing� solutions.

We� differentiate� ourselves� from� our� competitors� with:

•�Dedicated,�passionate�employees:�PRA’s�operational�model�empowers�employees� to�

determine� the�best� solutions� for�each� client’s�needs.�Driven�by� compassion� for�patients�

and� the� drive� to� redefine� excellence� in� clinical� research,� our� people� deliver� quality�

results� that� drive� development� of� safe,� effective� treatments.

•� Flexible� approaches:� We� anticipate� challenges� and� develop� creative� solutions� to�

optimize� timelines� and� outcomes.

•� Innovative� technologies:� We� combine� our� strategic� approach� with� state-of-the-art�

technologies� and� the� power� of� data-driven� decision� making� to� deliver� reliable,�

insightful� data� and� promote� information� sharing.

•�Leading�scientific� expertise:� Science�guides�our�goals�and� strategies�and�our�experts�

lead� the� industry� in� using� public� and� private� data-mining� and� medical� informatics� to�

select� the� most� appropriate� regions,� countries,� and� sites� for� successful� recruitment.

•�Meaningful�global�presence:�Every�global� study� is� executed� locally.�Working� in�80+�

countries,�our�project� teams�offer� exhaustive� local� knowledge�of� regulations,� standards�

of� care,� and� cultures.

•� Dynamic� early-phase� development:� Our� Early� Development� Services� (EDS)�

pharmacology� experts� deliver� innovative� solutions� from� state-of-the-art� facilities� in�

Europe�and�North�America.�PRA�also�operates�GLP-compliant� laboratories� close� to�our�

clinical� units,� enabling� us� to� quickly� analyze� timecritical� samples.

•� Dedicated� late-phase� expertise:� Our� global� teams� define� real-world� solutions� that�

help� clients� optimize� their� post-marketing� investment� and� result� in� safer,� more�

accessible� drugs.� Strategically� located� around� the� globe,� PRA’s� multi-lingual� country�

experts� successfully� manage� studies� of� any� size.

No.� of� Regulatory

Inspections

ClassificationFDA

(US)

EMA

(EU)

PMDA

(Japan)

CFDA

(China)

DCI

(India)Others

Pre-Clinical� AreaPRA�only� shares�publicly� available� information.�Please� refer� to�

the�attached�overview� (“KDRA�RFI_PRA�Regulatory� Inspection�

History_9Sept2016”).� In�addition,�PRA�has�been� inspected�by�

other� regulatory� agencies� who� do� not� publicly� disclose�

results.� However,� whenever� there� were� findings� reported,�

they� were� all� addressed� to� the� regulatory� agencies�

satisfaction� (e.g.,� through� CAPAs)

Clinical� Area

Manufacturing� Area

Others

Current� Status� of •� ACRO� (Association� of� Clinical� Research� Organizations)

4.� Corporate� Competitiveness

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Accredited�

Certification

•� ABRACRO� (Association� of� Brazilian� CROs)

•� MCC� (Metrics� Champion� Consortium)

•� ENCePP� (European� Network� of� Centres� for� Pharmacoepidemiology� and�

Pharmacovigilance)

•� Corporate� Sponsor� of� CDISC� since� 2004;� active� on� their� Industry� Advisory� Board

•� EcoVadis� Sustainability� Award� (Since� 2015,� Last� Scoring� May� 2016)

•� Early� Development� Services:

•� GCP� 2001

•� GMP� 2006

•� GLP� 1994� (EDS-NL� laboratory)

•� Certified� laboratories� for� radioisotope� analysis

•� BIORAD� certificate� for� participating� in� the� external� quality� assessment� program�

2009

•� KKGT_SKML� certificate� for� Testing� Drugs� of� Abuse� 2010

•� SKML� certificate� for� external� quality� assessment� 2010

•� Regional� Quality� Program:� Hematology� 2010

•� Internal� Quality� Program� for� analysis� of� urine� samples� N/A

•� Labor;� eg,� SA8000� -� PRA� complies� with� all� applicable� labor� standards.

•� Environment;� eg,� OSHA� -� PRA� complies� with� all� applicable� workplace� safety�

regulations� including� OSHA.

•� Training� -� PRA� complies� with� all� applicable� training� standards.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 459

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in�recent�3�years

Countries� which

clients� belong� to

We� do� not� specifically� track� our� clients� by� country.� PRA� works� with� more� than� 390�

clients� in� various� therapeutic� areas,� and�we� have� collaborated�with� 20� of� the� top� 25�

large� pharmaceutical� companies� and� 8� of� the� top� 20� biotechnology� companies

Asian� Clients'

Composition(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

53 13 29 5

No.� of� Asian� Clients

in� recent� 3� years

While�PRA�does�not� track�our� clients�by� country,� in� the�past�3� years,�PRA�has�worked�

with� at� least� 30� different� Asian� clients,� as� well� as� Asian� subsidiaries� of� other� clients.�

We� have� worked� on� over� 175� clinical� studies� involving� Asian� countries� in� the� past� 3�

years,� as� well� as� providing� consulting� services� for� over� 60� non-clinical� projects

Major� Service� Range

with�Asian�Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D ○

Pre-ClinicalPre-clinical

Test� Sample

R&D� Strategy

&�Management○

Phase� I Clinical� Trials ○

Phase� II ○Clinical� Test

Sample

Finished

Products

Regulatory

Affairs○

Phase� III ○

Finished

Product

Business

Development○

Phase� IV ○Sales� &

Marketing○

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6.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

PRA�has�15�years�of� experience� in� the�Middle�East� and�Africa,�with�offices� in� Israel,� Turkey,� and�South�Africa,�as� well� as� a� legal� entity� in� Egypt.

Through� our� dedicated� site� managers� based� in� South� Africa� we� have� adopted� a� ‘cross-border’� strategy� to�cover� sites�across�Africa.� In�addition�our�partner,�MCT,� is� also�able� to�provide� resources� in�Ghana�and�Senegal.�MCT� is� a� leading� CRO� in� the� area,� thanks� to� its� unique� strong� local� presence,� excellent� knowledge� of� the�field,� and� experience� in� international� R&D� studies.� PRA� has� a� Governance� Plan� and� structure� in� place� to�manage� the� partnership� with� MCT� with� regards� to� communication,� issue� resolution,� and� performance�management.�

MCT� employs� approximately� 90� staff� across�Middle� East� and� Africa� and� provides� coverage� for� a� number� of�countries� in� this� region.

In� the� last� 5� years,� PRA� has� conducted� 34� clinical� studies� and� provided� consulting� services� for� 8� projects� in�Africa.� We� have� also� conducted� 81� clinical� studies� and� provided� consulting� service� for� 11� projects� in� the�Middle� East

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 461

Corporate� Name PharmaNet/i3

Corporate� Ownership Private� Company

Head� Office� Address 504� Carnegie� Center� Princeton,� NJ� 08540,� USA

Facilities� City� &� Country

Buenos� Aires� -� ARGENTINA�외 1개,� São� Paulo� -� BRAZIL,� Montréal� -� CANADA�외2개,� Santiago� -� CHILE,� Beijing� -� CHINA� 외 3개,� Prague� -� CZECH� REPUBLIC,� Paris�

-� FRANCE� 외 1개,� Berlin� -� GERMANY� 외 3개,� Bangalore� -� INDIA� 외 6개,� Milan-�

ITALY�외 1개,�Tokyo� -� JAPAN,�Kuala� Lumpur� -�MALAYSIA,�Mexico�City� -�MEXICO,�

The� Hague� -� NETHERLANDS� 외 1개,� Lima� -� PERU,� Manila� (Makati� City)�

-PHILIPPINES,�Warsaw�-POLAND�외 1개,�Bucharest� -�ROMANIA,�Moscow�-�RUSSIA�

외 2개,� Beograd� -� SERBIA,� Singapore� -� SINGAPORE,� Bratislava� -� SLOVAKIA,� Seoul�

-� SOUTH� KOREA,� Barcelona� -� SPAIN� 외 1개,� Madrid� -� SPAIN,� Stockholm� -�

SWEDEN,� Zurich� (Küsnacht)� -� SWITZERLAND,� Taipei� -� TAIWAN,� Bangkok� -�

THAILAND,� Kyiv� -� UKRAINE,� Maidenhead� -� UK� 외 3개,� Ann� Arbor,� MI� -� USA� 외

13개

Korean� Business� Office13th� Floor� Gangnam� Finance� Center,� 737� Yeoksam-dong

Gangnam-gu,� Seoul� 135-984

Web-site� Address www.pharmanet.com

No.� of� Employees 6000

Financial� Status

Sales� Revenue� in� 2010

(US� K$)Capital(US� K$) Dept-equity� Ratio(%)

$900� Million� US - -

Contact

(Korean�

Business)

Name Na-Young� Lee

Address13th� Floor� Gangnam� Finance� Center,� 737� Yeoksam-dong

Gangnam-gu,� Seoul� 135-984

Telephone +82� (0)� 2� 6206� 1604

E-mail [email protected]

106. PharmaNet/i3Inc.

1.� Corporate� General� Information

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Company� History

The� PharmaNet/i3� brand� was� created� in� July� 2011� through� the� combination� of� PharmaNet� and� i3� as� the�

clinical� business� segment� of� inVentiv� Health.

The� Companies� bring� a� legacy� of� high� quality� service� and� clinical� development,� bioanalytical,� staffing,�

resourcing� and� regulatory� expertise,� to� their� clients� developing� innovative� therapeutics.

PharmaNet/i3� is� a� world� leading� clinical� research� organization� (CRO)� with� annual� revenue� of� $900� million�

and� more� than� 6,000� employees� dedicated� to� clinical� research� in� more� than� 30� countries.

Company� Description� &� Organization

About� PharmaNet/i3

PharmaNet/i3,� the� inVentiv� Health� clinical� segment,� is� recognized� as� a� leading� provider� of� global� drug�

development� services� to� pharmaceutical,� biotechnology,� generic� drug,� and� medical� device� companies,�

including� therapeutically� specialized� capabilities� forPhase� I-IV� clinical� development,� bioanalytical� services,� and�

staffing� from� a� single� clinical� professional� to� an� entire� functional� team.� For� intelligent� solutions� needed� to�

accelerate� high� quality� drug� development� programs� of� all� sizes� around� the� world,� PharmaNet/i3� works� for�

you.� For� more� information,� visit� http://www.pharmanet-i3.com

About� inVentiv� Health

inVentiv� Health,� Inc.� is� a� leading� global� provider� of� best-in-class� clinical,� commercial� and� consulting� services�

to� companies� seeking� to� accelerate� performance.� inVentiv’s� client� roster� includes� more� than� 550�

pharmaceutical,�biotech�and� life� sciences�companies.�With�13,000�employees� in�40� countries,� inVentiv� rapidly�

transforms�promising� ideas� into�commercial� reality.� inVentiv�Health� Inc.� is�privately�owned�by� inVentiv�Group�

Holdings� Inc.,� an� organization� sponsored� by� affiliates� of� Thomas� H.� Lee� Partners,� L.P.,� Liberty� Lane� Partners�

and�members�of� the� inVentiv�management� team.�For�more� information,� visit�http://www.inventivhealth.com.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 463

2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

○ ○

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US ○ US US US ○

Canada ○ Canada Canada Canada ○

EU ○ EU EU EU ○

Asia ○ Asia Asia Asia ○

Global ○ Global Global Global ○

Other ○ Other Other Other ○

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D

Pre-Clinical Pre-clinical

Test� Sample

R&D� Strategy

&� Management

Phase� I ○ Clinical� Trials ○

Phase� II ○Clinical� Test

Sample

Finished

Products

Regulatory

Affairs○

Phase� III ○Finished

Product

Business

Development

Phase� IV ○Sales� &

Marketing

Corporate�

Product� Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

○ ○ ○ ○

Generics APIs Devices Others

○ ○

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In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

Focusing�

Therapeutic� Area

Oncology,� Neurosciences,� Cardiovascular,� Vaccines,� Endocrinology/Metabolism,�

Rheumatology,� Pain� Management,� Infectious� ,� iseases,� Respiratory/Pulmonology,�

Dermatology,� Ophthalmology,� Urology,� Nephrology,� Rheumatology,� Women’s� Health

General� Overview

of� Corporate's� Key

Contract� Services

Phase� I-IIa

For� proof-of-concept,� First� in� Human� (FIH)� or� bioequivalency� studies,� our� database� of�

study� participants� and� relationships�with� leading� hospitals� ensure� rapid� recruitment� and�

execution� of� your� early� development� study.�

Phase� IIb-III

PharmaNet/i3� combines� therapeutic� knowledge� and�a� commitment� to� quality� to� offer� a�

full� range� of� clinical� trial� services� including� biostatistics,� clinical� monitoring,� data�

management,� global� safety� and� pharmacovigilance,� regulatory� consulting,� medical�

writing,� project� management� and� full-service� patient� recruitment� and� retention.�

Phase� IV�

PharmaNet/i3� offersservices� including� strategic� and� operational� planning,� observational�

studies� and� patient� registries,� health� economics� and� outcomes� research,� safety/risk�

management� and� epidemiology,� traditional� interventional� studies.

Strategic� Partnerships/FSP

We� can� provide� a� customer-focused� team� tailored� exclusively� to� your� business� goals�

whether� it� is� for� a� single� function,� a� range�of� functions,� a� complete� staff� lift-out� or� any�

other� defined� need.� We� currently� have� 32� active� partnerships� dating� back� to� 1999.

Staffing

i3� Pharma� Resourcing� has� the� experience� in� staffing� and� business� process� outsourcing�

solutions� to� help� you� find� the� right� clinical� development� professionals,� when� you� need�

them.

Bioanalytical

PharmaNet/i3� experts� develop,� optimize,� and� validate� analytical� methods� and� rapidly�

process� sample� analysis� of� drugs� from� toxicokinetic,� PK,� bioavailability,� bioequivalence,�

and� all� stages� of� clinical� studies� for� small� and� large� molecules

Contract� Service�

Capacity� Affordable�

by� Service� Area

PharmaNet/i3� has� experience� conducting� studies� in� all� phases,� including� I-IV.� We� have�

the� capability� to�manage� studies� of� all� sizes,� from� small� phase� I� through� global� studies�

with� hundreds� of� sites� and� thousands� of� patients.� PharmaNet/i3� has� also� managed�

registry� studies,� including� a� cardiovascular� registry�with�more� than� two�million� patients.

Specifically,� since� 2004,� PharmaNet/i3� has� provided� services� on� a� combined� 8,432�

projects� (this� number� is� both� full� service� and� stand-alone� projects).� These� projects�

covered� all� phases,� from� phase� I-IV,� including� expanded� safety,� post-marketing�

surveillance,� and� expanded� access.�

Communication� Dispositoion� of The� center� of� the� PharmaNet/i3team� is� the� Project� Manager.� � This�

3.� Corporate� Business�Overview

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with� Clients

Project� Manager

Responsible

person� is� the� main� point� of� contact� of� the� Client� and� coordinates�

the� activities� from� every� department.� Providing� the� function� of�

oversight,� support� and� advice,� each� project� also� has� a� very�

experienced� Project� Director� which� supervises� the� activities� of� the�

Project�Manager�and� is� able� to� step� in�at� any�given� time�to� support�

the�PM.� �Furthermore,�each�of� the�departments� that�are� involved� in�

the� study� will� have� a� departmental� representative� that� acts� as� a�

liaison�between� the�members�of� their�department�and� the�PM.�Very�

large� studies� may� also� use� the� structure� of� Regional� Project�

Managers� with� a� Global� Project� Manager� overseeing� the� entire�

study.

Providing� Realtime

Service� Delivery

A�detailed� timeline�Gantt� chart�would� be�developed�with� the� client�

at� the� start� of� the� project� as� part� of� the� SAP� plan.� The�

PharmaNet/i3EVA� system� is�used� for�budget�management.� � Progress�

of� a� document� is� routinely� checked� against� the� timeline,� and� the�

budget� is�monitored�against�percent�achieved�of�a� document.� �Any�

variances� are� immediately� addressed� so� that� they� can� be� resolved.� �

For� full� service� projects� the� project�management� function� is� usually�

assigned� to� a� clinical� project� manager.

Realtime

Feed-back

PharmaNet/i3� monitors� client� satisfaction� through� continuous�

communication.� For� each� project,� PharmaNet/i3� holds� monthly�

internal� reviews� done� to� assess� project� performance.�

The� first� is� the� project� excellence� meeting,� which� is� run� by�

therapeutic� area.� Each� therapeutic� head� meets� with� the� head� of�

project� management,� project� manager,project� director,� medical,�

clinical,� and�data� team�members�and� reviews� the�project� for�metric�

performance� as� well� as� timelines,� quality,� and� forecasting�

requirements.

PharmaNet/i3� also� conducts� top� ten� review� meetings.� These�

meetings� focus� on� special� projects� and� are� run� by� the� heads� of�

project� management� and� the� senior� vice� president� of� clinical�

operations.� The� attendance� for� this� meeting� includes� all� the�

operational� heads� in� PharmaNet/i3.� The� project� manager� and�

project� director� present� their� project� in� a� formal�manner� and� focus�

on� financials,� project� issues� and� resolutions,� metrics,� review�

deliverables� and� quality� as� well� as� the� client’s� satisfaction.

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4.� Corporate� Competitiveness

Corporate

Competitiveness

Clinical� Trial� Experience� (Number� of� studies)

Oncology� 387

Neuroscience� 565

Endocrinology� and� Metabolic� Disorders� 145

Respiratory� and� Infectious� Diseases� 350

Phase� IV� 204

Cardiology� 135

Rheumatology� 165

Gastrointestinal� 63

Quality� Systems� and� Practices

Quality� is� integrated� into� all� of� our� practices.� The� PharmaNet/i3QA� team� interacts�

directly�with� clients� to� understand� the� specific� requirements� for� their� clinical� study� or�

drug� development� project.� Together,� our� quality� and� regulatory� affairs� specialists�

oversee�conformance�with�client� requirements�and�applicable� regulations� such�as�U.S.�

Food�and�Drug�Administration� (FDA)� regulations,�Canada’s�Health�Products�and�Food�

Branch� Inspectorate� regulations,� European� Union� directives,� ANVISA� and� other�

applicable� international� agencies’regulations� during� each� phase� of� the� clinical� trial�

process.� Our� experience� and� oversight� ensures� that� our� clinical� and� bioanalytical�

services� comply� with� applicable� Good� Clinical� Practices� (GCP),� Good� Laboratory�

Practices� (GLP)� and� International� Conference� on�Harmonisation� (ICH)�GCP� guidelines�

(E6).

Employee� Training�

PharmaNet/i3’s� training�catalog� contains�hundreds�of� courses� that�are�available� to�our�

employees� online� 24/7.� We� maintain� a� full-time� training� department� producing�

learning�materials,�which�are� convenient� to� employees� in� all� time�zones.� If� employees�

are� in� the� clinical� area,� we� require� classes� based� on� ICH� GCP� including� managing�

essential� documents,� trial� master� file� requirements,� drug� safety� reporting�

requirements,� ethics� obligations,� IRB/IEC,� and� project� management,� among� many�

others.� Data� management� classes� focus� on� PharmaNet’s� data� systems,� as� well� as� on�

principles�of�data�management.�Other�departments�provide� specific� training� related� to�

finance,� IT,� regulatory� affairs,� and� other� areas.� English� languagelessons� are� also�

offered� through� an� engaging� online� program.

No.� of� Regulatory

Inspections

Classification FDA(US) EMA(EU) PMDA(Japan) Others

Pre-Clinical� Area NA NA NA NA

Clinical� Area 2 5 01� -� KFDA�

(South� Korea)

Manufacturing� Area NA NA NA NA

Others1�­�Ukraine,�1-�

Germany�

Current� Status� of

Accredited�

Certification

GLP,� GCP

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5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� to

PharmaNet/i3� has� offices� and� staff� in� several� Asian� countries.� Project� management,�

clinical�monitoring,� regulatory� affairs� and�medical:� China,�Korea,�Hong�Kong,� Taiwan,�

Australia,� Philippines,� Thailand,� Malaysia,� Singapore,� India.� Data� management� center�

-� India� (Mumbai� &�Bangalore).�Next� target� countries� are� Japan� and� possibly� Vietnam.�

Due� to� the� tripartite� agreement� and�mutual� acceptance� of� data� among� China,� Japan�

and� Korea,� there� is� an� increase� in� the� number� of� regional� trials� to� support� drug�

registration� in� Japan.

Asian� Clients'

Composition(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

N/A� % N/A� % N/A� % N/A� %

No.� of� Asian� Clients

in� recent� 3� years

PharmaNet/i3� has� conducted� approximately� 265� studies� in� 14� different� therapeutic�

areas� since� January� 2006,� in� the� US,� European,� and� Asian� clients.

Major� Service� Range

with�Asian�Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D

Pre-ClinicalPre-clinical

Test� Sample

R&D� Strategy

&�Management

Phase� I Clinical� Trials

Phase� II ○Clinical� Test

Sample

Finished

Products

Regulatory

Affairs

Phase� III ○

Finished

Product

Business

Development

Phase� IV ○Sales� &

Marketing

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Corporate� Name Pharmaseed

Head� Office� Address 9� Hamazmera� St.� Ness� Ziona� 74047,� Israel

Facilities� City� &� Country Israel

Web-site� Address www.pharmaseedltd.com

Contact

(Korean�

Business)

Telephone +972-8-930-2771

E-mail [email protected]

Company� Description� &� Organization

Pharmaseed� is� Israel’s� largest� GLP-certified� pre-clinical� CRO� specializing� in� translational� and� regenerative�

studies.� We� are� equipped� for� the� execution� of� studies� of� NCEs,� biologics� and� medical-devices� and� follow�

them� from� the� development� stage� to� first-in-man� trials.� These� include� safety� and� efficacy� evaluation� in�

various� animal� models� as� well� as� complementary� in-vitro/ex-vivo� models� and� on-site� human� anatomy�

services.

Our� expertise� in� pre-clinical� studies� lies� mostly� in� the� following� areas:� Stem� cell� and� cellular� therapeutics,�

Angiogenesis,� Cancer,� Inflammation,� CNS,� Pain,� Metabolic� Disorders,� Toxicology� and� Medical� Devices.

Founded� in� 2003,� Pharmaseed� is� a�GLP-certified� contract� research� organization� (CRO)� providing� pre-clinical�

and� consulting� services� for� medical� device,� biotechnology� and� pharmaceutical� companies.� We� also� provide�

pre-formulation� services� for� small� and� medium-size� start-ups� as� well� as� idea� and� feasibility� companies.

Pharmaseed’s� lean� and� experienced� team� forms� an� efficient� organization� whose� global� reach� includes� a�

network� of� sponsors� from� the� U.S.,� Europe,� Canada� and� Israel.� This� network� has� enabled� Pharmaseed� to�

establish� JV�programs�with�pharmaceutical�companies�and�academia�as�well�as� a� top-tier�S.A.B./K.O.L.�panel�

from� multinational� bio-pharma� companies.

All� our� services� are� priced� at� a� competitive� rate� in� comparison� to� European� and� U.S.-based� companies.

107. Pharmaseed

1.� Corporate� General� Information

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108. Polaris Life Sciences

1.� Corporate� General� Information

Corporate� Name Polaris� Life� Sciences

Corporate� Ownership Private� Company

Head� Office� Address 133� Montfort� Drive

Facilities� City� &� Country Belle� Mead,� NJ� -� U.S.A.

Korean� Business� OfficeGyeonggido,� Ahnyang� City,� Dongan-gu,� Gwanyang-dong,� 1597,� Hanyang�

Worldville,� 915

Web-site� Address www.plsbio.com

No.� of� Employees 3

Financial� Status

Sales� Revenue� in� 2010

(US� K$)Capital(US� K$) Dept-equity� Ratio(%)

$250 $� 100 0

Contact

(Korean�

Business)

Name Howard� H.� Kim

Address 133� Montfort� Drive

Telephone +1� (609)� 933-8282� and� +82� (10)� 2837-1039

E-mail [email protected]

Company� History

The� company� was� started� in� 2008� assisting� Korean� companies� to� market� their� products� in� the� U.S.� and� in�

Europe.� � We� provided� consulting� to� a� Korean� company� to� successfully� transfer� manufacturing� technology�

from�Germany� to�Korea.� �We� introduced�a�Korean�API�producer� to�an�U.S.�biotech� company.� � In� the�process,�

we� are� selling� the� API,� and� file� DMFs� in� the� U.S.,� Canada,� Europe� and� South� America.

Company� Description� &� Organization

Polaris� Life� Sciences� (PLS)� provides� expertise� and� direction� to�manufacturing� and� service� companies� desiring�

to� expand� into� developed� markets� in� the� U.S.� and� in� Europe.� � PLS� will� help� your� company� bridge� the� gap�

between� the� East� and� the�West� in� the�pharmaceutical� and� chemical� industries.�We� specialize� in� customizing�

our� technical� know-how�and�management� skills� to� improve�your�performance�by�successfully�developing�and�

launching� new� business� opportunities.

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2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

○ ○ ○ ○

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US ○ US ○ US ○ US ○

Canada ○ Canada ○ Canada ○ Canada ○

EU ○ EU ○ EU ○ EU ○

Asia ○ Asia ○ Asia ○ Asia ○

Global ○ Global ○ Global ○ Global ○

Other Other Other Other

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research ○ API ○

APIs ○

R&D ○

Pre-Clinical ○ Pre-clinical

Test� Sample○

R&D� Strategy

&� Management○

Phase� I ○ Clinical� Trials

Phase� II ○Clinical� Test

Sample○

Finished

Products○

Regulatory

Affairs○

Phase� III ○Finished

Product○

Business

Development○

Phase� IV ○Sales� &

Marketing○

Corporate�

Product� Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

Generics APIs Devices Others

Represent� many�

producers

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3.� Corporate� Business�Overview

Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

10% 25%

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

Sales� Office

Focusing�

Therapeutic� Area

Generic�pharmaceutical,� Consumer�Health�products,� intermediates�and�API� in� new�drug�

development

General� Overview

of� Corporate's� Key

Contract� Services

We� work� with� a� number� of� key� Contract� Services� that� specialize� in� various� areas.

4.� Corporate� Competitiveness

Corporate

Competitiveness

PLS� is� also� certified� as� a�Minority� Business� Enterprise.� �We�have� offices� in� Korea� that�

can� respond� to� Korean� companies� promptly.� � We� have� over� 30� years� of� experience�

in� the� area� so� we� can� work� efficiently� to� achieve� companies’� needs.

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5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� toKorea,� U.K.,� Germany,� China,� India,� Switzerland

Asian� Clients'

Composition(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

20%

No.� of� Asian� Clients

in� recent� 3� years

OCI,�OCI�Materials,�Nexolon,�AnyGen,�GL�Rapha,�Daelim�Chemical,�Well� E&C,�Yuhan,�

Estech� Pharma�

Major� Service� Range

with�Asian�Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research ○ API ○

APIs ○

R&D ○

Pre-ClinicalPre-clinical

Test� Sample○

R&D� Strategy

&�Management○

Phase� I Clinical� Trials ○

Phase� IIClinical� Test

Sample○

Finished

Products○

Regulatory

Affairs○

Phase� III

Finished

Product○

Business

Development○

Phase� IVSales� &

Marketing○

6.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

We� are� flexible� to� meet� the� Korean� companies’� needs.� � If� PLS� cannot� provide� such� service,� then� we� know�

exactly� who� can� provide� those� services.

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109. PPD, Inc.

1.� Corporate� General� Information

Corporate� Name PPD,� Inc.

Head� Office� Address 929� North� Front� Street,� Wilmington,� NC� 28401-3331,� United� States

Korean� Business� Office402,� 4th� Floor� Keungil� Tower,� 677-25,� eoksam-dong,� Gangnam-gu,�

Seoul135-080

Web-site� Address www.ppdi.com

No.� of� Employees 11,000+

Contact

(Korean�

Business)

Name Insook� Cho

Address 4F,� Keungil� Tower,� 223� Teheran-ro,� Gangnam-gu,� Seoul� 135-080� Korea

Telephone +82-2-3490-1702

E-mail [email protected]

Contact

(Korean�

Business)

Name Michael� Clay

Address10� Science� Park� Road,� 02-04� The� Alpha,� Singapore� Science� Park� II,� Singapore,�

117684

Telephone +65� 6302� 9551

E-mail [email protected]

Company� History

From� its�beginnings� in�1985�as�a� one-person� consulting� firm� in�Maryland� to� its�position� today�as� one�of� the�

world's� leading�contract� research�organizations� (CRO),�PPD�has�offices� in�44� countries�and�more� than�11,000�

professionals� worldwide.� Four� themes� drive� PPD's� success:� engaged� employees,� medical� and� scientific�

expertise,� quality� execution� and� globalreach.

Now� celebrating� 25� Years� of� Advancing� Drug� Development,� PPD� appliesits� therapeutic� expertise� and�

commitment� to� quality� to� help� clients� and�partners� accelerate� the� delivery� of� safe� and� effective� therapeutics�

and� maximize� the� returns� on� their� R&D� investments.

Company� Description� &� Organization

PPD� is� a� leading� global� contract� research� organization� providing� drug� discovery,� development� and� lifecycle�

management� services.� Our� clients� and� partners� include� pharmaceutical,� biotechnology,� medical� device,�

academic� and� government� organizations.

With� offices� in� 44� countries� and� more� than� 11,000� professionals� worldwide,� PPD� applies� innovative�

technologies,� therapeutic� expertise� and� a� commitment� to� quality� to� help� clients� and� partners� accelerate� the�

delivery� of� safe� and� effective� therapeutics� and� maximize� the� returns� on� their� R&D� investments.

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2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

○ ○

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US ○ US US US ○

Canada Canada Canada Canada ○

EU ○ EU EU EU ○

Asia ○ Asia Asia Asia ○

Global ○ Global Global Global ○

Other ○ Other Other Other ○

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research ○ API

APIs

R&D ○

Pre-Clinical ○ Pre-clinical

Test� Sample

R&D� Strategy

&� Management○

Phase� I ○ Clinical� Trials ○

Phase� II ○Clinical� Test

Sample

Finished

Products

Regulatory

Affairs○

Phase� III ○Finished

Product

Business

Development○

Phase� IV ○Sales� &

Marketing○

Corporate�

Product� Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

○ ○ ○ ○ ○

Generics APIs Devices Others

○ ○ ○ ○

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 475

3.� Corporate� Business�Overview

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

○ ○ ○

Focusing�

Therapeutic� Area

Oncology,� CNS,� cardiovascular,� infectious� disease,� critical� care,� dermatology,� general�

medicine,� immunology,� ophthalmology,� pediatrics,� urology

4.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Major� Service� Range

with�Asian�Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research ○ API

APIs

R&D ○

Pre-Clinical ○Pre-clinical

Test� Sample

R&D� Strategy

&�Management○

Phase� I ○ Clinical� Trials ○

Phase� II ○Clinical� Test

Sample

Finished

Products

Regulatory

Affairs○

Phase� III ○

Finished

Product

Business

Development○

Phase� IV ○Sales� &

Marketing○

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110. PRA International

1.� Corporate� General� Information

Corporate� Name PRA� International

Head� Office� Address 4130� ParkLake� Avenue� -� Suite� 400� Raleigh,� North� Carolina� 27612

Korean� Business� Office 20F,� Trade� Tower,� 159,� Samsung-1-dong� Gangnam-gu,� Seoul,� 135-729,� Korea

Web-site� Address http://www.prainternational.com/

Contact

(Korean�

Business)

Name -

Address 20F,� Trade� Tower,� 159,� Samsung-1-dong� Gangnam-gu,� Seoul,� 135-729,� Korea

Telephone +82� (2)� 585-8155

E-mail -

Company� History

2011.� Acquired� Kinship� Technologies,� a� Chennai,� India� based� software� developer� and� services� company

2010.� PRA� opens� North� American� Bioanalytical� Laboratory� in� Lenexa,� KS,� USA

PRA� has� 38� global� offices,� employs� over� 3,600� staff� and� performs� studies� in� 85+� countries� on� 6� continents

2008.� Moved� Golbal� Headquarters� to� Raleigh,� North� Carolina,� USA

2007.� Acquired� Pharmacon,� a� clinical� research� organization� based� in� Berlin,� Germany,� that� specializes� in�

conducting� PhaseⅠ� studies� with� patients� in� several� Central� European� countries

PRA� returned� to�being�a�privately�held�company�when� it�was� reacquired�by�Genstar�Capital,� LLC� in�December�

2007.� Genstar� had� been� PRA's� largest� investor� before� the� initial� public� offering� in� 2004

Company� Description� &� Organization

PRA� is� a� global� Clinical� Research�Organization� providing� services� through� all� phases� of� clinical� development.�

We� specialize� in�oncology,�CNS,� respiratory/allergy,� cardiovascular� and� infectious�diseases.�PRA�has� supported�

over� 2,100� clinical� trials� in� more� than� 80� countries� on� 6� continents� through� our� global� offices.� PRA's�

therapeutic� expertise,� global� reach,� and� project� experience� with� local� knowledge� enable� our� project� teams�

to� deliver� consistent� and� on� time� performance� for� our� clients.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 477

2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

〇 〇

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US 〇 US US US

Canada 〇 Canada Canada Canada

EU 〇 EU EU EU

Asia 〇 Asia Asia Asia

Global 〇 Global Global Global

Other 〇 Other Other Other

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D

Pre-ClinicalPre-clinical

Test� Sample

R&D� Strategy

&� Management〇

Phase� I 〇 Clinical� Trials 〇

Phase� II 〇 Clinical� Test

Sample

Finished

Products

Regulatory

Affairs〇

Phase� III 〇Finished

Product

Business

Development〇

Phase� IVSales� &

Marketing

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3.� Corporate� Business�Overview

Focusing�

Therapeutic� Area

•Cardio-Metabolic� � � � � � � � � � � � � � � � � � � � � � � � � � •Infectious� Diseases

•Neurosciences� � � � � � � � � � � � � � � � � � � � � � � � � � � � •Oncology� and� Hematology

•Respiratory/Allergy

General� Overview

of� Corporate's� Key

Contract� Services

PRA�offers� a� full� range�of� clinical�drug�development� services� in� over� 85� countries�world�

wide.

We� have� a� successful� track� record� of� managing� programs� in� all� phases� of� clinical�

development.� In� Phase� I-IIa,�we� conduct� studies� in� healthy� volunteers� as�well� as� patient�

populations� with� specific� medical� conditions.� PRA� distinguishes� itself� by� having� mobile�

Phase� I� units� and� facilities� inside� hospitals� to� allow� rapid� recruitment� of� patients� and�

volunteers.� In� Phase� II-III,� PRA� has� executed� many� pivotal� trials� that� led� to� FDA� and/or�

international� regulatory� approval.� In� late� phase,�we� assist� clients�with� the� post-approval�

process� by� planning� and� conducting� large,� simple� studies,� registries,� outcome� studies,�

and� risk� management� programs.

Our� comprehensive� services� include:

•Phase� I-IIa�

•Phase� II-III

•Post� Approval

•Safety� &� Risk� Management

•Therapeutic� Expertise

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 479

Corporate� Name Q-Trials� Ltd.

Head� Office� Address Seeds� Technologies� Bldg,� 1st� floor,� Kfar� Ruth� 73196,� � Israel

Facilities� City� &� Country Israel

Web-site� Address www.q-trials.com

Contact

(Korean�

Business)

Telephone +972� (8)� 9714919

E-mail [email protected]

Company� Description� &� Organization

If� you� are� looking� for� a� CRO� in� Israel� which� will� carry� out� your� study� from� A� to� Z� down� to� a� T,� you� are�

in� the� right� place.� Q-Trials� is� a� leading,� independent� CRO,� established� in� 2007.� � �

Q-Trials� is:

•� Highly� recommended� and� well� known� for� our� Quality

•� Connected� to� excellent� sites� with� high� recruitment� rates

•� Completely� self-sufficient

•� A� one-stop-shop� for� trial� services

•� Certified� for� our� translation� services� by� an� international� standard

Our� entire� team� is� trained� in-house� for� maximal� performance,� no� exceptions.� We� believe� in� personal�

uncomplicated� client� contact� and� full� availability.

111. Q-Trials Ltd.

1.� Corporate� General� Information

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Corporate� Name QUADRO� CRO

Head� Office� Address

Tunalı� Hilmi� Caddesi

No:� 99/4� Çankaya

Ankara� -� Türkiye

Facilities� City� &� Country Turkey

Web-site� Address www.quadro-cro.com

Contact

(Korean�

Business)

Telephone +90� 312� 466� 66� 48�

E-mail [email protected]

Company� Description� &� Organization

[Mission]

Our� mission� is� to� become� a� solution� partner� offering� the� highest� standards� by� continuously� improving�

ourselves� and� our� technological� infrastructure,� by� developing� better� goods� and� services,� by� ensuring�

customer� satisfaction� and� adding� value� for� our� clients,� to� offer� the� Clinical� Trials� community� with�

educational,�organizational� and�consultancy� services,�drawing�on�our� technological� infrastructure,� experience�

and� expertise.

[Vision]

Our� vision� is� to� become� a� high-end� company,� open� to� change� and� continuously� aligning� with� all� sectoral�

developments� in� a� reasonable� timeframe,� and� always� upholding� satisfaction� of� internal� and� external� clients�

by� solutions� that� it� offers� for� the� sector.

112. QUADRO CRO

1.� Corporate� General� Information

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 481

Corporate� Name Quintiles

Corporate� Ownership Private� Company

Head� Office� Address 4820� Emperor� Blvd.� Durham,� NC� 27703� � USA

Facilities� City� &� Country >100� offices,� >60� countries

Korean� Business� OfficeQuintiles� Transnational� Korea� Co.,� Ltd.� 13th� floor,� World� Tower� Bldg� 7-25�

Sincheon-dong� Songpa-gu� Seoul� 138-731,� Republic� of� Korea

Web-site� Address www.quintiles.com

No.� of� EmployeesQuintiles� has�more� than� 27,000� dedicated�professionals� serving� all� Quintiles� lines�

of� business� worldwide.�

Financial� Status

Sales� Revenue� in� 2011(US�

K$)Capital(US� K$) Dept-equity� Ratio(%)

Approximately� USD$3�

billion- -

Contact

(Korean�

Business)

Name MiSook� Hyun

Address 13th� floor�World� Tower� Bldg� � 7-25� Sincheon-dong,� Songpa-gu,� Seoul,� 138-731

Telephone +82� 2� 2046� 8805

E-mail [email protected]

Company� History

Quintiles� has� been� an� ally� to� the� biopharmaceutical� and� medical� device� industries� for� more� than� 30� years.�

Quintiles� was� founded� in� 1982� by� Dennis� Gillings,� CBE,� Ph.D.,� to� offer� biostatistical� &� data� management�

services� to� the� pharmaceutical� industry.� Dr.� Gillings� continues� to� lead� the� company� as� Executive� Chairman.� �

Quintiles� began� its� international� expansion� in� 1987� with� the� opening� of� an� office� in� London� to� serve�

customers� in� Europe.�Quintiles� established� its� first� offices� in� the� Asia-Pacific� region� in� 1993,� opening� offices�

in� Sydney,� Australia,� and� Tokyo.� Headquartered� near� Research� Triangle� Park,� we� now� have� offices� in� 60�

countries� and� provide� clinical� monitoring� services� in� many� more.� �

113. Quintiles

1.� Corporate� General� Information

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Company� Description� &� Organization

With�a�network�of�more� than�27,000�professionals�working� in�more� than�80�countries,�Quintiles�have�helped�

develop� or� commercialize� all� of� the� world’s� top� 50� best-selling� drugs.�With� extensive� therapeutic,� scientific�

and� analytics� expertise,� we� help� biopharmaceutical� and� health� sciences� customers� navigate� the� increasingly�

complex� landscape� with� more� predictability� to� enable� better� outcomes.� Our� expertise� and� insights� help�

customers� optimize� the� value� of� their� drug� development,� commercialization� and� health� care� delivery.�

Through�our�extensive� range�of� services� ­� from� initial�human� testing� through�patent�expiration,� from�strategy�

through�planning�and�execution� ­�we�decrease�costs,� improve�productivity,� and�save� time.�All� along,�we�work�

with� an� unwavering� dedication� to� patients,� safety� and� ethics.

Our� Product� Development� group� enables� our� customers� to� outsource� the� entire� development� process� from�

first-in-man� studies� to� post-launch� evaluation.� Our� Integrated� Healthcare� Services� address� the� outsourced�

commercial� needs� of� biopharma� companies� as� well� as� those� of� payers,� providers� and� other� healthcare�

stakeholders� for� value-based� analyses,� research� studies� and� evidence-based� medicine.�

We� lead� with� science,� leveraging� extensive� therapeutic� expertise,� with� more� than� 650� medical� doctors� on�

staff.� Over� the� past� 10� years,� Quintiles� has� started� up� 100,000� investigator� sites.�When� a� customer� needed�

an� accelerated� sales� force� build� across� seven� countries,� Quintiles� recruited,� trained� and� implemented� highly�

effective� field� sales� teams� in� just� four� months.

Quintiles’� success� begins� and� ends� with� our� customers’� success.�We� help� them� rapidly� assess� the� viability� of�

potential� new� therapies;� successfully� launch�new�products;� and�evaluate� their� impact� and�appropriate�use� in�

patients.� � By� applying� a� variety� of� outsourcing� models� from� single� source� to� full� service,� from� functional�

outsourcing� through� portfolio� management,� Quintiles� builds� the� right� customer� relationship� to� deliver�

maximum� value.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 483

2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

○ ○ ○

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US ○ US US ○ US ○

Canada ○ Canada Canada ○ Canada ○

EU ○ EU EU ○ EU ○

Asia ○ Asia Asia ○ Asia ○

Global ○ Global Global ○ Global ○

Other ○ Other Other ○ Other

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D ○

Pre-Clinical Pre-clinical

Test� Sample

R&D� Strategy

&� Management○

Phase� I ○ Clinical� Trials ○

Phase� II ○Clinical� Test

Sample

Finished

Products○

Regulatory

Affairs○

Phase� III ○Finished

Product

Business

Development○

Phase� IV ○Sales� &

Marketing○

Corporate�

Product� Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

○ ○

Generics APIs Devices Others

○ ○

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3.� Corporate� Business�Overview

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

○ ○

Focusing�

Therapeutic� Area

Since� 2001,�Quintiles� has� been� involved� in� over� 4,500� studies� involving� over� 11�million�

patients.� Quintiles� has� extensive� experience� in� almost� all� therapeutic� areas� including:�

infectious� diseases� (incl.� bacterial,� fungal,� viral� and� parasitic� infections� and� vaccines),�

allergies,� immunology,� anti-inflammatories,� cardiovascular� therapeutics� (incl.� blood� and�

vascular� disorders),� dermatology,� endocrinology� (incl.� diabetes),� gastroenterology,�

genitourinary� disorders,�medical�devices� in� a�wide� range�of� therapeutic� areas,�metabolic�

disorders�and�nutrition,�musculoskeletal� and�connective� tissue� disorders,�neurology� (incl.�

stroke�and�trauma),�oncology� (including�hematology�and�palliative� care),�ophthalmology,�

psychiatry,� and� respiratory� therapeutics.

We�also�have�extensive�experience�with�women’s�health,�pediatrics,� and�diseases�mostly�

afflicting� eldely� or� geriatric� populations.

Communication�

with� Clients

Dispositoion� of

Project� Manager

Responsible

Quintiles� has� a� robust�Clinical� Project�Management� (CPM)�group� in�

our� Asia-Pacific� regional� therapeutic� delivery� unit� � with�many� years�

of� experience� in� a� wide� range� of� therapeutic� areas� and� indications

Providing� Realtime

Service� Delivery

Timelines� are� fundamental� to� any� project� and� we� take� them� very�

seriously.� CPMs� are� closely� involved� in� developing� project� timelines�

and� utilize� the� real� world� clinical� trial� performance� data� that�

Quintiles� has� generated,� from� more� than� 30� years� of� clinical� trial�

research,� to� scale� the� study� appropriately� in� order� to� meet� its�

timeline.

This�enables�us� to�make� realistic�projections� that�assist� in�managing�

our� customers’� and� their� products� timelines.

Realtime

Feed-back

Regular� customer� status� meetings� (usually� teleconferences)� are�

conducted.� These�meetings�are� led�by� the�CPM�and�attended�by� the�

service� line� team� leads.�

Should� a� critical� issue� arise;� the� CPM� will� escalate� problems� by�

alerting�senior�management�at�both� companies,� in�accordance�with�

the� Project� Communications� Plan.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 485

4.� Corporate� Competitiveness

Corporate

Competitiveness

We� lead�with�science,� leveraging�extensive� therapeutic�expertise,�with�more� than�650�

medical� doctors� on� staff� representing� numerous� fields.� Our� medical� experts�

understand� the� scientific� advances� and� implications� of� the� changing� landscape.�

We� also� have� substantial� quantitative,� analytical� and� applied� technology� capabilities,�

with� hundreds� of� employees� possessing� Ph.D.s� in� mathematics,� statistics,� computer�

science� or� related� fields.� Our� award-winning,� innovative� technology� solutions� have�

been� recognized� frequently� by� industry� and� IT� experts� including� our� top� 10� ranking�

in� the� InformationWeek� 500� for� two� years� straight.�

Quintiles� also� takes� ethics� and� compliance� very� seriously.� Quintiles� has� established� an�

Ethics� Compliance� Office� (ECO)� led� by� our� Chief� Compliance� Officer.� An� important�

part�of�our�ethics�and�compliance�program� is� training.�The�ECO�has�developed�a�core�

compliance� curriculum� that� includes� three� interactive,� mandatory� training� courses:�

Global� Privacy� Awareness;� Introduction� to� Anti-Bribery;� and� Business� Ethics� at�

Quintiles.� � These� courses� are� required� to� be� taken� by� all� employee� sand� contractor� s�

within� a� specified� period.

Current� Status� of

Accredited�

Certification

We�maintain� our� standard� operating� procedures� in� accordance� with� regulations� and�

guidelines� appropriate� to� the� region� where� they� will� be� used,� to� help� ensure�

compliance� with� all� applicable� standards� of� GxP� including� but� not� limited� to� GCP,�

GDP� and� GLP.

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5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� to

Operating� in� 15� countries� in� Asia-Pacific,� with� 28� offices� and� over� 5,000� employees�

in� the� region�Quintiles� has�worked�with� a�multitude� of� Asian� customers� in� the� last� 3�

years� ­� working�with� them� locally� in� individual�markets� and� helping� them� enter� new�

countries� and� regions

No.� of� Asian� Clients

in� recent� 3� years

Operating� in� 15� countries� in�Asia-Pacific,� 28� offices� and�over� 5,000� employees� in� the�

region� Quintiles� has� worked� with� a� multitude� of� Asian� customers� in� the� last� 3� years�

­� working� with� them� locally� and� helping� them� enter� new� markets�

Major� Service� Range

with�Asian�Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D ○

Pre-ClinicalPre-clinical

Test� Sample

R&D� Strategy

&�Management○

Phase� I ○ Clinical� Trials ○

Phase� II ○Clinical� Test

Sample

Finished

Products○

Regulatory

Affairs○

Phase� III ○Finished

Product

Business

Development○

Phase� IV ○Sales� &

Marketing○

6.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

Since�2011,�Quintiles�has�partnered�with� the�Korea�National�Enterprise� for�Clinical�Trials� (KoNECT)� to�provide�

educational�events� involving� investigators,� local�and�multi-national�biopharmaceutical� companies�and� relevant�

government� officials.� � This� collaboration� is� designed� to� further� enhance� the� growth� of� high-quality� clinical�

research� in� Korea,� one� of� Asia’s� fastest-growing� countries� for� biopharmaceutical� development.� � The�

collaboration� is� another� example� of� Quintiles’� long-standing� commitment� to� advancing� clinical� research� and�

raising� professionalism,� not� only� in� Korea� but� globally.� � KoNECT� and� Quintiles� share� a� common� vision� of�

building� a� clinical� research� support� infrastructure� in� Korea� that’s� second� to� none.�

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 487

Corporate� Name R2S

Head� Office� Address8,� Rue� Abou� Kacem� Achabbi� et� Hafidi� Brahim,� Quartier� Gauthier,� 20060�

Casablanca� Anfa,� Morocco

Facilities� City� &� Country Morocco

Web-site� Address en.r2scro.com

Contact

(Korean�

Business)

Telephone +212� (0)� 5� 22� 47� 64� 85/86

E-mail [email protected]

Company� Description� &� Organization

R2S� CRO� is� composed� out� of� 4� departments:

•� Clinical� operations� department;

•� Regulatory� and� Quality� Insurance� department;

•� I.T� department;

•� Accountancy� and� Administrative� department.

R2S� CRO� Team� is� having� doctors,� pharmacists� and� biologists� full� of� experience� in� the� field� of� medicinal�

industry.

R2S� CRO� is� having,� as� a� complement� to� its� staff,� a� network� of� professionals� ready� to� intervene� whenever�

there� is� emergency� or� the� volume� of� tasks� is� calling� for� it.�

114. R2S

1.� Corporate� General� Information

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488� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name RAY

Head� Office� Address6� Al� Sahaba� Mosque� Square� ­

23� Gamal� Salem� Street,� Mesadak,� Dokki,� Giza,� Egypt�

Facilities� City� &� Country Egypt

Web-site� Address www.ray-cro.com

Contact

(Korean�

Business)

Telephone +202� 37619782

E-mail [email protected]

Company� Description� &� Organization

[Mission]

RAY� aims� at� reaching� excellence� in� providing� high� quality� clinical� research� support� to� the� Pharmaceutical,�

Academic,�Medical�Device�and�Biotechnology� industries� in� their�Endeavour� towards�developing�products� for�

the� benefits� of� mankind.� We� provide� a� wide� range� of� Clinical,� Medical� Affairs,� Pharmacovigilance� and�

Regulatory� services� with� the� key� advantage� of� cost� effectiveness.

[Vision]

To� become� the� first� choice� Regulatory� &� Pharmaceutical� and� Pharmacovigilance� consulting� services�

organization� in� the� Middle� East� region� and� North� Africa.� Partnering� Global� and� Local� pharmaceutical,�

Academic,� Medical� Device,� Biotechnology� Companies� and� International� CROs,� that� effectively� deliver�

sophisticated� clinical� development� services� critical� to� development� pathways� without� compromising� quality�

or� timelines.

115. RAY

1.� Corporate� General� Information

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 489

Corporate� Name ReachBio� LLC

Corporate� Ownership Private� Company�

Head� Office� Address 123� NW� 36th� Street,� Suite� 235,� Seattle,� WA,� 98107� USA

Facilities� City� &� Country Seattle(USA)

Web-site� Address www.reachbio.com

No.� of� Employees 8

Contact

(Korean�

Business)

Name Robert� Chaney

Address ReachBio,� 123� NW� 36th� Street,� Suite� 235,� Seattle� WA,� 98107,� USA

Telephone 206-420-0307

E-mail [email protected]

Company� History

ReachBio� LLC� was� incorporate� in� 2007� through� founding� members� with� an� extensive� background� in� a�

number� of� areas� including� hematology� and� immunology� with� a� special� emphasis� on� the� application� of�

primary�cell� systems� in�drug�development�and�drug�screening,�providing� for�greater�clinical� relevance.� �Over�

the� last� few�years,�ReachBio�has�evolved� into�a�multifaceted�company�offering�both� services�and�cell�based�

products� to� the� research� community.

Company� Description� &� Organization

ReachBio� LLC� is� a� privately� owned� life� sciences� company� providing� specialized� contract� assay� services� (in�

vitro� and� in� vivo)� and� cell-based� products� to� life� science� organizations�worldwide.� The� company’s� focus� is�

on� the� use� of� primary� cell� systems� for� high� value� applications� such� as� drug� discovery� &� screening� and�

toxicity� testing.

Our� focus� is� in� blood� and� bone� marrow,� offering� a� variety� of� non-GLP� contract� services� that� include�

hemotoxicity,�differential� toxicity,�multiple� species�and� lineages,�cancer� stem�cell�assays,�drug�efficacy,� flow�

cytometry� and� customized� cell� biology.� � We� also� offer� specialized� media� for� hematopoietic� and�

mesenchymal� cell� culture.� Our� cell� products� include� various� subsets� derived� from� primary� human� whole�

blood,� mobilized� blood,� cord� blood� and� bone� marrow.�

116. ReachBio LLC

1.� Corporate� General� Information

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490� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US US US US

Canada Canada Canada Canada

EU EU EU EU

Asia Asia Asia Asia

Global ○ Global Global Global

Other Other Other Other

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research ○ API

APIs

R&D ○

Pre-Clinical ○ Pre-clinical

Test� Sample

R&D� Strategy

&� Management○

Phase� I ○ Clinical� Trials

Phase� IIClinical� Test

Sample

Finished

Products

Regulatory

Affairs

Phase� IIIFinished

Product

Business

Development

Phase� IVSales� &

Marketing

Corporate�

Product� Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

Generics APIs Devices Others

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 491

3.� Corporate� Business�Overview

Clients'�

Composition

(%)

Big� PharmasMid� or� Small-size�

PharmasBiotech� Companies Star-ups

30% 20% 30% 20%

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

○ ○

General� Overview

of� Corporate's� Key

Contract� Services

Our� key� services� include� the� following.

Hemato-immuno�toxicity� testing�of�various�drugs�using�a�variety�of� in�vitro�and� in�vivo�

assay� systems.� �

Immunology� services� that� include� customized� cell� sorting� and� flow� cytometry�

evaluating� the� effects� of� drug� interactions� on� various� cell� types� including� clone�

generation,� expansion� and� storage.� �We� also�provide� specialized� services� addressing� a�

variety� of� immunomodulatory� effects� of� compounds� (e.g.� inflammatory� cytokine�

models,� effects� of� compounds� on� immune� cell� via� functional� assays).

We� have� a� strong� background� in� assay� and� analysis� of� cancer� stem� cell� assays� with�

expertise� in� hematological� diseases.

We� specialize� in� offering� customized� studies� tailored� to�meet� client� demands� that� are�

not� often� found� with� other� services� providers.� � Examples� range� from� dendritic� cell�

biology,� multi-drug� resistance,� potency� assessment� of� new� cellular� therapeutics,�

functional� and� predictive� assay� services� for� biotherapeutic� development,� etc.� � �

For� all� assays,� we� strive� to� use� clinically� relevant� and� predictive� systems.

Contract� Service�

Capacity� Affordable�

by� Service� Area

ReachBio�has�expertise�and�experience� in�a� variety�of�cell� biology�applications� that�we�

apply� to� answering� questions� clients� have� with� their� compounds� in� preclinical� and�

phase� I� development.� We� rely� on� clinically� relevant� assay� systems,� making� liberal� use�

of�primary�cell� systems,� involving�both� in�vitro�and� in�vivo�assays� to�address� such� issues�

as� toxicity,� efficacy,� mechanism� of� action,� etc.� � We� are� also� current� with� our�

application� of� our� assays� and� have�worked�with� a� number� or� clients� currently� and� in�

the�past�addressing�specific�hemato-immuno� toxicity� liabilities�with�clients�TKI� (tyrosine�

kinase� inhibitors)� compounds.� �More� recently,�we�have�been�working�with� clients� that�

have� biotherapeutic� agents� (antibodies,� antibody-drug� conjugates,� peptide�

therapeutics,� etc.)� in� development� and� we� are� addressing� a� variety� of� efficacy� and�

toxicity� questions� using� our� assays.� � � � �

Our� clients� range� from� small� start-up’s� to� big� pharma.� � We� can� screen� a� range� of�

compounds� in� a� given� assay� and� tailor� the� assays� to� each� individual� question� to� be�

addressed.� �We� have� clients� in� the� USA,� Canada,�Western� Europe� and� Asia.� �We� are�

extremely�conscious�of�escalating�costs�and�work�with�clients� to� find� the�most�effective�

and� economical� solution� without� compromising� quality.

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Communication�

with� Clients

Dispositoion� of

Project� Manager

Responsible

Each study is assigned a project manager (scientist) along withsupport from a variety of lab staff and we are in constantcommunication with clients by email and telephone. Projectmanagers are extremely client focused with a high capacity forflexibility, patience and ability to react quickly to client demands.

Providing� Realtime

Service� Delivery

Contract service study reports are routinely forwarded to clients byshared online sites as well as email. Hard copies are delivered onceresults are finalized, however we keep clients ‘up-to-date’ withrealtime results as study progresses to allow better decision making.

Realtime

Feed-back

Our mangers and staff are available by telephone during normalbusiness hours (9 – 5) on the west coast of USA. However weprovide most of our communication to North American andnon-North American clients via email communication and webinar.We can be available after hours for important communication.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 493

4.� Corporate� Competitiveness

Corporate

Competitiveness

As� mentioned,� all� of� our� services� are� non-GLP.� � However� ReachBio� has� a� quality�

management� system� in� place� and� this� facilitates� the� tracking� of� client� materials� as�

well� as� conducting� studies� with� appropriate� SOP’s,� etc.� � All� of� the� raw� data� is�

collected� into� client� specific� notebooks,� securely� locked� in� fire-proof� cabinets� with�

key� access� (accessible� by� study� staff� only)� and� collated� electronically� as� well� under�

appropriate� client� specific� folders� (accessible� by� study� staff� only)� on� our� server�

(locally)� with� redundant� back� up� processes� in� place.� � We� have� training� procedures�

in� place� for� all� new� and� existing� staff� for� relevant� functions.� � Training�manuals� are�

in� place�with� specific� performance� criteria.� �We� have� a� safety� officer� that�manages�

our� safety� training� program� for� all� employees.�

Our�scientific�director�and� laboratory� staff�have�extensive�experience�and� training� in�

all� related� in� vitro� and� in� vivo� assay� techniques� with� particular� expertise� in� cell�

biology� including� stem� cell� biology,� primary� cell� biology,� immunology� and�

hematology�as�well�as�molecular�biology�and�other�disciplines.� �Our�business�director�

has� extensive� experience� in� the� CRO� marketplace� coupled� with� a� scientific�

background� in� cell� biology.� � We� are� adept� at� developing� assay� systems� for� drug�

testing� and� evaluation.� � Service� contracts� are� competitively� priced� and� we� have� a�

very� good� track� record� of� client� retention� and� follow-on� contracts.� � � Our� contracts�

with� clients� are�managed� with� a� director� and� appropriate� staff� from� start� of� study�

design� through� completion.� � Once� contracts� are� signed,� every� effort� is� made� to�

schedule� work� to� be� started� within� days� or� the� week� of� contract� completion�

(signed).� � Delays,� if� they� happen,� rarely� occur� due� to� ReachBio� scheduling� conflicts�

but� rather� to�other� issues� concerning� client� compound�delivery,�material�delays,�etc.� �

Additionally,� once� the� study� is� initiated,� ReachBio�works� diligently� to� keep� on� track�

with� agreed� upon� timelines.

Current� Status� of

Accredited�

Certification

All� services�are�non-GLP� in�nature,�however�we� follow�GLP�protocols� for� the�majority�

of� our� assays.

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5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� to

USA,� Canada,� Taiwan,� India,� Australia,� Germany,� Switzerland,� France,� Sweden,�

Denmark,� Belgium

Asian� Clients'

Compositions(%)

Big� PharmasMid� or� Small-size�

PharmasBiotech� Companies Star-ups

100%

No.� of� Asian� Clients

in� recent� 3� yearsWe� have� worked� with� two� Asian� clients� in� past� three� years.

Major� Service� Range

with�Asian�Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D

Pre-Clinical ○Pre-clinical

Test� Sample

R&D� Strategy

&�Management

Phase� I Clinical� Trials

Phase� IIClinical� Test

Sample

Finished

Products

Regulatory

Affairs

Phase� IIIFinished

Product

Business

Development

Phase� IVSales� &

Marketing

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 495

6.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

Although�we�have�worked�with� smaller� companies� in�Asia,�we� routinely�work�with� big�pharma� companies�

in� USA� and� Europe.� �We� do� have� a� partner� in�Germany� as� well�who�works� with� us� in� Europe� facilitating�

certain� client�management� functions,� however� we�maintain� direct� one-to-one� relationships�with� all� clients�

and� this� includes� help� with� study� design,� technical� support,� pricing,� communication,� etc.� � In� Asia,� we� do�

not� have� any� partners� but� have� facilitated� communication� successfully� ourselves.� � However� we� realize� the�

benefit� of� a� Korean�partner� for� the� Korean�market� to� be�more� successful� and�would� be� very� interested� in�

help� with� identifying� a� suitable� partner� to� help� with� aspects� of� client� management� and� marketing� of�

services.� � We� are� very� much� interested� in� expanding� our� services� to� clients� in� Korea� and� other� Asian�

markets.� �Additionally,�we�can�provide� teleconference�and,� if�warranted,� travel� to�South�Korea.� �This� is�one�

area� that� we� think� would� be� beneficial� with� a� Korean� partner� to� set� up� visits� within� Korea.� � If� there� is�

interest,� we� are� willing� to� make� such� travel� arrangements� and� our� directors� have� experience� travelling� to�

Asia,� and� in� particular� to� South� Korea� and� Japan.� �

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496� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name Research� &� Development� RA.� S.A.

Head� Office� AddressAv.� Federico� Lacroze� 2252� 7� A� (C1426CPU)

� Buenos� Aires,� Argentina

Facilities� City� &� Country Argentina

Web-site� Address www.rd-latam.com

Contact

(Korean�

Business)

Telephone +54-11� 4771-4600� /� 4772-3924� /� 4775-3057

E-mail [email protected]

Company� History

Research�&�Development� RA� SA� CRO� is� a� full-service� contract� research� organization� based� in� Buenos� Aires,�

Argentina.� It� was� founded� in� 1993� as� a� family� enterprise,� by� Santiago� Liuboschitz,�MD� and� his� son,� Pablo�

Liuboschitz,� BsC.

Research� &� Development� CRO� has� been� operating� in� the� Latin� American� market� for� more� than� 20� years.�

Considering� that� the� first� regulation� for� clinical� trials� in� Latin� America�was� approved� in� 1997� in� Argentina,�

it� is� easy� to� see� that� Research� &� Development� CRO� has� been� active� and� present� since� the� very� beginning.

Dr.� Santiago� had� developed� his� career� since� 1972� within� the� pharmaceutical� industry,� after� 10� years� of�

medical� practice.� He� had� started� off� as� Medical� Director� at� Merck� Sharp� &� Dhome� where� he� stayed� until�

1980,� was� later� the� Head� of� Clinical� Research� at� Ciba-Geigy� Argentina� until� 1992� and� finally� was� the�

Southern� Cone� Regional� Medical� Director� at� SmithKline� Beecham� until� 2000.

He� was� Research� &� Development’s� CEO� until� 2008� and� is� currently� the� Vice-President.

� Pablo� Liuboschitz,� was� a� Bachelor� in� Science� at� that� time,� and� he� began� to� work� in� clinical� research� in�

1995.� He� was� a� researcher,� later� became� a� CRA� and� clinical� research� advisor� and� finally� was� the� Clinical�

Research�Manager� of� Research�&�Development� CRO.� After� completing� a�Master� in� Business� Administration�

he� took� over� the� CEO� position� in� 2008.

In� 2000,� Research� &� Development� was� able� to� expand� their� services� to� Brazil.� In� 2001� expansion� reached�

Mexico,�Costa�Rica�and�Chile.� In�2009�Uruguay�was� included�as�well� and� in�2014� through�a�Clinical�Research�

117. Research & Development RA. S.A.

1.� Corporate� General� Information

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 497

Consortium� composed� of� 8� other� CROs� we� are� now� able� to� go� global� with� clinical� trials,� offering�

outstanding� quality� and� local� “know-how”� within� affordable� budgets.

We� can� provide� full� support� for� bioequivalence� studies,� clinical� trials� from� phase� I� to� IV� and� product�

registration.� Our� client� list� includes� small� and� medium-sized� biotech� companies,� national� and� multinational�

pharmaceutical� companies� and� CROs.� For� disclosure� of� Client� List� please� contact� us.

� Research� &� Development� CRO� is� the� first� national� member� of� CAOIC� [http://www.caoic.org.ar/],� the�

Argentine� Chamber� of� CROs.

Company� Description� &� Organization

Our�Mission� is� to� provide� professional,� cost-� effective� and� timely� assistance� to� our� Clients� to� contribute� to�

their�drug�development�efforts� and� to�guarantee� the� collection�of� �high-quality� clinical�data� in� Latin�America,�

in� compliance� with� research� ethics,� international� standards� and� local� regulations� that� warrant� subject�

protection.

Through�our�strong�project�management�skills,�proactivity,� local�expertise,� flexibility�and� integrity�we�commit�

to� achieve� and� exceed� � the� client’s� expectations� for� individual� projects,� while� we� foster� and� nurture�

long-term,� trusting,� synergistic� relationships� with� them� for� future� developments.

Our� Vision� is� to� become� the� leading� experts� in� clinical� trials� in� Latin� America� due� to� our� quality� services,�

the� guarantee� of� study� subject� protection,� our� reliability� in� providing� outstanding� results� and� establishing�

long-term� trusting� relationships� with� our� Clients.

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118. Ricerca Biosciences, LLC

1.� Corporate� General� Information

Corporate� Name Ricerca� Biosciences,� LLC

Corporate� Ownership Private� Company

Head� Office� Address 7528� � � Auburn� Road,� Concord� � OH� � 44077USA

Facilities� City� &� Country Concord,� Bothell� -� United� States,� Taipei� -� Taiwan,� Lyon� -� France

Web-site� Address www.ricerca.com

No.� of� Employees 750� worldwide

Contact

(Korean�

Business)

Name Alton� Yu

Address Taipei,� Taiwan,� 158� Li-Teh� Road,� Peitou,� Taipei,� Taiwan� 112� R.O.C.

Telephone +886� 2� 2892� 3517

E-mail [email protected]

Company� History

Ricerca� was� founded� in� 1986� on� the� site� of� a� former� Diamond� Shamrock� facility.� � It� is� well� suited� to� serve�

the� needs� of� the� biopharmaceutical� industry� and� collocates�plant� and� lab� facilities� that� provide� unique� value�

to� our� clients� by� allowing� us� to� perform� a� variety� of� services� on� one� site.

Company� Description� &� Organization

Ricerca�Biosciences�offers�a� comprehensive�suite�of�discovery,�preclinical�and�development�services� to�support�

drug� candidates� from� lead� identification� through� IND� and� NDA� on� a� global� scale.� Capabilities� include�

molecular� through� in� vivo� screening� and� profiling,� as� well� as� medicinal� chemistry,� radiochemistry,�

IND-enabling� toxicology,�API�process� chemistry� and�cGMP�manufacturing�of�clinical�and�commercial�API.�Our�

experienced� scientists� deliver� world-class� expertise� and� services� to� help� you� shorten� time� to� IND� and� bring�

molecules� to� the� clinic� faster.

In� addition� to� U.S.-based� facilities� in� Concord,� Ohio,� and� Bothell,� Washington,� Ricerca� also� has�

ISO9001-certified� facilities� in� Taipei,� Taiwan,� and� Lyon,� France.� The� Concord� and� Lyon� facilities� also� hold�

certification� from� the� Association� for� Assessment� and� Accreditation� of� Laboratory� Animal� Care(AAALAC).

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 499

2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

○ ○

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US ○ US ○ US US ○

Canada Canada Canada Canada

EU ○ EU EU EU

Asia ○ Asia Asia Asia

Global ○ Global Global Global

Other Other Other Other

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research ○ API ○

APIs

R&D

Pre-Clinical ○ Pre-clinical

Test� Sample○

R&D� Strategy

&� Management

Phase� I Clinical� Trials

Phase� IIClinical� Test

Sample○

Finished

Products

Regulatory

Affairs○

Phase� IIIFinished

Product○

Business

Development

Phase� IVSales� &

Marketing

Corporate�

Product� Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

Generics APIs Devices Others

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500� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

3.� Corporate� Business�Overview

Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

40% 15% 30% 15%

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

○ ○ ○

Focusing�

Therapeutic� Area

Cardiovascular,� CNS,� Gastrointestinal,� Immunology/Inflammation,� Infectious�

(anti-infective),� Metabolic/Endocrine,� Oncology,� Pain,� Respiratory

General� Overview

of� Corporate's� Key

Contract� Services

Ricerca� Biosciences� offers� a� comprehensive� suite� of� discovery,� preclinical� and�

development� services� to� support� drug� candidates� from� lead� identification� through� � IND�

and�NDA�on�a�global� scale.�Capabilities� include�molecular� through� in�vivo�screening�and�

profiling,� as� well� as� medicinal� chemistry,� radiochemistry,� IND-enabling� toxicology,� API�

process� chemistry� and� cGMP� manufacturing� of� clinical� and� commercial� API.� Our�

experienced�scientists�deliver�world-class�expertise�and� services� to�help�you�shorten� time�

to� IND� and� bring� molecules� to� the� clinic� faster.

Contract� Service�

Capacity� Affordable�

by� Service� Area

Discovery� Pharmacology� services� include� molecular� profiling� &� screening,� functional�

pharmacology,� cellular� toxicology,� cellular� oncology� and� immune� systems,� in� vivo� safety�

and� disease� models,� and� discovery� DMPK.

Chemical� Development� capabilities� include� medicinal� chemistry,� analytical� chemistry,�

process� chemistry.� engineering� and� scale-up,� radiosynthesis,� and� API� production� with�

cGMP� controls.

Drug� Safety� and� Metabolism� services� include� general� toxicology,� safety� pharmacology,�

continuous� infusion,� juvenile� toxicology,� DART� and� bioanalytical� services.

Communication�

with� Clients

Dispositoion� of

Project� Manager

Responsible

For� IND� Packages,� a� program�manager� is� able� to� integrate� and� act�

as� single� point� of� communication.

Providing� Realtime

Service� Delivery

Project� updates� are� available� at� anytime� desired� by� the� client.� �

Ricerca� can� provide� teleconferences� and� written� updates� to� the�

client� at� anytime� that� the� client� desires.

Realtime

Feed-back

Since� Ricerca� is� a� Global� Company� with� representation� in� Asia� our�

ability� to� facilitate� any� communication� is� guaranteed.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 501

4.� Corporate� Competitiveness

Corporate

Competitiveness

Ricerca� has� an� online� catalog� for� pharmacology.� � For� preclinical� studies,� each� study�

or� request� is� priced� depending�on� the� scope� and�work� required.� In� this�way,�we� can�

custom� price� a� package� of� work� to� be� competitive.

No.� of� Regulatory

Inspections

Classification FDA(US) EMA(EU) PMDA(Japan) Others

Pre-Clinical� Area2� per� year� on�

avaerageYes

Clinical� Area

Manufacturing� Area Yes

Others

Current� Status� of

Accredited�

Certification

GLP/GMP/AAALAC/ISO

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502� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� toGlobal

Asian� Clients'

Composition(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

40% 15% 30% 15%

No.� of� Asian� Clients

in� recent� 3� years>50

Major� Service� Range

with�Asian�Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research ○ API ○

APIs

R&D

Pre-Clinical ○Pre-clinical

Test� Sample○

R&D� Strategy

&�Management

Phase� I Clinical� Trials

Phase� IIClinical� Test

Sample○

Finished

Products

Regulatory

Affairs

Phase� III

Finished

Product

Business

Development

Phase� IVSales� &

Marketing

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 503

Corporate� Name Scidre

Head� Office� Address

11� El� Thawra� Street,

� El� Korba� Square,

� Heliopolis,� 11341,� Cairo,� Egypt.

Facilities� City� &� Country Egypt

Web-site� Address www.scidreco.com

Contact

(Korean�

Business)

Telephone +20� 2� 2690� 9510

E-mail [email protected]

Company� Description� &� Organization

[Mission]

Our�mission� is� to�help�our� clients�bring� the�medical�product� to�market� faster� through�adhering� to� the�highest�

standards� of� scientific� quality� and� medical� ethics.

[Vision]

Our� vision� is� to� be� recognized� by� clients� as� the� top� quality� provider� of� clinical� development� services� to� the�

pharmaceutical,� device� development� and� biotechnology� industries.

119. Scidre

1.� Corporate� General� Information

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504� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name Shanghai� Cares� Biotech� Co� Ltd�

Corporate� Ownership Private� Company

Head� Office� AddressUnit� 18E,� Building� 1,� Huayuan� Plaza,� 3500� Kai-Xuan� Road,� Xuhui� District,�

Shanghai� 200030,� China�

Web-site� Address www.shcares.com.cn

Contact

(Korean�

Business)

Name -

AddressUnit� 18E,� Building� 1,� Huayuan� Plaza,� 3500� Kai-Xuan� Road,� Xuhui� District,�

Shanghai� 200030,� China�

Telephone +86� 21� 3425� 0062�

E-mail [email protected]

Company� Description� &� Organization

Cares� is� recognized� by� the� pharmaceutical� industry� as� one� of� the� leading� Clinical� Research� Organizations�

(CRO)� in�China.� It�provides�a� full� range�of� services� including�product� registration,�project�management�and�

monitoring� for� Phase� I� to� IV� registration� and� global� trials,� patient� recruitment,� data�management,� statistic�

analysis,� and� consulting� services� related� to� clinical� development.� Its� staff� has� extensive� experience� and� a�

track� record� of� achievements� in� these� various� areas.

It� has� conducted� some� dozens� of� clinical� trials� involved� more� than� thousands� of� patients.� It� maintains�

extensive� contact� networks� and� business� relationships�with� key� officials� and� personnel� in� the� government�

departments,� industry,� hospitals� and� institutional� organizations.

Cares’� services� are� cost� and� time� saving,� in� order� to� successfully� deal�with� the� strong� competition�and� the�

increasing� importance� of� the� first-mover-advantage.� That� customer� driven� approach�allows�Cares’� clients� a�

faster� entry� to� China's� growing� pharmaceutical� market,� guaranteeing� their� share� of� it.�

We�assure� the� high�quality� of�our� services� by� recruiting�only� experienced�and�well� educated�professionals.�

Cares� consists� of� a� young,� well-established� and� highly� motivated� team,� which� can� handle� any� kind� of�

challenge� under� high� time-pressure.�With�most� of� our� employees� holding� advanced� degrees,�we� are� able�

to�offer� a� very� individual� service,� focusing�on� the�needs�of�our� clients� and�always�meeting/exceeding� their�

expectation.

120. Shanghai Cares Biotech Co Ltd

1.� Corporate� General� Information

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 505

Corporate� Name Shanghai� Genomics,� Inc.

Corporate� Ownership Private� Company

Head� Office� AddressBuilding� #1,� 647� Song� Tao� Road,� Zhangjiang�Hi-Tech� Park,� Pudong� New�Area,�

Shanghai� 201203,� China

Web-site� Address www.shanghaigenomics.com

Contact

(Korean�

Business)

Name Ying� Luo,� Ph.D.

AddressBuilding� #1,� 647� Song� Tao� Road,� Zhangjiang�Hi-Tech� Park,� Pudong� New�Area,�

Shanghai� 201203,� China

Telephone +86� 21� 5080� 2536�

E-mail [email protected]

Company� History

2005/11/12� Dr.� Ying� Luo� was� invited� to� give� a� speech� at� the� Pacific� Forum� on� Life� Sciences� &�

Entrepreneurship� Conference� in� San� Diego.� � His� presentation� and� the� panel� discussion� in� which� he�

participated� focused� on� the� recent� trend� of� Western� pharmaceutical� companies’� outsourcing� to� biotech�

companies� in� China.� � This� conference� was� organized� by� the� Sino-American� Biotechnology� and�

Pharmaceutical� Professional� Association.�

2012/06/18�Dr.� Luo�will� attend�BIO�2012� in�Boston,�USA,�and�he�will� present�about�how� to� expedite� the�

fibrotic� drug� development� in� China.�

2012/04� The�China� Pharmaceutical�&� Biotechnology� Review,�a�monthly� publication� covering� all� aspects� of�

the� industry� (2012� volume� 58),� published� a� panel� discussion� with� Dr.� Ying� Luo� and� other� Experts� from�

biotechs� and� research� institutes� in� China.�

2012/03/11�Dr.�Luo�was� invited� to�attend�Drug�Discovery�World�Asia�2012� in�Singapore,�and�he� reviewed�

the� development� of� orphan� drug� F647� in� China� and� received� video� interview.�

2012/03/14� The� Chinese� Pharmacological� Bulletin� (2012� Jan:� 28(1):� 136-9)� pulished� an� article� authored�

by�National� Institute� for�Food�and�Drug�Control.�The�article� included� the� results�of�F573's� therapeutic�effect�

on� ConA-induced� acute� liver� injury� in� mice.� Dr.� Luo� is� the� co-author� of� the� article.�

121. Shanghai Genomics, Inc.

1.� Corporate� General� Information

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506� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Company� Description� &� Organization

Shanghai� Genomics,� a� drug� discovery/development� company� was� founded� in� August� 2001,� by� returnees�

Dr.� Ying� Luo� and�Dr.� Jun�Wu,� with� funding� of� RMB� 43�million� from� Shanghai� Venture� Capital� Company�

and� Shanghai� Zhangjiang� Hi-Tech� Park� Corp.� In� 2005,� the� company� merged� with� GNI.� The� company�

currently� employs�more� than�100�people�with� about� 80%� in� R&D,� including�17� Ph.D.� scientists.� Shanghai�

Genomics� occupies� 40,000-square-foot� buildings� located� in� the� dynamic�metropolitan� Shanghai,� which� is�

one� of� the� most� modern� laboratory� facilities� in� China.� The� company� went� public� on� the� Tokyo� Stock�

Exchange� on� August� 31,� 2007.

Its�mission� is� to� develop� novel� therapeutic� products� for� diseases� prevalent� in�Asian,� especially� in� the� areas�

of� lung� fibrosis,� liver� fibrosis,� cancer,�and�new�biomaterials� for�bone�healing.�Leveraging� its�highly�efficient�

drug� registration� team� and� extensive� nationwide� clinical� research� network,� it� provides� drug� registration�

service�and� clinical�CRO.� Shanghai�Genomics�has� also�built� an� integrated�drug�discovery�and�development�

platform,� including� signaling� pathway� mapping,� gene� expression� profile� studies,� protein� expression� and�

purification,� knock-down/knock-out,� in� vivo� animal� modeling,� antibody� generation� and� purification,� and�

bioinformatics.� These� programs� have� resulted� in� contract/collaborative� research� services� with�

pharmaceutical� companies� worldwide.�

The�Department� of�Clinical�Affairs�was� established� in� 2005,�with� a�major�mission� to� conduct� clinical� trials�

for� the� two� Category� 1.1� new� chemical� drug� candidates.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 507

Corporate� Name Shanghai� Loudon� Marketing� Consultant� Co� Ltd�

Corporate� Ownership Private� Company

Head� Office� Address 15�F� /A-C,�Haiyi�Business�Building,�310�Tianshan�Road,�Shanghai�200336,�China

Web-site� Address www.loudon-research.com

Contact

(Korean�

Business)

Name XiaoFeng.Yu

Address 15�F� /A-C,�Haiyi�Business�Building,�310�Tianshan�Road,�Shanghai�200336,�China

Telephone +86� 21� 6290� 2121�

E-mail [email protected]

Company� History

Loudon� Far� East� (LFE)� is� a� consulting� company� specialized� in� pharmaceuticals,� medical� device,� functional�

foods,� other� healthcare� and� life� science� industries.�

Loudon� China� was� established� in� 1996,� which� has� more� than� 16� years� of� experience,� it� provide� services�

of�primary�marketing� research,�business�consulting�services� and� interactive�marketing�services� in�China.�Our�

offices� are� located� in� Shanghai,� Beijing� and�Guangzhou.�We� had� completed�more� than�650�projects� until�

the� end� of� 2011.

Loudon� China� as� the� leading� health� consulting� firm� in� China,� in� the� marketing� research� field� it� provides�

services� for� most� of� international� pharmaceutical� and� other� health� care� companies.� Loudon� China� also�

provides� business� consulting� services� in� the� field� of�market� entry� strategy,�merger� and� acquisition� of� local�

pharmaceutical� and� medical� device� companies,� and� portfolio� management.� Loudon� China� also� provides�

Sales� Force� Effectiveness� (SFE)� consulting� services� to� international� pharmaceutical� companies.

Loudon�China� has� in-depth� knowledge�on� regulatory� affairs� and� administrative� regulation.�Good� expertise�

and� networking� with� healthcare� related� organizations� and� institutions,� e.g.� the� State� Food� and� Drug�

Administration� Bureau� (SFDA),� the� Ministry� of� Health� (MOH),� the� National� Development� and� Reform�

Committee� (NDRC),� etc..

Loudon� China� can� conduct� strategy� consulting� projects� with� key� stakeholders,� includes� officials,� industry�

executives,� hospital� directors,� hospital� pharmacy� heads,� KOLs� and� key� distributors.

122. Shanghai Loudon Marketing Consultant Co Ltd

1.� Corporate� General� Information

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508� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Company� Description� &� Organization

Loudon� Far� East� (LFE)� is� a� research� company� providing� out� sourcing� service� for� pharmaceuticals,� medical�

device� and� other� healthcare� industries.� Shanghai� Loudon� Marketing� Consultant� Co� Ltd� is� a� fully� owned�

subsidiary�of�LFE� in�China�with�a�unique�status:� it� is�a�wholly� foreign�owned� legal�entity.�LFE�China�provides�

marketing� research�and�business�consulting�services,�and�specific�CRO�services� such�as�Patient�Referral�and�

Clinical�Data�Management� (CDM).� It� offices� are� located� in� Shanghai�&� Beijing,�with� access� to�China�main�

cities.

LFE� as� the� leading� health� care� research� agency� in� China� in� the�marketing� research� field� provides� services�

for� most� of� the� key� leading� foreign� pharma� and� other� health� care� companies� in� China.� LFE� China� also�

provides� business� consulting� service� in� the� field� of�Market� Entry� Strategy,�Merger�and�Acquisition� of� Local�

Pharmaceutical� Companies,�Molecule� Screening� and� Portfolio�Management� and� Sales� Force� Effectiveness.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 509

Corporate� Name SHIVA� ANALYTICALS� (INDIA)� PRIVATE� LIMITED

Corporate� Ownership Private� Company

Head� Office� Address #� 24D� [P]� &� 34D� KIADB� INDUSTRAIL� AREA,� HOSKOTE

Facilities� City� &� Country BANGALORE(INDIA)

Web-site� Address WWW.SHIVAANALYTICALS.COM

No.� of� Employees 120

Financial� Status

Sales� Revenue� in�

2012(US� K$)Capital(US� K$) Dept-equity� Ratio(%)

195.35 2,549.38 19:25

Contact

(Korean�

Business)

Name G.SUDESH� KUMAR

Address#� 24D� [P]� &� 34D� KIADB� INDUSTRIAL� AREA,� HOSKOTE,� BANGALORE� -�

562114

Telephone 9880106073

E-mail [email protected]

Company� History

Shiva� Analyticals� (India)� Pvt.� Ltd.� was� established� in� a� 40,000� sq.ft� state-of� the-art� facility� in� 1997� for�providing� innovative,� reliable� and� cost-effective� analytical� solutions� for� companies� outsourcing/offshoring�

their� testing� requirements� to� India.� A� high-throughput� fire� assay� facility� for� the� estimation� of� gold� and� the�

first� commercial� ICP-MS� facility� for� the� estimation� of� trace� level� analytics� made� Shiva� the� market� leader� in�those�high-volume�and�high-precision�measurement�capabilities.� Estimation�of�percentage� level� to�ultra-trace�

level� elemental� compositions� in� Certified� Reference� Materials� and� metals/alloys� using� state-of-the-art�

instrumentation� and� highly� skilled� knowledge� workers� was� another� strategic� goal.

Company� Description� &� Organization

Mapping�Mineral�Resources:�To�help� in�exploration�and�mapping�of�mineral� sources� i.e�gold,�platinum�group�

elements,� rare� earths,� base� metals,� precious� metals,� in� Africa� and� Asia.

Materials� Characterization:� To� assess� and� improve� product� safety� and� regulatory� compliance� through�chemical,� microscopic,� thermal� and� biological� characterization� techniques.

Food� and� Nutrition:� To� participate� in� “Farm� to� Fork”� Supply� Chain� Solutions� for� food� safety� at� production,�

preservation� and� consumption� stages� by� being� a� trusted� quality� assurance� partner.Health� Care� and� Personal� Care:� To� promote� human� health� through� testing� of� pharmaceutical� and� personal�

care� products� for� pharmacoepial� and� regulatory� compliance� and� to� develop� new� validated� methods� of�

testingIndustrial� Hygiene:� To� promote� clean� and� green� environment� by� identification,� evaluation� and� control� of�

toxic� substances� and� harmful� physical� agents� in� the� work� place� and� environment.�

Fuels� and� Oils:� Testing� of� Diesel� specification� requirements� as� per� IS:� 1460-2005;� Testing� of� Petrol�specification� requirements� as� per� IS:� 2796-2000;� Testing� of� contaminants� and� Adulteration� in� various� Fuels

123. SHIVA ANALYTICALS(INDIA) PRIVATE LIMITED

1.� Corporate� General� Information

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510� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

2.� Corporate� Service� &�Business� Area

Corporate� Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US ○ US US US

Canada Canada Canada Canada

EU EU EU EU

Asia ○ Asia Asia Asia

Global Global Global Global

Other Other Other Other

Focusing� Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research ○ API

APIs

R&D ○

Pre-ClinicalR&D� Strategy

&� ManagementPre-clinical

Test� SamplePhase� I Clinical� Trials

Phase� IIClinical� Test

Sample

Finished

Products

Regulatory

Affairs○

Phase� IIIBusiness

DevelopmentFinished

ProductPhase� IV

Sales� &

Marketing

Corporate� Product�

Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

Generics APIs Devices Others

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 511

3.� Corporate� Business�Overview

Clients'� Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

20 50 30

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

Focusing� Therapeutic� Area

Oncologics Lipid�RegulatorsRespiratory�

AgentsAnti-ulcerants

Angiotensin� � � II�

Antagonists

10 10 10 10 10

AntipsychoticsAutoimmune�

agentsAntidepressants Analgesics Others

10 10 10 10 10

General� Overview

of� Corporate's� Key

Contract� Services

Pharmaceuticals� Testing� Services;� Any� pharmaceutical� quality� control� laboratory,�

serves� one� of� the� most� important� functions� in� pharmaceutical� production� and�

control� i.e.,� regulatory� compliance� testing� of� the� products.�A� significant� portion�

of� the� cGMP� regulations� (21� CFR� PART� 211)� and� all� pharmacopeia� methods�

such� as�USP,� IP,� and�BP�pertain� to� the� quality� control� procedures� and� complete�

testing� of� products,� which� includes� Raw�materials,� APIs� and� Bulk� drugs� .� Shiva�

provides�expert�analysis� in�all� areas�of� testing,�beginning�with�analysis� from� raw�

materials,� finished� products,� stability� testing,� related� substances,� impurities� and�

active� assays� for� the� pharmaceutical� industry.� Shiva’s� sophisticated�

pharmaceutical� testing� lab� operates� as� an� extension� of� yours� QC/QA� lab.� Our�

services� include� all� pharmacopeia� methods� for:

Raw� materials;� Active� pharmaceutical� ingredients(APIs);� Finished� products;�

Residual� solvents;� Analytical� method� development� and� validation� as� per� ICH�

guidelines;� Development� of� Stability-indicating� methods;

Impurity� profiling� and� identification;� Personal� care� and� Herbal� product� analysis;�

Cleaning� validations;� Dissolution� and� disintegration� testing;� Stability� studies� as�

per� ICH� guidelines

Contract� Service� Capacity�

Affordable� by� Service� Area100� Samples� Per� Day

Communication� with�

Clients

Dispositoion� of

Project� Manager

Responsible

KEY� ACCOUNT� MANAGER� &� STUDY� DIRECTORS

Providing�

Realtime

Service� Delivery

REPORTS� BY� E-MAIL� &� WEBSITE� REPORTING� POSSIBLE

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512� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

4.� Corporate� Competitiveness

No.� of� Regulatory

Inspections

ClassificationFDA

(US)

EMA

(EU)

PMDA

(Japan)

CFDA

(China)

DCI

(India)Others

Pre-Clinical� Area

Clinical� Area

Manufacturing� Area

Others ○ ○

Current� Status� of

Accredited� CertificationISO� 17025,� ISO� 9001,� US� ­� FDA� COMPLIANT

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� toUS,� MALAYSIA,� INDIA

Asian� Clients'

Composition(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

30 30 40

Major� Service� Range

with� Asian� Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research ○API

APIs

R&D ○

Pre-ClinicalR&D� Strategy

&� ManagementPre-clinical

Test� SamplePhase� I Clinical� Trials

Phase� II Clinical� Test

Sample

Finished

Products

Regulatory

Affairs

Phase� IIIBusiness

DevelopmentFinished

ProductPhase� IV

Sales� &

Marketing

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 513

124. SHJNJ PHARMATECH INC

1.� Corporate� General� Information

Corporate� Name SHJNJ� MODERN� PHARMACEUTICAL� TECHNOLOGIES� INC.

Corporate� Ownership Private� Company

Head� Office� Address A401,� 271,� Lvke� Rd,� Pudong� District

Facilities� City� &� Country Shanghai(China)

Web-site� Address www.shjnj.com

No.� of� Employees 20

Financial� Status

Sales� Revenue� in�

2013(US� K$)Capital(US� K$) Dept-equity� Ratio(%)

US$� 3,00� million US$� 2,00� million 3%

Contact

(Korean�

Business)

Name Liu� Yuebin/Liu� Xiying

Address A401,� 271,� Lvke� Rd,� Pudong� District,� Shanghai,� China

Telephone 8621-50911366

E-mail [email protected]� /� [email protected]

Company� History

SHJNJ� is� established� in�Shanghai�2000.�Over�14-year�history,� SHJNJ�has�earned�a� reputation� in�domestic�and�

foreign� pharmaceutical� industry.� It� establishes� and� invests� a� great�many� enterprises� covering� fine� chemicals�

industry,� import� and� export� trade,� health� industry,� business� consultation,� etc.� with� customers� widely�

distributed� in� Southeast� Asia,� Japan,� India,� Europe,� USA� and� so� on.�

Parallel� development� of� R&D� of� drugs,� import� and� export� trade,� health� industry,� and� cross-subject�

industrialization� operation� along� a� line� of� technical� consultation� is� SHJNJ’s� strategy.

Company� Description� &� Organization

SHJNJ�MODERN�PHARMACEUTICAL� TECHNOLOGIES� INC.� is� an� enterprise� focusing�on�CMO,�CRO,� technical�

consultation,� research� and� development� technology,� as� well� as� international� business.

The� founder�and�partner� leverage�over�20� years’� experiences� in�management,�development,�production�and�

sales� in�Multinational� Corporation� and� accumulate� abundant� customer� recourses� and� social� connections� in�

China� and� global� pharmaceutical� industry.� SHJNJ� gathers� a� number� of� rich� experienced� advisory� panels� in�

multi-subject� and� different� fields.

SHJNJ� continually� research� and� develop� active� pharmaceutical� ingredients,� pharmaceutical� preparation�

products,� and�special�materials� applying� in� the�pharmaceutical� field� in� its�R&D�center.�The�company�provides�

abundant� suitable� products� and� technology� to� local� research� institutes� and� manufacturers� through� import�

and�export� supply�channels,� and� spares�no�effort� to�help�Chinese�products� to�establish�channel� and�provide�

support� for� going� out� for� overseas� to� push� home� products� to� global� market.

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514� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

2.� Corporate� Service� &�Business� Area

Corporate� Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

○ ○ ○ ○

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Russia Russia Russia Russia

CIS CIS CIS CIS

US US US ○ US

EU EU EU ○ EU

Asia ○ Asia ○ Asia ○ Asia ○

ROW ROW ROW ROW

Focusing� Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research ○ API ○

APIs ○

R&D ○

Pre-ClinicalR&D� Strategy

&� Management○

Pre-clinical

Test� Sample○

Phase� I Clinical� Trials

Phase� IIClinical� Test

Sample○

Finished

Products○

Regulatory

Affairs○

Phase� IIIBusiness

Development○

Finished

Product○

Phase� IVSales� &

Marketing○

Corporate� Product�

Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

○ ○ ○ ○

Generics APIs Devices Others

○ ○ ○

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 515

3.� Corporate� Business�Overview

Clients'� Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

10 70 10 10

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

○ ○ ○

General� Overview

of� Corporate's� Key

Contract� Services

We� have� a� group� of� experts� in� drug� R&D� and� preparation� technology.�We� have�

rich� experiences� in� synthesis� of� compounds� and� preparation� of� insoluble� drugs.�

We� can� provide� technology� evaluation� and� consultation,� solve� difficulties� and�

bring� in� advanced� technology� for� Korean� pharmaceutical� enterprises.

Communication� with�

Clients

Dispositoion� of

Project� Manager

Responsible

Make� plan,� guide� the� client,� get� in� touch� with� lab� and�

manufacturer,� solve� problems

Providing� Realtime

Service� DeliveryProvide� plan� by� email� or� fax� in� time

Realtime

Feed-backBy� email� or� Fax

4.� Corporate� Competitiveness

Corporate

Competitiveness

We� invest� a� R&D� lab� and� establish� platforms� of� synthesis� of� compounds,� insoluble�

drugs� technology,� and� new� pharmaceutical� technology,� which� involves� in� solid�

dispersion,� lipid� some,� nanoparticle,�micro� capsule,�micro� emulsion,�micro� balloon,�

oral� controlled� release� system,� immediate� release� oral� drug� delivery,� etc..

No.� of� Regulatory

Inspections

Classification FDA(US) EMA(EU)PMDA

(Japan)Russia CIS Others

Pre-Clinical� Area

Clinical� Area

Manufacturing�

Area○ ○ ○

Others

Current� Status� of

Accredited� CertificationGMP

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516� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� toSouth� Korea,� Japan

Asian� Clients'

Composition(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

10 80 10

No.� of� Asian� Clients

in� recent� 3� yearsFive� main� Asian� clients

Major� Service� Range

with� Asian� Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research ○ API ○

APIs ○

R&D ○

Pre-ClinicalPre-clinical

Test� Sample

R&D� Strategy

&� Management○

Phase� I Clinical� Trials

Phase� IIClinical� Test

Sample

Finished

Products○

Regulatory

Affairs

Phase� IIIFinished

Product○

Business

Development○

Phase� IVSales� &

Marketing○

6.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

Other� services� SHJNJ� can� provide:

� 1.� CMO,� CRO.

We�provide� the�services�and�assist� to� tackle� technology�problems� for�home�and�abroad�enterprises,�as�well�

as� develop� high-tech� products� covered� by� intellectual� property� rights.

� 2.� KFDA� Drug� Registration� with� Korean� partners,� and� GMP� training� certification.�

SHJNJ�has�experts�covered�around�the�world,� including� retirement�officials�of� FDA.�We�deeply�understand�

the�policy�of� each� country�and�have�assisted�domestic�enterprises� to�pass� through� inspection�of�USA�FDA,�

Japan� PMDA,� and� Korean� KFDA.� We� successfully� help� them� obtain� the� certificate� licenses� and� export�

products� to� these� countries.

� 3.� Compile� DMF,� EDMF� files

Our� company� has� skilled� in� compiling� DMF� file� and� assisted� domestic� enterprises� to� compile� tens� of�

products�DMF� files,� and�most�products� succeeded� in�passing� inspection�and� exporting� to� other� countries.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 517

Corporate� Name Sinolite� Industrial� Co.Ltd

Corporate� Ownership Private� Company

Head� Office� Address 19Floor,� CIBC� Holley� International,� No.198,� Wuxing� Road,� Hangzhou,� China

Facilities� City� &� Country Hangzhou,� China

Web-site� Address www.china-sinolite.com

No.� of� Employees 70

Financial� StatusSales� Revenue� in� 2012 Capital(US� K$) Dept-equity� Ratio(%)

US$� 70� million - -

Contact

(Korean�

Business)

Name Mr.� Michael� Zheng

Address 19Floor,� CIBC� Holley� International,� No.198,� Wuxing� Road,� Hangzhou,� China

Telephone +86-571-86772651

E-mail [email protected]

Company� History

Established� on� 1998� to� now

Company� Description� &� Organization

Sinolite� Industrial� Co.,Ltd� established� in� 1998,� � with� core� values� of� “Intergrity,� Pioneering,� Service”,� we�

principally� engaged� in� the�business� of�APIs,� Intermediates�and�Fine� chemicals,� serve�private,� institutional� and�

corporate� clients� in� the� field� of� pharmaceuticals� for� long� time� with� good� reputation� by� convincing� quality�

and� services.�

� � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �

We�are�manufacturer�as�well�as� trading�company,�our� sales�office� located� in�Hangzhou�city�with�70�people�

,� the� professional� team�consists� of� sales,� logistic� and�documentation.�We�are� taking�pride� in� fulfilling� your�

requirements�of�Pharmaceutical�APIs�and� their�advance� level� intermediates� from� ISO�Certified,�GMP,�cGMP,�

DMF� approved� units� with� supportive� regulatory� documents.

125. Sinolite Industiral Co. Ltd

1.� Corporate� General� Information

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518� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

〇 〇 〇 〇

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US 〇 US 〇 US 〇 US 〇Canada Canada Canada Canada

EU 〇 EU 〇 EU 〇 EU 〇Asia 〇 Asia 〇 Asia 〇 Asia 〇Global 〇 Global 〇 Global 〇 Global

Other Other Other Other

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research 〇 API 〇APIs 〇

R&D 〇Pre-Clinical 〇 Pre-clinical

Test� Sample

R&D� Strategy

&� Management〇

Phase� I Clinical� Trials 〇Phase� II

Clinical� Test

Sample

Finished

Products〇

Regulatory

Affairs〇

Phase� IIIFinished

Product

Business

Development〇

Phase� IVSales� &

Marketing〇

Corporate�

Product� Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

Generics APIs Devices Others

〇 〇 〇

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 519

3.� Corporate� Business�Overview

Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

40% 35% 20% 5%

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

〇 〇

General� Overview

of� Corporate's� Key

Contract� Services

Sinolite� Industrial� Co.,� Ltd.is� a� highly� professional� company� engaged� in� R&D� and�

manufacturing� of� Pharmaceutical� intermates� and� speciality� chemicals,� aftersale� service�

is� alsp� provided�which� including� � logistic� and� documentation.�We� are� taking� pride� in�

fulfilling� your� requirements� of� Pharmaceutical� APIs� and� their� advance� level�

intermediates� from� ISO� Certified,� GMP,� cGMP,� DMF� approved� units� with� supportive�

regulatory� documents.

Contract� Service�

Capacity� Affordable�

by� Service� Area

Our�company�has�our�R&D�center�which�has�adequate�well-equipped�and�modern� labs�

(including�1�Kilo� lab),� and� also� has� the� production� capability� ranged� from�gram� to�kg�

to� metric� ton� level.� Our� workshop� will� also� be� put� to� use� in� the� next� year,� the�

formulation� of� which� is� designed� in� strict� compliance� with� the� international� cGMP�

standard.

Communication�

with� Clients

Dispositoion� of

Project� Manager

Responsible

The� project� manager� has� the� responsibility� for� the� execution� of�

company� projects,� to� ensure� projects� are� delivered� on� time,� on�

budget,� on� target� and� according� to� client� expectations.

Providing� Realtime

Service� Delivery

Our� company� has� the� production� capability� ranged� from� gram� to�

kg� to� metric� ton� level,� and� we� are� able� to� do� high-tech� quality�

analysis� and� monitoring

Realtime

Feed-back

We�would� report�progress�on�projects� to� the�client� in�and�on� time�

at�each�stage,�highlighting� the� issues�which�could�effect�on�quality�

and� cost� to� customer.

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4.� Corporate� Competitiveness

Corporate

Competitiveness

Firstly,�we� have� a� stable� and� highly� professional� R&D� team.� The�majority� of� our�

staff� has� years�of� experience� in�organic� synthesis� as�well� as� the� project�manager�

has� experience� of� innovative� drug� development� can� reduce� R&D� risks.� what's�

more,� our� employee� is� taking� part� in� professional� internal� or� external� training.

Secondly,� Our� R&D� center� has� adequate� well-equipped� and� modern� labs�

(including�1Kilo� lab),�and�have� the�production�capability� ranged� from�gram�to�kg�

to� metric� ton� level,� and� we� are� able� to� do� high-tech� quality� analysis� and�

monitoring.� The� GMP� workshop� will� also� be� put� to� use� in� the� next� year,� the�

formulation� of� which� is� designed� in� strict� compliance� with� the� international�

cGMP� standard.

At� last,� we� have� a� very� professional� marketing� team� and� after-sales� service�

(including� logistic� and� documentary� supports)� .�

Current� Status� of�

Accredited� Certification,�

GLP/GCP/GMP/GSP/GAP

/ISO/AAALAC� etc

Our�R&D�workshop�will� be�put� to�use� in� the�next� year,� the� formulation�of�which�

is� designed� in� strict� compliance� with� the� international� cGMP� standard.

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� whichclients� belong� to

INDIA,� KOREA,� AMERICA,� EUROPE,� JAPAN

Asian� Clients'Composition(%)

Big� PharmasMid� or� Small-Size� Pharmas

BiotechCompanies

Start-ups

40% 20% 10% 30%

Major� Service� Rangewith�Asian�Companies

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing

Consulting

Research 〇 API 〇APIs

R&D 〇Pre-Clinical 〇 Pre-clinical

Test� Sample

R&D� Strategy&� Management

〇Phase� I Clinical� Trials 〇Phase� II

Clinical� TestSample

FinishedProducts

RegulatoryAffairs

Phase� IIIFinishedProduct

BusinessDevelopment

Phase� IVSales� &Marketing

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 521

126. SolucionesGXP Infodynamics s.r.l.

1.� Corporate� General� Information

Corporate� Name SolucionesGXP� Infodynamics� s.r.l.

Corporate� Ownership Private� Company

Head� Office� Address José� Luis� Zorrilla� de� San� Martín� 233

Facilities� City� &� Country Montevideo(Uruguay)

Web-site� Address www.solucionesgxp.com

No.� of� Employees 20

Financial� Status

Sales� Revenue� in�

2014(US� K$)Capital(US� K$) Dept-equity� Ratio(%)

756,128 15,081 -

Contact

(Korean�

Business)

Name Eleonora� Scoseria

Address José� Luis� Zorrilla� de� San� Martín� 233

Telephone +598� 2710� 0499

E-mail [email protected]

Company� History

The� company�was� founded� in� 1995� by� Eleonora� Scoseria� and� Yolanda� Perez.� Currently� we� have� about� 20�

people�within� the� two� business� areas.�We� have� grown� over� the� years� and�has� become� a� reference� reginal,�

has� developed� in� different� practice� areas� providing� an� integrated� response� to� our� customers.

Company� Description� &� Organization

Infodynamics� has� two�main� areas:� Consulting� GMP� and� Regulatory� Affairs.� Our� director,� Eleonora� Scoseria�

is� pharmaceutical� chemistry� since� 1990,� has� a� long� career� in� consulting.�We�have� a� technical� team� in� each�

area� to� manage� different� projects,� providing� answers� to� our� clients.

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522� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

2.� Corporate� Service� &�Business� Area

Corporate� Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Central� &�

South�

America

Central� &�

South�

America

Central� &�

South�

America

Central� &�

South�

America

US US US US

EU EU EU EU

Asia Asia Asia Asia

Russia� &�

CIS

Russia� &�

CIS

Russia� &�

CIS

Russia� &�

CIS

ROW ROW ROW ROW

Focusing� Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D

Pre-ClinicalR&D� Strategy

&� ManagementPre-clinical

Test� SamplePhase� I Clinical� Trials

Phase� IIClinical� Test

Sample

Finished

Products

Regulatory

Affairs○

Phase� IIIBusiness

DevelopmentFinished

ProductPhase� IV

Sales� &

Marketing○

Corporate� Product�

Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

○ ○ ○ ○ ○

Generics APIs Devices Others

○ ○ ○ ○

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 523

3.� Corporate� Business�Overview

Clients'� Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

20 50 5 25

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

Focusing� Therapeutic� Area

Oncologics Lipid�RegulatorsRespiratory�

AgentsAnti-ulcerants

Angiotensin� � � II�

Antagonists

AntipsychoticsAutoimmune�

agentsAntidepressants Analgesics Others

General� Overview

of� Corporate's� Key

Contract� Services

In� the� area� Consulting� services� are:�GXP�Assurance� for� different� industries� such�

as� pharmaceutical,� veterinary,� cosmetic;� Equipment� and� Facilities� qualification;�

Validation;� Plant� design;� Audits� and� Training.

Regulatory� Affairs:� Product� dossier� preparation� and� submissions;� company�

registration.

Contract� Service� Capacity�

Affordable� by� Service� Area

We� have� a� team� composed� of� 20� professionals� in� the� life� science� area.

Our� services� range� from� small� consulting� projects� to� full� outsourcing� /� turn� key�

projects.

Communication� with�

Clients

Dispositoion� of

Project� Manager

Responsible

Good� disposition� of� project� managers

Providing�Realtime

Service� Delivery

The� times� depend� on� the� project,� a� few�weeks� is� estimated�

to� complete� projects.

Realtime

Feed-back

Feedback� is� expected� in� days,� giving� answers� on� the� same�

day� or� within� a� short� interval� of� time

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524� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

4.� Corporate� Competitiveness

Corporate

Competitiveness

The� services� are� priced� depending� on� the� project� scope,� the� duration� of� the� same�

depend� heavily� on� customer� response� times� and� regulators.� We� have� a� technical�

team� in� regulatory� affairs� and� an� important� network� of� information.� One� of� our�

team� served� as� inspector� of� the� Ministry� of� Health� inspectorate.�

Current� Status� of

Accredited� CertificationWe� are� not� currently� certified.

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� toBrazil,� Argentina,� United� States,� Chile,� Uruguay,� England,� Ecuador,� Panama

No.� of� Asian� Clients

in� recent� 3� yearsWe� had� no� customers� in� Asia� in� the� last� 3� years

6.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

We� can� provide� Korean� pharmaceutical� companies� with� the� expertise� to� register� and� distribute� products�

in� Latin� America.� Also,� should� a� company� want� to� perform� manufacturing� operations� in� our� region� we�

can� provide� full� services� from� plant� design� to� licensing.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 525

Corporate� Name SRK� Strategies,� LLC

Corporate� Ownership Private� Company

Head� Office� Address 30� RAYMOUND� BLVD

Facilities� City� &� Country PARSIPPANY,NJ07054,� USA

Web-site� Address UNDER� CONSTRUCTION

No.� of� Employees 1-2

Contact

(Korean�

Business)

Name Nitin� Shah,� MBA

Address 30� Raymound� Blvd,� Parsippany,� NJ� 07054� USA

Telephone 973-515-5155� or� 862-703-6774(c)

E-mail [email protected]

Company� History

Company� formed� in� 2006.

Company� Description� &� Organization

Pharmaceuticals� business� development� professional�with� over� fourteen� years� of� demonstrated� success� in� the�

areas� of� strategies,� products� acquisition,� products� divestment,� licensing,� activities,� strategic� business�

development�at�global�markets,�alliance�management,� scientific�assessment,�CRO�collaborations�and�business�

project� management.� Strong� organizational,� decision-making,� communication� and� analytical� skills� coupled�

with� demonstrated� capabilities� in� contract,� negotiations� deliver� creative� deal� structures.� Adept� at� efficiently�

organizing� and� utilizing� business� and� project� processes� while� managing� multiple� projects� simultaneously.�

Intimate� knowledge� of� products,� opportunities,� organizations,� and� strategies� in� the� generic/specialty�

pharmaceutical� arena.� New� Business� Relationships� with� Emerging� Markets,� global� network� with� industry�

leaders� and� senior� management.

Worked�on�pharmaceuticals�business�development,� licensing�deal� structures,�negotiations,� strategic,� scientific�

and� financial� valuations,� product� licensing,� product� acquisition,� evaluate� drug� delivery� technology,� new�

product� assessment,� evaluation,� due� diligence,� benchmark� analysis,� contract� manufacturing� opportunities,�

competitive� intelligence,�market�drivers,�market�economic�behavior/market� trend,�pricing,�market� share,�costs,�

package� sizes,� SWOT� analysis� (Strengths,� Weaknesses,� Opportunities� and� Threats)� and� M&A� activities�

127. SRK Strategies, LLC

1.� Corporate� General� Information

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526� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

(initiations,� analyzing,� execution�of�Deal),� in� and�out� licensing,� R&D�pipeline� valuation,� contract� negotiation,�

draft� co-promotion� contracts,� CSO,� CRO,� strategies� for� client� companies,� concept� for� joint� venture,�

manufacturing,� supply� chain,� licensing� and� other� agreements.� Create� and� implement� business� development�

database� including� therapeutic� class,� API,� ANDA,� 505(b)� 2,� legal/Para� IV,� new� product� selection,� portfolio�

analysis,� IP,� contracts,� regulatory� and� other� functional� area.

Professional� Experience:

SRK� Strategies,� LLC� -� President� -� (Business� Development/Licensing/Partnership)

PLIVA-� Associated� Business� Development

Barr� Labs� -� Project� Manager� -� Strategic� Planning� and� New� Product� Development

Lederle� (Wyeth/Pfizer)� -� Control� Microbiologist

BioCraft� (TEVA)� -� Miccrobiologist

Education:

Stern�School�of�Business� -�New�York�University,�NY� -�Executive�Programs�(Finance� for�Non�Financial�Manager)

Fairleigh� Dickinson� University,� Rutherford,� NJ� -� MBA,� (Chemicals� and� Pharmaceuticals)

University� of� Bombay,� Bombay,� India� -� DMS(Diploma� in� Management� Studies)�

Sardar� Patel� University,� Vallabh� Vidyanagar,� India� -� BS� (Microbiology)

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 527

2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

〇 〇 〇 BUSINESS�

DEVELOPMENT-� M&A

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US 〇 US 〇 US 〇 US 〇Canada 〇 Canada 〇 Canada 〇 Canada 〇EU 〇 EU 〇 EU 〇 EU 〇Asia 〇 Asia 〇 Asia 〇 Asia 〇Global 〇 Global 〇 Global 〇 Global 〇Other Other Other Other

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research 〇 API 〇APIs 〇

R&D 〇Pre-Clinical Pre-clinical

Test� Sample

R&D� Strategy

&� Management〇

Phase� I Clinical� Trials 〇Phase� II

Clinical� Test

Sample

Finished

Products〇

Regulatory

Affairs〇

Phase� IIIFinished

Product〇

Business

Development〇

Phase� IVSales� &

Marketing〇

Corporate�

Product� Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

〇 〇 〇 〇Generics APIs Devices Others

〇 〇

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528� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

3.� Corporate� Business�Overview

Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

15% 70% 5% 10%

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

COLLOBORATION COLLOBORATION COLLOBORATION COLLOBORATION COLLOBORATION

Focusing�

Therapeutic� Area

GENERICS,� BRAND,� BIOSIMILAR:� PAIN� MANAGEMENT,� DERMATOLOGY,� CNS,�

ONCOLOGY� ETC.

General� Overview

of� Corporate's� Key

Contract� Services

BUSINESS� DEVELOPMENT/IN� AND� OUT� LICENSING/CORPORATE� DEVELOPMENT,� M&A,�

DUE� DILLIGENCE,� BUSINESS� PLAN� ETC

Contract� Service�

Capacity� Affordable�

by� Service� Area

BUSINESS� DEVELOPMEN

Communication�

with� Clients

Dispositoion� of

Project� Manager

Responsible

SUCCESSFULLY� COMPLETED� TECH.� TRANSFER� PROJECT-�

PRODUCT/S� LAUNCH� IN� USA

Providing� Realtime

Service� DeliveryPROVIDED� RESULTS� ON� TIME-� WITHOUT� TIME� LOSS

Realtime

Feed-backRECEIVED� ANOTHER� CONSULTING� WORK

4.� Corporate� Competitiveness

Corporate

Competitiveness

EXPERINCE� IN� GLOBAL� MARKET,� LICENSING� ACTIVITIES,� CONTRACT�

MANUFACTURING,� PROJECTS-PRODUCT� VALUATIONS,� STRATEGY,� BUSINESS� PLAN,�

GLOBAL� ALLIANCES.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 529

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� toINDIA,� S.KOREA,� JAPAN

Asian� Clients'

Composition(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

100%

Major� Service� Range

with�Asian�Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D 〇

Pre-ClinicalPre-clinical

Test� Sample

R&D� Strategy

&� Management〇

Phase� I Clinical� Trials 〇

Phase� IIClinical� Test

Sample

Finished

Products〇

Regulatory

Affairs〇

Phase� III

Finished

Product〇

Business

Development〇

Phase� IVSales� &

Marketing〇

6.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

COLLOBORATIONS� FOR� MARKETING� S.KOREAN� PHARMACEUTICAL� PRODUCTS� IN� USA.

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530� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

128. SSS International Clinical Research GmbH

1.� Corporate� General� Information

Corporate� Name SSS� International� Clinical� Research� GmbH

Corporate� Ownership Private� Company

Head� Office� AddressSSS� International� Clinical� Research� GmbH,� Landsberger� Str.� 23/25,� 82110�

Germering,� Germany

Facilities� City� &� CountryGermering� -�Germany,� London� -�United�Kingdom,�Timisoara� -�Romania,�Wroclaw�

-� Poland

Web-site� Address www.cro-sss.eu

No.� of� Employees 60

Financial� Status

Sales� Revenue� in� 2010

(US� K$)Capital(US� K$) Dept-equity� Ratio(%)

5.000 1.200 0

Contact

(Korean�

Business)

Name Dr.� Michael� Sigmund

Address Landsberger� Str.� 23/25,� 82110� Germering

Telephone +49� 89� 800650� 20

E-mail [email protected]

Company� History

SSS� International� Clinical� Research� GmbH� (head� office)� was� founded� by� Dr.� Michael� Sigmund� as� a� Clinical�

Research� Organisation� (CRO)� in� September� 1993� in� Munich,� Germany.�

SSS� has� ample� experience� in� setting-up� and� running� clinical� trials� in� all� European� countries.

Over� the� last� 17� years� we� have� expanded� our� international� co-operations� in� Western,� Central� and� Eastern�

Europe.� Currently� we� employ� about� 70� project� managers,� clinical� research� associates,� and� associated� staff.�

SSS�has� subsidiaries� in�UK� (SSS�Regulatory�Services�Ltd.),� in�Romania� (SSS�Clinical�Research�S.R.L.,�and�Poland�

(SSS� Clinical� Research� Polska� Sp.� zo.� O).

The�quality� system�of�SSS�was� first� certified� in� 1997.� In� June�2011� last� re-certification�was�performed�by� the�

Moody� International� Certification� Agency� (DIN� EN� ISO� 9001:2008).

Company� Description� &� Organization

SSS� International� Clinical� Research� is� a� Clinical� Research� Organization� specialized� on� clinical� operation� in�

Europe.� Additionally,� together� with� cooperation� partners� (for� data� management,� biometrics� and� electronic�

data� capture),� we� also� provide� full� service� for� clinical� studies� phase� II� to� IV� and� for� post� marketing� studies�

and� registries.� We� have� a� database� containing� several� thousand� evaluated� potential� investigators� in� Europe�

and� can� therefore� recruit� sites� very� efficiently.� Our� key� services� include� full� service� for� clinical� trials� (phase�

II-IV),� project� management� for� international� clinical� trials,� monitoring� of� clinical� trials� in� Europe� (phase� I-IV,�

NIS),�EDC� (Electronic�Data�Capture)� for� clinical� trials�and�non-interventional� studies.�Additionally,�we�perform �

and� support� Post� Marketing� Surveillance� Studies,� Non-Interventional� Studies,� and� Post� Authorization� Safety�

Studies

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 531

2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

○ ○

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US US US US

Canada Canada Canada Canada

EU ○ EU EU EU ○

Asia Asia Asia Asia

Global Global Global Global

Other Other Other Other

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D

Pre-Clinical Pre-clinical

Test� Sample

R&D� Strategy

&� Management

Phase� I Clinical� Trials ○

Phase� II ○Clinical� Test

Sample

Finished

Products

Regulatory

Affairs

Phase� III ○Finished

Product

Business

Development

Phase� IV ○Sales� &

Marketing

Corporate�

Product� Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

○ ○ ○ ○ ○

Generics APIs Devices Others

○ ○

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532� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

60% 20% 20% -

Focusing�

Therapeutic� AreaOncology,� Respiratory,� Neurology,� Cardiology,� Diabetes.

General� Overview

of� Corporate's� Key

Contract� Services

Full� service� clinical� trials� (phase� II-IV,� NIS)

Project� management�

Monitoring� (phase� I-IV,� NIS)

EDC� (Electronic� Data� Capture)� for� clinical� trials� and� non-interventional� studies

PMS� (Post� Marketing� Surveillance� Studies,� NIS(Non-Interventional� Studies),� PASS(Post�

Authorization� Safety� Studies)

Quality� assurance� audits

Providing� personnel� to� sponsors

Contract� Service�

Capacity� Affordable�

by� Service� Area

Clinical� Operation� Services:

-� Project� planning� (medical,� statistical)�

-� Study� design,� protocol� development� �

-� (e)CRF� design� (and� printing� if� required)�

-� Recruitment� of� investigational� sites�

-� Regulatory� submissions�

-� Submission� to� ethics� committees�

-� Project� management�

-� Pre� study� site� assessment�

-� Initiation� of� study� sites� � �

-� Monitoring� services� in� Western,� Central� and� EasternEurope

-� Handling� of� Serious� Adverse� Events� (SAEs)

Medical� Writing� Services:

-� Study� protocol�

-� Case� report� forms� (CRFs)�

-� Clinical� study� reports� (Phase� I-IV)�

-� Investigator� brochure�

-� Patient� information/informed� consent�

-� Pharmaco-economic� reports� �

-� Manuscripts� for� publication� �

-� International� conference� communications� (abstracts,� posters)

-� Data� Management� Service:

3.� Corporate� Business�Overview

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 533

-� CRF� design� and� annotation

-� Definition� of� data� handling� manual� and� validation� plan

-� Database� design� and� check� programming

-� CRF� tracking� &� scanning� (online� access� to� CRF� images� via� scanTrace)

-� Double� data� entry�

-� Import� and� processing� of� data� from� external� sources

-� Medical� and� data� management,� review� of� CRF� data

-� Data� cleaning� and� query� management

-� Medical� coding� (MedDRA,� WHO� Drug� Dictionary� Enhanced)�

-� SAE� management� (reconciliation,� production� of� narratives)�

-� Database� quality� control� and� audits

-� Data� export/transfer� (CDISC� or� sponsor� standards)

Contract� Service�

Capacity� Affordable�

by� Service� Area

Biostatistical� and� Reporting� Services:

-� Statistical� planning� of� clinical� trials� (including� flexible/adaptive� designs)

-� Sample� size� calculation� and� justification

-� Protocol� and� CRF� review

-� Randomization� (including� central,� dynamic� procedures)

-� Statistical� Analysis� Plan� (with� mock-up� tables� and� listings)

-� SAS� programming� of� TFLs

-� Statistical� analysis

-� Statistical� and� integrated� clinical� trial� reports

-� Data� transfer� (CDISC� SDTM� and� ADaM� standards)

EDC� Services:

-� Definition� of� eCRF� layout,� eCRF� dynamics� and� plausibility� checks

-� eCRF� implementation� and� validation

-� User� training� (includes� trial� specific� user� manuals� and� video� clips)

-� Helpdesk� &� support

-� Archiving� (archiving� of� data� and� application� at� end� of� study,� PDF� print-out� of� eCRFs)

-� Data� export� (XML2SAS,� CDISC)

-� Data� hosting

Services� in� Observational� &� Non-interventional� Studies� (including� Registries):

-� Planning� and� setup� of� study� protocol� or� observation� plan

-� Submission� to� responsible� ECs,� notification� to� authorities

-� Development� of� study-related� documentation

-� Design� of� paper-based� CRFs� (incl.� printing)

-� Set-up� of� eCRFs� and� training

-� Logistics

-� Distribution� of� documentation

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534� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

-� Mailshots� &� newsletters

-� Investigator� remuneration

-� Project� management

-� Communication� &� coordination

-� Status� reporting

-� Helpdesk� and� support

-� On-site� monitoring� (if� applicable)

-� Data� management� and� data� validation

-� Statistical� analysis� and� reporting

-� Pharmacoeconomic� analyses

Communication�

with� Clients

Dispositoion� of

Project� Manager

Responsible

Designated� project� manager� is� available� via� telephone,� e-mail,�

mobile� phone� and� Blackberry� during� office� hours.� Back-up� project�

manager� is� nominated� for� project� contingency� and� emergency�

cases.

Providing� Realtime

Service� Delivery

Read� access� to� SSS’s�web� based� clinical� trail�management� system� is�

granted� to� sponsor� staff.�All� important� project�metrics� are� available�

on-line,� additionally� to� standard� reporting� (pdf� and/or� paper).

Realtime

Feed-backAll� sponsor� requests� are� answered� within� one� business� day.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 535

4.� Corporate� Competitiveness

Corporate

Competitiveness

Core� ideology� of� SSS.�

The� core� values� are� summarized� in� the� "SSS� way":�

•Trust� in� its� employees,�

•adhere� to� the� principals� of� Total� Quality� Management,�

•commitment� to� innovation� and� service� quality,�

•comfortable� work� environment� and� growth� from� profits.�

It� is� the� purpose� of� the� company� to� be� number� one� in� matters� of� quality,� respond�

with� its� services� to� the� requests�of� the�society�and�earn� the� trust�of� its� customers.� The�

envisioned� future� of� SSS� is� to� stay� number� one� in� customer� satisfaction� and�perform �

international� clinical� trials� of� outstanding� quality.� SSS� is� recognized� as� an�

internationally� leading,� quality� driven� Contract� Research� Organization.

No.� of� Regulatory

Inspections

Classification FDA(US) EMA(EU) PMDA(Japan) Others

Pre-Clinical� Area

Clinical� Area

1� (German�

GCP�

authorities)

Manufacturing� Area

Others

Current� Status� of

Accredited�

Certification

DIN� EN� ISO� 9001:2008

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536� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� toJapan

Asian� Clients'

Composition(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

100%

No.� of� Asian� Clients

in� recent� 3� years1

Major� Service� Range

with�Asian�Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D

Pre-ClinicalPre-clinical

Test� Sample

R&D� Strategy

&�Management

Phase� I Clinical� Trials ◌

Phase� IIClinical� Test

Sample

Finished

Products

Regulatory

Affairs

Phase� III ◌

Finished

Product

Business

Development

Phase� IVSales� &

Marketing

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 537

129. Sundia MediTech Company, Ltd.

1.� Corporate� General� Information

Corporate� Name Sundia� MediTech� Company,� Ltd.

Corporate� Ownership Private� Company

Head� Office� Address Building� 8,� 388� Jialilue� Road,� Zhangjiang� Hi-Tech� Park

Facilities� City� &� Country Shanghai(CHINA)

Korean� Business� Office#720� Sebang� Global� city,� 1595,� Kwanyang-dong,� Dongan-gu,� Anyang-city,�

Gyeonggi-do,� Korea

Web-site� Address www.sundia.com

No.� of� Employees Over� 700� Employees

Contact

(Korean�

Business)

Name 유켐(U� Chem)� /� David� Kwon(HoYoung,� Kwon)

Address 경기도 안양시 동안구 시민대로 277,� 1502

Telephone 070-8718-1830

E-mail [email protected],� [email protected]

Company� History

•� 2012:� Named� Deloitte� Technology� Fast� 500� Asia� Pacific� for� 5th� Consecutive� Year

•� 2012:� Passed� Workplace� Conditions� Assessment� Audit� and� got� Achievement� Award� by� Intertek

•� 2011:� Named� Deloitte� Technology� Fast� 500� Asia� Pacific� for� 4th� Consecutive� Year

•� 2011:� Received� 2011� Zero2IPO� Venture� 50� Award

•� 2010:� Authorized� ISO� 9001:2008� Quality� System� Certificate

•� 2009:� Sundia� oncology� and� CNS� service� platform� established

•� 2009:� A� USA� company� audited� for� API/cGMP� Kilo� lab

•� 2008:� The� first� integrated� drug� discovery� collaboration� program� IND� got� approval� from� SFDA

•� 2007:� Second� run� of� VC� investment� into� Sundia�

•� 2007:� SFDA� inspection� for� IND� filing�

•� 2005:� The� first� drug� discovery� collaboration� program� started

•� 2005:� IDG� investment� into� Sundia�

•� 2004:� Sundia� MediTech� established� in� Shanghai,� China

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Company� Description� &� Organization

Founded� by� a� group� of� veterans� from� the� US� biopharmaceutical� industry� in� 2004,� Sundia� MediTech�

Company� Ltd.� is� now� a� leading� Shanghai-based�CRO� company� providing� drug�discovery� and�development�

services� worldwide.� With� our� technical� expertise� and� excellent� research� facilities,� we� offer� broad� and�

integrated� chemical� synthesis� (custom� synthesis,� library� design� and� synthesis),� medicinal� chemistry� (hit�

generation,� lead� optimization,� and� preclinical� development),� biological� (early� hit� screening,� assay�

development,� in� vitro� and� in� vivo� pharmacology,� in� vitro� and� in� vivo� DMPK),� new� technology� platforms�

(molecular� diagnostics� and� PBSDD� and� nanotechnology),� and� pharmaceutical� development� (process�

research�and�development,�API�manufacture,�pre-formulation�and� formulation,�analytical�and�QA/QC,�CMC�

and� regulatory� submission)� services

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 539

2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

○ ○

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US ○ US US US ○

Canada ○ Canada Canada Canada ○

EU ○ EU EU EU ○

Asia ○ Asia Asia Asia ○

Global ○ Global Global Global ○

Other Other Other Other

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research ○ API ○

APIs

R&D ○

Pre-Clinical ○ Pre-clinical

Test� Sample○

R&D� Strategy

&� Management○

Phase� I Clinical� Trials ○

Phase� IIClinical� Test

Sample

Finished

Products

Regulatory

Affairs○

Phase� IIIFinished

Product

Business

Development○

Phase� IVSales� &

Marketing

Corporate�

Product� Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

○ ○ ○

Generics APIs Devices Others

○ ○

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540� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

3.� Corporate� Business�Overview

Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

30% 30% 20% 20%

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

○ ○

General� Overview

of� Corporate's� Key

Contract� Services

•� Library� design� and� synthesis

•� Synthetic� chemistry� (intermediates,� reference� compounds)

•� Medicinal� chemistry� (lead� generation� and� optimization)

• Biological� science� (assay� development,� compound� screening,� in� vivo� pharmacology,�

in� vitro� and� in� vivo� DMPK)

• Preclinical� development� (Individual,� combinational� or� integrated� service:� CMC,�

DMPK,� pharmacology,� toxicology,� pilot-trail� sample� preparation,� project�

management� and� IND� filling)

• Pharmaceutical� development� (process� research� and� development,� API�

manufacturing,� preformulation� and� formulation� development� till� tech-transfer,�

analytical� development,� QA/QC,� regulatory� affairs� and� CMC� submission.

Contract� Service�

Capacity� Affordable�

by� Service� Area

Sundia’s� development� has� been� focusing� on� our� clients’� needs.� We� have� strong�

expertise� in� synthetic,�medicinal�and�process�chemistry.�While�we�are�versatile� to�serve�

different� demands� from� our� clients,� our� other� efforts� are� in� oncology� and� CNS� drug�

discovery.

Communication�

with� Clients

Dispositoion� of

Project� Manager

Responsible

Director� or� above� of� the� department� will� take� charge� of� projects�

and� make� regular� communications� regarding� projects.� We� also�

have� project� management� group� to� take� over� logistics� and� other�

services� for� our� clients.

Providing� Realtime

Service� DeliveryWe� have� SOP� of� delivery� in� customer� service� department.

Realtime

Feed-back

We� have� weekly� project� review/� project� meeting� internally;� while�

externally,� we� have� bi-weekly� research� report� and� regular�

teleconferences� to� timely� communicate� with� clients� and� solve�

issues� as� well.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 541

4.� Corporate� Competitiveness

Corporate

Competitiveness

Sundia� MediTech� Company� Ltd.� is� now� a� leading� Shanghai-based� CRO� company�

providing� drug� discovery� and� development� services� worldwide.

We� have� comprehensive� project� timeline� management.� Internally� we� have� 1)� CBIS�

data�management;2)�Weekly� project� review� /� project�meeting;3)� SOP� of� delivery� in�

customer� service� department.� Externally,� we� have� 1)� “Open� Communication”�

principle� 2)� Bi-weekly� research� report� 3)Regular� teleconferences� 4)� Frequent� email�

communications� 5)� Timely� address� issues� and� find� solutions

Sundia� understands� that� our� customer's� intellectual� property� is� of� utmost�

importance.� We� take� comprehensive� measures� to� safeguard� and� ensure� the�

confidentiality�of�all�projects.�Sundia�has�adopted�and� reinforced�a�strict� IP�assurance�

policy� throughout� the� whole� company.

For� Sundia,� our� professional� leadership� is� an� important� asset.� Our� management�

team� is� made� up� of� scientists� with� advanced� degrees� or� training� and� who� have�

extensive� working/management� experience� in� North� America.� Our� team� has� rich�

experience� in� organic� synthesis,� medicinal� chemistry,� process� chemistry,� biology,�

business�management,� and� law.� Our� research� team� comprises� over� 600� employees�

(HQ),� among�which�70%�have�a�Ph.D.�or� a�MS;�About�8%�are�overseas� returnees.

No.� of� Regulatory

Inspections

ClassificationFDA

(US)

EMA

(EU)

PMDA

(Japan)

CFDA

(China)

DCI

(India)Others

Pre-Clinical� Area >15

Clinical� Area

Manufacturing�

Area

Others

Current� Status� of

Accredited�

Certification

ISO� 9001:2008� Quality� System� Certificate� by� SGS

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542� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� to� � China,� Japan,� Korea� and� Singapore

Asian� Clients'

Composition(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

30% 20% 20% 30%

No.� of� Asian� Clients

in� recent� 3� years� � Around� 100

Major� Service� Range

with�Asian�Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research ○ API ○

APIs

R&D ○

Pre-Clinical ○ Pre-clinical

Test� Sample○

R&D� Strategy

&�Management○

Phase� I Clinical� Trials ○

Phase� IIClinical� Test

Sample

Finished

Products

Regulatory

Affairs○

Phase� IIIFinished

Product

Business

Development○

Phase� IVSales� &

Marketing○

6.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

Sundia� is� conveniently� located� at� Zhangjiang� Hi-tech� Park,� also� known� as� China's� Silicon� Valley

The� industries� in� the� park� have� leading� roles� in� innovation� and� would� drive� future� economic� growth

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 543

130. Symbiosis Group SA

1.� Corporate� General� Information

Corporate� Name Symbiosis� Group� SA

Corporate� Ownership Private� Company

Head� Office� Address Carlos� Pellegrini� 781,� floor� 7

Facilities� City� &� Country Buenos� Aires(Argentina)

Web-site� Address www.symbiosis.com.ar

No.� of� Employees 9

Contact

(Korean� Business)

Name Mariana� Degan

Address Carlos� Pellegrini� 781,� floor� 7,� Buenos� Aires,� Argentina

Telephone +54� 11� 4328� 2481

E-mail [email protected]

Company� History

Symbiosis�was� established� in� 2003� and� it� started�with� active� pharmaceutical� ingredients� business.�We� have�

created� strong� relationships� with� Chinese� suppliers� and� also� have�working�with� Korean� companies� such� as�

Samsung� C&T,� Hanwha� L&C,� Rocket� and� LG� Life� Science.�

Since� 2012,� it� has� incorporated� consulting� and� financing� services� meeting� the� local� market� demand� and�

recently� it� has� acquired� a� Pharmaceutical� Wholesaler� to� import� and� distribute� API.

Company� Description� &� Organization

Symbiosis� is� involved� in� different� commercial� activities.� It� offers� financing� and� consulting� services� to� local�

companies� to� import� raw�material,�agrochemicals� and�machinery.� There� is�also�a�pharmaceutical�division� that�

imports� and� distributes� API.

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544� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

2.� Corporate� Service� &�Business� Area

Corporate� Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

○ ○

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Central� &�

South�

America

Central� &�

South�

America

Central� &�

South�

America

Central� &�

South�

America

US US US US

EU EU EU EU

Asia Asia Asia Asia

Russia� &�

CIS

Russia� &�

CIS

Russia� &�

CIS

Russia� &�

CIS

ROW ROW ROW ROW

Focusing� Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs ○

R&D

Pre-ClinicalR&D� Strategy

&� Management○Pre-clinical

Test� SamplePhase� I Clinical� Trials

Phase� IIClinical� Test

Sample

Finished

Products

Regulatory

Affairs○

Phase� IIIBusiness

Development○

Finished

ProductPhase� IV

Sales� &

Marketing○

Corporate� Product�

Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

Generics APIs Devices Others

○ ○ ○

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 545

3.� Corporate� Business�Overview

Clients'� Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

- 100 - -

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

General� Overview

of� Corporate's� Key

Contract� Services

-� Imports� financing

-� API� imports� and� sales

-� Machinery

-� Consulting� services

Contract� Service� Capacity�

Affordable� by� Service� AreaWe� can� give� a� solution� according� to� each� company� need.

4.� Corporate� Competitiveness

Corporate

Competitiveness

We� are� flexible� and�work�with� our� customers� and� suppliers� to� create� long-term �

relationships.� Our� products� and� services� meet� the� Argentinian� companies’�

demand� due� to� our� solid� experience� in� the� market.

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546� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� toArgentina,� Paraguay� and� Uruguay.

Major� Service� Range

with� Asian� Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API ○

APIs ○

R&D

Pre-ClinicalPre-clinical

Test� Sample

R&D� Strategy

&� Management

Phase� I Clinical� Trials

Phase� II Clinical� Test

Sample

Finished

Products

Regulatory

Affairs○

Phase� IIIBusiness

Development○

Finished

Product

Phase� IVSales� &

Marketing○

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 547

131. Syngene International Limited

1.� Corporate� General� Information

Corporate� Name Syngene� International� Limited

Corporate� Ownership Public� Company

Head� Office� AddressPlot� #� 2&3,� Jigani� Link� Road,� Bommasandra� IV� Phase,� Bangalore,� Karnataka� -�

560099� India

Facilities� City� &� Country Bangalore(INDIA)

Web-site� Address www.syngeneintl.com

No.� of� Employees

Syngene�has�an�overall� strength�of�2150+�employees�at�present�with� the� largest�concentration� of� scientific� talent� in� the� country� encompassing� 1850+� scientists�from�the�best�national�&� international�universities�with�21%�PhDs,�73%�Masters�and�6%�BS�degrees� in�various� fields.�Our�highly� experienced�scientists�bring�with�them�the�experience,�knowledge�and�skill� to� support�our�clients‟�R&D�programs�ensuring� timely� delivery� of� projects�meeting� the� highest� standards� of� quality� in�a� timely� manner.

Financial� Status

Sales� Revenue� in� 2012

(US� K$)Capital(US� K$) Dept-equity� Ratio(%)

~� 100� Mio

Contact

(Korean�

Business)

Name Mr.� Sivaram� V

AddressSyngene� International� Limited,� Plot� #� 2� &3,� Jigani� Link� Road,� Bommasandra� IV�

Phase,� Bangalore,� Karnataka,� 560099,� India

Telephone +91� 802� 808� 3181

E-mail [email protected]

Company� History

Syngene�was� incorporated� in� 1994�with� its� corporate� office� in� Bangalore,� India.�With� a� niche� start-up� of�

just� 5�members� in� the� team,� Syngene�was� offering� early� chemistry� and� simple� biology� services.� However,�

we� have� consistently� evolved� over� the� years� and� have� made� a� significant� growth� from� the� year� 2000�

onwards.� We� have� expanded� exponentially� in� various� areas� such� as� services,� infrastructure,� people� and�

investments.� Since� inception,� Syngene�envisioned�of�becoming�a�preferred�partner�of� its� clients� and� today,�

proudly�embodies� itself�as� India‟s� largest�CRO�providing�end-to-end�discovery�and�development�services� for�

both� small� and� large� molecules.

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Company� Description� &� Organization

Syngene� International� Limited,� established� in� 1994,� is� India‟s� largest� CRO,� providing� discovery� and

development� services� to� the� pharmaceutical� and� biotech� industry� over� past� 19� years.� We� have� capabilities�

in� medicinal� chemistry,� biology,� in� vivo� pharmacology,� toxicology,� custom� synthesis,� process� R&D,� cGMP�

manufacturing� and� formulation�development� for�both� small� and� large�molecules.�With�a� team�of�over�2150�

multidisciplinary� scientists� and� investments� of� over� USD� 120� million� in� state-of-the-art� facilities� spread� over�

90� acre� campus,� Syngene� has� successfully� forged� alliances� with� several� companies� globally� including� 8� out�

of� the� top� 10� global� pharmaceutical� companies.�We� are� ISO� 9001,� ISO� 14001,�OHSAS� 18001� certified� and�

have� an� AAALAC� and� OECD� GLP� certified� animal� facility.

Syngene� is� recognized� as� a� pioneer� in� providing� contract� research� services� in�Asia� and� today�manages� some�

of� India‟s� largest� R&D� collaborations.� Syngene‟s� focal� point� is� R&D� productivity� and� operational� efficiencies.�

A�global�mindset�with�emphasis�on�world� class� talent�and� infrastructure�makes�Syngene�a�preferred�employer�

in� the� life� science� industry.� This� is�backed�by�elaborate� training�and�development�programs,� strong�corporate�

governance� framework,� high� standards� in� quality� and� safety,� sound� IP� protection,� efficient� supply� chain� and�

logistics� support� and� robust� data� confidentiality� practices� with� state-of-the-art� IT� capabilities.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 549

2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

○ ○

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US ○ US ○ US US

Canada ○ Canada ○ Canada Canada

EU ○ EU ○ EU EU

Asia ○ Asia ○ Asia Asia

Global ○ Global ○ Global Global

Other ○ Other ○ Other Other

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research ○ API ○

APIs

R&D

Pre-Clinical ○ Pre-clinical

Test� Sample○

R&D� Strategy

&� Management

Phase� I ○ Clinical� Trials

Phase� II ○Clinical� Test

Sample○

Finished

Products

Regulatory

Affairs

Phase� III ○Finished

Product

Business

Development

Phase� IV ○Sales� &

Marketing

Corporate�

Product� Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

○ ○

Generics APIs Devices Others

○ ○ ○ ○

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550� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

3.� Corporate� Business�Overview

Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

44% 27% 15% 14%

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

○ ○ ○ ○

General� Overview

of� Corporate's� Key

Contract� Services

Syngene� is� a� leading� contract� research� and� manufacturing� organization� in� Asia� and�

provides� end-to-end� discovery� and� development� services.� We� have� multi-disciplinary�

skills� in� integrated� drug� discovery� and� development,� with� capabilities� in� medicinal�

chemistry,� biology,� in� vivo� pharmacology,� toxicology,� custom� synthesis,� process� R&D,�

cGMP� manufacturing� and� formulation� development� for� both� small� and� large�

molecules.

While� we� offer� these� services� individually,� it� is� our� ability� to� seamlessly� integrate� our�

comprehensive�capabilities� that�differentiates�us� from�the�competition.�We�accomplish�

this� integration�by� formation�of�multidisciplinary� teams�which�work�cohesively,�monitor�

projects� on� continuous� basis,� proactively� address� critical� issues� and� resolve� them� in� a�

timely� manner.

Contract� Service�

Capacity� Affordable�

by� Service� Area

Syngene� has� state-of-the-art� facilities� spreading� across� 90� acres� campus� and� having�

1,000,000� sq.� ft.� of� working� space.� This� includes� approximately� 500,000� sq.� ft.� of�

Chemistry�&� Biology� laboratories,� cGMP� Kilo� Lab,� Bio�manufacturing� Facilities,� Animal�

Facility�and�Formulation�Development�Centre.�Syngene�has�added�varied�services� to� its�

portfolio� by� setting� up� the� world� class� cGMP� facility� for� manufacturing� APIs� and�

intermediates� spread� across� 60,000� sq.� ft.� Recently,� we� have� also� set� up� a� high�

potency� API� plant� for� the� manufacturing� of� cytotoxic,� cytostatic� high� potent�

compounds.�Our� formulation�development� facility� layout� is�as�per�cGMP�and�Schedule�

„M‟�of� the�„Drugs�and�Cosmetics�Act‟� and� is�equipped� for�manufacturing�of�Oral�Solid�Dosage�Forms�at�1� to�50�kg�scale.� Syngene�also�has�a�world� class� animal� research� lab�

facility� spread� across� 47,900� sq.� ft� to� support� discovery� and� regulatory� toxicology�

studies.� At� present,� Syngene� has� a� capacity� utilization� of� 65%� -� 75%� across� most�

functions.� Syngene� is� also� creating� additional� capacities� to� meet� the� future� demands�

from� its� existing� and� potential� customers.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 551

Communication�

with� Clients

Dispositoion� of

Project� Manager

Responsible

Project� Manager� ensures� that� all� the� projects� carried� out� at�

Syngene� meets� Clients‟� standards,� monitored� and� will� be� in�

communication� frequently� with� the� Clients‟� Project� Lead.� He� is�

responsible� for� the� overall� management� of� the� facility,� ensures�

timely� submission� of� reports.� Syngene� provides� periodic� progress�

reports� by� updating� the� information� in� e-Room/Virtual� Sites.

Providing� Realtime

Service� Delivery

Lead� time� varies� for� each� service;� it� is� also� dependent� on� the�

specific� requirements� of� clients.� Our� facility� is� in� a� Special�

Economic� Zone� which� enables� easy� import� of� materials� and� we�

have� a� dedicated� SEZ� officer� to� ensure� speedy� clearance� of�

material� coming� in.� The� average� lead� time�would� depend� on� the�

product�but�our�average� lead� times� range� from�1�day� to�3-4�weeks�

in� case� of� special� custom� made� compounds.

Realtime

Feed-back

Syngene� uses� the� following� modes� of� communication� as�

convenient� by� the� client:

• Frequent� e-mail� updates

• Periodic� progress� reports� by� updating� the� information� in�

e-Room/Virtual� Sites� for:

� �− Experimental� updates� ­� weekly� �− Compound� tracker� ­� weekly� �− Analytical� data� �− Consolidated� reports� (process� and� analytical� details)• Tele-conferences/Video-conference�and/or� face-to-face�meetings�

on� a� regular� basis

• Share� point� access/� FTP� server� as� required

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4.� Corporate� Competitiveness

Corporate

Competitiveness

Syngene� is� one� of� the� leading� contract� research� and�manufacturing� organization� in�Asia� and� provides� end-toend� discovery� and� development� services.� We� have�multi-disciplinary� skills� in� integrated� drug� discovery� and� development,� with�capabilities� in�medicinal�chemistry,�biology,� in�vivo�pharmacology,� toxicology,�custom�synthesis,�process�R&D,�cGMP�manufacturing�and� formulation�development� for�both�small� and� large�molecules.�While�we�offer� these� services� individually,� it� is�our� ability�to�seamlessly� integrate�our�comprehensive�capabilities� that�differentiates�us� from�the�competition.Syngene�has�an�unparalleled�experience�of�19�years�offering�huge�benefits�and�value�of� our� services� to� its� customers.� The� key� differentiators� are� listed� below:•� Integrated� Development� -� One-stop� Solution•� End-to-end� discovery� and� development� capabilities� for� both� small� and� large�molecules

•� Processes� and� teams� to� handle� multi-disciplinary� development•�Syngene� -�Clinigene�axis� ­� from�early�discovery�and�development� to�clinical� studies•� Global� Standards•� People� -� Building� talent� with� global� education/� experience� base� (20%� of� our�scientific� staff� is� US/� EU� trained),� specialized� skill� sets

•� Infrastructure� ­� Building�world-class� infrastructure� with� capacities/� capabilities� to�meet� increasing� industry� demands

•� Systems� ­� Best� in-industry� Quality/� EHS� practices/� clear� position� on� IP� rights� (IP�always� belongs� to� the� client),� robust� communication,� secured� data� sharing�systems

•� Developing� Differentiators•� Innovative� hybridoma� platform,� human� xenograft� model,� HPAPI� manufacturing�capabilities,� polymer� sciences� division,� scale-up� chromatographic� capabilities,�bioanalytical� testing,� etc.

• Antibody�Drug�Conjugate:�develop/discover�a�novel� linker�which�can�be�patented�and� used� as� a� platform� for� any� ADC� generation� program

• Unique� in�vivo�models:�Developing�human�primary�and�secondary� tissue�xenograft•� Early� and� Rapid� Profiling� of� Cardio� and� Hepato-Toxicity� using� IN� cell� analyzer�technology� from� GE

•� Innovative� Business� Models•�Customized�models�bringing� flexibility�as�per�client‟s�needs.�e.g.�Dedicated� facility�with� Client� Supervision

•� Geared� up� to� manage� large� relationships•� Customization� with� speed•� Ability� to� quickly� understand� clients‟� requirements� and� leverage� on� existing�infrastructure,� systems,� talent� pool� to� customize� our� services� to� meet� clients‟�needs.

•� Competitive� pricing� with� volume� discounts•� Syngene� continuously� works� on� cost� reduction� by�maintaining� its� focus� on� R&D�productivity� and� operational� efficiencies.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 553

No.� of� Regulatory

Inspections

ClassificationFDA

(US)

EMA

(EU)

PMDA

(Japan)

CFDA

(China)

DCI

(India)Others

Pre-Clinical� Area 2

Clinical� Area 2 2 4 4

Manufacturing�

Area

Others 1 3

Current� Status� of

Accredited�

Certification

Syngene� is� committed� to� provide� highest� quality� services� to� its� clients,� right� from�

R&D� to� production.�We� continuously� implement,�monitor� and� upgrade� the� Quality�

Systems� in� the� Company� as� per� the� current� and� evolving� global� standards.

Syngene‟s� facilities� are� also� audited� and� accepted� by�QPs� from� various� big� pharma�

companies.

Syngene� has� the� following� certifications:

-� ISO� 9001:2008

-� ISO� 14001:2004

-� OHSAS� 18001:2007

-� GLP� Certificate� by� National� GLP� Compliance� Monitoring� Authority� of� India

-�GMP� certificates� for�manufacturing� and�07.05.2013�07.05.2014� -� testing� facilities

-� AAALAC� Accredited� Vivarium� Facility

-� DSIR� certificate

-� USFDA� Registration

-� Laboratory� accreditation� certificate� issued� in� FORM� -37,� by� Government� of�

Karnataka� Drugs� control� department.

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5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� to

Over� the�past�19�years,�we�have� successfully�partnered� right� from�startup�companies�

to� big� pharmaceuticals� and� biotech� companies� offering� a� wide� range� of� services�

through� flexible� and� customized� business� model.� We� have� collaboration� with� eight�

of� top� ten� “BIG”�Pharmaceutical�Companies.�We�have�collaborations�with�most�of� the�

leading� Asian� pharmaceutical� &� biotech� companies� from� countries� including� Korea,�

Japan,� Australia,� Singapore,� and� India� as� well.

Asian� Clients'

Composition(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

21% 32% 25% 22%

No.� of� Asian� Clients

in� recent� 3� years� Syngene� has� more� than� 60� Asian� clients� in� recent� 3� years.

Major� Service� Range

with�Asian�Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research ○ API ○

APIs

R&D

Pre-Clinical ○Pre-clinical

Test� Sample

R&D� Strategy

&�Management

Phase� I ○ Clinical� Trials

Phase� II ○Clinical� Test

Sample

Finished

Products

Regulatory

Affairs

Phase� III

Finished

Product

Business

Development

Phase� IVSales� &

Marketing

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 555

6.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

Syngene�has� consistently�made� significant� contributions� to� its� customers‟� efforts� to� enhance� the� success�

of� their�R&D�programs�and� is�keen� to�strengthen� its� relationship�with�Korean�pharmaceutical�and�biotech�

companies.� Syngene� provides� the� following� benefits:

· Offers� all� the� R&D� activities� from�a� single� site� R&D� location.� In� such� a� case,� Clients� can�avoid�dealing�

with� multiple� suppliers� leading� to� efficient� execution� of� all� the� projects.

· A�centralized�project�management� team�minimizing� the� complexity� arising�due� to�projects�handled�at�

multiple� locations.

· High� process� efficiency� for� both� integrated� projects� and� stand-alone� service� verticals.

· Adequate� scale� &� capacity

· Capable� in� building� a� strategic� partnership� with� Clients� starting� from� phased� approach� to� large�

collaborations

· Frequent� communication� and� information� updates� to� clientele.

· High� quality� standard� report� templates� leading� to� immediate� communication� of� the� results� to� Clients

· Meeting� timelines

· In�compliance�with� the�global� standards�and�have�an�effective� „Environment,�Health�&�Safety‟�policies�across� the� organization.

· Flexible� business� model

· Leverage� on� the� cost� advantage� as� all� the� programs� can� be� done� at� single� site� location� minimizing�

the� logistics� cost� and� other� additional� costs.� Also,� as� Syngene‟s� facility� is� in� Special� Economic� Zone,�

providing� various� advantages� of� SEZ� tax� incentives� which� will� be� passed� on� to� Clients.

· Maintaining� cost� and� pricing� transparency� with� Clients

· Standard� pricing� structure� and� template� across� all� the� laboratory� services

· Easy�and� fast� import�and�export�of�materials� to�and� from�Syngene‟s�SEZ� facility�as�we�have�a�dedicated�

SEZ� officer� to� ensure� speedy� clearance� of� material� coming� in� and� going� out.

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132. Target Health Inc.

1.� Corporate� General� Information

Corporate� Name Target� Health� Inc.

Corporate� Ownership Private� Company

Head� Office� Address 261� Madison� Avenue,� NY,� NY10016

Web-site� Address www.targethealth.com

No.� of� Employees 50

Contact

(Korean�

Business)

Name Warren� M.� Pearlson

Address Target� Health� Inc,� 261MadisonAvenue,NY,NY10016

Telephone 212-681-2100

E-mail [email protected]

Company� History

Established� in� 1993,� New� York� City� based.

Company� Description� &� Organization

Target� Health� Inc.,� established� in� 1993,� is� a� privately� held,� New� York� City-based,� full� service� eCRO� with�

fulltime� staff� dedicated� to� all� aspects� of� Regulatory� Affairs,� Chemistry,�Manufacturing� and� Controls,� Clinical�

Research,� Biostatistics,� Data�Management.� Medical�Writing� and� Strategic� Planning,� with� particular� expertise�

and� interest� in� strategic� development� of� drugs/devices� with� unmet� medical� needs.�

TARGET�HEALTH� is� committed� to�bridging� Internet-based� technology�with� the�drug�and�device�development�

processes.� � Target� Health� has� developed� a� full� suite� of� eClinical� Trial� software� including� 1)� Target� e*CRF® �

(EDC� plus� randomization� and� batch� edit� checks),� 2)� Target� e*CTMS™,� 3)� Target� Document®,� 4)� Target�

Encoder®,� 5)� Target� Newsletter®,� 6)� Target� e*CTR™� (electronic� medical� record� for� clinical� trials).

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 557

2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

○ ○

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US ○ US US US ○

Canada ○ Canada Canada Canada ○

EU ○ EU EU EU ○

Asia ○ Asia Asia Asia ○

Global ○ Global Global Global ○

Other ○ Other Other Other ○

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D ○

Pre-Clinical Pre-clinical

Test� Sample

R&D� Strategy

&� Management○

Phase� I ○ Clinical� Trials ○

Phase� II ○Clinical� Test

Sample

Finished

Products

Regulatory

Affairs○

Phase� III ○Finished

Product

Business

Development○

Phase� IV ○Sales� &

Marketing

Corporate�

Product� Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

○ ○ ○ ○ ○

Generics APIs Devices Others

○ ○ ○

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3.� Corporate� Business�Overview

Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

30% 30% 20% 20%

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

Focusing�

Therapeutic� Area

Broad� Range� of� therapeutic� areas� including� (but� not� limited� to)� oncology,� rare� and�

orphan� diseases,

Anti-inflammatory� and� men’s� and� women’s� health.

General� Overview

of� Corporate's� Key

Contract� Services

Target� Health� Inc.,a� full� service� e*CRO,� is� committed� to� serve� the� pharmaceutical� and�

medical� device� industries� through� knowledge,� experience,� technology� and� connectivity.� �

We� strive� to� optimize� the� life� cycle� of� drugs,� biologics� and� devices� with� expertise,�

leadership,� innovation� and� teamwork.

Contract� Service�

Capacity� Affordable�

by� Service� Area

TARGET�HEALTH� INC.� is� a�New�York�City�based� full� service�CRO�with� staff�dedicated� to�

all� aspects� of� Regulatory� Affairs,� Clinical� Research,� Biostatistics,� Data� Management,�

Strategic� Planning� and� Drug� and� Device� Development.� � TARGET� HEALTH� INC.� also� has�

a�group�of� specialized�advisors� in� the�areas�of� Toxicology,�Analytical�Methods�Validation,�

Product� and� Process� Development,� Quality� Assurance� and� Manufacturing.

Communication�

with� Clients

Dispositoion� of

Project� Manager

Responsible

Provide� real� time� data� through� our� CTMS� system.

Providing� Realtime

Service� DeliveryWeb� based� software� provides� real� time� access� to� data

Realtime

Feed-backOur� success� is� measured� by� the� clients� success.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 559

4.� Corporate� Competitiveness

Corporate

Competitiveness

TARGET� HEALTH� INC.� submits� approximately� 3� INDs� per� year,� 2-3� 510(k)s� and� is�

currently� involved�with�10�active� INDs�and�2�active� IDEs.� � TARGET�HEALTH� INC.� clients�

include� Fortune� 100� companies� as� well� as� many� smaller� companies.

We� are� very� pleased� to� announce� that� there� are� now� 30� marketed� products� that�

Target� Health� contributed� to� including� 20� unique� products� (NDA/MAA-6;� PMA-11;�

Canadian� Device-1:� BLA-1;� and� 510k-1)� with� marketing� approval� that� used� Target�

e*CRF®� for� their� pivotal� trials.� �

We� are� efficient� and� very� cost� competitive.

Current� Status� of

Accredited�

Certification

In� May� 2008,� FDA� completed� a� 4� day,� unannounced� though� not� unexpected,�

inspection�of�Target�Health� for� an�NDA�under� review.� � For� this�program�Target�Health�

performed� all� of� the� clinical� and� regulatory� strategic� planning,� toxicology,� regulatory,�

study� designs,�monitoring�of� the� clinical� trials� (Phase� 1,� 2� and�3),� data�management,�

including�Target�e*CRF®� (EDC),� statistics,�medical�writing�and�preparation�of� the�NDA.�

There�were�2�pivotal� trials�and�a� rescue�protocol� for� treatment� failures.� �The�FDA�audit�

also� included� a� detailed� review� of� Target� e*CRF®� and� data� management.� � The�

outcome� of� the� inspection� was� No� 483� issued.

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5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� toKorea

No.� of� Asian� Clients

in� recent� 3� yearsWe� have� partnered� with� LSK� Global� Pharma� Services� on� numerous� projects.

Major� Service� Range

with�Asian�Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D

Pre-Clinical Pre-clinical

Test� Sample

R&D� Strategy

&�Management○

Phase� I ○ Clinical� Trials ○

Phase� II ○Clinical� Test

Sample

Finished

Products

Regulatory

Affairs○

Phase� III ○Finished

Product

Business

Development○

Phase� IV ○Sales� &

Marketing

6.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

What� differentiates� Target� Health� is

1)� Regulatory� experience,� since� 1993,� we� assisted� in� the� approval� of� 27� products.� In� 2009,� Target� Health�

was� directly� involved� with� 4� regulatory� approvals� on� behalf� of� our� clients.� � Two� were� in� the� U.S.,� one� in�

Europe� and� one� in� Canada.� We� received� an� additional� 2� approvals� in� 2010.

We� represent� over� 30� companies� at� the� FDA.

2)Our� full� suite� of� clinical� trial� software� includes� Target� e*CRF®� (EDC� plus� randomization� and� batch� edit�

checks),� Target� e� Studio� (tech� transfer� version� of� eCRF),� Target� e*CTMS™,� Target� Document®,� Target�

Encoder®,� Target� Newsletter®� and� 6)� Target� e*CTR™� (electronic� medical� record� for� clinical� trials).

Our� software� is� being� used� by� a� number� of� CROs� and� pharma� companies

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 561

Corporate� Name TCA� Clinical� Research� Ltd.

Head� Office� Address POB� 504� Tzur� Moshe,� 42810� Israel

Facilities� City� &� Country Israel

Web-site� Address www.tca.co.il

Contact

(Korean�

Business)

Telephone +972� 54� 4768833

E-mail [email protected]

Company� Description� &� Organization

[Vision]

At� TCA� Clinical� Research� Ltd.,� we� believe� that� properly� performed� clinical� research� plays� a� crucial� role� in�

advancing� medical� knowledge� and� patient� care.�

Committed� to� this� principle� we� pledge� best� working� practices� and� accountability� to� ensure� a� successful,�

reliable� and� integrated� clinical� trial� process.Our� expertise� and� customer-focused� approach� helps� every� client�

navigate� an� increasing� complex� landscape� of� global� and� local� regulations� and� tightening� budgets.�

133. TCA Clinical Research Ltd.

1.� Corporate� General� Information

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Corporate� Name TechnoSTAT

Head� Office� Address 34�Jerusalem�Rd.,�Beit�Gamla� -Bldg�B,�5th� Floor,�Raanana,�4350108,� Israel

Facilities� City� &� Country Israel

Web-site� Address technostat.co.il

Contact

(Korean�

Business)

Telephone +972-9-7669333� ext.� 6

E-mail [email protected]

Company� Description� &� Organization

TechnoSTAT� is� a� privately� owned,� Israel-based� company� serving� clients� internationally� in:

•� Clinical� trial� management� and� monitoring� (CRO)

•� Data� management

•� Biostatistics

We� offer� services� from� early� stage� non-clinical� development� and� bench� testing,� to� all� clinical� study� phases�

in�protocol�development,� clinical� trial�management,� through� regulatory� submission� to�agencies�such�as�FDA,�

EMA� and� European� certification� authorities.� TechnoSTAT� supports� its� clients’� marketing� activities� as� well,�

including� post-market� studies� and� assistance� in� the� preparation� of� scientific� articles� and� conference�

presentations.

Since� its� inception� in� 1993,�TechnoSTAT�has�worked� closely�with� pharmaceutical,�device� and�biotechnology�

companies� in� numerous� areas� of� medical� research,� providing� clients� with� a� wide� range� of� high� quality,�

integrated� services.�We�have�a� long�and�successful� track� record�of� success� that� includes�dozens�of� regulatory�

approvals� in�both�U.S.�and�Europe.�We�are�committed� to� the�highest� standards,�with�SOPs� that�comply�with�

industry� standards,� helping� biomedical� organizations� develop� their� technologies,� bring� them� to�market� and�

promote� them.

134. TechnoSTAT

1.� Corporate� General� Information

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 563

135. Techtrials Pesquisa e Tecnologia Ltda.

1.� Corporate� General� Information

Corporate� Name Techtrials� Pesquisa� e� Tecnologia� Ltda.

Corporate� Ownership Private� Company

Head� Office� Address Av� Roque� Petroni� Junior� 1089,� Cj� 313

Facilities� City� &� Country São� Paulo,� BrazilWeb-site� Address www.ttrials.com

No.� of� Employees 60

Financial� Status

Sales� Revenue� in� 2015�

(US� K$)Capital(US� K$) Dept-equity� Ratio(%)

2,500 - -

Contact

(Korean�

Business)

Name Douglas� Andreas� Valverde

Address Av� Roque� Petroni� Junior� 1089,� Cj� 313,� São� Paulo� ­� SP� /� BrazilTelephon

e+55� 11� 97048-1000

E-mail [email protected]

Company� History

Techtrials� was� founded� 8� years� ago� aiming� to� be� the� Leading� Brazilian� CRO� and� offering� the� best� service�

solutions� for� Multinational� and� Local� Pharma� Companies.� Today,� Techtrials� reached� it’s� objective� and� is� the�

Leading�Brazilian�CRO�which�has�been�growing�exponentially� in� the�past�5�years� (CAGR�+59%)� through�high�

quality� clinical� research� and� outsourcing� services� coupled� with� distinctive� responsiveness� and� expertise.

We� have� fully� managed� projects� in� most� therapeutic� areas� and� all� phases� of� clinical� research.� Additionally,�

Techtrials� is�now�preferred�vendor� for� several� Top�Pharma�companies�and�was� successfully� audited�and� rated�

by� multiple� Pharmas� and� also� Dun� &� Bradstreet.�

Company� Description� &� Organization

Techtrials� was� founded� 8� years� ago� aiming� to� be� the� Leading� Brazilian� CRO� and� offering� the� best� service�

solutions� for�Multinational� and� Local� Pharma� Companies.� Our� core� services� comprise:� Outsourcing� (Services�

&� Contractors),� Full� Service� Project� Management,� Monitoring,� Regulatory� Affairs,� Bioequivalence�

Management� &� Monitoring� (Analytical� &� Clinical),� Medical� Services� Management� (Protocol� Writing,�

Epidemiology,� HEOR,� Market� Access,� Biostatistics)� and� Drug� Development� Strategy.�

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564� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

○ ○

Geographical

Business�Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Middle�

East

Middle�

East

Middle�

East

Middle�

East

Africa ○ Africa Africa Africa

US ○ US US US ○

EU ○ EU EU EU

Asia ○ Asia Asia Asia

Russia&CIS ○ Russia&CIS Russia&CIS Russia&CIS

Central� &�

South�

America

Central� &�

South�

America

Central� &�

South�

America

Central� &�

South�

America

ROW ROW ROW ROW

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D

Pre-ClinicalR&D� Strategy

&� ManagementPre-clinical

Test� SamplePhase� I ○ Clinical� Trials ○

Phase� II ○Clinical� Test

Sample

Finished

Products

Regulatory

Affairs○

Phase� III ○Business

Development○

Finished

ProductPhase� IV ○

Sales� &

Marketing○

Corporate�

Product� Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

○ ○ ○ ○ ○

Generics APIs Devices Others

○ ○

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 565

3.� Corporate� Business�Overview

Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

50 30 20 0

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

Focusing�

Therapeutic� Area

(%)

Oncologics Lipid� RegulatorsRespiratory�

AgentsAnti-ulcerants

Angiotensin� II�

Antagonists

15 10 10 5 5

AntipsychoticsAutoimmune�

agentsAntidepressants Analgesics Others

5 5 5 5 35

Core� services:� Outsourcing� (Services� &� Contractors),� Full� Service� Project� Management,�

Monitoring,� Regulatory�Affairs,� Bioequivalence�Management�&�Monitoring� (Analytical�&�

Clinical),�Medical� Services�Management� (Protocol�Writing,� Epidemiology,� HEOR,�Market�

Access,� Biostatistics)� and� Drug� Development� Strategy.

Easy�contract�procedures� ­� Fast� contract�analysis� and� signature;�Budgeting/pricing�usually�

done� via� turn� key� analysis/model;� Unit� pricing� also� possible� and� already� used� in� some�

current� contracts;� Study� pricing� tool� developed� in-house;� Open� negotiation� for� pricing�

to� make� your� project� feasible.

General� Overview

of� Corporate's� Key

Contract� Services

Core� services:� Outsourcing� (Services� &� Contractors),� Full� Service� Project� Management,�

Monitoring,� Regulatory�Affairs,� Bioequivalence�Management�&�Monitoring� (Analytical�&�

Clinical),�Medical� Services�Management� (Protocol�Writing,� Epidemiology,� HEOR,�Market�

Access,� Biostatistics)� and� Drug� Development� Strategy.

Easy�contract�procedures� ­� Fast� contract�analysis� and� signature;�Budgeting/pricing�usually�

done� via� turn� key� analysis/model;� Unit� pricing� also� possible� and� already� used� in� some�

current� contracts;� Study� pricing� tool� developed� in-house;� Open� negotiation� for� pricing�

to� make� your� project� feasible.

Contract� Service�

Capacity� Affordable�

by� Service� Area

Fast� hiring� scheme.� Large� CV� database.

Communication�

with� Clients

Dispositoion� of

Project� Manager

Responsible

Project� Managers� with� approximately� 15� years� experience� with�

Clinical� research� within� different� therapeutic� areas� such� as�

Cardiology,� Infectious� Diseases,� Oncology,� Vaccine,� Genitourinary�

and� others.� Highly� focused� in� quality,� timelines� and� deliverables.�

Flexibility� and� agility� to� attend� project� and� client� demands.

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4.� Corporate� Competitiveness

Corporate

Competitiveness

Techtrials� is� the� leading� Brazilian� CRO� due� to:� High� quality� research� and� outsourcing�

services;� Preferred� vendor� of� big� pharma� companies;� Successfully� audited� and� rated�

(eg.� D&B);� Prompt� answers;� Efficient� process� &� procedures;� Open� dialogue;� open� to�

negotiation.�

Current� Status� of

Accredited�

Certification

Techtrials� is� registered� in� ANVISA� (Brazilian� Regulatory� Agency)� as� CRO� and�member�

of� ABRACRO� (Association� of� Brazilian� CROs).

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� toNo� Asian� clients� until� now

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 567

Corporate� Name Theorem� Clinical� Research,� Inc.

Corporate� Ownership Private� Company

Head� Office� AddressTheorem� Clinical� Research,� Inc.� 1016� West� Ninth� Avenue,� King� of� Prussia,�

Pennsylvania� 19406� USA

Facilities� City� &� Country

King� of� Prussia,� Pennsylvania(USA),� San� Jose,� California(USA),� Buenos�

Aires(Argentina),� North� Ryde(Australia),� Mississauga(Canada),� Beijing(China),�

Shanghai(China),� Gentilly(France),� Cologne(Germany),� Bad� Soden(Germany),�

Bangalore(India),� Warsaw(Poland),� Chippenham(UK)

Korean� Business� OfficeTheorem� Clinical� Research� YH� Stargallery� Bridge� 6F� 1553-3� Seochodong�

Seocho-Gu� Seoul,� 137-070� Republic� of� Korea

Web-site� Address www.theoremclinical.com

No.� of� Employees ~1,000

Financial� Status

Sales� Revenue� in� 2011�

(US� K$)Capital(US� K$) Dept-equity� Ratio(%)

Theorem� is� a� private�

entity�and�therefore�does�

not� provide� this�

information� publicly

Theorem� is� a� private�

entity� and� therefore�does�

not� provide� this�

information� publicly

0%

Contact

(Korean�

Business)

Name Nitin� Jain,� Vice� President� and� General� Manager,� Asia

Address 8� Marine� Blvd.� #05-02� Marine� Bay� Financial� Centre� Singapore� 0189081

Telephone Tel:� +65� 90101780

E-mail [email protected]

Company� History

Theorem� offers� 25+� years� of� clinical� research� experience,� beginning� in� 1985� with� our� legacy� company,�

Bio-Pharm.� During� the� course� of� our� evolution,� Theorem� predecessor� companies� have� been� known� by�

different� names� (including�Omnicare� Clinical� Research)� and� since� 2011�has� been� operating� under� the� name�

of� Theorem� Clinical� Research�when�we�were� acquired� by� Nautic� Partners,� LLC,� a� private� equity� fund� based�

in� the� US� with� over� $2.5� billion� of� equity� capital� under� management.� Our� affiliation� with� Nautic� marks� a�

new�era� for�our�business� that� provides�us� renewed� strength� and� the� ability� to�make�vital,� strategic�decisions�

more� efficiently.

136. Theorem Clinical Research, Inc.

1.� Corporate� General� Information

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Company� Description� &� Organization

Theorem� Clinical� Research� is� a� full-service� CRO,� headquartered� in� the� US,� with� approximately� 1,000�

employees� across� offices� in� 30� countries.� Theorem� is� organized� into� four� distinct� business� units,�

BioPharmaceutical� (Phase� I-IV),� Medical� Device� and� Diagnostics,� Clinical� Analytics� and� Clinical� Supplies,�

enabling� us� to� focus� on� customer� satisfaction� and� operational� excellence.� �

Theorem’s� Mission� is� to� become� the� partner� of� choice� for� pharmaceutical,� biotech� and� medical� device�

companies� around� the� world� by:

•Providing� high-quality,� clinical� trial� services� for� specific� indications� so� diseases� can� be� diagnosed� and�

managed� as� rapidly� and� effectively� as� possible�

•Delivering� customized� solutions,� resources� and� expertise� to� design� and� conduct� the� most� complex� trials,�

every� time

•Recruiting,� retaining� and� developing� industry-leading� experts� in� specific� therapeutic� areas� we� serve

Theorem’s� Vision� is� to� improve� patients’� lives� by� providing� pharmaceutical,� biotech� and� medical� device�

companies� around� the� world� with:

•Customized� solutions� that� produce� optimum� quality� of� research� possible,� providing� our� clients� with� data�

and� answers� to� accelerate� product� development�

•Innovative� processes� and� eClinical� technologies� to� help� our� clients� make� more� informed� decisions� that�

advance� trials� as� soundly� as� possible

•Dedicated� executive� oversight,� the� industry’s� leading� research� services� from� operational� experts,� and�

superior� customer� service,� all� of� which� will� build� enduring� relationships

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2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

○ ○ ○

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US ○ US ○ US US ○

Canada ○ Canada ○ Canada Canada ○

EU ○ EU ○ EU EU ○

Asia ○ Asia ○ Asia Asia ○

Global ○ Global ○ Global Global ○

Other Other Other Other

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D ○

Pre-Clinical ○ Pre-clinical

Test� Sample○

R&D� Strategy

&� Management○

Phase� I ○ Clinical� Trials ○

Phase� II ○Clinical� Test

Sample○

Finished

Products

Regulatory

Affairs○

Phase� III ○Finished

Product○

Business

Development○

Phase� IV ○Sales� &

Marketing

Corporate�

Product� Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

○ ○ ○ ○ ○

Generics APIs Devices Others

○ ○ ○ ○

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570� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

3.� Corporate� Business�Overview

Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

25 40 25 10

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

○ ○

Focusing�

Therapeutic� Area

(%)

Oncologics Lipid� RegulatorsRespiratory�

AgentsAnti-ulcerants

Angiotensin� II�

Antagonists

20 6 7 7 5

AntipsychoticsAutoimmune�

agentsAntidepressants Analgesics Others

7 7 6 7 28

In� the� last� five� years� Theorem� has� managed� over� 1,000� clinical� studies.� � Our� top� 10�

therapeutic� areas� of� expertise� are� as� follows:

-� Oncology:� 189� studies

-� Immunology/Infectious� Disease:� 167� studies

-� CNS:� 133� studies

-� Cardiovascular:� 111� studies

-� Endocrinology� and� Metabolism:� 97� studies

-� Respiratory� Disorders:� 67� studies

-� Gastroenterology:� 64� studies

-� Dermatology:� 44� studies

-� Rheumatology:� 40� studies

-� Musculoskeletal:� 33� studies

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General� Overview

of� Corporate's� Key

Contract� Services

Theorem’s� core� service� offerings� are� as� follows:

•Project� Management,� including� Project� Leaders,� Project� Support� and� Vendor�

Management.

•Clinical�Monitoring� Services,� including� Site� Visits,� Site�Maintenance,� and� Coordinating�

Centers.

•Clinical� Services� Center,� including� Investigator� Identification/Recruitment,� Investigator�

Meetings,� Ethics� Committee/IRB� Submissions,� and� Essential� Document� Collection.�

•Investigator� Relations,� including� Investigator� Agreements,� Grant� Administration,� and�

Feasibility.�

•Medical� Monitoring,� including� Consulting� and� Medical� Review� of� Data

•Pharmacovigilance,� including� Safety� Plan,� Safety� Database,� Safety� Monitoring,� Safety�

Reporting,� and� Safety� Narratives.�

•Data� Management,� including� CRF� and� Database� Development,� Data� Entry,� Query�

Resolution,� Edit� Programming,� Coding,� Data� Loads,� EDC/Paper� Data� Management.�

•Biometrics,� including� Statistical� Analysis,� Statistical� Report,� Sample� Size/Power�

Determination,� full� DSMB/IDMC� services,� CDISC� data� migration� and� conversion� to�

SDTM� datasets.�

•Clinical� Writing,� including� Clinical� Study� Reports,� Manuscript� Development,� Protocol�

Development,� ISS/ISE,� Informed� Consent� Form� Development,� and� Patient� Narratives.�

•Comprehensive� Regulatory� Services,� including� Meetings� with� Regulatory� Agencies�

worldwide,�preparation�and� submission�of� INDAs,�CTAs�worldwide,� IMPD,�Pre-Market�

Approval,� 510k,� IDE,� CTD/eCTD,� S505� b� (2),� Biosimilars,� MAAs,� and� Consulting� .

•eClinical� Technology,� including� EDC� partnerships,� TrialShare� (web-portal),� and�

Theorem� University� (learning� management� system)� �

•Clinical� Supplies,� including� Clinical� Supply� Manufacturing,� Drug� Labeling,� Packaging,�

Shipping� and� Distribution.� �

•Clinical� Quality� Assurance,� including� Quality� Plans� and� Audits

Contract� Service�

Capacity� Affordable�

by� Service� Area

Theorem�manages�workforce� capability� and�capacity� through�a�dynamic,� integrated�and�

prospective� Centralized� Resourcing� process� that� occurs� at� the� departmental� level,�

through� use� of� data� driven� from� our� timesheet� system�and�global� project�management�

process.� Project� Teams� are� staffed� through� a� collaborative� process� between� the� Project�

Team� Leader� and� the� functional� units� representing� the� discipline� and� expertise� required�

on� the�Project.� � Theorem�adapts� its�workforce�size�and�capability�according� to� the�needs�

of� its� Sponsors� through� careful�management� of� its� human� resource� pool.� �We� respond�

to� changes� in� workforce� needs� by� hiring� permanent� staff,� utilizing� temporary� staff� and�

consultant�staff�when�necessary,� and�by�cross-utilization�of�existing�staff�where� feasible.�

Provided� below� are� the� number� of� employees� Theorem� currently� has� by� service� area:

•Project� Management:� 102

•Clinical� Monitoring:� 212

•Clinical� Services� Center:

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•Investigator� Relations:� 17

•Medical� Monitoring:� 5

•Pharmacovigilance:� 17

•Data� Management:� 300

•Biometrics:� 113

•Clinical� Writing:� 4

•Regulatory:� 19

•Clinical� Supplies:� 20

•Clinical� Quality� Assurance:� 12

Communication�

with� Clients

Dispositoion� of

Project� Manager

Responsible

On� average,� Theorem’s� Project� Leads� (Project� Directors� and� Project�

Managers)�has�eight� years�of�experience�with�Theorem�and�12�years�

industry� experience.� Many� of� our� project� management� staff� hold�

advanced� scientific� and/or� nursing� degrees� and� are� Project�

Management� Professional� (PMP)� accredited.

Providing� Realtime

Service� Delivery

Project� Leads� have� full� accountability� to� ensure� the� projects� they�

manage� are� delivered� on� time� and� on� budget.� They� act� as� primary�

point� of� contact� for� the� Sponsor� and� are� responsible� for:

-� Providing� leadership/oversight� to� the� Project� Team

-� Managing� project� budget

-� Provides� on-going� status� reports� to� the� Sponsor�

-� Issue� identification/resolution�

Realtime

Feed-back

In� addition� to� regular� communication� and� metrics� reporting�

provided� by� Theorem’s� Project� Leads,� our� Sponsors,� along�with� the�

entire� Project� Team,� are� able� to� track� study� progress� deliverables�

through�Theorem’s� secure�web�portal,� TrialShare,�24�hours�a�day,�7�

days� a� week� from� anywhere� in� the� world.� �

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Corporate

Competitiveness

Theorem� believes� that� we� are� the� “Right-Size� CRO”� ­� we� have� offices� around� the�

globe,� while� maintaining� the� flexibility� and� nimbleness� of� a� smaller,� entrepreneurial�

organization.� Theorem’s� strong� emphasis� on� Project� Management� and� collaborative�

working� relationships� with� its� Sponsors� is� the� hallmark� principle� that� competitively�

positions� Theorem� in� the� market� place.

Theorem’s� business� unit� structure� (Biopharmaceutical,� Medical� Device-Diagnostic,�

Clinical�Analytics� and�Clinical�Supplies)�provides�our�clients�with� increased�efficiencies,�

decreased� costs,� targeted� outcomes� and� direct� access� to� Senior�Management� within�

Theorem.� Each� business� unit� is� comprised� of� representatives� from� Theorem’s�

functional� departments� and� is� led� by� a� Vice� President-level� Franchise� Lead� who� is�

responsible� for�driving�operational�excellence�and�customer� satisfaction� for�all� projects�

within� the�business�unit.� Theorem�operates�under�a�credo� that�espouses� the� following�

ideals� of� excellence:

•Deliver� on� What� we� Promise:� We� execute� our� projects� with� a� “can-do”,�

“make-it-happen”� approach� that� is� supported� by� strong� leadership� and� project�

management.�

•Partnership� and� Responsiveness:� We� know� how� to� partner� so� that� we� become� an�

extension� of� our� Sponsors’� portfolio� development� team.� Theorem� practices� a�

philosophy� that� includes� being� available� and� responsive� at� any� time� to� meet� the�

needs� of� our� Sponsors.� �We� believe� this� philosophy� has� been� a� component� of� the�

long-standing� relationships� Theorem� has� with� many� of� its� Sponsors.�

•Flexibility:� We� have� the� flexibility� to� rapidly� adapt� resources� and� processes� to� our�

Sponsors’� needs

•Quality:� Theorem� develops� a� quality� plan� for� each� project� at� the� outset� so� that�

quality� is�built� into� the�process.�Our�process� is�backed�by�monthly� checkpoint� review�

meetings� through� our� project� management� process� and� by� internal� quality� audits.� �

•Proactive� Solutions:� Our� risk� management� strategy� outlines� contingency� plans� and�

triggers� for� risks� in� advance� of� beginning� a� project.

No.� of� Regulatory

Inspections

Classification FDA(US) EMA(EU) PMDA(Japan) Others

Pre-Clinical� Area

Clinical� Area ○ ○ ○

Manufacturing� Area ○

Others

부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 573

4.� Corporate� Competitiveness

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Current� Status� of

Accredited�

Certification

Theorem� works� according� to� Federal� Regulations,� current� ICH/� GCP� guidelines� and�

applicable� local� regulations.� �Regulatory�Compliance� is�maintained� through�adherence�

to� Standard� Operating� Procedures� � � and� Local� Working� Practice� Guidelines.

Several� Theorem� Clinical� Research� offices� have� been� inspected� by� the� respective�

regulatory� authorities� for� GMP� and� GCP� compliance.� In� the� US,� our� offices� King� of�

Prussia� and� San� Jose� have� both� been� inspected� and� passed� GCP� compliance� by� the�

USFDA.� � In� Europe,� the� German� offices� in� Bad� Soden� have� been� inspected� for� and�

passed� GCP� compliance� by� the� local� health� authority� (Regierungspräsidium�

Darmstadt).�Our�UK�office� has� been� inspected�by� the�MHRA,� and� a�GCP�Compliance�

Statement�has�been� issued�at� inspection� closure.�Theorem’s�Clinical� Supplies� facility� in�

Bad�Soden� (Germany)� is� inspected�every� second�year� for�GMP�compliance�by� the� local�

health� authority� (Regierungspräsidium� Darmstadt)� and� GMP� compliance� has� been�

issued� in� the� respective� inspection� reports.�

Further,� Theorem� is� member� of� a� CRO� organization� in� Germany,� the� BVMA.�

Memberships� in� this�organization� require� regular� audits� from�a� third�party� in�order� to�

become� and� remain� a� member.� � The� audit� cycle� for� these� audits� is� every� third� year,�

and� is� conducted�by� independent� third�party�auditors.� � The�BVMA�accreditation�audits�

in� Germany� have� taken� place� in� 2000,� 2003,� 2006,� and� 2009.

Theorem� has� been� accredited� for� several� years� now� at� Crédit� Impôt� Recherche� in�

France.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 575

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� toChina,� Singapore,� Korea,� Australia� and� Japan

Asian� Clients'

Composition(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

30 40 20 10

No.� of� Asian� Clients

in� recent� 3� years50+� clients

Major� Service� Range

with�Asian�Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D ○

Pre-ClinicalPre-clinical

Test� Sample

R&D� Strategy

&�Management○

Phase� I ○ Clinical� Trials ○

Phase� II ○Clinical� Test

Sample

Finished

Products

Regulatory

Affairs○

Phase� III ○

Finished

Product

Business

Development

Phase� IV ○Sales� &

Marketing

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576� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

6.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

Theorem�has� been� conducting� studies� in� the�Asia-Pacific� region� for�more� than�15� years.�We�have� a� broad�

range�of� therapeutic� experience� in� Asia-Pacific� countries� totaling� approximately� 250� studies� in� the� last� five�

years� across� 4,600� sites,� in� 76,000� patients,� with� more� than� 10%� of� these� studies� being� conducted� in�

Korea.� Our� top� areas� of� therapeutic� experience� in� the� Asia-Pacific� region� include� oncology,�

endocrinology-metabolism,� cardiovascular,� immunology-infectious� disease,� respiratory� and� CN,� respectively.� �

Theorem� has� 10� offices� in� the� Asia-Pacific� region� located� in� China,� Korea,� Australia,� India,� Taiwan,�

Singapore,� The�Philippines�and�Japan,�with�Theorem’s�Korean�office�second�only� in�size�and� scope� to�China.�

Each� of� our� offices� has� local,� highly� experienced� staff� to� manage� and� conduct� our� Asia-Pacific� Sponsors’�

trials.� In� addition� to� these� offices,�we�have� regional� CRAs� available� to�monitor� sites� in�Malaysia,� Indonesia,�

Hong� Kong� and� Thailand.

Theorem�has� strategic�Regulatory�Affairs�personnel�positioned� in� the�Asia-Pacific� region�who�are�well�versed�

in� the� specific� requirements� for� trial� applications� and� product� registrations� in� this� region.�We� can� provide�

full� Data� Management� and� Biometrics� services� out� of� our� Indian� and� Australian� hubs� for� trials� in� the�

Asia-Pacific� region,� where� we� employ� over� 100� Data� Management� and� Biometrics� staff.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 577

Corporate� Name Tigermed� Consulting� Co� Ltd�

Corporate� Ownership Private� Company

Head� Office� Address Room�805,�Qianjiang�Keji� Tower,�388�Wensan�Road,�Hangzhou�310012,�China

Facilities� City� &� Country Shanghai,� Beijing(CHINA)

www.tigermed.netWeb-site� Address

No.� of� Employees 700� staff

Contact

(Korean�

Business)

Name Jenny� Zhang

AddressRoom� 813-815,� Huawen� Guoji� Plaza,� 999� Zhongshan� Xi� Road,� Changning�

District,� Shanghai� 200051,� China

Telephone +86� 21� 3250� 3700;� 32503708�

E-mail [email protected],� [email protected]

Company� History

On�December�15th�2004,� Foundation�of�Tigermed� in�Hangzhou,�and�establishment�of�offices� in�Shanghai,�

Beijing,� Chongqing� and� Guangzhou� to� complete� basic� corporate� organization;

In� 2005,� Addition� of� Xi’an� office,� with� 40� staff� in� total;

In� 2006,� Addition� of� Chengdu� and� Nanjing� offices,� and� establishment� of� Shanghai� Tigermed� consulting�Co.,Ltd.,� with� over� 50� staff� in� total;

In� 2007,� Addition� of� Changsha,� Shenyang� and� Wuhan� offices,� with� over� 60� staff� in� total;

In�2008,�Addition�of� Jinan,�Tianjin,�Harbin,�Fuzhou�offices,�and�establishment�of�Hunan�Tiger-Xiangya�Drug�R&D� Co.,� Ltd.,� with� over� 100� staff� in� total;

In� 2009,� Addition� of� Zhengzhou,� Changchun,� Wenzhou,� Kunming� and� Qingdao� offices,� acquisition� of�

MacroStat� (China)� Clinical� Research� Co.,� Ltd.,� with� over� 200� staff� in� total;In� 2010,� Addition� of� Nanning,� Haikou,� Suzhou,� Shiyan,� Yangzhou,� Wuxi,� Urumchi� offices,� and�

establishment� of� Jiaxing� Tigermed� Data� Management� Co.,� Ltd.,� with� over� 400� staff� in� total.

In�2011,Addition�of�Shiyan,�Yangzhou,�Wuxi,� Jingzhou,�Haikou,�Amoy,�Nanchang,�Yinchuan,�Shijiazhuang,�Taiyuan,� Dalian,� Inner�Mongolia,� Urumchi,� Shenzhen,� Lanzhou� and�Guiyang� offices,� and� establishment� of�

Hangzhou� Simo�Co.,Ltd.� ,Tigermed� Research� Institute� and�Hongkong� Tigermed�Co.,Ltd.,�with� 566� staff� in�

total.In� 2012,� Tigermed� was� listed� in� Shenzhen� ChiNext� with� stock� symbol� 300347,� meanwhile,� new� offices�

opened� in� both� Hefei� and�Ningbo� and� establishment� of� Shanghai� Tigermed�Medical� Consulting� Co.,� Ltd.,�

and� Fantastic� Bioimaging� Co.,� Ltd.� Total� headcount� over� 700� staff.

137. Tigermed Consulting Co Ltd

1.� Corporate� General� Information

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578� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Company� Description� &� Organization

Tigermed� is� a� leading�Contract�Research�Organization� (CRO)� in�China�providing�a�broad� range�of� contract�

research,� medical� communications� and� consulting� services� to� worldwide� pharmaceutical,� biotechnology�

industries.�Tigermed�has�developed� rich�expertise� in�offering�all� stages�of�clinical� trials,�product� registration,�

biostatistics,�medical� translation�and�R&D�consulting�services� for�drugs,�medical�devices,�diagnostic� reagents�

and� functional� food� products� etc.

Since� inception� in� 2002,� Tigermed� has� been� committed� to� accelerate� your� product� development� timeline�

while� reducing� R&D� costs� and� risks.� Tigermed� has� successfully� rendered� significant� amount� of� clinical�

studies,� biostatistics� and� product� registration� services� for� global� and� local� customers.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 579

Corporate� Name Triumpharma

Head� Office� Address07� Building,� Al� Yarooty� Street,� Amman,� Jordan,� PO� Box� 2233,� Amman�

11941,� Jordan

Facilities� City� &� Country Jordan

Web-site� Address triumpharma.com

Contact

(Korean�

Business)

Telephone 00962� 6� 5350582

E-mail [email protected]

Company� Description� &� Organization

The� following� information� outlines� specifically� Triumpharma’s� work� within� Phase� I� and� bioequivalence�

studies.� Phase� I� refers� to� new�drugs� that� have� been� through� years� of� testing� in� animals� and� are� now� ready�

to� be� administered� to� people.

The� main� objective� of� this� type� of� study� is� to� determine� the� safe� dosage� range� at� which� a� drug� can� be�

administered� and� the� methods� of� absorption� and� elimination� of� the� drug� by� the� body.� A� bioequivalence�

study� seeks� to� prove� that� two� medications� are� exactly� the� same,� although� they� are� produced� by� two�

different� companies,� as� in� the� case� of� generic� drugs.

138. Triumpharma

1.� Corporate� General� Information

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580� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

139. Truven Health Analytics Inc.

1.� Corporate� General� Information

Corporate� Name Truven� Health� Analytics� Inc.

Corporate� Ownership Private� Company

Head� Office� Address 777� E.� Eisenhower� Parkway� Ann� Arbor,� Michigan� 48108� US

Facilities� City� &� CountrySao� Paulo(Brazil),� Brussels(Belgium),� Montreal(Canada),� London(United�

Kingdom),� Dubai(UAE),� Chennai/Hyderabad(India),� Singapore(Singapore)

Korean� Business� Office 16th� Floor,� 1321-1� Seocho-dong� Seocho-gu,� Seoul� 137-070� South� Korea

Web-site� Address www.truvenhealth.com

No.� of� Employees 2,300� employees� worldwide

Contact

(Korean�

Business)

Name Dae� Rhee

AddressGangnam� Building� 16th� Floor,� 1321-1� Seocho-dong� Seocho-gu,� Seoul�

137-070

Telephone +82.2.2190.3723� � �

E-mail [email protected]

Company� History

For� more� than� 35� years,� our� insights� and� solutions� have� been� providing� life� sciences� companies,� hospitals�

and� clinicians,� employers� and� health� plans,� state� and� federal� government� agencies,� and� policymakers� the�

facts� they� need� to� make� confident� decisions� that� directly� affect� the� health� and� well-being� of� people� and�

organizations� in� the� U.S.� and� around� the� world.� We� were� previously� the� Healthcare� business� of� Thomson�

Reuters� and� became� Truven� Health� Analytics� in� 2012.�

Company� Description� &� Organization

Truven� Health� Analytics™� delivers� unbiased� information,� analytic� tools,� benchmarks,� and� services� to� the�

healthcare� industry.� Pharmaceutical� and� medical� device� companies,� hospitals,� government� agencies,�

employers,� health� plans,� and� clinicians� have� relied� on� us� for� more� than� 35� years.� We� bring� deep� clinical,�

financial,� and� healthcare� management� expertise,� and� innovative� technology� platforms� and� information�

assets,� to� collaborating� with� our� customers� to� uncover� and� realize� opportunities� for� improving� quality,�

efficiency,� and� outcomes.

Truven�Health�Analytics�owns� some�of� the�most� trusted�brands� in�healthcare,� such�as�MarketScan,�100�Top�

Hospitals,�Advantage�Suite,�Micromedex,�Simpler,�ActionOI,� and�JWA.�Truven�Health�has� its�corporate�office�

in� Ann� Arbor,� Michigan� USA,� with� international� offices� in� Brussels,� London,� Montreal,� Chennai,� Dubai,�

Singapore,� and� Sao� Paulo.� For� more� information,� please� visit� truvenhealth.com.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 581

2.� Corporate� Service� &�Business� Area

Corporate� Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Central� &�

South�

America

Central� &�

South�

America

Central� &�

South�

America

Central� &�

South�

America

US US US US ○

EU EU EU EU ○

Asia Asia Asia Asia ○

Russia� &�

CIS

Russia� &�

CIS

Russia� &�

CIS

Russia� &�

CIS

ROW ROW ROW ROW

Focusing� Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D

Pre-ClinicalR&D� Strategy

&� ManagementPre-clinical

Test� SamplePhase� I Clinical� Trials

Phase� IIClinical� Test

Sample

Finished

Products

Regulatory

Affairs

Phase� IIIBusiness

Development○

Finished

ProductPhase� IV

Sales� &

Marketing○

Corporate� Product�

Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

○ ○ ○ ○

Generics APIs Devices Others

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3.� Corporate� Business�Overview

General� Overview

of� Corporate's� Key

Contract� Services

Truven� Health� Analytics� is� a� full� service� HEOR,�Market� Access,� and� Stakeholder�

Management� consultancy� working� with� biopharmaceutical� and� medical�

technology� companies� across� the� globe.� We� help� clients� develop� the� rigorous�

scientific� evidence� needed� to� demonstrate� value� and� check� alignment� with�

stakeholders’� opinions.� We� understand� client� challenges� because� we’ve� lived�

them� in�our�own�careers�working� in� industry.�We�provide�health�economics�and�

outcomes� research,� economic� model� development,� literature� reviews� and�

research� services,� value� dossier� development,� and� stakeholder� management�

solutions� ­�all�at� the�global�and� local� levels.�The�Truven�Health�Heartbeat�Profiler�

stakeholder� database,� the� largest� such� global� database� available,� contains�

profiles� on� 2.5� million� KOLs� and� market� access� stakeholders.� Coupled� with�

Heartbeat� Advisor,� our� virtual� advisory� board� platform,� we� are� able� to� identify,�

profile,� map,� and� engage� key� stakeholders� in� discussions� about� product� value.�

We� can� help� you� to� put� the� right� scientific� information� into� the� right� hands� ---�

anywhere� in� the� world.

Contract� Service� Capacity�

Affordable� by� Service� Area

While� we� provide� services� globally,� in� regard� to� this� specific� request,� we� have�

a� team� that� services� Latin� and� South� America.� This� team� is� based� out� of� Sao�

Paulo,� Brazil.

Communication� with�

Clients

Dispositoion� of

Project� Manager

Responsible

Each� project� we� conduct� for� clients� is� assigned� a� project�

manager� who� creates� the� team� of� Truven� experts� from�

anywhere� in� the� world� to� execute� on� the� assignment.� The�

project� manager� is� the� key� point� of� contact� for� the� client.�

Providing�

Realtime

Service� Delivery

With� the� exception� of� access� to� the� Heartbeat� Profiler�

stakeholder� database� and� several� analytic� tools,� service�

delivery� is� not� real-time� as� it� is� custom� research.�

Realtime

Feed-back

Real-time� feedback� is� executed� via� phone,� web� conference,�

and/or� e-mail� per� the� client’s� preference.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 583

4.� Corporate� Competitiveness

Corporate

Competitiveness

We� have� provided� services� to� pharmaceutical� clients� for� over� 20� years.� We� are�

unique� in� the� industry�due� to�our� length�of� service,�and�the� fact� that�we�have�both�

in-house,� proprietary� research� data� and� analytic� � � capabilities.� Our� solutions�

incorporate�strategic�understanding�of�key�stakeholder� issues� in� the�development�of�

scientific� evidence� needed� to� demonstrate� value� and� we� have� experience� gained�

from� working� in-industry� and� as� healthcare� stakeholders� ourselves.� We� have� a�

broad�global�perspective�based�on�our�global� footprint�and�experience�with�a� local�

presence� in� Latin� America,� Asia-Pacific,� Europe,� North� America,� the� Middle� East,�

and� Africa.� We� offer� world-class� strategy,� scientific� research,� and� best-in-class�

stakeholder� engagement.� We� have� decades� of� expertise� in� managing� large� data�

sets�and�developing�powerful� analytic� research� tools�and�are�known� for� the� largest,�

longest� running� proprietary� US� claims� database� available� for� research� at� our�

fingertips� ­� the�MarketScan�Family�of�Research�Databases.�We�also�have� the� largest�

global� stakeholder� profiles� database� available.�While� we� work� in� all� disease� areas,�

we�do�have�extensive�oncology,� inflammatory,� infectious,� and�rare�disease�expertise�

due� to� the� size� of� our� data� assets.

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� to

Specific� to�Asia,�we�have� conducted�projects� for� clients� located� in�China,� Japan,�

South� Korea,� Singapore,� India,� Indonesia,� Malaysia,� Philippines,� Israel,� Turkey,�

Russia,� UAE.� In� addition,�we� have�worked�with� global� and� regional� life� sciences�

companies� who� cover� Asia� from� locations� in� other� parts� of� the� world.

No.� of� Asian� Clients

in� recent� 3� yearsNearly� 100� global� headquarters� and� local� affiliates� located� in� Asia.

Major� Service� Range

with� Asian� Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D

Pre-Clinical Pre-clinical

Test� Sample

R&D� Strategy

&� Management

Phase� I Clinical� Trials

Phase� IIClinical� Test

Sample

Finished

Products

Regulatory

Affairs

Phase� IIIBusiness

DevelopmentFinished

ProductPhase� IV

Sales� &

Marketing○

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584� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

6.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

We� have� extensive� experience� working� with� major� pharmaceutical� companies� in� Central� and� South�

America

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Corporate� Name VIMTA� LABS� LIMITED

Corporate� OwnershipPUBLIC� COMPANY� LISTED� IN� THE� BOMBAY� STOCK� EXCHANGE� &� NATIONAL�

STOCK� EXCHANGE,� INDIA

Head� Office� AddressRegistered� Office� &� Central� Lab� 142,� IDA,� Phase� II,Cherlapally,� Life� Sciences�

Campus� #5,� Alexandria� KnowledgePark,� Genome� Valley,� Shameerpet,

Facilities� City� &� Country HYDERABAD� -� INDIA

Web-site� Address WWW.VIMTA.COM

No.� of� Employees 700

Financial� Status

Sales� Revenue� in� 2010�

(US� K$)Capital(US� K$) Dept-equity� Ratio(%)

US� $� 21.25� Million US� $� 980,000 0.29� :� 1.00

Contact

(Korean�

Business)

Name SREENIVAS� NEERUKONDA� ,� MANAGER-� BUSINESS� DEVELOPMENT

AddressVIMTA� LABS� LIMITED,� Life� Sciences� Campus� #5,� Alexandria� KnowledgePark,�

Genome� Valley,� Shameerpet

Telephone +� 91-40-67� 40� 41� 25

E-mail [email protected]

Company� History

Established� in� 1984,�VIMTA�has�an�extensive� track� record�of�providing� contract� research�and� testing� services�

to�several�pharmaceutical� and�biotech� companies� from�all�around�the�globe.�By�virtue�of�being� India’s� largest�

CRO,� in� terms� of� experience,� infrastructure� and� human� resources,� VIMTA� is� the� right� partner� for� the�

Pharmaceutical� &� Biotech� industry� to� outsource� their� testing� requirements.� VIMTA� is� a� Public� Limited�

company� and� the� only� CRO� listed� on� the� national� stock� exchanges� of� India� and� is� financially� stable.� VIMTA�

is� truly� independent� and� not� affiliated� to� any� pharmaceutical� or� other� drug� development� companies� or� any�

other� organizations.

부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 585

140. VIMTA LABS LIMITED

1.� Corporate� General� Information

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VIMTA� through� its� approach� and� experience� strives� to� help� improve� the� Quality� and� overall� value� of� the�

Pharmaceutical� products.� VIMTA� has� organizational� and� staff� experience� in� working�with� global� companies�

and� in� enabling� rapid� implementation� of� critical� project� activities.

VIMTA’s� long� term� relationships� with� multinational� Pharma� companies� helped� us� further� improve� Quality�

Systems� and� comply� with� global� quality� requirements.

VIMTA� maintains� world� class� service� standards,� by� e-enabling� the� entire� business� functioning,� rapid�

innovations� and� building� a� people� centric� approach.� VIMTA� has� the� knowledge� and� mindset� of� GXPs� (GLP�

/�GCP�/� cGMP),� ISO�17025,�and� ISO�15189�and� is�pre-qualified�by� the�World�Health�Organization,� accredited�

by� CAP� &� AAALAC.

Company� Description� &� Organization

Vimta� Labs� Ltd� is� the� leading� Indian� CRO� providing� drug� discovery� and� development� services� to� global�

customers� for� last� 28� years.� VIMTA� is� a� multi-site� organization� with� more� than� 350,000� sft.� of� world� class�

laboratory� facilities.� VIMTA� provides� quality� services� in� compliance� with� GLP,� GCP� and� cGMP� standards�

established� by� the� US� FDA.� VIMTA� adheres� to� and� operates� in� line�with� ICH� guidelines� and� is� accredited� as�

per� ISO17025� and� ISO15189.

Our�management�approach�and� systems� are�geared� to� support�our� corporate� vision�of� development.�VIMTA�

has� invested� over� $30� million� to� build� a� truly� world� class� bench� mark� facility.� It� is� a� scientifically� designed�

CRO� lab� to� meet� cGMP� requirements.

VIMTA� offers� services� in� the� areas� of� :

Preclinical

In-vitro� Biology.

Cellular� &� Molecular� Biology

Clinical� Reference� Lab

Analytical� Testing� ­.� Drugs� &� Pharma,� Food,� Water,� Trace� Analysis,� Physical� characterization,� Stability� and�

Microbiology.

Clinical� Research

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 587

2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US ○ US US US

Canada ○ Canada Canada Canada

EU ○ EU EU EU

Asia ○ Asia Asia Asia

Global ○ Global Global Global

Other Other Other Other

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research ○ API

APIs

R&D

Pre-Clinical ○ Pre-clinical

Test� Sample

R&D� Strategy

&� Management

Phase� I Clinical� Trials

Phase� II ○Clinical� Test

Sample

Finished

Products

Regulatory

Affairs

Phase� III ○Finished

Product

Business

Development

Phase� IV ○Sales� &

Marketing

Corporate�

Product� Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

Generics APIs Devices Others

VIMTA�offer�Preclinical� Services,�Analytical� Services�&�Molecular�biology� services� to� the�above�

areas� of� development.

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588� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

20% 30% 30% 20%

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

○ ○ ○

Focusing�

Therapeutic� AreaWe� offer� efficacy� models� in� the� areas� of� Pain� &� Inflammation� &� Metabolic� Disorders.

General� Overview

of� Corporate's� Key

Contract� Services

※ Preclinical� -�VIMTA's�AAALAC�accredited� facility�offers�a� complete� range�of�Pre-clinical�

Pharmacology,� ADME/PK,� Toxicity� &� Safety� Assessment� &� Invitro� Services� to� support�

Drug� Discovery� &� Development� for� submissions� to� regulatory� authorities� globally� in�

rodents� and� non-rodents

※ In� Vitro� Biology� ­Cell-based� and� cell-free� drug� screening� (Inflammation,� Oncology),�

enzyme� and� receptor� based� assays,� cloning,� expression� and� purification� of� drug�

targets,� Bioassays� for� Biotherapeutic� and� Polyclonal� Antibody.

※ Cellular� &� Molecular� Biology� ­VIMTA� offers� sequencing,� genotyping� with� Mass� array�

and�Affymetrix�Microarrays,�gene�expression�using�Affy� chips,�micro� satellite�analysis,�

Proteomics� (MALDI-MS/MS� Analysis)� and� peptide� synthesis� services.� Biomarker� and�

Bioinformatics� Research� support� is� provided� for� both� preclinical� and� Clinical� studies�

and� Translational� Research

※ Clinical�Reference�Lab� -�VIMTA�offers� services� in� safety�monitoring,�biopharmaceutical�

clinical� trial� support,� biomarker� assay� development� and� validation,� molecular�

diagnostic� assay� development� and� validation,� validation/verification� of� commercial�

diagnostic� assays.

※ Analytical� Testing� -� VIMTA� offers� testing� services� for� Drugs,� Pharma,� Food,� Water,�

Trace� Analysis,� Physical� characterization,� Stability� and� Microbiology.

※ Clinical�Research� -�VIMTA�offers� BA/BE�and� Phase� I� clinical� studies,� site�management,�

and� pharmacovigilance.

3.� Corporate� Business�Overview

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Communication�

with� Clients

Dispositoion� of

Project� Manager

Responsible

Project�Manager� ­Will� be� the� primary� customer� contact� person� and�

manages� day-to-day� project� information� and� customer� interactions.

Effectively� communicates� with� the� customer� on� project� status� and�

provides� status� reports.� Has� thorough� understanding� of� contractual�

obligations� and� project� deliverables.� Attends� conference� calls� and�

client� meetings� and� maintains� the� minutes� of� the� same.

Identifies� actionable� items� arising� out� of� such�meetings� and� ensure�

responsibilities� for� each� task� are� identified,� and� the� tasks� are�

completed� in� stipulated� time.� Possesses� a� good� general�

understanding� on� the� technical� nature� of� the� various� projects�

undertaken.

Providing� Realtime

Service� Delivery-

Realtime

Feed-back-

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Corporate

Competitiveness

VIMTA�has� procedures� in� place� that� facilitate� the� operational� capabilities� of� the�work�

flow� to� progress� in� a� smooth� and� timely� fashion.�VIMTA�has�established� systems� that�

operate� under� a� stringent�Quality� program� and� tools� to� enforce� such� quality� policies.�

We� are� equipped� with� systems� and� software� that� enables� us� to� carry� out� the� work�

undertaken� from� sample� registration� to� final� report� submission.� VIMTA’s� robust�

Labware� Laboratory� Information� Management� System� [LIMS]� not� only� facilitates�

sample� tracking� and�project� progress� but� enables�workload� and� resource�monitoring.�

VIMTA’s� approach� to� work� flow� is� strong� and� effective� due� to� the� fact� that� there�

exists� a�good�understanding�and� internal� communication�between� inter-departmental�

personnel.

VIMTA� has� strong� Quality� Assurance� team� that� is� well� versed� in� cGMP,� ISO17025,�

ISO15189,� and� ICH� requirements.� The� Quality� Assurance� team� ensures� that� all�

protocols,� standard� operating� procedures,� are� followed� as� per� requirements.� Quality�

at� VIMTA� is� strictly� adhered� to� and� is� implemented� by� the� QA� team� by� providing�

proper� continuous� training� to� the� personnel,� and� by� conducting� internal� audits,� etc.�

Our� laboratory� facilities� operate� in� a� GxP� environment� to� allow� strict� adherence� to�

protocols� in� executing� the� project[s]� on� hand.

The� laboratory� has� got� a� structured�way� of� functioning�with� dedicated� functions� and�

responsibilities,�which�are�well�described� in� the� respective� Job�Descriptions.� The�quality�

control� function� is� independent� and� the� management� ensures� that� they� are� not�

subject� to� commercial,� political,� financial,� and� other� pressures� or� any� conflict� of�

interest� that�may� adversely� affect� the� quality� of� their�work.� The� laboratories� are� well�

designed� and� equipped� as� per� the� safety� requirements� and� the� safety� procedures� are�

in� place� for� carrying� out� the� day� to� day� activities.

Client� specific� CDA/NDA� ensures� the� confidentiality� of� the� client� data� as� per� their�

terms� and� conditions� and� as� required.� Individual� samples� are� coded� with� unique�

identity� number� (Registration� Number)� prior� to� testing,� to� the� extent� possible.� All�

information� obtained� from� the� client� is� treated� as� confidential.� This� is� not� made�

accessible� to� the� personnel� performing� the� tests,� unless� essential.� All� data� generated�

are� safely� and� securely� archived� till� the� contractual� retention� period� and� returned� to�

the� client� as� per� contract� or� destroyed� as� required.

Additionally,� security� is� ensured� by� providing� controlled� access� to� personnel� working�

in� specific� laboratory� areas� where� analytical� testing� is� performed.

There� is� an� Integrated� Building� Management� System� in� place� to� monitor� 18�

4.� Corporate� Competitiveness

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parameters� and� a� scalable� infrastructure.� Software� such� as� Empower,� SDMS� and�

Labware� LIMS� are� in� place� to� ensure� proper� and� efficient� workflows,� real� time� data�

generation� and� audit� trails.� Apart� from� this� there� are� customer� specific� labs� with�

access� to� data� on� a� real� time� basis.

VIMTA� has� a� world� class� facility� and� a� large� team� of� expert� human� resources� to�

provide� services� that�meet� the�expectations�of� the� clients� in� terms�of�quality,� timelines�

and� cost.

At� VIMTA,� we� have� a� State-of-the-art� data� centre,� IT� infrastructure� and� secure�

networks� designed,� built� by� IBM.

No.� of� Regulatory

Inspections

Classification FDA(US) EMA(EU) PMDA(Japan) Others

Pre-Clinical� Area

※ CPCSEA-� India

※ AAALAC

※ GLP�

MONITORINGA

UTHORITY,�

INDIA

※ Multiple� audits�

by� global�

pharma� &�

biotech�

companies.

Clinical� Area 6 2

※ MHRA

※ AFSSAPS

※ DRA’S� OF�

Sweden,�

Denmark,�

Portugal

※ BfArM-�

Germany

※ DCGI

※ WHO

Manufacturing� Area

Others

Current� Status� of

Accredited�

Certification

ISO� 17025� Accredited,� ISO� 15189� Accredited,� AAALAC� Accredited,� CAP� Accredited,�

CGMP,� GLP,� GCP,� WHO� ­Pre-qualified� quality� control� lab.

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592� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� to

Some�of� the�major� countries�are� listed:�USA,�UK,� Ireland,�England,�Scotland,�Germany,�

Switzerland,� Denmark,� Japan,� Korea,� Malaysia,� Singapore,� Indonesia,� Australia,� New�

Zealand,� African� countries� and� many� more� countries� globally

Asian� Clients'

Composition(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

30% 30% 25% 15%

No.� of� Asian� Clients

in� recent� 3� years

More� than� 100� companies� in� the� area� of� Drug� &� Pharma� Quality� control� testing,�

Clinical� Research,� Preclinical� Research,� Food� &� Water� Analysis� &� Environment� Impact�

assessment� &� monitoring

Major� Service� Range

with�Asian�Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research ◌ API

APIs

R&D

Pre-Clinical ◌Pre-clinical

Test� Sample

R&D� Strategy

&�Management

Phase� I Clinical� Trials

Phase� II ◌Clinical� Test

Sample

Finished

Products

Regulatory

Affairs

Phase� III ◌

Finished

Product

Business

Development

Phase� IV ◌Sales� &

Marketing

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141. WCCT Global, LLC

1.� Corporate� General� Information

Corporate� Name WCCT� Global,� LLC

Corporate� Ownership Private� Company

Head� Office� Address 5630� Cerritos� Avenue,� Cypress,� CA,� USA

Web-site� Address WWW.WCCT.COM

No.� of� Employees

Cunningham�&�Associates� consultants� and� advisors� are� not� employees� but� rather�

independent� contractors.� We� can� assemble� a� team� to� handle� small,� medium,� or�

large� transactions,� as� needed

Financial� Status

Sales� Revenue� in� 2010

(US� K$)Capital(US� K$) Dept-equity� Ratio(%)

- - Company� is� debt� free

Contact

(Korean�

Business)

Name Kenneth� Kim

Address 5630� Cerritos� Avenue,� Cypress,� CA� 90630

Telephone 714-252-0788

E-mail [email protected]

Company� History

WCCT�Global�was� founded� by� Dr.� Kenneth� Kim�who� is� board� certified� in� Internal�Medicine� and�Allergy� and�

Asthma� in� 1998.�WCCT�Global� is� an� early� phase� drug�development� clinical� CRO,� based� in� the� United� States�

with� 150� beds� in� 2� locations.� � As� a� drug� development� partner,� WCCP� Global� partners� with� domestic� and�

foreign� innovator� companies�who� need� regulatory� and� strategic� develop� support� from� First-in-Man� thru� the�

proof� of� concept� stage.� WCCT� Global� also� specializes� in� special� patient� population� phase� 1� studies� that�

require� complex� study� designs� and� procedures� including� thorough� QTc� and� ethnobridging� studies.

Company� Description� &� Organization

WCCT� Global,� LLC� (WCCT-G)� is� an� early� phase� drug� development� CRO,� based� in� the� USA� with� 180� beds�

at� 2� locations.� WCCT-G� partners� with� domestic� and� foreign� innovator� firms� that� require� reg-� ulatoryand�

strategic� development� support� from� first-in-man� through� proof� of� concept.� �WCCT-G� specializes� in� Phase� 1�

studies� that� require� complex� designs� and� procedures� (i.e.� thorough� QTc,� PK-PD,� Ethnobridging).

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594� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

○ ○

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US US US US

Canada Canada Canada Canada

EU EU EU EU

Asia Asia Asia Asia

Global ○ Global Global Global ○

Other Other Other Other

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D

Pre-Clinical Pre-clinical

Test� Sample

R&D� Strategy

&� Management○

Phase� I ○ Clinical� Trials ○

Phase� II ○Clinical� Test

Sample

Finished

Products

Regulatory

Affairs○

Phase� IIIFinished

Product

Business

Development

Phase� IVSales� &

Marketing

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3.� Corporate� Business�Overview

Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

45% 30% 20% 10%

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

Phase� 1� CPUs

Focusing�

Therapeutic� Area

Early� development� healthy� subjects� and�many� special� populations� ­� allergy,� asthma� CV,�

diabetes,� ophthalmology,� pediatric,� elderly,� postmenopausal� and� women’s� health,�

dermatology,� hepatitis� B/C,� Renal� impaired� and� dialysis,� hypertension,�

hypercholesterolemia,� pain� management� &� Asian� bridging

General� Overview

of� Corporate's� Key

Contract� Services

Regulatory� agency� consulting� including� IND� preparation� and� submission� and� brochure�

preparation;�Drug�development� consulting� for�program�development� and�drafting� study�

designs.� �Full�execution�of�Phase� I�healthy�volunteer�and�patient�proof�of�concept� studies�

includingfull� program� design,� protocol� design/development,� data� management,� clinical�

study� report� preparation,� medical� writing/publishing.

4.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Asian� Clients'

Composition(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

80% 20%

No.� of� Asian� Clients

in� recent� 3� yearsOver� 10

5.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

We� have� worked� with� several� large� Korean� pharma� studies� with� regulatory� and� drug� development�

consulting� and� phase� 1� execution

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596� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name XCENE� Research

Head� Office� Address Xcene� Research� Corporate� Office,� 90� B� Opebi� Road,� Ikeja,� Lagos,� Nigeria

Facilities� City� &� Country Nigeria

Web-site� Address www.xceneresearch.com

Contact

(Korean�

Business)

Telephone +23� 48090723870

E-mail [email protected]

Company� Description� &� Organization

[Mission]

Xcene� Research� is� dedicated� to� providing� services� to� pharmaceutical,� biotechnological� and� medical� device�

companies� and� academic� institutions,� advancing� their� research� efficiency� and� core� competitiveness� —� and�

ultimately� improving� their� productivity.

We� strive� to� change� the� landscape� of� clinical� research� on� the� continent� of� Africa� by� placing� an� emphasis�

on� patient� safety,� productivity� and� development.� Our� team� upholds� standards� of� excellence� that� are�

unmatched� on� a� global� scale.

[Vision

We� pride� ourselves� as� visionaries� in� the� field� of� scientific� development,� having� gained� the� trust� and�

confidence� of� professionals� in� the� field.� From� inception� to� the� safe� procurement� of� new�medical� therapies,�

Xcene� Research� will� continue� to� be� a� strong� catalyst� in� modern� medicine.

Our� success� is� your� success!� As� the� premier� provider� to� biopharmaceutical� companies� and� medical�

institutions,�we� foresee�more� complex�medical� breakthroughs� ahead�with� us� at� the� helm,� providing� clinical�

solutions� at� each� stage� of� the� way.

142. XCENE Research

1.� Corporate� General� Information

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Corporate� Name ZEINCRO

Head� Office� Address

Barbarοs� Mah.� Gulpinar� Sok.� No:5/1,

34746� Atasehir,

Istanbul,� Turkey

Facilities� City� &� Country Turkey

Web-site� Address www.zeincro.com

Contact

(Korean�

Business)

E-mail [email protected]

Company� Description� &� Organization

[Mission]

“We� provide� Contracted� Services� in� the� pharmaceutical� sector� of� ensured� compliance,� in� targeted�

international�markets,� through�a� team�of� committed�experts� and�we� strive� to�be� long-term� trusted�partners�

of� major� innovative� health� organisations”

[Vision]

“To�achieve� leading�presence�with� local� expertise� in�an� expanding�geography�of� international� CRO�markets,�

through� a� network� of� selected� partners,� developing� top� professionals� and� providing� cutting� edge�

infrastructure”

143. ZEINCRO

1.� Corporate� General� Information

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598� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

144. Zhiwe Chem-Tech Inc

1.� Corporate� General� Information

Corporate� Name Zhiwe� Chem-Tech� lnc

Corporate� Ownership Private� Company

Head� Office� Address 3F� Bul� A2� No� 699� Chuanghong� Rd.

Web-site� Address WWW.apichem.cn

No.� of� Employees 10� Employees

Financial� Status

Sales� Revenue� in� 2012

(US� K$)Capital(US� K$) Dept-equity� Ratio(%)

0.8� million 0.05million

Contact

(Korean�

Business)

Name Mr� Kyree

Address 3F� Bul� A2� No� 699� Chuanghong� Rd.

Telephone 139� 1744� 6399� ,� 86(21)20221225

E-mail [email protected],� [email protected]

Company� History

2009.3� is� APIchem�

2010.4� is� zhiwe�

2012� A� Chinese� patents

Company� Description� &� Organization

Established� in�2009,� ZHIWE�Chemical� (APIchemTM� )� is�a� leading�company� focusing�on�Active�Pharmaceutical�

Ingredients� (API)� and� intermediates.

APIchemTM� built� R&D� center� in� Shanghai� as� well� as� manufacturing� facilities� in� Hebei� � province.� The� R&D�

center� has� equipped� with� advanced� instruments� and� machines,� including� high-pressure� tank,�

low-temperature� equipment� (-120℃),� HPLC� and� GC� etc.� APIchemTM� can� offer� products� ranging� from�

milligram� level,� kilogram� level,� up� to� bulk� tons.

Our� clients� widely� spread� from� Europe,� North� America,� and� Asia.

APIchemTM� is� skilled�at�R&D�of�new�drugs,�as�well�as�custom�synthesis�and�contract� research.� “Create� value�

for� clients”� is� our� mission,� and� upon� this� mission� we� cooperate� with� our� clients� to� lower� their� cost� with�

more� efficiency.

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부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 599

2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

○ ○

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US US US US

Canada Canada Canada Canada

EU EU EU EU

Asia Asia Asia Asia

Global ○ Global Global Global ○

Other Other Other Other

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D

Pre-Clinical Pre-clinical

Test� Sample

R&D� Strategy

&� Management○

Phase� I ○ Clinical� Trials ○

Phase� II ○Clinical� Test

Sample

Finished

Products

Regulatory

Affairs○

Phase� IIIFinished

Product

Business

Development

Phase� IVSales� &

Marketing

Page 603: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

600� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

3.� Corporate� Business�Overview

Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

45% 30% 20% 10%

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

Phase� 1� CPUs

Focusing�

Therapeutic� Area

Early� development� healthy� subjects� and�many� special� populations� ­� allergy,� asthma� CV,�

diabetes,� ophthalmology,� pediatric,� elderly,� postmenopausal� and� women’s� health,�

dermatology,� hepatitis� B/C,� Renal� impaired� and� dialysis,� hypertension,�

hypercholesterolemia,� pain� management� &� Asian� bridging

General� Overview

of� Corporate's� Key

Contract� Services

Regulatory� agency� consulting� including� IND� preparation� and� submission� and� brochure�

preparation;�Drug�development� consulting� for�program�development� and�drafting� study�

designs.� �Full�execution�of�Phase� I�healthy�volunteer�and�patient�proof�of�concept� studies�

includingfull� program� design,� protocol� design/development,� data� management,� clinical�

study� report� preparation,� medical� writing/publishing.

4.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Asian� Clients'

Composition(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

80% 20%

No.� of� Asian� Clients

in� recent� 3� yearsOver� 10

5.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

We� have� worked� with� several� large� Korean� pharma� studies� with� regulatory� and� drug� development�

consulting� and� phase� 1� execution

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부록 2� �전략적 협력사 디렉토리 ❚ 601

순번 기업명 국가 페이지 2015 2016

1 ABL 브라질 605 ○ ○

2 Accelera� Srl 이탈리아 606 ○(신규)

3 Access� Bio 미국 608 ○ ○

4 AGIO 인도 609 ○ ○

5 Akrikhin 러시아 611 ○ ○

6 Alkor� Bio 러시아 615 ○ ○

7 Amgen 미국 616 ○ ○

8 AnaPath� Services� GmbH 스위스 618 ○(신규)

9 APOTEX 멕시코 619 ○ ○

10 Apsen 브라질 620 ○ ○

11 ARTERIUM 우크라이나 622 ○ ○

12 AstraZeneca 영국 624 ○ ○

13 AVID 미국 627 ○ ○

14 AZT� Pharma� K.B. 러시아 629 ○ ○

15 bcpp 우크라이나 630 ○ ○

16 BEPTEKC 러시아 632 ○ ○

17 Bestpharma 칠레 633 ○ ○

18 Binzhou� Hollyally.Pharmaceutical� Co.,Ltd. 중국 634 ○ ○

19 Biocad 러시아 635 ○ ○

20 BioInvent� International� AB 스웨덴 637 ○ ○

21 BIOLA 카자흐스탄 641 ○ ○

22 BioRelix 미국 642 ○ ○

23 Biosano 칠레 643 ○ ○

24 BIOSINTEZ 러시아 645 ○ ○

25 Blisfarma 브라질 646 ○ ○

【부록 2】� �전략적 협력사 디렉토리

본 디렉토리북 수록내용은 해당 기업의 회신 내용을 바탕으로 수록된 내용으로서 신뢰성 여부는 주최측이

보증하지 않음을 유의하시기 바랍니다. 따라서, 글로벌 시장 진출시 본 디렉토리북 내용에 수록된 기업과의

접촉시 업체별로 신뢰성 여부에 대한 사전 조사를 당부드립니다.

본 디렉토리북에 수록된 특허분포도는 조사시 회신 받은 자료가 아닌 자체 특허분석 자료임을 밝힘.

■�전략적 협력사 디렉토리 수록 기업 리스트 128개사

Page 605: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

602� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

순번 기업명 국가 페이지 2015 2016

26 BMS 미국 648 ○ ○

27 BSL� BIOSERVICE� Scientific� Laboratories� GmbH 독일 650 ○(신규)

28 Celgene 미국 652 ○ ○

29 CHEM 러시아 655 ○ ○

30 Chengdu� CSHPHARM� Co.,Ltd. 중국 656 ○ ○

31 Clinical� Development� Services� Agency 인도 657 ○ ○

32 CMIC� Korea� Co,.� LTD. 한국 658 ○ ○

33 DiaProph� Med 우크라이나 660 ○ ○

34 Drogueria� Eurofarma� SA 아르헨티나 664 ○(신규)

35 EBIME 멕시코 665 ○ ○

36 Ecron� Acunova� Ltd� 인도 666 ○ ○

37 EKOlab 러시아 669 ○ ○

38 Eli� Lilly� &� Co 미국 671 ○ ○

39 Farmak 우크라이나 674 ○ ○

40 Farmamed 러시아 676 ○ ○

41 Farmproekt 러시아 677 ○ ○

42 FERANE 러시아 678 ○ ○

43 Ferrer� Argentina� S.A. 아르헨티나 681 ○ ○

44 G.� C.� CHEMIE� PHARMIE� LTD 인도 684 ○ ○

45 GalenoPharm 러시아 685 ○ ○

46 GENOSCO 미국 688 ○ ○

47 GEROPHARM 러시아 689 ○ ○

48 Gramón� -� Bagó� de� Uruguay� S.A. 우루과이 691 ○ ○

49 GSK 영국 692 ○ ○

50 GUANGDONG� BOHONG�MEDICINE� CO.,� LTD. 중국 695 ○ ○

51 GVK� BIOSCIENCES� PVT.� LTD. 인도 697 ○ ○

52 H.� Lundbeck� A/S 덴마크 699 ○ ○

53 Janssen� Korea� Ltd. 미국 704 ○ ○

54 JURABEK 우즈베키스탄 707 ○ ○

55 KRKA 슬로베니아 712 ○ ○

56 Kyiv� Vitamin� Factory 우크라이나 716 ○ ○

57 Laboratorio� Dosa� S.R.L. 아르헨티나 719 ○ ○

58 LaboratorioDr.Lazar&Cia.S.A.Q.eI� 아르헨티나 720 ○ ○

59 Laboratorio� Elea� S.A.C.I.F.� y� A. 아르헨티나 722 ○ ○

60 LABORATORIOS� AC� FARMA� S.A. 페루 723 ○ ○

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부록 2� �전략적 협력사 디렉토리 ❚ 603

순번 기업명 국가 페이지 2015 2016

61 Laboratorios� Bagó� S.A. 아르헨티나 724 ○ ○

62 Laboratorios� Bernabó� S.A. 아르헨티나 725 ○ ○

63 Laboratorios� Fabra� S.R.L. 아르헨티나 726 ○ ○

64 Laboratorios� IMA� S.A.I.C. 아르헨티나 727 ○ ○

65 Laboratorios� LIOMONT 멕시코 728 ○ ○

66 Laboratorios� Phoenix� S.A.I.C.� y� F. 아르헨티나 729 ○ ○

67 Laboratorios� Poen� S.A.C.I.F.I. 아르헨티나 730 ○ ○

68 Lekhim 우크라이나 732 ○ ○

69 LS� SAVAL 칠레 734 ○ ○

70 MEGA 태국 735 ○ ○

71 Merck 미국 740 ○ ○

72 MICRO� GEN 러시아 744 ○ ○

73 Moscow� Endocrine� Plant 러시아 746 ○ ○

74 MosFarma 러시아 748 ○ ○

75 MSD� Korea 미국 750 ○ ○

76 MSP 카자흐스탄 754 ○ ○

77 NALpharma 미국 756 ○ ○

78 Namiki� Shoji� Co.,.� Ltd 일본 758 ○(신규)

79 NEKTAR 미국 760 ○ ○

80 NEOLPHARMA 멕시코 763 ○ ○

81 Ningbo� Menovo� Pharmaceutical� Co.,� Ltd. 중국 764 ○(신규)

82 Novartis� AG 스위스 766 ○ ○

83 NPO� PETROVAX� PHARM 러시아 769 ○ ○

84 Pfizer 미국 770 ○ ○

85 PHARM� SINTEZ 러시아 772 ○ ○

86 PHARMASOFT 러시아 773 ○ ○

87 Pharmasset 미국 774 ○ ○

88 PHARMASYNTEZ 러시아 776 ○ ○

89 Phs� Pharmstandard 러시아 778 ○ ○

90 PIQ� Pharma 러시아 779 ○ ○

91 PiSA 멕시코 781 ○ ○

92 PluriCell� Biotech 브라질 783 ○(신규)

93 POLYSAN 러시아 784 ○ ○

94 PROTEK 러시아 787 ○ ○

95 PTC 미국 789 ○ ○

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604� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

순번 기업명 국가 페이지 2015 2016

96 Purdue 미국 791 ○ ○

97 RANDALL� LABORATORIES 멕시코 794 ○ ○

98 RC� CORP 미국 795 ○ ○

99 Ricerca� Biosciences 미국 796 ○ ○

100 Roemmers� S.A.I.C.F. 아르헨티나 798 ○ ○

101 SANOFI 프랑스 800 ○ ○

102 Serendex� aps 덴마크 805 ○ ○

103 SERVIER 프랑스 806 ○ ○

104 Shanghai� Tenry� Pharmaceutical� Co.,� Ltd 중국 809 ○ ○

105 SHJNJ� PHARMATECH� INC. 중국 810 ○ ○

106 SibEnzyme 미국 812 ○ ○

107 Silanes 멕시코 814 ○ ○

108 SINOLITE� INDUSTRIAL� CO.,LTD 중국 816 ○ ○

109 SINTEZ 러시아 817 ○ ○

110 SomaGenics,� Inc. 캐나다 818 ○ ○

111 STADA� CIS 러시아 820 ○ ○

112 STENDHAL 멕시코 824 ○ ○

113 TATCHEPHARMPREPARATY 러시아 826 ○ ○

114 THERAMYT� NOVOBIOLOGICS� PRIVATE� LIMITED 인도 831 ○ ○

115 Tuteur� S.A.C.I.F.I.A 아르헨티나 832 ○ ○

116 UNIPHARM 멕시코 833 ○ ○

117 Unitedmedical 브라질 834 ○ ○

118 Valeant 미국 835 ○ ○

119 VaxInnate 미국 836 ○ ○

120 veropharm 러시아 838 ○ ○

121 Vesalius� pharma� SA 칠레 842 ○ ○

122 WCCT� Global,� LLC 미국 844 ○ ○

123 YURiA-PHARM 우크라이나 845 ○ ○

124 ZHEJIANG� EXCEL� PHARMACEUTICAL� CO.,� LTD 중국 848 ○ ○

125 Zhiwe� Chem-Tech� lnc 중국 849 ○ ○

126 Zodiac 브라질 850 ○ ○

127 Zuellig� Pharma� Korea 싱가포르 851 ○ ○

128 zvezda 우크라이나 852 ○ ○

Page 608: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

부록 2� �전략적 협력사 디렉토리 ❚ 605

Corporate� Name ABL

Head� Office� Address Alameda� dos� Maracatins,� 508� ­� 7º� andar� Indianópolis� ­� São� Paulo� ­� SPFacilities� City� &� Country Brazil

Web-site� Address www.ablbrasil.com.br

Company� History

Antibióticos� do� Brasil� Ltda.� (ABL)� was� created� in� January� 2003� from� a� division� of� Eli� Lilly� do� Brasil,� an�American� multinational,� remaining� under� ABL� brand� the� entire� hospital� medication� line� of� Eli� Lilly.

In�April� 2003,�ABL�was� incorporated� to�ACS�Dobfar,� an� Italian� group�with� over�40� years�of� experience� and�one� of� the� global� leaders� in� the� manufacturing� and� commercialization� of� antibiotics� (API� and� finished�products).Therefore� ABL� was� born� in� Brazil,� owning� a� modern� antibiotics� factory� with� the� technological� support� of�a� sector’s� global� leader.� Its� pharmochemical� plant� is� the� only� one� in� Latin� America� to� have� international�approval� for� producing� cephalosporin� for� USA,� Europe� and� Japan.

In� August� 2011� ,as� part� of� the� business� expansion,� � ACS� Dobfar� acquired� Beker,� a� parenteral� solutions�manufacturer�which� has� been�present� in� the� Brazilian�market� for� over� 30� years.� Since� the� acquisition� Beker�has� been� implementing� ABL’s� product� line.ABL� has� its� production� plants� located� in� Cosmópolis� and� Sumaré� in� the� State� of� São� Paulo;� its� Commercial�Office� and� Pharmacovigilance� Department� in� São� Paulo,� as� well� as� Regional� Sales� Representatives� and� a�Distribution� Center� in� Itajaí� in� the� State� of� Santa� Catarina.

Company� Description� &� Organization

MissionOur� priority� is� quality.� We� produce� pharmaceutical� products,� API� and� finished� dosage� form,� for� the� local�market� and� for� exportation� using� world-class� manufacturing� techniques.� Our� products� are� of� high� quality�at� a� fair� price.VisionOur� vision� is� to�be� the�market� leader� in� the�hospital� industry.� Therefore�we�are�aware� that�our�high�demand�in� quality� must� be� extended� to� our� products,� processes� and� services.ValuesOur� values� underpin� our� quality� mission:� safety,� ethics� and� respect� for� the� environment.

1. ABL

1.� Corporate� General� Information

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606� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

2. Accelera Srl

1.� Corporate� General� Information

Corporate� Name Accelera� Srl

Web-site� Address www.accelera.org

Contact

(Korean� Business)

Name GINAPATH,� Co.,� Ltd

Address1009,� 10th,� ZERO� Bldg,� 14,� Teheran-ro,� 84-gil,� Gangnam-gu,� Seoul,�

06178,� Korea

Telephone +82� 10� 6405� 7493

E-mail [email protected]

Page 610: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

부록 2� �전략적 협력사 디렉토리 ❚ 607

Collaboration�

Opportunities� for� R&D�

Co-works

Accelera,� European�one� stop� shop� service� provider� for� drug�development,� offers�

a� unique� background,� built� on� years� as� part� of� global� R&D� organisations� as�

Pharmacia/Pfizer.�We�provide� customer� tailored� services� and�advice� to� select� the�

best� drug� candidates� and� develop� NCEs,� NBEs,� Biosimilars,� and� Cell� Based�

Therapies,� running� optimised� IND� enabling� studies,� as� well� as� reproductive�

toxicology� and� ADME� studies�

Services:

•� Acute� and� Chronic� Toxicology� GLP� studies

•� Carcinogenicity� studies

•� GLP� studies� in� Rodends,� Rabbits,� Dogs,� Monkeys

•� ADME/PK� studies� in� all� animal� species,� including� Non-Human� Primates

•� QWBA�

•� Safety� Pharmacology

•� Reproductive� Toxicology� packages� in� rats� and� rabbits

•� IND/CTA� enabling� packages

•� Bioanalysis� and� PK� for� preclinical� and� clinical� studies� for� small� molecules� and�

biologics

•� Immunogenicity

•� High-throughput� preclinical� profiling� and� PB/PK� modeling

•� PK/PD,� and� population� PK� data� analysis

•�Custom�synthesis� and� radiolabelling�of� small�molecules�and�biologics� (14C,�3H,�

13C,� 2H,� 18O,� 15N,� 125I,� etc.)�

•� Consultancy� and� preparation� of� regulatory� documentation

•� Project� Management

•� Special� expertise� in� the� preclinical� development� of� Oncology� drugs

Accelera� is� represented� in�South�Korea�by�Ginapath�Co,Ltd.� and� is�part�of� Safety�

Alliance,� a� selected� number� of� complementary,� high-level� CRO's� located� in�

Europe.

Collaboration�

Opportunities� for� (Co-)�

Marketing� &� Sales

As� we� are� representative� by� Ginapath� for� Korean� market,� therefore,� please�

contact� Ginapath� for� possible� Collaboration� opportunities.

2.� Description� of� Collaboration�Opportunities

Page 611: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

608� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

3. Access Bio

1.� Corporate� General� Information

Corporate� Name Access� Bio

Web-site� Address www.accessbio.net

Contact

(Korean� Business)

Name Young� Ho� Choi

Address 65� Clyde� Rd.� Suite� A,� Somerset,� NJ� 08732� USA

Telephone 732-873-4040�

E-mail [email protected]

2.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

Access� Bio� ,� Inc.

Access� Bio� is� a� Korean� owned� young� and� vibrant� medical� device� manufacturer� in� Somerset,� New� Jersey�

USA..� The� company� is� registered�with� US� FDA�and� ISO13485:2003� certified.�Management� team� of� Access�

Bio� consists�of�experts� in�business,�marketing,� regulatory�affairs,�manufacturing�and�R�&�D�with�many�years�

of� experience� in� medical� device� fields.� Access� Bio� has� several� FDA� approved� products� and� many� products�

in� the� pipeline.� Access� Bio� has� an� expertise� in� designing� and� developing� medical� diagnostic� devices,�

especially� in� infectious� disease� area� in� the� format� of� point-of-care.�

CareStart� Malaria� test� is� the� flagship� product� of� Access� Bio� and� its� high� quality� has� been� recognized� by�

many�world� renowned� laboratories� such�as�Pasteur� Institute�and�health�organizations� including�WHO,�CDC�

and�UNICEF.� � Access� Bio�malaria� tests� has� been� selected� as� the� highest� quality� products� in� every� round� of�

WHO�malaria� test� evaluation�among� about� 70�products� submitted�by�manufacturers�worldwide.�Currently,�

Access� Bio� shares� 30%� of� malaria� test� market� and� exceeding� $20,000,000� sales� per� year.�

Access� Bio� holds� several� technology� patents� related� to� the� rapid� diagnostic� test,� signal� enhancing�

mechanism� and� molecular� biology.� With� these� technologies� Access� Bio� is� exploring� into� new� field� of�

diagnostic� areas� namely� ROSUS™,� ROSGENE

™� POTC� and� DNA� Banker.� �

Access� Bio� welcomes� any� biotechnology� or� pharmaceutical� companies� for� collaboration� in� business,�

marketing� and� R� &� D� in� mutually� benefited� fashion.

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부록 2� �전략적 협력사 디렉토리 ❚ 609

4. AGIO

1.� Corporate� General� Information

Corporate� Name AGIO

Head� Office� AddressMittal� Towers,� C� -� Wing� 113,� 11th� Floor,� Nariman� Point,� Mumbai� -� 400�

021,� India.

Web-site� Address http://www.agio-pharma.com

Contact E-mail [email protected]

Company� Description� &� Organization

AGIO� Pharmaceuticals� Limited� was� instituted� in� 1991� to� augment� a� focused� approach� towards� global�

pharmaceutical� brand� marketing.� Today,� like� the� prism� we� have� spread� our� aura� of� being� a� professionally�

managed� and� a� committed� organization� over� several� countries.�

Careful� planning� and� sound� understanding�of� various� countries� and� their�medical� needs,� has� enabled�us� to�

enjoy� the� trust� and� support� of� the� medical� fraternities� in� these� countries� in� the� areas� of� Ethical� medicine,�

OTC�medicine,�Herbal� formulations�and�Veterinary� formulations.�Our� pharmaceutical� and�veterinary�product�

range� includes� a� combination� of� over� 365� formulations� in� over� 20� therapeutic� segments.� Hence� we� are�

known� as� a� progressive� total� solutions� provider� with� a� vision� that� is� global� and� an� expertise� which� is� local�

to� various� markets.

Understanding� the� various� complexities� of� marketing� and� compliance� of� various� international� regulatory�

formalities� has� facilitated� our� entry� and� helped� us� establish� a� strong� base� in� the� CIS� -� spanning� over� 12�

countries� and� 300� registered� products.� � Along� with� a� vast� operation� in� CIS� countries,� we� also� operate� in�

other� parts� of� the� world;� such� as� Europe,� Asia� and� Africa.

AGIO� has� made� inroads� into� the� domestic� market� of� the� subcontinent� of� India.� Presently� spanning� across�

Western� India,� we� have� a� well-knit� distribution� channel,� penetrating� the� very� interiors� of� the� country�

ensuring� the�availability�of�quality�medicines� for� every� individual,� accessible�not�only�at�affordable�prices,�but�

also� well� within� reach.

Acknowledging� the� importance� of� targeted,� customer� focused� marketing;� AGIO� has� its� sales� divisions�

focused� around� the� specialty� customer.� Our� sales� force� constantly� endeavors� to� promote� our� world-class�

products�

Changing�pharmaceutical� scenarios�have�encouraged�us� to� initiate�projects� into� various�areas� like�Bulk�Drugs,�

Nutraceuticals� and�Consumer� Products.�When� appropriate,�we� actively� seek� opportunities� to� extend� the� life�

of� these� products� through� innovative� line� extensions.

•� Offers� finished� formulations� � meeting� cGMP� Quality� � Standards� �

•� Product� range� spanning� several� therapeutic� categories� such� as� � Antibiotics,� Antidiabetics,�

Antihypertensives,� Haematinics� ,� � � PPIs� ,Dermatologicals

•� Manufacturing� expertise� encompassing� � tablets� ,� liquids� ointments� capsules� ,� powders� &� injections�

•� Engaged� in� CRAMS

•� Research� and� technology� driven� ,DSIR� approved� facility

•� Compliant� with� FDB,PPB,IDA� &� NDA� NORMS

•� Offers� Technical� expertise� in� successful� pharmaceutical� project� management�

•� Provides� expertise� for� Capital� goods� procurement� and� Strategic� Sourcing

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2.� Additional� Business� Propositions� for� Collaboration

Vision

To� become� a� leading� pharmaceutical� solutions� provider,� adding� value� to� the� global� healthcare� industry�

ensuring� availability� of� quality� medicines� for� every� individual� to� help� augment� their� quality� of� life.

Mission

We�will� provide� exceptional� healthcare� solutions�while�maintaining� the� highest� ethical� standards� through�

our� passion� for� excellence� and� unwavering� commitment.

To� achieve� our� mission,� we� will:

•Use� our� advantage� of� understanding� newer� geographies� through� our� expertise� and� customer� oriented�

approach.�

•Provide� a� nurturing� work� culture� that� stimulates� professional� excellence� through� training.�

•Empower� with� accountability� and� recognition.�

INTEGRITY:� We� take� responsibility� of� our� actions� and� avoid� easy� way� outs

QUALITY:� We� commit� quality� to� our� patients� and� doctors� and� exceed� quality� expectations� of� our�

regulators

INNOVATION:� Our� constant� challenge� and� endeavor� is� to� stand� out� in� a� clutter� and� win!�

CUSTOMER� ORIENTED:� Our� responsibility� is� to� our� stakeholders,� where� we� care� and� make� a� difference�

TEAMWORK:� The� key� word� at� Agio� is� ‘Together’.� We� achieve� more� by� working� together.

LEADERSHIP:� We� foster� capable� people� to� become� leaders.

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부록 2� �전략적 협력사 디렉토리 ❚ 611

Corporate� Name Akrikhin

Head� Office� AddressRiverside� Towers� Business� Center� 115054,� Russia,� Moscow,�

Kosmodamianskaya� Naberezhnaya,� 52� bld� 5,� "AKRIKHIN"

Web-site� Address http://akrikhin.com

Contact E-mail [email protected]

Company� History

1936� —� company� foundation

Akrikhin� is� one� of� the� founders� of� the� Russian� pharmaceutical� industry.� The� company� was� established� in�

1936,� when� the� first� batch� of� Akrikhin,� a� drug� for� treatment� of�malaria� was� produced.� The� company�was�

named� after� this� drug� which� made� it� possible� to� eliminate� such� a� dangerous� disease� as� malaria� within� a�

very� short� time� period.

1950-1990� —� production� of� substances

Akrikhin� was� one� of� the� main� Soviet� Union� producers� of� pharmaceutical� substances,� accounting� for� 24% �

of� the� total� substance� production� output� in� the� country.� The� substances� produced� were� supplied� to� 44�

enterprises� of� the� Soviet� Union.� The� list� of� exporting� countries� counted� 54� states,� including� developed�

countries� such� as� the� US,� Canada,� England,� Italy� etc.

1990-2007� —� production� of� finished� pharmaceutical� products

In� 1992�Akrikhin�was� reorganized� into� an�open� joint-stock� company.� A�decision�was� taken� to� redesign� the�

company’s� profile� from� chemical� synthesis� of� substances� to� the� production� of� finished� pharmaceutical�

products.� A� policy� of� import� substitution� was� adopted,� i.e.� active� development� and� production� of� generic�

drugs� (copies).�Marketing� and� field� force� divisions�were� formed� in� the� company,�with� quality�management�

system� introduced� and� new� production� facilities� opened� and� certified� in� accordance� with� the� GMP�

standards.�During� this� period�Akrikhin�occupied� the� first� place� in� the� annual� Rating�of� the�most� recognized�

players� of� the� Russian� pharmaceutical�market� for� four� years� running.� Akrikhin� is� also� a� triple� award�winner�

of� the�Platinum�Ounce�prize� -� the�most�prestigious�award� in� the�pharmaceutical�market� -� in� the�nomination�

Company�of� the� year,� thus�confirming� the� company’s� leading�position� in� the�Russian�pharmaceutical� industry.

2007� was� marked� by� the� start� of� strategic� partnership� with� Polpharma,� the� biggest� Polish� pharmaceutical�

5. Akrikhin

1.� Corporate� General� Information

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company� in� the� field� of� development,� production,� promotion� and� distribution� of� pharmaceutical� products.

2008-till� present� —� sustainable� growth

Currently�AKRIKHIN� is� in� the� top�10�of�Russian�pharmaceutical�manufactures� in� terms�of� sales.�The� company�

ranks� third� among� the� local� pharmaceutical� manufacturers� in� terms� of� rate� of� growth� of� pharma� drugs�

production� volume.�AKRIKHIN�actively� develops� its� product�portfolio,� annually�bringing� to� the�market�about�

10� and� more� new�medicinal� products,� both� through� developments� of� its� own� Research� and� Development�

Center� and� in� cooperation� with� foreign� pharmaceutical� companies� and� research� institutions.

In� the� period� 2010-2016� AKRIKHIN� has� been� implementing� a� large-scale� investment� program� to� upgrade�

and� expand� the� company's� manufacturing� complex.

In� 2011� Polpharma� expanded� the� partnership� and� became� the� majority� shareholder� of� AKRIKHIN,� thus�

consolidating� business� in� Russia.

AKRIKHIN� actively� develops� the�medical� representatives� service� interacting�with�medical� and� pharmaceutical�

community� in� 70� cities� of� this� country.� In� the� period� from�2008� to� 2014� the� company's� sales� volume�more�

than� doubled.

AKRIKHIN� continues� to� develop� fast,� basing� on� the� accumulated� experience� and� knowledge� and� actively�

using� the� latest� modern� business� standards� and� technologies.

Company� Description� &� Organization

Today�AKRIKHIN� is�one�of� the� leading�Russian�pharmaceutical� companies�manufacturing�affordable,� effective�

and� high� quality�medicinal� products.� AKRIKHIN� was� established� in� 1936.� The� company� is� in� the� top� 10� of�

largest� local� pharmaceutical� manufacturers� in� terms� of� sales� and� production� volume� in� the� Russian�

pharmaceutical� market.

In� the� company’s� product� portfolio� there� are� more� than� 200� medicinal� products� (over� 100� brands)� of� the�

main� pharmacotherapeutic� fields:� cardiology,� neurology,� dermatology,� gynecology,� pediatrics,�

ophthalmology,�urology.� These�are�medicinal�products�manufactured�by�AKRIKHIN�or�brought� to� the�Russian�

market� in� partnership� with� other� companies.

AKRIKHIN� produces� a� wide� range� of� socially� significant� pharmaceutical� drugs,� contributing� to� the�

development� of� the� Russian� health� care� system.� The� company� is� one� of� the� largest� Russian�manufacturers�

of� medicines� included� in� the� list� of� vital� and� essential� drugs� (VED),� as� well� as� of� medicines� for� treatment�

of� tuberculosis� and� diabetes.

AKRIKHIN� manufacturing� facility� is� located� 20� km� from� Moscow.� The� company� production� includes�

workshops� for� manufacturing� of� medicinal� products� of� almost� all� forms:� tablets,� capsules,� liniments,�

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부록 2� �전략적 협력사 디렉토리 ❚ 613

ointments,� creams,� syrups,� gels,� suppositories,� and� others.� The� annual� production� output� is� more� than� 50�

million�packages.�Medicines�are�produced�using� foreign�equipment,�high�quality� raw�materials� and� the� latest�

technologies.�Modern�AKRIKHIN�warehouse� complex� holds�more� than� 8� thousand�pallet� positions� ensuring�

proper� storage� of� medicinal� products.

Since� 2007� Polpharma� has� been� the� strategic� partner� of� AKRIKHIN� in� the� Russian� pharmaceutical� market.�

Strategic� cooperation� of� AKRIKHIN� and� Polpharma� includes:

·the� integrated� product� portfolio,

·transfer� of� production� technologies� and� cooperation� in� the� field� of� research� and� development,

·access� to� international� standards� and� management� solutions,� staff� training,� exchange� programs.

In� 2011,� Polpharma� strengthened� and� extended� the� partnership� through� acquisition� of� a�majority� stake� in�

AKRIKHIN.�

AKRIKHIN� ranks� third� in� the� Rating� of� significant� Russian� pharmaceutical� market� entities� (according� to�

research� conducted� by� Pharmaceutical� Bulletin� together� with� RNC� Pharma� in� February� 2014).�

AKRIKHIN� is� in� the� top� three� of� leaders� of� the� rating� in� the� terms� of� confidence� and� preference� for�

cooperation� among� Russian� pharmaceutical� companies.� According� to� a� survey� conducted� in� 2013� by� the�

independent� project� Centre� of� Social� Economy,� AKRIKHIN� was� ranked� third.�

Resting� upon� 78� years� of� successful� business� in� the� Russian� pharmaceutical� market,� the� company� actively�

introduces� advanced� research� and� production� technologies,� as� well� as� high� corporate� management�

standards.

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2.� Additional� Business� Propositions� for� Collaboration

By� developing� and� producing�modern,� effective� and� high-quality�medicines,�Akrikhin� improves� the� health�

and� wellness� of� Russian� citizens.� That’s� Akrikhin’s� mission.

Our�business� vision� is� staying�committed� to�sustainable�growth� for� the�benefit�of�all�Akrikhin� stakeholders�

through� being� maximum� responsive� to� the� needs� of� government,� healthcare� professionals� and� patients�

in� our� core� markets� in� Russia.

Akrikhin� is� about� connections.� Connecting� our� long� history� in� Russia� with� our� future� strategies� and�

successes.�Connecting�our�products�with� the�people�we� seek� to�help�—patients,�doctors�and�pharmacists.�

Connecting� our� company� directly� with� the� Russian� government’s� priority� to� improve� the� health� and�

well-being� of� Russian� citizens.� These� are� the� vision� and� guiding� principles� of� Akrikhin,� a� company�

committed� to� caring� for� people.

Capabilities� and� strengths:

•therapeutic� focus� and� expertise� in� cardiovascular,� tuberculosis,� diabetes,� dermatology,� pediatrics,�

neurology

•deep� understanding� and� knowledge� of� the� Russian� pharmaceutical� market� and� its� regulatory� system

•established� multiple� routes� to� market� covering� all� important� target� groups� and� channels:� wholesalers,�

pharmacy� chains� and� pharmacies,� hospitals,� OTC� market,� Rx� sales

•intellectual� property� expertise

•targeted� solid� relations� with� decision-makers� and� opinion-leaders

•profound� commercial� capabilities� both� on� the� commercial� and� public� procurement� sectors

•effective� sales� and�marketing� teams� able� to� launch� and�optimise� commercialization�of� brands� all� across�

the� country

•presence� in� all� regions� across� Russia,� efficient� FF� team� of� more� than� 350� dedicated� employees

•modern� production� facilities� meeting� the� standards� of� the� Good� Manufacturing� Practice� (GMP)

•production� of� a� vast� specter� of� drug� forms:� tablets,� creams,� ointments,� gels,� capsules,� syrups

•strong� competences� in� research� and� development

•recognition�of�business� circles�and�authorities� in�pharmacy�and�medicine�­� three� times� “Platinum�Ounce”�

(the�most� prestigious� award� on� the� Russian� pharmaceutical� market)�winner,� in� top� 3�most� recognized�

Russian� companies� on� the� market

Partnering� opportunities� include� license� manufacturing,� contract� manufacturing,� distribution� and�

marketing� collaboration.

Besides� Akrikhin� is� interested� in� purchase� of� APIs� for� Company� current� product� portfolio.

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부록 2� �전략적 협력사 디렉토리 ❚ 615

6. Alkor Bio

1.� Corporate� General� Information

Corporate� Name Alkor� Bio

Head� Office� Address 192148,� Saint-Petersburg,� Russia,� � p.o.b.� 44

Web-site� Address http://www.alkorbio.ru/

Contact E-mail [email protected]

Company� Description� &� Organization

“Alkor�Bio”� company�was� founded� in�1992.�Nowadays� it�evolved� into� the� largest� in�Saint-Petersburg� region�

biotechnological� holding� consisting� of� several� companies.

� “Alkor� Bio”� is� well� known� as� one� of� the� ELISA� kits� manufactory� leaders.� Among� company’s� products� are�

kits� for� diagnostics� of� hormones,� tumor� markers,� inflectional� diseases,� allergy� diagnostics� and� control�

materials� for� ELISA.� Diagnostics� of� genetic� predisposition� to�multifactorial� disease� is� our� new� research� and�

manufactory� direction.

“Alkor� Bio”� catalog� includes� more� than� 60� positions� and� almost� all� kits� have� CE� mark.

Special� attention� is� paid� to� quality� of� all� processes� including� research,� manufacture� distribution� and�

marketing� which� is� confirmed� by� certificatesISO� 9001:2008.

Furthermore� in� 2010� whole� Group� of� Companies� “Alkor� Bio”� was� found� to� be� corresponding� to� ISO�

13485:2003.� Certificate� ISO� 13485:2003� specifies� requirements� for� a� quality� management� system� where�

an� organization� needs� to� demonstrate� its� ability� to� provide� medical� devices� and� related� services� that�

consistently� meet� customer� requirements� and� regulatory� requirements� applicable� to� medical� devices� and�

related� services

Automated�manufacture�with�contemporary�equipment�and�Depatment�of� the�Biological�and�Technological�

Control� allows� to� guarantee� producing� only� high� quality� kits.

The� main� secret� of� «Alkor� Bio»� success� is� high� attention� to� customer� needs� and� performing� kits� of�

international� quality� standarts.

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7. Amgen, Inc.

1.� Corporate� General� Information

Corporate� Name Amgen,� Inc.

Web-site� Address www.amgen.com

Contact

(Korean� Business)

Name Sang� H.� Kim �

Address 360� Binney� Street,� Cambridge,� MA� 02142

Telephone 617-444-5521

E-mail [email protected]

2.� Description� of� Collaboration�Opportunities

Collaboration�

Opportunities� for� R&D�

Co-works

Our� company� is� looking� for� any� innovative� research� towards� drug� discovery� and�

development� in� areas� like� oncology,� neuroscience,� inflammation� and� metabolic�

diseases.

Collaboration�

Opportunities� for�

In-Licensing

Recently� our� company� purchased� BioVex� for� $1� billion� for� their� cancer� vaccine�

programs.

Collaboration�

Opportunities� for�

Out-Licensing

In� oncology�we� have�many� late� stage� candidates� for� out-licensing� opportunities.

Collaboration�

Opportunities� for� (Co-)�

Marketing� &� Sales

Our� company�has�a�partnership�with�GlaxoSmithKline� in�Europe�and� some�other�

counties� for� sales� of� Prolia.

3.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

Our� company�has�been�working�with�outside� companies� for�outsourcing� services,� like�chemical�compounds�

synthesis,� assays� (enzyme-� or� cell-based)� development,� and� also� for� chemical� library� screenings,� etc.

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부록 2� �전략적 협력사 디렉토리 ❚ 617

4.�특허분석 결과

Amgen사의 특허분포도를 볼 때 기술 중에 대표적으로 Diseases� Maladies� Conditions� Analogs� Pridrugs�

Pharnacetifically� Encompasses� Novel(우측 상단 붉은 원),� Pain� Causalgia� Sympathetically� Pain�

Deafferentation� Syndromes� Pain� Dental� Pain(하단 붉은 원)의 키워드를 가진 기술에 많은 특허가 분포하고

있는 것으로 나타남.

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618� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

8. AnaPath Services GmbH

1.� Corporate� General� Information

Corporate� Name AnaPath� Services� GmbH

Web-site� Address www.Anapath.ch�

Contact

(Korean� Business)

Name GINAPATH,� Co.,� Ltd

Address1009,� 10th,� ZERO� Bldg,� 14,� Teheran-ro,� 84-gil,� Gangnam-gu,� Seoul,�

06178,� Korea

Telephone +82� 10� 6405� 7493

E-mail [email protected]

2.� Description� of� Collaboration�Opportunities

Collaboration�

Opportunities� for� R&D�

Co-works

AnaPath� and� the� Safety� Alliance

AnaPath� is� the� one� of� the� largest� European� CRO� specialized� in� toxicologic�

pathology� based�on� a� vast� and�general� knowledge� of� non-clinical� safety� in� drug�

development� and� product� development.� Based� in� Switzerland� we� serve� and�

support� CROs,� Pharmaceutical� and� Biotechnology� Industry,� Medical� Device�

companies� with� service� and� in� histotechnology,� fetal� pathology,� pathology� and�

anatomy.� �

Every� project� starts� with� scientific� and� regulatory� support.�We� provide� scientific,�

regulatory� and� operational� management� of� pre-clinical� workpackages,� which�

includes� strategy� development,� project� management� and� the� conduct� through�

Safety� Alliance� CRO� Partners.�

The� Safety� Alliance� is� a� network� of� specialized� and� experienced� CRO.� The� CROs�

are� midsize,� which� means� they� are� flexible� and� fast� moving� client� oriented�

organizations.� We� have� selected� our� Alliance� partner� due� to� their� experience,�

performance� and� reliability.� The� Safety�Alliance� is� a� department� of� AnaPath� and�

both� are� managed� by� Dr.� Klaus� Weber,� Toxicological� Pathologist.�

Collaboration�

Opportunities� for� (Co-)�

Marketing� &� Sales

As�AnaPath�and�the�Safety�Alliance� is� represented�by�GinaPath,� therefore,�please�

contact� Ginapath� for� collaboration� opportunities.

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부록 2� �전략적 협력사 디렉토리 ❚ 619

9. APOTEX

1.� Corporate� General� Information

Corporate� Name APOTEX

Corporate� Ownership Americo� Garcia� Elizondo

Head� Office� AddressDamas� No.� 120� Col.� San� José� Insurgentes,� Benito� Juárez� 03900� México,�

D.F

Facilities� City� &� Country Mexico

Web-site� Address www.apotex.com.mx

Company� Description� &� Organization

Apotex� Inc.� was� founded� in� 1974,� and� is� the� largest� Canadian-owned� pharmaceutical� company.� From� its�

2� employees,� 5,000� square� foot� beginning,� the� company� has� grown� to� employ� over� 10,000� people� in�

research,�development,�manufacturing�and�distribution� facilities�world-wide.� The�Canadian�operations�of� the�

Apotex� Group� of� Companies� has� approximately� 5,500� employees.� Extensive� investments� in� Canadian�

facilities� include� over� 3� million� square� feet� in� manufacturing� and� R&D� facilities� in� Richmond� Hill,� Toronto,�

Etobicoke,� Brantford,�Windsor� and�Winnipeg.� Apotex� produces� more� than� 300� generic� pharmaceuticals� in�

approximately� 4,000� dosages� and� formats� which,� in� Canada,� are� used� to� fill� over� 89� million� prescriptions�

a� year� -� the� largest� amount� of� any� pharmaceutical� company� in� this� country.

Today,� Apotex� is� a� necessary� and� trusted� member� of� Canada's� healthcare� community.� The� company's�

pharmaceuticals�can�be� found� in�virtually�every�pharmacy�and�healthcare� facility� in�Canada�and�are�exported�

to�over�115�countries�around� the�globe.�Export�markets� represent�an�ever�growing�portion�of� the� total� sales.�

Apotex� has� also� established� a� presence� through� subsidiaries,� joint� ventures� or� licensing� agreements� in�

Australia,� Belgium,� Czech� Republic,� Mexico,� Netherlands,� New� Zealand� and� Poland� to� name� just� a� few.�

Healthcare� professionals� around� the� world� rely� on� Apotex� for� quality� and� value.

Although� the� company's� own� business� is� developing� and� manufacturing� generic� pharmaceuticals,� the�

success� of� Apotex� has� enabled� it� to� diversify� into� a� number� of� other� health-related� areas.� The� Apotex�

Pharmaceutical�Group�of�Companies�also� researches,�develops,�manufactures�and�distributes� fine� chemicals,�

non-prescription� and� private� label� medicines,� and� disposable� plastics� for� medical� use.

The� worldwide� sales� of� the� Apotex� Group� of� companies� exceed� $2� billion� (Canadian� $)� per� year.

Mission,� Vision� and� Values

To� offer� the� best� affordable,� quality� and� certified� drug� variety,� in� benefit� of� human� kind,� than� allows�

company� growth,� a� better� way� of� life� to� our� employees� and� great� benefit� to� Mexican� society.

To�grow�up� to�occupy� the�35�position� in� the�Mexican�pharmaceutical�market� for�2020,� to�achieve� leadership�

in� generics� market� share� and� become� an� internationalsupplier� source.

Values�are� fundamental� to�support� a�wealthy� company,� they�guide�our�professional�performance,� to�believe�

and� promote� them� is� part� of� us:� Competition,� commitment,� congruity,� integrity,� service� and� teamwork.

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620� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name Apsen

Corporate� Ownership Renato� Spallicci

Head� Office� Address Rua� La� Paz,� 37,67� CEP� 04755-020� São� Paulo/SPFacilities� City� &� Country Brazil

Web-site� Address www.apsen.com.br

No.� of� Employees 885� (2014)

Financial� Status

Sales� Revenue� in� 2014 Capital(US� K$) Dept-equity� Ratio(%)

R$� 426,9� millions� - -

Company� History

A�shared�dream.�Thus�was�born�a� success� story� that� has�already� lasted�over�40� years.� The� Italian� immigrant�

Mario� Spallicci� and� his� wife� Irene� Spallicci� opened� the� doors� of� the� laboratory� on� June� 3,� 1969� in� Santo�

Amaro,�São�Paulo� (SP),� initially�producing� raw�materials�derived� from�animal� sources� for� the�pharmaceutical�industry.

In� these� four�decades�and�more,�Apsen�has� launched�products,�expanded� its�manufacturing�plant,� increased�

its� staff,� won� several� awards,� conquered� the� pharmaceutical� market,� and� has� grown� with� strength� and�

constancy� over� the� years.

Today� Apsen� is� a� 100%� Brazilian� company� and� operates� in� fields� such� as� urology,� rheumatology,� ENT,�

neurology,�geriatrics,�psychiatry,�gynecology,�gastroenterology,�pediatrics,�orthopedics�and�general�medicine.

With� a� mission� to� research,� develop� and� deliver� state-of-the-art� medicines,� Apsen� has� an� ongoing�

commitment� to� improve� quality� of� life� and� invests� in� social,� cultural� and� sports� activities.� Furthermore,,� we�

provide� information� on� our� products� to� both� patients� and� physicians� about� certain� specialties� such� as:�

Alzheimer's� Disease,� Fibromyalgia,� cystitis,� depression� and� dizziness.

1969

Founding� Date� of� Apsen� by� Mario� Spallicci� and� his� wife� Irene� Spallicci� in� Santo� Amaro,� São� Paulo� (SP).70's

10. Apsen

1.� Corporate� General� Information

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부록 2� �전략적 협력사 디렉토리 ❚ 621

Renewal� of� the� Product� Line,�Modernization�of� the� factory� and� technology� park� for� the� production� of� pills.�

80's

Renewal� of� the� production� line� and� increase� in� production� areas.

Purchase� of� the� main� building�

90's

Renato� Spallicci� is� the� new� president

International� license� agreements

Expansion� into� new� therapeutic� areas� with� launch� of� new� products�

2000-2009

Products� with� patent� pending� (Postec� and� Fitoscar);

Association� with� international� partners� and� export� of� products

Creation� of� PAR� -� Apsen� Recycles� Program� for� employees�

2010-2015

Program� for� Culture,� Sports� and� Social� Incentives.

Renata� Spallicci� is� the� new� Corporate� Director;

New� Branding

Launch� of� new� products:� Fitoscar,� Tomat,� DeSOL,� Lactosil,� Digeliv,Foline� e� Motilex

New� R&D� Building�

Company� Description� &� Organization

Vision

To� be� the� best� Brazilian� pharmaceutical� company.

Mission

Research,� develop� and� deliver� excellent� medicines.

Values

•� Satisfaction� and� pride� in� what� we� do

•� Transparency� and� ethics

•� Credibility� and� respect

•� Permanent� commitment� to� quality

•� Zeal� with� Employees� and� their� Families

•� Shared� experience� and� knowledge

•� Team� freedom� of� speech�

•� Loyalty� to� our� partners

•� Respect� for� the� environment

•� Profit� as� a� result� of� our� success

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622� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

11. ARTERIUM

1.� Corporate� General� Information

Corporate� Name ARTERIUM

Head� Office� Address 139,� Saksaganskogo� str.,� Kyiv,� Ukraine,� 01032

Web-site� Address http://www.arterium.ua

Contact E-mail [email protected]

Company� History

The� Arterium� Corporation� was� created� in� 2005� by� two� leading� pharmaceutical� enterprises� -�

Kievmedpreparat,� JSC,� the� national� leader� in� manufacturing� antibiotics,� and� Galychpharm,� JSC,� the� largest�

producer� of� herbal� medications.

The� success� of� our� corporation� on� the� national� and� foreign� markets� is� based� on� 160-year� research�

experience,� development� and� market� launch� of� the� medications.� We� are� proud� of� our� achievements� and�

history.

Company� Description� &� Organization

The� Arterium� Corporation� is� one� of� the� leading� Ukrainian� pharmaceutical� companies.

Under� the� corporate�name�Arterium�we�have�united� the�experience�of� two� long-established�pharmaceutical�

enterprises� of� Ukraine� —� Kievmedpreparat,� JSC,� the� largest� Ukrainian� manufacturer� of� antibacterial�

medications� with� 160� years’� experience,� and� Galychpharm,� JSC,� one� of� the� national� leaders� in� production�

herbal-based� medications,� which� has� been� operating� successfully� in� Ukrainian� pharmaceutical� industry� for�

nearly� 100� years.

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부록 2� �전략적 협력사 디렉토리 ❚ 623

2.� Additional� Business� Propositions� for� Collaboration

Mission

The� Arterium� Corporation� develops,� produces� and� promotes� high� quality� and� efficient� medications� for�

both� the� Ukrainian� and� CIS� markets,� to� ensure� healthy,� long� and� productive� lives� of� our� customers.

Vision

We� aim� towards� long-term� leadership� in� the� Ukrainian� pharmaceutical� industry� in� terms� of� income� and�

profits,� the� dynamic� launching� of� new� products� and� business� expansion� on� CIS� markets.

Business� Philosophy

Our� cooperation� with� our� customers� and� partners� is� based� on� the� corporate� values� and� philosophy�

outlined� in� our� motto� ­� “Closer� to� People”.� We� hold� human� relationships� built� on� principles� of�

responsibility,� trust� and� care� in� the�highest� esteem.� That� is�why,� by�developing�high�quality,� effective� and�

affordable� medications,� we� take� care� of� all� the� stakeholders� with� whom� we� cooperate.

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624� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

12. AstraZeneca

1.� Corporate� General� Information

Corporate� Name AstraZeneca

Web-site� Address http://www.astrazeneca.com/Home�

Contact

(Korean� Business)

Name YoonJoo� Cho

Address16 th F l oo r , Lu the rB u i l d i ng ,7 -20 ,S i n ch eon -dong , Songp a -gu ,�

Seoul,138-240,Korea

Telephone 02-2188-0971

E-mail [email protected]

2.� Description� of� Collaboration�Opportunities

Collaboration�

Opportunities� for� R&D�

Co-works

Research� collaboration� for� the� early� stage� candidates� with� AZ� R&D� centers

Interesting� area� :� CV,� metabolic� syndrome,� CNS,� GI,� antibiotics� and� oncology

Collaboration�

Opportunities� for�

In-Licensing

Preferred� post� phase� IIb� status� candidates.�

New� Chemical� Entity,� Bio-similar,� Bio-better� and� innovative� Fixed� Dose�

Combination

Collaboration�

Opportunities� for�

Out-Licensing

Out-licensing� is� limited�option,�but� considered� for�non-promoted�products� in�Asia�

area� countries

Collaboration�

Opportunities� for�

Manufacturing

Considered� if� provide� competitive� price� and� good� quality

Collaboration�

Opportunities� for� (Co-)�

Marketing� &� Sales

Depends� on� product� profile� and�market� needs,� co-marketing� and� co-promotion�

can� be� an� option.

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부록 2� �전략적 협력사 디렉토리 ❚ 625

3.�특허분석 결과

AstraZeneca사의 특허분포도를 볼 때 기술 중에 대표적으로 Metalloproteinase� Inhibitors� Inhibiors� Especally�

Inhibitors� Mmp,� Manufacture� Manufacture� Mediciament� Concerns,� Therapy� Pharmaceutical�

Formulations� Containing� Well� 등의 키워드를 가진 기술에 많은 특허가 분포하고 있는 것으로 나타났다.

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626� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

2006년 01월 01일부터 2012년 12월 10일까지 출원된 AstraZeneca사의 특허의 키워드 분포는 붉은 점으로

나타난다.

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부록 2� �전략적 협력사 디렉토리 ❚ 627

13. AVID Radiopharmaceuticals

1.� Corporate� General� Information

Corporate� Name AVID� Radiopharmaceuticals

Web-site� Address www.avidrp.com

Contact

(Korean� Business)

Name Seok� Rye� Choi�

Address 3711� Market� Street,� Philadelphia,� PA� 19104

Telephone 215-298-0708

E-mail [email protected]

Contact

(Korean� Business)

Name Robert� Morrsion,� PhD

Address 3711� Market� Street,� Philadelphia,� PA� 19104

Telephone 215-298-9813

E-mail [email protected]

2.� Description� of� Collaboration�Opportunities

Collaboration� Opportunities�

for� R&D� Co-works

현재로는 모회사인 릴리와 연구개발을 함께 하고 있고,� 파킨슨병에 관한 연구는

MJFF(Michael� J� Fox� Foundation)와 함께 하고 있습니다.�지적 소유권 문제 때문에 외

부와 함께 연구하는 것에 소극적이라고 생각됨

Collaboration� Opportunities�

for� In-Licensing

Neurodegenerative� diseases,� diabetes,� tumor� imaging에 적용할 수 있는 화합물의

in-licensing에는 적극적이라고 생각됨

Collaboration� Opportunities�

for� Out-LicensingOut-licnesing의 기회는 적다고 생각됨

Collaboration� Opportunities�

for� Manufacturing

방사성의약품은 동위원소의 짧은 반감기 때문에 현지 생산을 해야만 합니다.�따라서 제

조는 당연히 각국의 제조업체와 협력을 해야만 함

Collaboration� Opportunities�

for� (Co-)� Marketing� &� Sales

저희 회사가 릴리 소속인 관계로,�한국릴리가 판매에 관여할 것으로 예측되고 있으나 한

국릴리도 방사성 의약품 판매 경험이 없는 점 때문에,�다른 한국의 방사성 의약품 제조회

사와 판매를 함께 할 가능성이 있는 것으로 알고 있음

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628� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

3.�특허분석 결과

AVID사의 특허분포도를 볼 때 기술 중에 대표적으로 Attrobute� Media� Segment� Identified� Indication,�

Memorry� Flaw�Control,� Frames� Sequence� Film,� Reader� Filed� Tag,� Device� Protocol� Signal의 키워드를 가진

기술에 많은 특허가 분포하고 있는 것으로 나타남.

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부록 2� �전략적 협력사 디렉토리 ❚ 629

14. AZT Pharma K.B.

1.� Corporate� General� Information

Corporate� Name AZT� Pharma� K.B.

Head� Office� Address 109033,� str.� Moscow,� str.� Samokatnaya,� etc.� 2A,� p.� 1

Web-site� Address www.aztpharma.ru

Contact E-mail [email protected]

Company� Description� &� Organization

Enterprise� «AZT� PHARMA� K.B.»,� manufacturing� antiviral� drugs� traces� its� history� back� to� 1992,� when� our�

country� began� vigorously� and� rapidly� to� change� under� the� impact� of� time.

In� those� years,� a� group� of� scientists,� headed� by� Academician� of� RAS� Alexander� Antonovich� Kraevskiy,� was�

invented�by�a�unique�drug�Phosphazid�belonging� to� the�class�of� reverse� transcriptase� inhibitors� intended� for�

the� treatment�and�prevention�of�human� immunodeficiency� virus� (HIV).�After� the�conducted�clinical� research�

and� development� of� industrial� technology,� the� drug� received� the� trade� name� Nikavir®� and� the� first�

registration� certificate,� dated� 1999.� For� its� production� and� was� organized� by� the� above� company.

At� the�end�of� the�XX�beginning�of� the�XXI�century� in� the� line�of� the� company�were�drugs�such�as�Acyclovir�

AZT� and� Terbinafine.� At� the� same� time� was� first� registered� drug� Nikavir� (Phosphazid).� At� about� this� time,�

the� company� set� a� course� for� production� and� development� of� new� drugs� against� HIV.� Currently,� the�main�

drug� remains� Никавир,� and� in� development� is� the� original� drugs.

At� the�present� time�LLC�«AZT�PHARMA�K.B.»� is�based�on� the�squares� FSBO�Russian�Cardiological�Research�

and� Production� Complex,� under� the� patronage� of� his� unchanging� Director� Evgeny� Ivanovich� Chazov,� who�

in� those� distant� years� unmistakably� been�discussed� potential� developed� a� unique�product� for� the� treatment�

and� prevention� of� HIV.

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630� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

15. bcpp

1.� Corporate� General� Information

Corporate� Name bcpp

Head� Office� Address 17� Myru� str.� Kyiv-134� Ukraine,� 03680

Web-site� Address http://bcpp.com.ua/

Contact E-mail [email protected]

Company� Description� &� Organization

PJSC� SIC� “Borshchahivskiy� CPP”� is� innovative� pharmaceutical� enterprise� of� European� level� that� successfully�

combines� the� scientific� potential� and� high-tech� modern� production� in� a� single� effective� complex;�

manufactures� the� products� under� the� international� quality� standards;� reliable� partner� that� clearly� fulfills� the�

obligations� and� acts� on� the� principles� of� mutually� advantageous� cooperation.

PJSC� SIC� “Borshchahivskiy� CPP”� is� the� first� pharmaceutical� plant� in� Ukraine� that� has� fully� implemented� the�

European� standards� in� quality� (GMP,� ISO� 9001),� distribution� (GDP),� environmental� management� (ISO�

14001),� energy�management� (ISO�50001),�Occupational�Health� and� Safety� (OHSAS�18001),� and� also� social�

accountability� (SA� 8000).

The� company� has� balanced� product� portfolio:� medicinal� products� (more� than� 100� items),� veterinary�

medications,� dietary/food� supplements,� disinfectants;� occupies� one� of� the� leading� positions� in� terms� of�

production� and� sales� volumes� of� finished� dosage� forms� among�Ukrainian�manufacturers;�manufactures� the�

products� of� different� price� groups� and� is� socially� oriented.

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부록 2� �전략적 협력사 디렉토리 ❚ 631

2.� Additional� Business� Propositions� for� Collaboration

R&D

PJSC� SIC� “Borshchahivskiy� CPP”� has� 20-years� experience� of� development� of� medicinal� products.

Due� to� the� formation�of� internal� research�and�development�centre�with� functional� system�of�development�

and� implementation� into� production� of� new� medicinal� products,� well-trained� qualified� personnel� and�

highly� equipped� laboratories� the� enterprise� managed� to� make� a� significant� step� in� receiving� and�

presentation� of� scientific� knowledge� about� the�medicinal� products� and� considerably� expand� the� product�

list.

Nowadays�more� than�10�%�of�scientists�and�experts�of� the�plant�are�working� in� the� field�of� research�and�

development.�Formula� for� success� is�also� in� cooperation�with�more� than�50� leading� institutes,� laboratories�

and� research� sites.

Pharmaceutical� innovations� are� the� complicated� creative� process� that� includes�much�more� elements� than�

researches.� The� important� task� of� the� system� for� development� and� implementation� into� the� production�

of�new�medicinal�products� is� to�provide� the� interrelation�with�other�processes�at� the�plant� relating� to� the�

life� cycle� of� medicinal� product.� Such� approach� allows� to� provide� the� quality� of� the� product� along� the�

technological� chain,� it� means� to� “build”� the� quality� in� the� product� starting� from� the� moment� of� its�

development�and�ensure� the� constant� reproduction�of� this�quality� from�batch� to�batch.�Moreover,� in�order�

to� provide� accessibility� of� medicinal� products� the� company� makes� maximum� efforts� on� minimization� of�

temporal� and� financial� expenses� starting� from� the� scientific� idea� through� the� development� and� ending� in�

regulatory� confirmation� and� marketing� of� the� product.

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632� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

16. BEPTEKC

1.� Corporate� General� Information

Corporate� Name BEPTEKC

Head� Office� Address Russia,� 199106,� � � St.� Petersburg,� Vasilevsky� Island,� � � 24-line,� d.� � 27A

Web-site� Address http://www.vertex.spb.ru

Company� Description� &� Organization

Substitution�of� imported� vital�medicines� is� one� the� of� priority� tasks� of� the� federal� program� Pharma�2020�

in� Russia.� For� 10� years� VERTEX� company� produces� quality,� safe� and� effective� medicines� complying� with�

all� requirements� of� the� pharmaceutical� market.�

� The� company's� activity� is� aimed� at� preserving� and� maintaining� the� health� of� millions� of� people,� the�

development� of� the� domestic� pharmaceutical� industry� and� compliance� with� current� standards� of�

manufacturing� practice� in� Russia.�

� VERTEX�today�has� three�manufacturing� facilities,�develops�original�medicinal� formulas,� and�has�more� than�

130� titles� in� assortment� range� as� well� as� their� own� brands.�

� The� basis� of� a� company� development� policy� is� priority� of� the� product� quality.�

� By� 2014� all� Russian� pharmaceutical� companies� should� go� over� to� a� mandatory� compliance� with� Good�

Manufacturing� Practices� ­� GMP.� The� VERTEX� company� focuses� on� them� already.

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부록 2� �전략적 협력사 디렉토리 ❚ 633

17. Bestpharma

1.� Corporate� General� Information

Corporate� Name Bestpharma

Head� Office� Address 03-475� Warsaw� 2� Borowskiego� street� (floor� 5)

Facilities� City� &� Country Chile

Web-site� Address www.bestpharma.pl

Contact

(Korean�

Business)

Name Elizabeth� Pinilla� Roa

E-mail [email protected]

Company� Description� &� Organization

Bestpharma�was� founded� in�pursuit�of� excellence.�By� focusing�all� of�our�attention�on� the� customers'�needs�

and� by� meeting� all� their� expectations� we� managed� to� establish� a� strong� position� on� the� polish� market.�

This� could�be�accomplished�by�gaining� trust�of�dietary� suplements,�nutraceutical,� and�OTC�manufacturers.

Thanks� to� establishing� and� developing� direct� contacts� with� ingredients�manufacturers� all� over� the�world,�

we� are� able� to� supply� high� quality�with� the� best� possible� prices.� The� quality� of� customer� relations� is� also�

one�of� the� reason�why� companies�choose�us�as�a�partner.�We�work�with� the� customer� to�best� fit�his�needs�

and� meet� his� expectations.

Mission

At� Bestpharma� we� believe� that� high� quality� shouldn't� be� accompanied� by� relatively� high� prices.� Thanks�

to� diversifying� oursuppliers� and� effective� negotiation,� we� deliver� highest� quality� products� sustaining�

reasonable� prices.

Bestpharma� supplies� and� distributes� standard� pharmaceutical� ingredients� as� well� as� specialized� products.�

Our� Pharma-targeted� approach�obligates� us� to� take� very� restrictive�measures� in� quality� assessment� of� our�

products�and�constant�engagement� in� customer� relations.�We�are�well� aware� that� that� in�many� cases� the�

well-being�of� patients� undergoing�pharmaceutical� treatment� depends� on�our� professionalism.� This� is�why�

we� supply� our� products� with� every� required� certificate� from� the� producer� as� well� as� EU� conformity�

certificates.

We� are� a� young� and� dynamic� company� with� a� stable� position� on� the� polish� pharmaceutical� ingredients�

market.�Our� goal� is� expansion�on�both� Polish� and� European�markets.�Our� team�devotes� itself� to� building�

strong� and� both� ways� beneficial� relationships� with� customers.� This� is� why� we� based� our� trade� and�

distribution� structure� on�observance�of� the� law�and� ethics� in� trading�by�always� fulfilling� commitments�we�

undertake.

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634� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

18. Binzhou Hollyally.Pharmaceutical Co.,Ltd.

1.� Corporate� General� Information

Corporate� Name Binzhou� Hollyally.Pharmaceutical� Co.,Ltd.

Web-site� Address www.hollyally.com

Contact

(Korean�

Business)

Name Shirly� Peng

Address No.15� Dapu� Road,Huangpu� District� Shanghai,P.R.China

Telephone 021-62386487

E-mail [email protected]

2.� Description� of� Collaboration�Opportunities

Collaboration� Opportunities�

for� R&D� Co-works

We� are� keen� to� collaborate� with� Korea� in� order� to� seek� new� business,�

we� have� long-term� cooperations� with� multiple� universities� and� research�

institution,� such�as�Zhejiang�University,�Zhejiang�University�of�Technology,�

Shanghai� Jiaotong� University.� The� opportunity� to� set� up� a� new� R&D�

center� is� longing� for� us.

Collaboration� Opportunities�

for� (Co-)� Marketing� &� Sales

We� are� looking� for� new� channel� to� expand� our� market,� the� chance� to�

co-marketing�with�Korea�will� be�great,�high�quality�and�competitive�price�

is� our� key� strength� to� develop� market� both� in� China� and� Korea

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부록 2� �전략적 협력사 디렉토리 ❚ 635

Corporate� Name Biocad

Head� Office� Address Ul.� Svyazi� 34-A,� Strelna,� Saint-Petesburg,� Russian� � � Federation,� 198515

Web-site� Address http://www.biocad.ru

Contact E-mail [email protected]

Company� Description� &� Organization

THE�MAIN�GOAL�OF�OUR�COMPANY� IS� TO� INCREASE� THE� LIFE� EXPECTANCY�AND� TO� IMPROVE�QUALITY�

OF� LIFE.�

We� have� created� an� innovative� biopharmaceuticals� company� that� is� focused� on� long-term� development.� In�

collaboration�with�our�partners,�and�by�applying� cutting-edge� science�and�management,�we�are�able� to� solve�

our� patients'� serious� health� problems.� Our� key� objective� is� to� adopt� creative� and� professional� approaches�

to� our� tasks.� We� are� always� mindful� of� the� fact� that� big� achievements� are� the� outcome� of� patience� and�

hard� work.�

Acquisition�and�accumulation�of�new�knowledge� is� the� foundation�of�our�business.� This� allows�us� to�discover�

new�ways�of�addressing�our�patients’�health�problems�and� to� improve� their�conditions� so� that� they� can� lead�

a� happy� life.�

Building�a�socially-oriented�business� that� is�based�on� the�principles�of� respect� for�human� rights�and�creating�

a� positive�environment� around� you� is�one�of� the� primary� goals� at�our� company.�Using�all� opportunities,�we�

contribute� to� the� economic� development� of� our� society,� recognizing� that� this� is� important� to� long-term �

health� of� our� business.�

WE�ARE�A�FULL�CYCLE�RUSSIAN�BIOPHARMACEUTICAL�COMPANY,�HOLDING�THE�LEADING�POSITION�FOR�

INVESTMENT� ATTRACTIVENESS� AMONG� LEADING� PHARMACEUTICAL� COMPANIES.�

For� patients�

We� pay� the� utmost� attention� to� our� patients.� Patient� satisfaction� and� quality� of� life� are� our� paramount�

guiding� principles� in� the� development� and�manufacturing� of� drugs.� Therefore,�we� consider� it� important� to�

identify�directly� the�needs�of�patients�and� to�be�proactive�by� creating�drugs� that� can� treat� diseases� that�are�

currently� non-curable.�

Our� products� are� more� valuable� to� patients� than� their� price.�

For� partners�

We� are� open� to� cooperation� with� significant� synergy� potential� and� a� view� to� robust� expansion� of� our�

markets� based�on�mutual� benefits�Understanding� the� complexity� of� the� challenges�we� face,�we� stay�within�

19. Biocad

1.� Corporate� General� Information

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636� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

our� core� competencies,� and� we� use� all� opportunities� from� our� related� knowledge.� We� do� this� by�

strengthening� our� own� research� and� development� activities,� and� by� actively� working� with� our� colleagues� -�

scientists,� doctors� and� pharmacists.�

For� employees�

We� believe� that� our� capital� is� in� our� personnel.� Realizing� that� the� results� of� our� operations� are� long-term,�

we� create� effective� teams� that� are� built� on� the� principles� of� trust,� understanding,� support,� teamwork,�

self-improvement,� and� generational� continuity� and� that� are� focused� on� better� results.�

Our� policy� with� respect� to� employees� is� built� on� the� principles� of� maximum� use� of� capacity� and� potential�

of�each�and�every�employee� .�We� reward� those�who�exceed�expectations�and�have�outstanding� results.�We�

attract� highly� skilled� employees,� and� for� this� we� have� created� a� corporate� culture� and� social� climate� that�

encourages� skilled� and� ambitious� people.�

For� stakeholders�

We� build� our� relationships�with� our� stakeholders� based� on�openness,� trust� and�mutual� understanding,� and�

strive� to� increase� the� value� of� their� investments.� We� believe� that� increased� confidence� in� the� company� is�

the� primary� factor� in� the� increase� of� capitalization.�

Social� responsibility�

We� are� socially� responsible� and� active� company.�We� honor� and� abide� by� the� laws� of� countries� where� we�

do� business.� We� clearly� understand� our� position� in� society� and� defend� it� if� necessary.

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부록 2� �전략적 협력사 디렉토리 ❚ 637

Collaboration�

Opportunities� for� R&D�

Co-works

Fully� Human� Therapeutic� Antibody� and� Target� Discovery

BioInvent� represents� high� quality� discovery� and� development� of� fully� human�

therapeutic� antibodies.� With� more� than� 20� years� experience� of� antibodies� and�

with� cutting� edge� technology� in-house,� BioInvent� is� the� partner� of� choice� for�

therapeutic� antibody� discovery� and� development.

At�BioInvent�we�combine�a�deep�knowledge�of� target�and�antibody�biology�with�

excellent� infrastructure� for� discovery� and� development,� e.g.� proprietary� fully�

human� n-CoDeR®� antibody� library,� automated� robotic� discovery� system,� high�

throughput� conversion� to� fully� natural� human� IgG,� disease� relevant� in-vitro� and�

in-vivo� functional� testing,� cell� line� development,� cGMP� manufacturing� and�

pre-clinical�and�clinical�development�expertise.� �We�are�committed� to� the�success�

of� our� partners� and� we� can� support� your� human� antibody� drug� development�

program� from� discovery� to� the� clinic.

Functionality� and� disease� related� discovery� are� in� focus� at� BioInvent.� The�

n-CoDeR®� discovery� process� can� utilize� cell� lines,� primary� cells,� patient�material�

and� soluble� targets� to� deliver� antibodies� to� proteins,� peptides,� carbohydrates,�

trans-membrane� receptors,� glycoproteins,� post-translationally� modified� proteins�

and� small� molecules.�

The� F.I.R.S.T.TM� platform� delivers� superior� functional� antibodies� and� targets�

together� without� prior� knowledge� of� the� identity� of� these� targets.� The� use� of�

primary� patient�material� throughout� the�discovery� ensures�antibodies� to� clinically�

relevant� up-regulated� targets� or� epitopes.� Patient� material� from� haematological�

cancer� e.g.� CLL,� AML,� available� at� BioIvent� for� Antibody� and� Target� discovery.

20. BioInvent International AB

1.� Corporate� General� Information

Corporate� Name BioInvent� International� AB

Web-site� Address www.BioInvent.com

Contact

(Korean� Business)

Name Kristina� Berggren

Address 223� 70� Lund,� Sweden

Telephone +46� 46� 2868550

E-mail [email protected]

2.� Description� of� Collaboration�Opportunities

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638� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Collaboration�

Opportunities� for� R&D�

Co-works The� n-CoDeR®� and� F.I.R.S.T.TM� system:�

•Fully� human� phage� display� libraries�

� (scFv,� Fab)

•High� diversity� and� functionality

•High� affinity� antibodies

Technical� Advantage:�

•Single� framework

•High� throughput� conversion� to� IgG

•Fully� natural� low� immunogenicity� IgG

•Rapid� discovery

Application:

•Antibodies

•Targets

Collaboration�

Opportunities� for�

Out-Licensing

•Research� license�and�transfer�of� fully�human�antibody� library�n-CoDeR®� for�use�

at� collaborator� site

•Research� license� and� antibody� discovery� using� n-CoDeR®� at� BioInvent

•Research� license� and� disease� related� Target� discovery� using� n-CoDeR®� and�

F.I.R.S.T.TM� at� BioInvent

•Disease� related� Target� discovery,� collaborator� defined� indication,� using�

n-CoDeR®� and� F.I.R.S.T.TM� at� BioInvent

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부록 2� �전략적 협력사 디렉토리 ❚ 639

3.�특허분석 결과

BioInvent� International� AB사의 특허분포도를 볼 때 기술 중에 대표적으로 Annel� Minus� Strands� Plus,�

Incorporating� Scaffold�Obtained,� Atherosclerosis� Human�Antibody� Passive� Immunization� �등의 키워드를

가진 기술에 많은 특허가 분포하고 있는 것으로 나타났다.

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640� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

2006년 01월 01일부터 2012년 12월 10일까지 출원된 BioInvent� International�AB사의 특허의 키워드 분포는

붉은 점으로 나타난다.

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부록 2� �전략적 협력사 디렉토리 ❚ 641

Corporate� Name BIOLA

Head� Office� Address Republic� of� Kazakhstan� Almaty� 050002,� Buzurbayev� Street� 13.

Web-site� Address http://www.biola.kz

Contact E-mail [email protected]

Company� Description� &� Organization

The�medical� pharmaceutical� company� Biola� was� incorporated� in� 1996,� i.e.� in� the� period� of� rapid� growth�

and� formation� of� Kazakhstan� pharmaceutical� market.

Today,�Biola� is� a�dynamic�marketing�company�which� responds�quickly� to�all� changes� in� the�pharmaceutical�

market� of� the� Republic.� The� principal� activity� is� delivery� of� new� high-quality� medicinal� preparations� and�

medical� items� from� the� largest� manufacturers� of� the� Eastern� and� Western� Europe,� the� USA,� India� and�

China

21. BIOLA

1.� Corporate� General� Information

2.� Additional� Business� Propositions� for� Collaboration

Our� clients

•� Amanat

•� Zerde

•� Medicus� -� Centre

•� Mediservice� Richter

•� Emity� International

•� Other� major� national� and� regional� wholesale� companies

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642� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

22. BioRelix, Inc.

1.� Corporate� General� Information

Corporate� Name BioRelix,� Inc.

Web-site� Address www.biorelix.com

Contact

(Korean� Business)

Name Brian� R.� Dixon,� Ph.D.� President� and� CEO

Address 401� Winchester� Avenue,� New� Haven,� Connecticut� 06511� � USA

Telephone +1� 203-785-9282

E-mail [email protected]

2.� Description� of� Collaboration�Opportunities

Collaboration�

Opportunities� for� R&D�

Co-works

BioRelix� Inc.� is� a� New� Haven,� USA,� biotech� firm� concentrating� on� research� into�

a� novel� family� of� drug� targets� in� microbes,� called� “riboswitches”,� and� on� the�

design�and�development�of� riboswitch-targeting�antibacterials.� � There� is� a�critical�

shortage� of� new,� viable� antibacterial� targets� and� novel� antibiotics,� and� BioRelix�

is� addressing� this� unmet� medical� need� by� developing� drugs� against� riboswitch�

targets� in� bacteria� having� serious� impact� on� human� health.

Riboswitches� are� essential� gene� control� elements� in� a� wide� variety� of� human�

pathogens,� and� a� number� of� riboswitch� classes� are� present� in� the� principal�

agents�of�a�wide�variety�of� clinically� important�bacterial� infections.� �With� its�own�

IP� portfolio� and� exclusive� world-wide� licenses� to� the� other� key� intellectual�

property� pertaining� to� riboswitches,� and� possessing� required� technology� and�

expertise,� BioRelix� is� uniquely� positioned� to� develop� novel� antibiotics� directed� at�

these� new� targets.

BioRelix� would� be� pleased� to� consider� opportunities� for� R&D� collaboration� and�

for� licensing� in� this� area.� � Currently� BioRelix� has� a� strategic� alliance� with� a�

subsidiary� of�Merck� &� Co.,� Inc.� to� identify� new� antibacterial� drug� candidates� by�

applying� BioRelix’s� propriety� riboswitch� technology� platform.

3.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

BioRelix� has� a� blue� chip� investor� base,� including� CHL�Medical� Partners,� Novartis� Venture� Funds,� New� Leaf�

Ventures,� Aisling� Capital,� Elm� Street� Ventures� and� Alexandria� Real� Estate� Equities.� � BioRelix� would� be�

pleased� to� consider� opportunities� for� additional� investments� for� our� current� R&D� programs.

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부록 2� �전략적 협력사 디렉토리 ❚ 643

Corporate� Name Biosano

Head� Office� Address Aeropuerto� 9941,� Cerrillos� Santiago� de� Chile

Facilities� City� &� Country Chile

Web-site� Address www.biosano.cl

Contact

(Korean�

Business)

Name C.Rodriguez

E-mail [email protected]

Company� History

Biosano’s� origin� dates� back� to� 1940,� beginning� with� the� manufacturing� of� supplies� in� order� to� cover� the�

important� demand� of� medicines� required� by� the� health� area� and� the� population� at� that� time.�

In� 1982,� along� with� the� change� in� its� owners,� a� strong� stage� of� modernization� begins,� through� the�

development,� automation� and� the� incorporation� of� new� work� techniques.� A� significant� increase� in�

production� was� achieved,� with� the� aim� of� responding� to� the� growing� demand.�

In� the� 90's,� Biosano� started� its� stage� of� globalization� entering� different� and� demanding� markets� of� Latin�

America� and� the� Caribbean.� Biosano� has� a� strong� presence� in� countries� such� as� Peru,� Ecuador,� Uruguay,�

Paraguay,�Nicaragua,� Panama,�Venezuela,�Honduras,�Dominican� Republic,� El� Salvador,� Colombia� and�Cuba.

In�order� to� take�advantage�of� the�position�achieved�by�Biosano�within� the�public� and�private�hospital�market�

in� Chile� and� other� countries� of� the� region,� in� the� year� 2000� Biosano� started� to� import� finished� medical�

products.� The� most� modern� and� efficient� health� solutions� present� in� the� markets� of� Canada,� France,�

Switzerland,� Italy,� Korea,�Mexico,� the�United� States� of�America,�China,� India,� the�Philippines,� among�others�

are� commercialized.

In� 2003,� a� new� modern� pharmaceutical� plant� of� about� 6,000� square� meters� is� inaugurated� which�

incorporates�Spanish�point� technology�which�meant�an� investment�of�US$15�million.� This� allows�Biosano� to�

become� the� first� Chilean� laboratory� to� be� validated�with� the�GMP� standard� for� the� production� of� vials� and�

ampoules.�

23. Biosano

1.� Corporate� General� Information

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644� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

New� offices� for� the� sales� team� were� instated� as� Headquarters� in� 2013,� located� in� “Nueva� Las� Condes”,� in�

Santiago� with� the� purpose� to� adequately� face� the� growing� process� of� internationalization� and� global�

presence� of� the� company.�

In� 2014,� a� new�project� of� remodeling� the� plant� is� carried� out,�which� involves� a� significant� investment�with�

the� main� purpose� of� being� at� the� forefront� in� the� global� pharmaceutical� production.

Company� Description� &� Organization

Mission

We� are� a� cutting-edge� laboratory� engaged� with� the� process� of� continuous� improvement� that� encourages�

the� professional� development� of� its� human� capital,� that� assumes� with� a� major� responsibility� the� role� that�

corresponds� within� the� world� of� health� care.�

Biosano� manufactures,� commercializes� and� distributes,� both� in� Chile� and� abroad,� pharmaceutical� products�

of� the� highest� quality,� at� affordable� prices,� ensuring� that� our� doctors� and� patients� receive� a� service� of�

excellence.

Vision�

Biosano�shall�be�one�of� the�most�modern�Chilean� laboratories�and�a� Latin�America� leader� in� the�production�

of�SVP,�dedicated� in� the�production,�marketing,� and�distribution�of�pharmaceutical�products�of�high�quality.�

Biosano� is� permanently� incorporating� the� most� innovative� technologies� and� worldwide� available� products,�

in� order� to� deliver� efficient� solutions� that� enable� health� professionals� to� address� the� problems� of� the�

population.

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부록 2� �전략적 협력사 디렉토리 ❚ 645

24. BIOSINTEZ

1.� Corporate� General� Information

Corporate� Name BIOSINTEZ

Head� Office� Address ОJSC� "Biosintez",� Druzhby� str.,� 4,� Penza,� Russia,� 440033

Web-site� Address http://www.biosintez.com

Contact E-mail [email protected]

Company� Description� &� Organization

The� Penza� plant� of�medical� preparations� was� established� in� 1959.� Production� of� antibiotic� substances� by�

fermentation�was�chosen�as�a�main�direction�of� its� activity,� and�antibiotic�biomycin� (chlortetracycline)�and�

vitamin� B12� were� the� first� products.� Later� other� antibiotic� substances� were� included� into� product� list:�

oleandomycin,� tetracycline,� nystatin,� heliomycin� (Gold� medal� of� Exhibition� of� Achievements� of� National�

Economy� in�1970),� fusidic� acid�and�sodium�fusidate,� levorin� (candicidin)� (Gold�medal�of�Plovdiv�Exhibition�

in� 1977),� benzylpenicillin� potassium,� mycoheptin,� as� well� as� cardiovascular� riboxin� (inosin).� Besides� the�

substances,� as� early� as� in�1961� the� Plant�began� to� produce� the� formulated�preparations,� tablets,� in� 1971�

manufactures� of� infusions� and� filling� of� powders� for� injection� were� put� into� operation.� Also� production�

of�endocrine�preparations�was�organized,� in�1986� ­� insulin,� in�1989� ­�heparin.� In�1987� the�Plant�had�been�

reorganized� in� the� Combine� of� medical� preparations� in� connection� with� multifarious� character� of�

manufacture,� and� in� November� 1992� it� had� been� reorganized� in� Open� Joint-Stock� Company� “Biosintez”.

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646� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name Blisfarma

Head� Office� Address Rua� Rodrigo,� 114� Jardim� Ruyce� Diadema� -� SP� CEP:� 09981-500

Facilities� City� &� Country Brazil

Web-site� Address www.blisfarma.com.br

Contact

(Korean�

Business)

E-mail [email protected]

Company� History

1997­� Founded� the� first� unit� of� the� Group:� BlisFarma� Indústria� e� Comércio� de� Embalagens� Ltda.

BlisFarma�Group� started� its� business�activities� in� the� pharmaceutical�market� in� 1997,�aiming�at� providing� its�

costumers� with� a� strong� partnership� in� the� contract� of� drugs� packaging� services.�

1999� ­� Building� of� two� additional� units:� Hormonal� and� Penicillin� Antibiotics.

Always� keeping� an� eye� on� the� marketing� needs,� aiming� at� complying� with� the� requirements� of� local� and�

national� regulatory� agencies� and� with� the� purpose� of� delivering� customized� solutions�

2006� ­� Borns� Itaboraí� Unit.

In�2006,�BlisFarma�Group�created�another�unit,� this� time�designed�for� customized� services� in�manufacturing�

and� packaging� of� non-specific� therapeutic� class� products,� which,� in� addition,� has� fully� fitted� physical,�

chemical� and� microbiological� control� lab� for� also� performing� raw� materials� and� finished� products� analysis�

services.

2010� ­� Start� up� of� Food� Products� Division.�

One� more� step� in� the� constant� evolution� of� BlisFarma� Group,� in� 2010� started� to� operate� its� new� Unit�

designed� to� outsourcing� of� Food� Products.

Company� Description� &� Organization

MISSION

To� establish� a� strong,� committed� and� solid� partnership� with� its� costumers� by� providing� them� efficient,� fast�

and� highly� qualified� products.

VISION

25. Blisfarma

1.� Corporate� General� Information

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부록 2� �전략적 협력사 디렉토리 ❚ 647

To�be� a� reference� and� leader� of� pharmaceutical�market� service� rendering� segment,� becoming� an� extension�

of� its� customers� in� their�manufacturing�and�packaging�processes,� in�addition� to�begin�a�model� of� efficiency�

and� reliability� for� its� employees,� costumers,� suppliers� and� the� society.�

VALUES

� -� Quality

� -� Agility

� -� Commitment

� -� Ethics

� -� Respect.

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648� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

26. Bristol Myers Squibb

1.� Corporate� General� Information

Corporate� Name Bristol� Myers� Squibb

Web-site� Address www.bms.com

Contact

(Korean� Business)

Name Younok� Shin

Address 1� Bristol� Drive,� New� Brunswick,� NJ,� 08903,� USA

Telephone 732-227-6624

E-mail [email protected]

2.� Description� of� Collaboration�Opportunities

Collaboration�

Opportunities� for� R&D�

Co-works

New� technology�on�discovering�and�developing� innovative�medicines� that�address�

serious� diseases� in� areas� of� significant� unmet� medical� need.�

Collaboration�

Opportunities� for�

In-Licensing

Innovative� medicines� or� technology� in� many� areas� such� as� Alzheimer’s� disease,�

atherosclerosis,� cancer,� diabetes,� hepatitis,� HIV,� rheumatoid� arthritis,� etc.�

Collaboration�

Opportunities� for�

Manufacturing

Parenteral� manufacturing,� sterile� powder� filling,� etc

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부록 2� �전략적 협력사 디렉토리 ❚ 649

3.�특허분석 결과

BMS사의 특허분포도를 볼 때 기술 중에 대표적으로 Multihopper� Embosser� Connected� Apparatus,� Bag�

Layer� Material의 키워드를 가진 기술에 많은 특허가 분포하고 있는 것으로 나타남.

Page 653: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

650� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Collaboration�

Opportunities� for� R&D�

Co-works

Eurofins� BioPharma� Product� Testing� Munich� and� BSL� BIOSERVICE� Scientific�

Laboratories� Munich� (Members� of� the� Safety� Alliance)�

Eurofins� is� a� first-class� Contract� Research� Organization� (CRO),� working� with�

pharmaceutical,� chemical,� biotechnology,� medical� device� and� cosmetic� clients.�

The� Group� covers� the� whole� chain� of� drug� development� thanks� to� an�

international�network�of� laboratories�and� testing�units�with�global� reach,�uniform �

QA� systems� and� high� quality� services.

With�more� than� 20� years� of� experience� and� thousands� of�GMP/GLP� studies� per�

year�Eurofins�BioPharma�Product�Testing�Munich�GmbH� in� cooperation�with�BSL�

BiOSERVICE� Scientific� Laboratories� Munich� supports� its� clients� especially� in� the�

fields� of� toxicology,� pharmacology,� bioassays,� microbiology,� biocompatibility,�

immuno-� and� bioanalytical� studies.� Eurofins� BioPharma� Product� Testing� and� BSL�

BIOSERVICE� offer� a� broad� range� of� biological� safety� and� activity� testing� services�

for� (Bio-)Pharmaceuticals,�Chemicals,�Medical�Devices,�Agrochemicals,�Cosmetics,�

and� Food� and� help� to� fulfill� special� requirements� either� by� standardized� test� or�

tailor-made� studies.

27. BSL BIOSERVICE Scientific Laboratories GmbH

1.� Corporate� General� Information

Corporate� Name BSL� BIOSERVICE� Scientific� Laboratories� GmbH

Web-site� Address www.eurofins.com,� www.bioservice.com

Contact

(Korean� Business)

Name GINAPATH,� Co.,� Ltd

Address1009,� 10th,� ZERO� Bldg,� 14,� Teheran-ro,� 84-gil,� Gangnam-gu,� Seoul,�

06178,� Korea

Telephone +82� 10� 6405� 7493

E-mail [email protected]

2.� Description� of� Collaboration�Opportunities

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부록 2� �전략적 협력사 디렉토리 ❚ 651

Eurofins� BioPharma� Product� Testing� and� BSL� BIOSERVICE� are� part� of� the� largest�

network� of� harmonized� bio/pharmaceutical� GMP� product� testing� laboratories�

worldwide�and�have�been� certified� in� accordance�with�Good�Laboratory�Practice�

(GLP),�Good�Manufacturing�Practice� (GMP),�AAALAC�and�DIN�EN� ISO�17025� for�

biocompatibility� testing� of� medical� devices.�

Collaboration�

Opportunities� for� (Co-)�

Marketing� &� Sales

As� BSL� is� represented� by� GinaPath,� therefore,� please� contact� Ginapath� for�

collaboration� opportunities.

3.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

Also� here� I� guess� GinaPath� know� best� the� Korean� market� and� opportunities.

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652� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

28. Celgene Corporation

1.� Corporate� General� Information

Corporate� Name Celgene� Corporation

Web-site� Address www.celgene.com

Contact

(Korean� Business)

Name TaeWook� Woo� (Peter� Woo/우태욱)

Address4F,� Samtan� Bldg.� 947-7� Daechi-Dong,� Gangnam-Gu,� Seoul� Korea�

135-735

Telephone +82-2-3469-7945

E-mail [email protected]

2.� Description� of� Collaboration�Opportunities

Collaboration�

Opportunities� for� R&D�

Co-works

Possibility� to� engage� in� clinical� studies� involving� other� compounds,� both� within�

IIT� setting� and� company� sponsored� setting.

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부록 2� �전략적 협력사 디렉토리 ❚ 653

3.�특허분석 결과

Celgene� Corporation사의 특허분포도를 볼 때 기술 중에 대표적으로 Retrovirus� Replication� Combat�

Cachexia� Cathexia� Endotoxic� Shock,� Substituted� Substituted� Phthalimides,� Polymorphic� Forms�

Crystaline� Forms� Repressented� Includes의 키워드를 가진 기술에 많은 특허가 분포하고 있는 것으로 나타났다.

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654� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

2006년 01월 01일부터 2012년 12월 10일까지 출원된 Celgene�Corporation사의 특허의 키워드 분포는 붉은

점으로 나타난다.

Page 658: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

부록 2� �전략적 협력사 디렉토리 ❚ 655

29. CHEM

1.� Corporate� General� Information

Corporate� Name CHEM

Head� Office� AddressLeningrad� region,� 188663,� Vsevoloshky� district,� settlement� Kuzmolovsky,�

district� railway� station� Kapitolovo,� building� 142

Web-site� Address http://www.npfkem.ru

Contact E-mail [email protected]

Company� Description� &� Organization

Scientific� and�production�company� “CHEM”�LTD� -� young,�dynamically�developing�production� company�which�

is� focused� on� production� of� the� medicines� substances,� based� by� group� of� experts� in� the� field� of� organic�

synthesis� in� 2006.

”CHEM”� company� consistently� leads� the� policy� aimed� at� the� creation� of� effective� and� safe� production,�

maintenance� the� high�quality� standards� in� the� released�pharmaceutical� substances,� using� the� possibilities� of�

modern� technologies,�high�potential�of� a�domestic� science�and� twenty� years'� experience� in� the�development�

of� organic� synthesis� technologies.�

From� the� date� of� the� basis,� the� company� is� developing� and� carrying� out� industrial� chemical� synthesis� of�

medicines� substances.�The�main�priority�of� the� company� is� the�development�of� science� intensive� technologies�

and� their�use� in� the� substances�production.� The�organization�of�pharmaceutical� substances�production�allows�

Russian�pharmaceutical� factories�be�supplied�with� the�necessary� raw�materials� for� the�production�of� finished�

pharmaceutical� products.�

One� of� the� main� values� of� “CHEM”� is� staff,� that's� why� we� pay� special� attention� to� increase� of� the� staff's�

social� security,� development� and� motivation� of� the� personnel� and� also� constant� improvement� of� working�

conditions.

“CHEM”� eternally� improves� its� research,� production� and� human� potential� for� embodiments� of� science�

achievements� the� production.�

The�company� “CHEM”� is� the�modern�complex�which� is� lockated� in� the�settlement�Kuzmolovsky� in� Leningrad�

region.� Production� rooms� are� equipped�with� the� modern� domestic� and� foreign� equipment.� Observance� of�

the� standards� during� production� process� is� constantly� supervised� by� quality� control� laboratory� of� the�

company.�

Incorporating� the� research� laboratory� the� company� has� a� possibility� to� develop� technology� and� make�

chemical� and�pharmaceutical� substances�by� request,�providing�dynamic� requirements�of� the�growing�market�

preparations.�

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656� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

30. Chengdu CSHPHARM Co., Ltd.

1.� Corporate� General� Information

Corporate� Name Chengdu� CSHPHARM� Co.,Ltd.

Web-site� Address www.cshpharm.com

Contact

(Korean� Business)

Name Bill.shu� zhi�

AddressBlock� B.Int.newhope� HI-Tech.zone,Chengdu� city,Sichuan� province�

P.R.of� China� 61000

Telephone +86-28-85321971

E-mail [email protected]

2.� Description� of� Collaboration�Opportunities

Collaboration�

Opportunities� for� R&D�

Co-works

From� bio-plants� &� herbs� ingredient,� active� pharmaceutical� ingredient� &� bulk�

drugs,� synthetic� products�

We� have� one� top� R&D� team� ,per� year� we� keep� 4to� 6� new� product�

developed,even� commercial� manufactured.

Collaboration�

Opportunities� for�

In-Licensing

We� can� develope� products� as� kore� partners� requirements

Collaboration�

Opportunities� for�

Out-Licensing

If� high� quality� or� high� value,new� product� ,we� hope� get� the� opportunities

Collaboration�

Opportunities� for�

Manufacturing

Both� our� current� products� or� requirements� products� we� would� manufacture�

according� to� partner� quality� specifications

Collaboration�

Opportunities� for� (Co-)�

Marketing� &� Sales

We�would� like� to� know� market� capacity� and� what� product� ,based� on� certain�

product� and� market� both� of� us� find� one� method

3.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

Now�we� have� one� first� class� product� :polyene� phosphatidyl� choline� ,alliin� 99%HPLC� ,phosphatidylserine,�

we� would� like� to� cooperate� with� Korean� pharmaceutical� companies

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부록 2� �전략적 협력사 디렉토리 ❚ 657

31. Clinical Development Services Agency

1.� Corporate� General� Information

Corporate� Name Clinical� Development� Services� Agency

Web-site� Address www.cdsaindia.in

Contact

(Korean� Business)

Name Dr.� Sudhakar� Bangera

Address 470,� Udyog� Vihar� Phase� 3

Telephone +91� 124� 287� 6666� or� +91� 8800654001� (hand� phone)

E-mail [email protected]

2.� Description� of� Collaboration�Opportunities

Collaboration�

Opportunities� for� R&D�

Co-works

CDSA� is�extramural�unit�of�Translational�Health�Science�&�Technology� Institute,�

Dept�of�Biotechnology,�Ministry�of�Science�&�Technology,�Government�of� India�

based� out� of� Gurgaon� (outskirts� of� New� Delhi),� India.

CDSA� is� open� to� alliances� with� Korean� Biopharmaceutical� companies� for�

monitoring,� project� management� and/or� audit� of� Korean� Pharma� phase� 2-4�

clinical� and� bioavailability-bioequivalence� studies� in� India.

3.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

Since� CDSA� is� a� not-for-profit� organisation� backed� by� Govt� of� India,� we� would� like� to� offer� project�

management�services� for� the�clinical� trials� that�can�be� conducted�by�Korean�Pharma� in� India.� In�addition,�

we� can� conduct� site� feasibility,� site� assessment,� study� assessment,� clinical� monitoring� and� data�

management� for� those� studies� where� Korean� Bio-Pharma� and�Medical� Device� companies� would� like� to�

take� India� as� a� site.

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658� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

32. CMIC Korea Co., LTD.

1.� Corporate� General� Information

Corporate� Name CMIC� Korea� Co,.� LTD.

Web-site� Address http://www.cmic.co.kr

Contact

(Korean� Business)

Name SeungWoo,� Song

Address#702� Hansan� Bldg,� 47-2,� Seosomun-dong,� Jung-gu,� Seoul,� 100-110,�

Korea

Telephone +82� 2� 3708� 3601

E-mail [email protected]

2.� Description� of� Collaboration�Opportunities

Collaboration�

Opportunities� for� R&D�

Co-works

We,� CMIC,� are� the� leading� clinical� CRO,� Asian� pharmaceutical� service� provider�and�major� site� in�Korea,� Japan,�China,� Taiwan,�Malaysia� and�Singapore�as�well�as� activities� in� all� other� Asian� countries.

-� Over� 20� years� of� solid� establishment� in� Japan� and� Asia.-� Supported� by� around� 5,000� full-time� professional� expertises.-�Completed�over�300�clinical�protocols� in�various� therapeutic�areas� for� the� last�3� years.-� Quality� recognized� by� regulatory� inspections� and� audits.

We� have� comprehensive� expertise� and� knowledge� in� country-specific�regulations� and� medical� practices.� We� have� well-established� relationship� with�and� access� to� local� investigators� and� the� authorities.

For� non-clinical� studies,�CMIC� had� co-worked� with� BSL/Anapath,� a� part� of� Eurofins� group,� located� in�Munich,�Germany.�BSL�had�operated�since�1984�and� is�an� internationally�active�contract� research� organization.BSL� BIOSERVICE� offers� a� broad� range� of� biological� safety� and� efficacy� testing�for� (Bio-)Pharmaceuticals,� Chemicals,� Medical� Devices,� Agrochemicals,�Cosmetics,� and� Food.Anapath� offers� high� quality� of� histopathology� service� for� Toxicological� studies�with� “Flying� necropsy� team”�

Therefore,�CMIC�will�be�able� to�be�a�successful�partner� from�early�development�to� clinical� trials,� as� a� one-stop� service� provider.

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부록 2� �전략적 협력사 디렉토리 ❚ 659

Collaboration�

Opportunities� for�

Manufacturing

CMIC� CMO� is� a� contract� manufacturing� organization� that� specializes� in�

providing� fully� integrated� pharmaceutical� solutions� including� formulation,�

analysis,� commercial� manufacturing� which� has� facilities� in� Korea,� Japan,� USA.�

-� Manufacturing� services� include� :� ointment,� cream,� gel,� lotion,� suppository,�

liquid,� tooth� paste,� tablets(uncoated� and� film-coated� tablets),� capsules,�

seamless-mini� capsules� etc.

-� Manufacturing� services� (packaging)� include:� blister� package� (PTP),� strip�

package� (SP)� and� capsules� etc.

-� Contract� Manufacturing� of� medical� products:� Ointment,� Cream,� Gel,� Lotion,�

Suppository,� Liquid,� Tooth� paste� etc.

-� Contract� Manufacturing� of� Quasi-drugs� /� Cosmetics� :� Toothpaste,� Cream

-� Quality� management� control

-� Import� of� medical� supplies� sale� duties

-� Manufacturing� services� (packaging):� Blister� package� (PTP)� and� Strip� package�

(SP)� for� Tablets,� Capsules� etc.

Collaboration�

Opportunities� for� (Co-)�

Marketing� &� Sales

CMIC� provide� a� Services� to� pharmaceutical� companies� related� to� support� for�

drug� sales� and� marketing�

-� Medical� Communication� with� Academic� Support.

-� Advertising� &� Promotion

-� Promotion� Strategy

-� Promotion� Materials

-� Contract� MR� (Medical� Representative)

-� MR� Training

-� Market� Assessment

3.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

CMIC� had� developed� several� orphan� drug� to� ensure� a� human� beings� against� life� threatening� disease.

But,� CMIC� is� not� a� pharmaceutical� company.� Therefore,� we� would� like� to� find� co-work� company� who�

can� control� and� make� a� sales� this� products� for� Korean� market.

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660� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name DiaProph� Med

Head� Office� Address 35,� Svetlitsky� str.,� Kyiv,� Ukraine,� 04123

Web-site� Address http://diaproph.com.ua

Contact E-mail [email protected]

Company� History

2014-08-08� �

� Our� product� range� is� supplemented

� DIA®-Hemostasis,� DIA®-D-dimer,� DIA®-Fibrin� soluble,� DIA®-Fibrinogen�

2014-06-13� �

� Good� Medical� Staff� Day!

� Dear� friends!� Our� best� wishes� for� a� Medical� Staff� Day!�

2014-05-19� �

� The� attention� of� consumers!

� New� certificates� of� conformity�

2014-04-30� �

� Annual� information

� Published� annual� information� about� the� shares� in� 2013.�

2013-12-30� �

� Our� congratulation� with� New� 2014� Year� and� Marry� Christmas!

� The� nicest� thing� about� the� Holiday� Season� is� telling� our� customers� and� partners� how�much�we� care� and�

appreciate� them!�

2013-12-24� �

� The� attention� of� consumers!

� The�state� re-registering�of�products�manufactured�by� JSC�«Diaproph-Med»�was� completed�and�new�state�

certificates� were� issued.�

33. DiaProph Med

1.� Corporate� General� Information

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부록 2� �전략적 협력사 디렉토리 ❚ 661

2013-11-29� �

� “Zdravookhraneniye� ’2013”

� We� invite� you� to� visit� the� exhibition� stand� of� our� distributor� in� Russia� "Epidbiomed-diagnostics"� Ltd.�

2013-11-08� �

� New� article

� Diagnostic� characterization� of� ELISA� test� systems� for� serological� detection� of� patients� with� syphilis� (in�

russian)�

2013-11-07� �

� The� attention� of� consumers

� The� scientific� and�practical� conference� “Actual�problems�of�diagnosis,� treatment,�and�prevention�of� chronic�

dermatoses� and� STDs”.�

2013-06-14� � �

� Happy� holiday,� dear� medics!

� Congratulations� to� medical� professionals.�

2013-03-07� �

� General� meeting� of� shareholders

� Private� Joint�Stock�Company�"Scientific-Production�Company�"DIAPROPH-MED»�reports� to� convene�annual�

general� meeting� of� shareholders.�

2013-03-06� �

� Dear� Ladies!

� On� the� eve� of� the� coming� The� International� Women‘s� day.�

2013-02-01� �

� Our� product� range� is� supplemented

� Immunochromatographic� assays� for� diagnosis� of� drug� and� alcohol.�

2012-12-17� �

� Our� congratulation� with� New� 2013� Year� and� Marry� Christmas!

� We� wish� you� health� and� fun,� for� your� business� ­� steadiness� and� development…�

2012-12-05� �

� 32� items� of� test� kits� registered� in� the� Russian� Federation

� Registration� certificates� #ФСЗ� 2012/13335,� ФСЗ� 2012/13336,� ФСЗ� 2012/13337,� issued� to�

"Epidbiomed-diagnostika"� Ltd.�

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662� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

2012-11-28� �

� “Zdravookhraneniye’2012”

� We� invite� you� to� visit� the� exhibition� stand� of� our� distributor� in� Russia� "Epidbiomed-diagnostics"� Ltd.�

2012-11-27� �

� New� article

� “Diagnostic� characterization� of� a� highly� sensitive� test� system� for� simultaneous� detection� of� p24� antigen� of�

HIV-1� and� anti-HIV-1� and� HIV-2”�

2012-10-02� �

� The� company� became� the� laureate� of� competition� «The� best� innovative� developments� a

� R&D�department�employees�of�PJSC�«SPC�«Diaproph-Med»�participated� in�an� International� scientific� and�

technical� forum� «Science.� Innovations.� Technologies� -� 2012».�

2012-07-07� �

� Certified� in� accordance� to� DSTU� ISO� 13485:2005

� JSC� "Diaproph-Med"� certified� the� QMS� in� accordance� to� DSTU� ISO� 13485:2005.�

2012-07-06� �

� Сonvene� of� special� general� meeting� of� shareholders

� Private� Joint� Stock� Company� “SCIENTIFIC-PRODUCTION� COMPANY� “DIAPROPH-MED”� reports� to� convene�

special� general� meeting� of� shareholders.�

2012-03-06� �

� General� meeting� of� shareholders

� Private� Joint�Stock�Company�"Scientific-Production�Company�"DIAPROPH-MED»�reports� to� convene�annual�

general� meeting� of� shareholders.�

2012-02-21� �

� Our� product� range� is� supplemented.

� Our� product� range� is� supplemented� by� four� PCR� test� systems� and� 18� serum� panels.�

2011-12-12� �

� Merry� Christmas� and� Happy� New� Year!

� May� all� your� dreams� come� true� in� the� coming� New� Year!�

2011-11-30� �

� December� 1� ­� World� AIDS� Day

� Since� December� 1,� 1988� World� AIDS� Day� was� dedicated.�

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부록 2� �전략적 협력사 디렉토리 ❚ 663

2007-03-03� �

� The� technology� for� the� production� of� high� purified� recombinant� interferon.

2006-10-16� �

� DIA-HIV� 1/2� bearing� CE-mark,� lot� No.� 064-06

� approved� for� commercializaion� in� EU�

2006-05-15� �

� CE-certification� of� the� Product� DIA-HIV� ½

� Certification� of� Quality� Management� System� of� Diaproph-Med� according� to� IVD-regulations� in� European�

Union.�

2006-03-29� �

� The� test� kit� for� diagnostics� of� H5N1� avian� influenza� A� virus

� The� test� kit� «DIA-Real� Avian� Influenza»� for� the� detection� of� viral� RNA� of� Н5N1� avian� influenza� А� virus�

in� clinical� materials� of� poultry� with� the� method� of� one-stage� Real� -� Time� RT-PCR� was� elaborated.� �

Company� Description� &� Organization

Directions� of� activity

•� Developments� of� diagnostic� platforms� for� detection� of� human� and� farm� animal� infections.

•� Development� and� manufacturing� of� diagnostic� products� for� laboratory� medecine� -� enzyme-linked�

immunosorbent� assays� (ELISA),� PCR� test� kits.

•� Scientific� developments� in� the� field� of� diagnostic� device� assessment.

•�Production�of� human� sera� panels� intended� for� use� in� sensitivity� and� specificity� assessment� of� commercial�

diagnostic� ELISA-based� kits,� external� control� and� testing� the� work� standards� of� clinical� diagnostic�

laboratories.

•� Production� of� recombinant� protein� monoclonal� antibodies� for� diagnostic� purposes.

•� Scientific� development� of� immunobiologicals.

•� Production� of� immunobiological� substances.

Quality� management� system

The� quality�management� system� ISO� 13485� is� designed� and� realized� in� JSC� "Diaproph-Med".� The� company�

was� certified� by� mdc� medical� device� certification� GmbH� (Germany)� in� 2006.

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664� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

34. Drogueria Eurofarma SA

1.� Corporate� General� Information

Corporate� Name Drogueria� Eurofarma� SA

Web-site� Address www.eurofarma.com.ar

Contact

(Korean� Business)

Name Mariana� Degan

Address Carlos� Pellegrini� 781,� floor� 1,� Buenos� Aires,� Argentina

Telephone +54� 11� 4328� 2481

E-mail [email protected]

2.� Description� of� Collaboration�Opportunities

Collaboration�

Opportunities� for� (Co-)�

Marketing� &� Sales

We� are� an� API� and� end� formulation� importing� company� and� distributor� in�

Argentina.�Our� customers�are� laboratories�and�we�are� constantly� looking� for�new�

suppliers�and�developments� to�meet�our� customer� requirements�and�Argentinian�

market� demand.

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부록 2� �전략적 협력사 디렉토리 ❚ 665

35. EBIME

1.� Corporate� General� Information

Corporate� Name EBIME

Head� Office� AddressAdolfo� Prieto� 1458-3� CP� 03100�

Col.� del� Valle,� Deleg.� Benito� Juàrez� Mèxico,� D.F

Facilities� City� &� Country Mexico

Web-site� Address www.ebime.com.mx

Contact

(Korean�

Business)

Name Lic.Arturo� Corete� Reyes

E-mail [email protected]

Company� Description� &� Organization

Mission

To� manufacture� and� trade� high� medical� specialty� devices,� based� on� world� class� technological� platforms�

and� developing� solutions� for� the� medical� area;� supported� in� innovation� and� research� that� improves�

people’s� quality� of� life� and� their� life� expectancy.�With� committed� personnel,� qualified� and� in� continuous�

development,� that� reaches� profitability� for� a� sustainable� growth� of� the� congruent� organization� with� the�

social� and� familiar� stability.

Vission

To� become� a� Mexican� company� leader� in� national� market� and� recognized� for� its� prestige� and� quality�

internationally�

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666� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

36. Ecron Acunova Ltd

1.� Corporate� General� Information

Corporate� Name Ecron� Acunova� Ltd�

Web-site� Address www.ecronacunova.com

Contact

(Korean� Business)

Name Ashlesha� Gaunder

Address Mobius� Towers� ,� SJR� i-Park,� EPIP,� Whitefield,� Bangalore� ­� 560� 066

Telephone +91� 9167776940

E-mail [email protected]

2.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

Ecron� Acunova� is� a� mid-sized� full� service� global� CRO.� We� provide� end-to-end� clinical� research� services�

for� Phase� I-IV� trials� and� BA-BE� studies.� Our� multinational� presence,� in� 19� European� countries,� 8� South�

East� Asian� countries� in� addition� to� the� USA� allows� us� to� engage� regulatory

authorities� and� identify� development� and� partnering� opportunities� across� the� world.� Our� flexibility� of�

association� allows� our� clients� to� use� our� services� for� fulfilling� specific� needs� or� engage� us� as� an� across�

the� board� partner� for� their� development� programs.

We� have� been� supporting� Pharma,� Biotech,� Device,� Neutraceuticals� and� Diagnostic� companies� globally�

with�over�25+�years�of�experience�and�400+�workforce� including�80�MDs�and�PhD.�Our�broad�spectrum�

of� services� helps� our� partners/clients� to� accelerate� their� product� development� starting� from� pre-clinical�

strategic� program� to� clinical� study� design� and� execution� and� finally� licensing� and/or� fund� raising.�

We� are� head� quartered� in� Bangalore.

Ecron� Acunova� offers� a� complete� continuum� of� ICH­GCP� compliant� clinical� development� solutions:

-� Pharmacokinetic/Pharmacodynamic� (PK/PD)

-� Phase� I� to� IV� Clinical� Trials

-� Clinical� Data� Management� and� Biostatistics�

-� Medical� Writing

-� Regulatory� Affairs

-� Pharmacovigilance

-� Central� Lab

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부록 2� �전략적 협력사 디렉토리 ❚ 667

SERVICES

Regulatory� Consulting

CRO�

Our� regulatory� consultant� group� is� experienced� in� the� development� of� positioning� strategies,� integrated�

planning,� management� and� submission� of� study� related� documents� to� regulatory� authorities� and� ethics�

committees.� Our� regulatory� experts� foster� effective� and� diplomatic� liaisons� with� regulatory� bodies� in� a�

wide� variety� of� indications;� they� are� at� your� service� to� represent� and� support� you� in� meetings� with�

regulatory� authorities.� Some� of� the� key� areas� of� support� include:� Application� for� an� Ethics� Committee�

opinion,� Clinical� trial� application� to� National� Health� Authorities� for� conduct� of� clinical� trials,� Selection� of�

coordinating� investigator,� Regulatory� consultation� of� development� programs,� Assessment� and� evaluation�

of� dossiers� for� regulatory� submission,� Preparation� and� compilation� of� regulatory� submissions� and�

protocols,� Assistance� with� independent� review� boards/� ethics� committees� approvals.� We� have� in� depth�

expertise� with� requirements� of� US� FDA,� European� Regulators� and� Asian� Regulatory� Authorities,� related�

to� clinical� development.�

Bioavailability� and� Bioequivalence� Services� (PK/PD)

CRO�

Benchmarking�major�Frost�and�Sullivan�have�selected�us�as� ‘Partner�of�Choice’� for�BABE�studies� for�quality�

of� services.� Our� service� offering� comprises� regulatory� consulting,� IP� import� and� sample� export,� protocol�

design,� ethics� committee� submissions,� safety� screening,� and� bio� analytical� testing.� In� addition,� we� have�

proven� expertise� in� clinical� study� management,�method� development� and� validation,� data�management�

with� Oracle� Clinical,� PK� analysis� using�WinNonlin,� statistical� analysis� using� SAS,� and� report� writing.� We�

have�a�database�of�over�4,500�volunteers� including� female� volunteers�and�special�populations� for� studies�

focused�on�post-menopausal�women,� geriatric� volunteers,� oncology,�psychiatry� and�dermatology,� as�well�

as� diabetes.� State-of-the-art� facilities� with� 116-Bed� CPU� in� Manipal� and� Mangalore� and� additional� 100�

Bed� CPU� at� Chennai� through� our� partners.� All� our� facilities� are� self-identified� to� USFDA.�

Clinical� Data� Management� and� Biostatistics

CRO�

We� provide� comprehensive� Clinical� Data� Management� and� Biostatistics� services� for� early� to� late� phase�

clinical� development� programs.� Our� focus� is� to� expedite� the� process� and� shorten� timelines� through�

innovative� thinking�and�uncompromising�quality.�Our�expertise�covers� a�broad� range�of� therapeutic�areas,�

data�management� technologies,� statistical�methodologies.�Our� team� is�experienced� in�working�on�a� range�

of� platforms,� including� Oracle®� Clinical,� Oracle®� RDC,� Oracle®� InForm,� Medidata� Rave®� ,SAS®� .�We�

are�CDISC�Registered�Solution�Provider.�Our�CRF� templates�are�compliant� to�CDISC�CDASH�standards� for�

data� collection� and�we� have� the� expertise� to� create� custom� CDASH� CRF’s� for� your� entire� protocol.� Our�

integrated� data� service� helps� to� address� this� challenge� through� faster� access� to� reliable� clinical� trial� data�

without� compromising� data� quality� or� accuracy.� Our� in-house� EDC� platform� provides� intuitive,�

user-friendly� interface� for�collecting�and�validation�clinical�data.�This� system� is� ideal� for�multi-centric� trials�

and� provides� solution� to� data� collection� for� phase� IV� studies� cost� effectively.�

Medical� and� Pharmacovigilance� Services

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668� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

CRO�

Our� team� of� dedicated,� professional� medical� writers� offers� a� comprehensive� suite� of� medical� writing�

services.� The� medical� writing� team� consists� of� M.D.,� Ph.D.� and� master’s� level� writers� who� supports� in�

compiling,� organizing,� writing� and� editing� the�wide� range� of�medical� and� scientific� documentation� that�

is� required� to� the�success�of�a�product� in�development.�We�provide�a�wide�array�of� services� starting� from�

Strategic� inputs� for� your� pre-clinical� program� development,� Protocol� writing,� Global� clinical� trial�

applications,� Regulatory� dossier� preparation,� Investigator� brochures,� Scientific� reports� and� summary�

writing,� Informed� consent� forms,� Clinical� study� reports,� Risk� evaluation� and� mitigation� strategies,� Data�

safety�monitoring�board�manuals,�Patient�narratives,�Medical�Data�Review,�Medical�and�scientific� literature�

reviews,�Manuscripts�and�posters.�Through�Pharmacovigilance�we�are�able� to� improve�patient�care,� safety�

and�public�health,�whilst� ensuring� a� rational� and�effective� use�of�medicines� and� therefore�also� providing�

cost� benefits� through� use� of� the� medicines.� Broadly� categorized,� our� Pharmacovigilance� services�

encompass� safety� management,� regulatory� reporting,� andpost-marketing� surveillance,� as� well� as�

technology� support.

Central� Laboratory

CRO�

At� Ecron� Acunova�we� offer� a� host� of� laboratory� services.�We� own� two� of� the� ten� CAP� accredited� labs�

in� India.� The� labs� are� situated� in� Whitefield,� Bangalore,� and� Kasturba� Hospital,� Manipal.� Our� labs� are�

accredited� by� the� College� of� American� Pathologists� (CAP)� and� the� National� Accreditation� Board� for�

Testing� Laboratories� (NABL)� of� the� governmental� Departmentof� Science� &� Technology� pursuant� to� ISO�

15189.

Ecron� Acunova� offers� world� class� services� for�

Central� Lab� testing� service� for� Clinical� Trials�

Patient� Testing� including� molecular� diagnostic� tests�

Pharma� company� research� testing� including� biomarker� validation�

We� conduct�pharmacokinetic� studies,� support� clinical� trials� and�provide� advanced�molecular� and� esoteric�

diagnostic� services� to� patients.� We� offer� custom� tailored� studies� using� molecular� and� cellular� sciences.

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부록 2� �전략적 협력사 디렉토리 ❚ 669

Corporate� Name EKOlab

Head� Office� Address 1� Budennogo� St.,� Elektrogorsk,� Moscow� Region,� 142530,� � � Russia

Web-site� Address http://www.ekolab.ru

Contact E-mail [email protected]

Company� Description� &� Organization

More� than�20� years�our� company�supplies� its�products� to� the�Enterprises�of�Health.� It�was� founded� in�1991�

in�Elektrogorsk� town� (Moscow�Region)�with� the� support�of� the� concern� "Immunogen".�We� started�with� the�

release�of� several�dozen�kits� for�diagnostics�of�HIV�and�Syphilis.�But� soon�after� foundation�we� increased� the�

production� rapidly� and� expanded� the� range� of� products.� As� a� result,� a� small� first� laboratory� became� one�

of� the� leading�Russian�manufacturers�of�diagnostic�products� for� in� vitro�using�and�entered� into� the� top� thirty�

of� Russian� pharmaceutical� producers.

Now� CJSC� "EKOlab"� is� a�modern� industrial� enterprise� with� a� wide� range� of� products,� including�more� than�

300�positions.� The� company�manufactures� immunoassay� test� kits� and�other�medical�diagnostic� kits�used� for�

in� vitro�diagnostics�of� infectious�and�noninfectious�diseases,� kits� for�biochemical,�hematological,�histological,�

microbiological� studies� and� ready� to� use� medicines� such� as� medicinal� tinctures,� syrups� and� oils.

The� structure� of� the� company� includes�Manufacture� of� Diagnostic� Kits� and�Medicines,� Quality� Department,�

Department� of� Biological� Control,� Research� and� Development� Laboratories.� The� company� has� its� own�

distribution� network.� On� the� basis� of� "EKOlab"� are� formed� and� work� subsidiary� distribution� companies:�

"EKOlab�Center"� (Moscow),� "EKOlab-diagnostics"� (Elektrogorsk).�The� company�has� its�own�Diagnostic�Center�

«El'Clinic»� that� successfully� working� in� Elektrogorsk.

The� company� continuously� and� successfully� engaged� in� trades� related� to� placing� an� order� for� the� needs� of�

government�and�municipal�medical� institutions.� Stable� trade� relations� for�export� to� the�CIS� countries:�Belarus,�

Azerbaijan,� Kyrgyzstan,� Uzbekistan,� Tajikistan,� Moldova� and� Armenia� were� established.� CJSC� "EKOlab"� is�

working� closely� with� leading� research� institutes� in� Russia� and� the� manufacturers� of� similar� products� from�

Germany,� Spain,� Britain� and� France,� which� allows� to� continuously� improve� quality� of� products� and� expand�

product� range.

There� was� a� rapid� expansion� of� the� product� range� through� the� creation� of� Research� and� Development�

Department� (1993).� Today� the� company� has� four� Research� and� Development� Laboratories:� The� Laboratory�

of� Immunoassay� Test� Systems,� Laboratory� of� Biochemistry,� Laboratory� of� Protein� Engineering,� Laboratory� of�

Medicines.

37. EKOlab

1.� Corporate� General� Information

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670� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

And� also:

•� laboratory� of� monoclonal� antibodies;

•� laboratory� for� virus� cultivation� (Cytomegalovirus,� Herpes� Simplex� Virus�

Types� I� and� II,� Epstein-Barr� Virus,� Measles� Virus)

•� laboratory�of�bacterial�antigens� (Treponema�pallidum,�Borrelia,� Pertussis,� Parapertussis,�Helicobacter�Pylori�

Infection).

New� developments� are� carried� out� with� participation� of� EKOlab� specialists.�

As� a� result� it� is� a� wide� range� of� products,� which� EKOlab� releases� today.� This� is� a� close� and� fruitful�

cooperation� allows� the� company� to� keep� pace� with� the� times� and� to� take� a� leading� position� among� the�

companies� of� this� profile.

EKOlab� produces� new� and� modern� diagnostic� test-systems:

•� for� diagnostics� diseases� by� means� of� immune� blotting;

•� for� diagnostics� and� confirmation� of� HIV� infection,� Hepatitis� and� ToRCH� infections;

•� a� full� line� of� products� for� the� diagnostics� of� syphilis.

Now� EKOlab� produces� monoclonal� antibodies,� latex� and� IFA� diagnostic� test-systems,� new� biochemical� kits.

“EKOlab”�uses�animal�donors� for� the�production�of�vaccines.� In� this� regard,�our� company�pays�great�attention�

to� the� care� of� laboratory� animals.

At� present� the� company� has� in� its� own� vivarium:

•� 120� sheep� and� goats

•� 1,000� rabbits

•� 1200� guinea� pigs

•� 300� laboratory� mice.

The�quality�of� company�products�are�guaranteed�by� International�Certificates�of�Quality� ISO�9001:2008�and�

ISO� 13485:2003,� obtained� in� 2004� and� confirmed� annually.� As� a� result� of� the� Russian� competition� for� the�

past� five�years,� the�company� "EKOlab"�places�among�the� "Top�100�of�The�Best�Companies�and�Organizations�

in� the� Russian� Federation."

CJSC� "EKOlab"� looks� ahead�with� confidence� and� increases� the� rate� of� development.� This� allows� employees�

to�be�proud�of� their� company�and� look�confidently� into� the� future,� and�gives� customers�assurance� that� they�

have� found� a� solid� and� reliable� business� partner.

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부록 2� �전략적 협력사 디렉토리 ❚ 671

38. Eli Lilly & Co

1.� Corporate� General� Information

Corporate� Name Eli� Lilly� &� Co

Web-site� Address www.Lilly.com

Contact

(Korean� Business)

Name Paul� H.� Huibers

AddressLilly� Korea� Ltd.� 4th� Fl,� STX� Namsan� Tower� 98� Huamro,� Jung-gu� Seoul,�

Korea� Post� Code� 100-958

Telephone 82-2-3459-6587

E-mail [email protected]

2.� Description� of� Collaboration�Opportunities

Collaboration�

Opportunities� for� R&D�

Co-works

We�have� started� contacts�with� the�KDDF� in� order� to� pursue� the�development� of�

drug� assets� which� can� be� made� available� for� Korean� local� development

Collaboration�

Opportunities� for�

In-Licensing

We� continuously� look� at� opportunities� in� Korea� to� see� if� there� are� drug�

candidates� which� are� of� interest� to� license� in.

Collaboration�

Opportunities� for�

Out-Licensing

Typically,�once�we�develop�our�own�drugs�we�do�not�out-license�as�we�have� the�

global� infrastructure� to� launch� the� drugs� ourselves

Collaboration�

Opportunities� for�

Manufacturing

Yes,� we� are� currently� in� negotiations� with� a� local� manufacturing� company� to�

manufacture� one� of� our� products� in� Korea

Collaboration�

Opportunities� for� (Co-)�

Marketing� &� Sales

Yes,� especially� in� the� clinic� sector� we� already� work� with� 2� local� firms

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3.�특허분석 결과

Eli� Lilly� &� Co사의 특허분포도를 볼 때 기술 중에 대표적으로 Protein� Release� Ruminant,� Muscarinic�

Muscarinic� Receptor�Modulation� Cancer,�Hydrogen�Alkyl� Phenyl,� Excitatory� Amino�Receptor� Treatment�

Neurological� Disorder� 등의 키워드를 가진 기술에 많은 특허가 분포하고 있는 것으로 나타났다.

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부록 2� �전략적 협력사 디렉토리 ❚ 673

2006년 01월 01일부터 2012년 12월 10일까지 출원된 Eli� Lilly� &� Co사의 특허의 키워드 분포는 붉은 점으로

나타난다.

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39. Farmak

1.� Corporate� General� Information

Corporate� Name Farmak

Head� Office� Address Ukraine,� 04080� Kyiv,� Frunze� Str.� 63

Web-site� Address http://www.farmak.ua

No.� of� Employees 2320� 명

Contact E-mail [email protected]

Company� Description� &� Organization

Market� leader

-� market� share� in� Ukraine� among� all� manufacturers� of� the� medicinal� products

-� market� share� in� Ukraine� among� domestic� manufacturers� of� the� medicinal� products

Export

-� In� 2013� exports� amounted� to� 17,5%� (increased� by� 23%� as� compared� to� 2012)

-� over� 20� destinations� ­� sales� geography� of� the� medicinal� products

Sales

-� UAH� 1.948� million� � in� 2013� (increased� by� 15%� as� compared� to� 2012)

The� product� portfolio� covers� all� therapeutic� groups� according� to� ATC� classification.� The�main� focus� is� on�

the� 6� groups:

1.� Alimentary� tract� and� metabolism

2.� Cardiovascular� system

3.� Antiinfectives� for� systemic� use

4.� Musculo-skeletal� system

5.� Nervous� system

6.� Respiratory� system

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부록 2� �전략적 협력사 디렉토리 ❚ 675

2.� Additional� Business� Propositions� for� Collaboration

Our� mission

We� improve� the� quality� of� life,� ensuring� human� right� to� get� effective� high-quality� medicines.

Our� vision

We� strive� to� be� the� leader� of� the� national� pharmaceutical� industry� and� a� competitive� player� in� the�

international� markets.

Our� values

-� People

� � We� build� relationships� with� each� employee� based� on� mutual� responsibility� and� trust.� We� unlock� the�

potential� of� each� employee,� ensuring� Farmak's� leadership� and� sustainable� development.

-� Innovations

� � We� understand� innovations� as� constant� improvements.� The� purpose� of� our� focus� on� innovation� is� to�

reach� company's� main� strategic� goals� rather� than� to� get� short-term� benefits.

-� Quality

� � We� use� modern� scientific� achievements� in� order� to� develop� and� produce� medicines.� High� quality�

standards� foster� customers’� loyalty� to� our� products.

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676� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

40. Farmamed

1.� Corporate� General� Information

Corporate� Name Farmamed

Head� Office� Address 5th� Upper� Lane.,� 19� Saint� Petersburg� 194292� The� Russian� Federation

Web-site� Address http://www.farmamedspb.ru

Company� Description� &� Organization

Founded� in� 2003,� and� its� history� from� the� pharmaceutical� trade.

Today� OOO� Farmamed� -� is� actively� developing� a� diversified� pharmaceutical� company� that� produces,� as�ready-made� pharmaceuticals� and� active� pharmaceutical� substances,� leading� his� own� research,� not� only� in�synthesis� technology� and� production,� but� also� in� the� direction� of� search� and� research� of� new� drugs.

Assortment�number�of� companies� -� is� ready�and�drugs� -�nitroglycerine,�Valemidin,�and�active�pharmaceutical�substances:� Unithiol,� Etilmetilgidroksipiridina� succinate,� Yodantipirin,� Howlin� alfostserat,� your� own� original�drug� "Imstikor.

The�main�product�at� the� time�of� foundation�of� the�company�were�Trituratsionnye�nitroglycerin� tablets,�which�for� the� time� of� the� company� in� the� market� have� received� due� recognition� from� the� public.

Nitroglycerin� sublingual� tablets� are� traditionally� for� decades� are� in� great� demand� among� domestic�consumers,� as� well� as� the� post-Soviet� territory.� The� product� combines� the� fast� action� -� in� the� first� seconds�of� the� reception� -� and� the� price� affordable� for� older� people.

From� the� first� days� of� its� activity� the� company� has� been� developing� new�medicines.� The� first� result� of� this�work�was� the� release�of�non-sterile� liquid� forms.�Currently�OOO�Farmamed�produces� jointly�with�"Euromed"�innovative� drug� "Valemidin»� R� -� holistic� medicine� based� on� herbal� tinctures,� providing� antihistaminic,�sedative� and� antispasmodic� action.

Since� 2006� the� company� started� work� on� the� study� and� synthesis� of� active� pharmaceutical� ingredients.� It�was� mastered� by� a� synthesis� of� technologically� complex� products� market� in� Russia� -� Unithiol� -� the� active�ingredient� of� the� popular� drug� "Zoreks,� providing� detoxication� action,� including� in� relation� to� the� product�half-life� of� ethyl� alcohol,� heavy� metals� and� their� compounds.

Another�mastered� in� the�production�of� the� substance�was�etilmetilgidroksipiridina� succinate,�best� known�as�the� finished� product� under� the� trademark� "Meksidol� (Farmasoft).� The� substance� is� part� of� the� preparations�are� widely� used� in� neurology,� surgery,� psychiatry� and� Addiction.

Today�OOO� Farmamed� "-� one� of� the� few� companies� in� Russia� capable� of� fine� organic� synthesis,� apply� and�develop� technology� with� a� complete� cycle� of� the� synthesis� of� pharmaceutical� substances� with� a� modern�industrial� and� technological� equipment,� research� laboratories� and� qualified� personnel.

All� technological�processes�of�production�of�drugs�and�substances�are�organized� to�meet�modern� standards�for� technological� processes� and� production� standards.

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41. Farmproekt

1.� Corporate� General� Information

Corporate� Name Farmproekt

Head� Office� Address 192236,� b.14,� Sofijskaya� str,� Saint-Petersburg,� Russian� Federation

Web-site� Address http://www.farmproekt.ru/

Contact E-mail [email protected]

Company� History

"Farmproekt"� is� a� private� company� that� was� founded� by� graduates� of� Saint-Petersburg� Chemical�

Pharmaceutical� Academy.� In� "Farmproekt"� works� more� than� 150� people.� 8� Phd� in� pharm.st.,� 3� Phd� in�

chem.st.,� 6� PhD� in� med.st.

2001�

Production�was� organized� in� St.� Petersburg� in� 2001� at� 1500�m2,� 300�m2� of� them�were� clean� rooms.� The�

portfolio� of� the� company� had� only� 2� registered� drugs.

2007�

The� company� increased� its� production� facilities.� Required� space� extended� to� 3500� m2,� out� of� which� 1000�

m2� were� clean� rooms.� Product� range� expanded� to� 12� items.

2013�

Now,� the�manufacture� covers�4500�m2,�1500�m2�of�which�are�clean� rooms.�The�portfolio�accounts� for�more�

than� 20� drugs� of� different� types

Company� Description� &� Organization

Our� mission� is� contribution� to� the� prosperity� of� a� healthy� society� � by� providing� the� population� with�

high-quality,� safe� and� affordable� medicine

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678� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name FERANE

Head� Office� Address 117105,� Moscow,� st.� Nagatinskaya,� 1

Web-site� Address http://ferain.com

Contact E-mail [email protected]

Company� History

Close� Joint-Stock�Company� “Brinsalov-A”� (“Ferane”)� is� former� Ferreins’� Pharmaceutical� Factory,� established� in�

1912.�Nowadays,� the�doubled�company’s�name� is�used� -�Close� Joint-Stock�Company� “Brinsalov-A”� ­� “Ferane”.

After� the� Russian�October� Revolution,� in� 1918,� the� Factory� has� been� nationalized.� Despite� of� the� Civil�War�

and� devastation� in� the� country,� the� Factory� raises� its� production� values.�

In� 1922� it� was� named� after� Lev� Karpov,� the� prominent� public� man� and� politician,� the� founder� of�

chemical-pharmaceutical� industry� of� the� USSR.

During� pre-war� period,� till� 1941,� the� year� of� the� beginning� of� Great� Patriotic� War,� the� Factory� reaches�

prominent� production� and� scientific� success.� It� becomes� the� experimental� platform� for� new� methods� of�

chemical� and� pharmaceutical� medicines� developing� and� introduction.� For� example,� in� 1923� the� Factory�

introduces� the� new� method� of� lactic� acid� production.� Later� the� method� has� been� taken� as� basic� for� the�

production�of� lactic�acid�at�other� factories�of� the� country.�Before� that� the� lactic�acid�has�been� imported� from�

other� countries.� During� the� described� period� the� factory� produces� 24� pharmaceutical� products� and� about�

75� reagents.

During� of� the� Great� Patriotic� War� (June,� 22,� 1941� -� May,� 9,� 1945)� the� Karpov� Factory� continues� the�

production.�The�military�1944�year�becomes� significant� for� the�Factory,� as� it�has�produced� the� first� thousand�

vials� of� penicillin.� The� researchings,� the� soviet� scientists� has� started� in� 1942,� result� in� industrial� production.�

The� personnel� and�workers� of� the� Factory� contribute� into� the� improvement� of� purification� and� creation� of�

methods�of�dry�penicillin�elaboration.� The�beginning�of�penicillin� industrial�production� in� the�USSR�has�been�

initiated.

Further� postwar� decades� (40� ­� 80� years� of� XX� century)� the� Factory� is� actively� developing� and� proving� its�

42. FERANE

1.� Corporate� General� Information

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technical� and� scientific� base.

The� 90� years� of� the� XX� century� the� USSR� disappears� and� the� new� country� appears� on� the�World’s� map� ­�

Russia.� These� years,� the� years� of� Perestroika,� do� not� favour� the� development� of� the� economics� of� the� new�

Country.� The� Factory� also� bears� difficult� times.� In� 1987� Vladimir� Brinsalov� starts� run� the� Factory.� He�makes�

large� investments,�keeps� its� specialization,�working�places,� actively� reorganizes�and� re-equips� it.� These�actions�

give� good� results� ­� the� Factory� stands� the� test.

� ZAO� “Brinsalov-A”� is� the� first� pharmaceutical� production� company� in� Russia,� which� gets� GMP� certificate.�

In�2005� it�gets� the�Certificate�#�РОСС�RU.3070.04ПР01.ОС51.С087�of� compliance�of�medicines�production�

to� the� demands� of� GOST� R� 52249-2009� and� EU� Guidelines� to� Good� Manufacturing� Practice� Medicinal�

Products� for� Human� and� Veterinary� Use”� (GMH� EU).

But� the�Company� could� not� avoid� the� difficulties.�Against� the� background�of�world� financial� crises� in� 2008�

it� has� to� reduce� the� production.� But,� in� 2010� the� Company� accepts� the� program� of� product� range�

enlargement.

At� present� the� Company� actively� realizes� the� program� of� creation� of� modern� production� of� the� whole�

spectrum� of� anty-tubercular�medicines.� At� the� same� time�with� anty-tubercular�medicines� ZAO� “Brinsalov-A”�

has� the� range� of� successful� projects.� These� are� the� patented� effective� medicines� for� the� cardiovascular�

diseases� therapy.

Paying� great� attention� to� the� innovations,� ZAO� “Brinsalov-A”� keeps� developing� its� traditional� trend� ­�

antibiotics� production.

The� Company� also� produces� anty-coagulants� and� coagulants,� analgesics,� anticancer� medicines,�

hondroprotectors,� vitamins� and� vitamin-like� medicines.

ZAO� “Brinsalov-A”� constantly� enlarges� the� production� of� medicines� from� the� Strategic� Medicines� List� and�

develops� new� medicines� on� the� basis� of� Federal� Goal-Oriented� Program� “Pharma� -� 2020”.

Company� Description� &� Organization

We� are� working� for� creation� and� production� of� highly� effective� and� qualitative� drugs,� which� meet� the�

demands� of� the� modern� medicine.

� Our� goals:

-� creation� of� strong� domestic� pharmaceutical� industry� capable� to� fill� the� Russian� market� with� vital� drugs;

-� creation� of� extensive� delivery� network� of� drugs� to� all� regions� of� Russia.

Our� activity� meets� the� requirements� of� our� clients.� We� believe� that� our� success� depends� on� our�

understanding� of� the� Russian� clients’� needs.

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We� bear� high� corporate� responsibility� ­� all� our� products� meet� the� highest� international� demands.

ZAO�“Brinsalov-A”�bears� the�Quality�Management�System�of�elaboration,�production,� storage�and�distribution�

of� products,�meeting� the� demands� of�GOST� R� ISO9001-2008� (ISO�9001:2008)� Certificate� of�Conformity�№ �

ROSS� RU.IS04.К00307,� and� GMP� Certificate� of� drugs� production� conformity� to� the� GOST� R� 52249-2004�

demands� №� ROSS� RU.3070.04PR01.ОС51.С087� and� “EU� Guidelines� to� Good� Manufacturing� Practice�

Medicinal� Products� for� Human� and� Veterinary� Use”� (GMH� EU).

All� the� shops� are� ecologically� friendly.� They� are� equipped� with� modern� dust,� gas� and� wastes� collection�

systems,� meeting� high� world� standards.

The� Company� is� especially� proud� of� its� strict� quality� control� system� of� the� products.� No� product� will� be�

delivered� to� you� without� careful� chemical,� microbiological� and� pharmacological� tests.� The� Factory� has� its�

own� Quality� Control� Department.

We� invest� into� the� production� development� and� into� introduction� of� new� medical� technologies.

� The�enlargement�of� the� range�of�products� is� the� constant�and� systematic� activity�of� the�Company,�but� the�

production� of� vital� drugs� is� in� its� priority.

Together� with� the� production� enlargement� the� Company� constantly� improves� the� production� technologies�

of� new� drugs.� These� questions� are� solved� by� the� laboratories� of� ZAO� “Brinsalov-A”� ­� “Ferane”,� its� Research�

and� Production� Department� in� collaboration� with� the� leading� Russian� and� foreign� institutions� and�

companies.

2.� Additional� Business� Propositions� for� Collaboration

Our� mission� ­� nations’� health� amendment� through� the� development� of� new� and� constant� improvement�

of� our� traditional� drugs’� production� forms.

We� constantly� perfect� the� scientific� and� technical� potential� of� the� Company� through� growth� of� its�

personnel� qualification� and� the� development� of� the� cooperation� with� the� physicians.

We�aspire� to�build�high� technological�and�socially�oriented�Company,�which� responses� to� the� requirements�

and� needs� of� each� patient.

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부록 2� �전략적 협력사 디렉토리 ❚ 681

Corporate� Name Ferrer� Argentina� S.A.

Head� Office� Address Arismendi� 2441� C1427� -� Capital� Federal

Facilities� City� &� Country Argentina

Web-site� Address www.ferrergrupo.com

Contact

(Korean�

Business)

E-mail [email protected]

Company� History

1959:� Foundation

� Ferrer� starts� a� new� era� under� the� leadership� of� Carlos� Ferrer� Salat� (b.1931-d.1998),� an� important� figure�

in� the�history�of�contemporary�Spain.�Among�his�many�achievements,�he�was� founder�and�Chairman�of� the�

CEOE� (the� Spanish� confederation� of� business� organizations)� and� President� of� the� European� Economic� and�

Social� Committee.� But� his�most� important� legacy� in� the�world� of� business�was� Ferrer� itself.� He� imbued� the�

company� with� his� singular� vision� of� success� based� on� innovation� and� internationalization.�

The� 60s:� Consolidation

� It�was� this�philosophy� that� led�Ferrer,�during� the�1960s,� to�become�a�major�player� in� the�Spanish�domestic�

market.� This� expansion� was� largely� a� consequence� of� the� company’s� own� research,� discovering� and�

developing� a� number� of� important� medicinal� products.�

The� 70s:� Internationalization,� integration� and� innovation

� The� early� 1970s� saw�Carlos� Ferrer� Salat’s� belief� in� Europe� and� the� importance� of� opening� Spain� up� to� the�

world� put� into� practice.� Ferrer� started� its� international� expansion� by� acquiring� Trommsdorff� GmbH,� a�

German� pharmaceutical� company� founded� 1797� near� Aachen� in� North� Rhine-Westphalia.� Its� new�

manufacturing� plant� was� opened� in� 1975.� The� process� of� internationalization� continued� with� the�

establishment� of� affiliates� in� the� important� emerging� markets� of� Latin� America.�

� Towards� the� end� of� the� decade,� Ferrer� moved� towards� full� vertical� integration� with� the� founding� of� two�

fine� chemicals� companies.�Exquim� (1976)�commercialized� fine� chemical� raw�materials� and� Interquim� (1978)�

manufactured� active� pharmaceutical� ingredients� (APIs)� and� intermediates.�

� As� ever,� the� commitment� to� innovation�was� continual;� 1977� saw� the� inauguration�of� a� new�purpose-built�

43. Ferrer Argentina S.A.

1.� Corporate� General� Information

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682� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

R&D� centre� in� Barcelona,� equipped� and� organized� to� carry� out� pharmaceutical� research� from� discovery� all�

the� way� through� to� registration.�

The� 80s:� Research,� commitment� and� diversification

� The� importance� of� innovation� to� Ferrer�was� further� demonstrated� in� 1984� by� the� establishment� the� Ferrer�

Research� Foundation� (Fundación� Ferrer� Investigación)� with� its� biannual� Severo� Ochoa� Prize� for� biomedical�

research.�

� Ferrer� also� maintains� a� longstanding� commitment� to� industrial� activity,� and� the� importance� of� ensuring�

vertical� integration� lead� to� the� implementation� of� good� manufacturing� practice� (GMP)� in� all� of� Ferrer’s�

manufacturing�plants.� This� focus�on�quality�manufacturing�put� the�company�at� the� forefront�of� technology.�

� Diversification� continued� with� the� acquisition� in� 1988� of� Zoster,� a� world� leader� in� the� extraction� of�

chemicals� from� vegetable� sources� for� the� food� and� pharmaceutical� sectors.� The� expansion� of� Medir� Ferrer�

and�Ferrer�Alimentación� further� strengthened�the� company’s�presence� in� the� food�additive�and� fine�chemical�

sectors

The� 90s:� Development� and� growth

� The� 90s� saw� one� of� the� most� important� developments� in� Ferrer’s� presence� in� the� pharmaceutical� sector,�

with� the�opening�of� its�hospital� sales�business�unit.� This� strategic� line� focuses�on�advanced� technologies�and�

therapies� in� the� fields� of� oncology,� intensive� medicine� and� palliative� care.� Its� pharmaceutical� products,�

medical� devices� and� hospital� equipment� now� represent� nearly� 20%� of� total� company� sales.�

� Further� improvements� in� technology,� research� and� manufacturing� in� the� chemical� division� served� to�

reinforce� Ferrer’s� presence� in� the� food� sector.�

Since� 2000:� Accomplishment,� expansion� and� sustainability

� By� the� start� of� the� new� millennium� Ferrer,� now� under� the� leadership� of� Sergi� Ferrer-Salat,� had� already�

established� itself� as� one� of� the� top� Spanish� innovative� pharmaceutical� companies.� During� the� following�

decade,� this� position� was� consolidated� by� eight� consecutive� years� of� double-digit� growth.�

� At� the� same� time,� new� subsidiaries,� joint� ventures� and� acquisitions� in� Southern� Europe� and� Latin�America�

extended� Ferrer's� international� presence.� International� sales� now� represent� nearly� 50%� of� the� total.�

� Ferrer�has�also�made�a�number�of� key�acquisitions� in�prescription,�OTC,� vaccinations,�chemicals� and�animal�

nutrition.� The� launch�of� Ferrer� inCode� in� the� fields� of�molecular� diagnostics� and�personalized�medicine� has�

taken� the� company� in� new,� cutting-edge� directions.� Now� Ferrer’s� products� and� services� cover� the� entire�

healthcare� spectrum.�

� But� this� expansion�has�been�combined�with�an� increased�awareness�of� the�question�of� sustainability.�Across�

Ferrer’s� many� centres,� environmental� concerns� are� prioritized,� with� the� highest� standards� applied� to�

manufacturing� processes� and� relevant� certification� being� implemented� across� the� board.�

� Ferrer’s� state-of-the-art� logistics� centre� and� the� enlargement� of� the� pharmaceutical� manufacturing� centre�

have�been�designed�to�obtain�Leadership� in�Energy�and�Environmental�Design� (LEED)�accreditation�awarded�

by� the� US� Green� Building� Council� for� environmentally� sustainable� construction.�

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부록 2� �전략적 협력사 디렉토리 ❚ 683

Company� Description� &� Organization

The� values� of� success

Maintaining� Ferrer’s� sustained� success� means� staying� true� to� our� convictions.� As� a� privately-held� company,�

Ferrer� can� focus� on� long-term� economic,� social� and� environmental� sustainability,� not� just� short-term� gains.

� We� have� to� align� our� strategies,� our� priorities� and� our� products�with� an� ever-changing�world.�We� believe�

that� the� future� requires� innovation,�diversification,�partnership�and�efficiency.�But�our�mission�and�our�values�

stay� constant.

� They� provide� the� foundations� that� have� made� Ferrer� a� trusted� and� respected� organization.� And� they� will�

drive� us� forward,� together� with� our� patients,� our� clients� and� our� partners.

Mission

To� advance� the� wellbeing� of� society.

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684� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

44. G. C. CHEMIE PHARMIE LTD

1.� Corporate� General� Information

Corporate� Name G.� C.� CHEMIE� PHARMIE� LTD

Web-site� Address www.gccpl.com

Contact

(Korean� Business)

Name Mrs.� Mita� Desai

Address5/C,�Shree�Laxmi� Indl�Estate,�New�Link�Road,�Andheri� ­� (West)�Mumbai�

(Bombay)� -� 400053

Telephone 00� 91� 22� 26330365

E-mail [email protected];� [email protected]

2.� Description� of� Collaboration�Opportunities

Collaboration�

Opportunities� for�

In-Licensing

Products� of� interest:� Vaccines,� mAbs,� Biotechnology� based� products.�

Collaboration�

Opportunities� for� (Co-)�

Marketing� &� Sales

Interested� companies� can� contact� us� for� India� market.�

3.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

Our� company� can� register� APIs,� Finished� formulations� and� market� same� in� India.�

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부록 2� �전략적 협력사 디렉토리 ❚ 685

Corporate� Name GalenoPharm

Head� Office� Address 191� 144,� St.� Petersburg,� Moiseenko� st.,� 24-a

Web-site� Address http://www.galenopharm.ru/

Contact E-mail [email protected]

Company� History

The� pharmaceutical� factory� of� St.� Petersburg� is� one� of� the� oldest�manufacturing� enterprises� in� this� sphere.�

Being� founded� in�1935� in� Leningrad,� the� Second� Pharmaceutical� Factory�named�after�D.M.�Mendeleev�was�

established� for� provision� of� Leningrad� inhabitants� with� necessary� drugs.�

In� the� years� of� the�Great�Patriotic�War,� the�majority� of� pharmaceutical� factories�of� Leningrad,�Moscow�and�

other� cities� were� evacuated.� The� Second� Pharmaceutical� Factory� continued� to� work� in� the� besieged� city.�

During� the�harsh�war� time,� the� factory� continued�manufacturing�essential�products.�The� factory� staff�packed�

medicinal� herbs,� powders,� antiseptic� solutions� for� the� Front,� for� city� inhabitants� and� for� wounded� men� in�

hospitals.� It� made� a� big� contribution� to� the� Great� Victory.�

Three� months� before� the� end� of� the� War,� a� galenical� production� was� established� which� gave� the� factory�

its� name.�

At� the� Leningrad� Galenical� Factory,� tinctures� and� ointments� were� produced,� powders� were� packed� -� the�

range� of� products� became�wider� year� after� year.� At� the� end� of� 1950s,� ampoule� production�was� launched.�

During� its�glorious�history,� the� factory�provided� inhabitants�of� the�city� and�country�with�highly�effective�and�

inexpensive� drugs.� The� products� of� the� famous� Leningrad� Factory� were� considered� as� the� quality� standard�

and� have� always� been� in� great� demand� among� population.� Numerous� well-known� tinctures� and�medicinal�

agents� were� developed� and� manufactured� by� the� factory� specialists.� Employees� of� profile� enterprises� from�

all� over� the� country� came� to� Leningrad� to� adopt� the� best� practices,� learn� principles� of� organization� for�

pharmaceutical� manufacturing� facilities� and� scientific� organization� of� labor.�

In� 1994,� the� factory� was� privatized� and� became� a� join� stock� company.�

In� 2000,� the� factory� launched� cosmetic� series� 5� days®� for� foot� care,� which� became� the� best� seller� among�

products� of� the� given� market� segment� in� Russia.� At� that� time,� we� started� to� sell� tincture�

45. GalenoPharm

1.� Corporate� General� Information

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686� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

“Echinacea-GalenoPharm®”-an� immunostimulating� agent� of� plant� origin.�

In� 2002,� on�manufacturing� site� for� solid�dosage� forms,�we� launched�manufacture� of� powder� dosage� forms�

in� sachet,� started� production� of� drug� Flucoldin®-� agent� for� symptomatic� treatment� of� influenza-like� states�

and� ARVI.�

2003� was� remarkable� with� launch� of� drug� Eucasept®� in� the� market� (nasal� drops� for� acute� and� chronic�

rhinitis),� and� also� drug� Sodecor®� (anti-inflammatory,� general� tonic� agent,� increases� non-specific� resistance�

of� organism,� promotes� increase� of� mental� and� physical� capability).�

In� 2005,� series� of� cosmetic� agents� Galenopharm®� appeared.� Manufacturing� equipment� and� employed�

packaging� materials� were� consistent� with� the� highest� quality� standards.� All� cosmetic� agents� were�

manufactured� in� line� with� international� rules� of� pharmaceutical� manufacture� ­� GMP.�

In� 2007,� we� received� the� patent� and� started� manufacture� of� drug� Galenofillipt®� -� antimicrobial� agent� of�

plant� origin,� antiviral� drug� Gervirax®� came� to� the� market.�

During� the� last� years,� the� strategic� trend� of� the� factory� -� activity� in�manufacturing� application� of� drugs� for�

treatment� of� bronchial� asthma� (BA)� and� chronic� obstructive� pulmonary� disease� (COPD).� In� 2009,� the� first�

non-freon� aerosol� drug� Beclospir®� was� registered� in� Russia.�

Since� its� foundation,� the� factory� has� been� working� in� constant� cooperation� with� the� Leningrad�

Chemical-Pharmaceutical� Institute� (now�the�State�Chemical� and�Pharmaceutical�Academy�of�St.� Petersburg).�

Nowadays,� the�Pharmaceutical� Company�of� St.� Petersburg� cooperates�with� the�State� Institute� for� Preclinical�

and� Clinical� Expertise� of� Medicinal� Products,� Institute� of� Human� Brain� RAS,� Institute� of� Nutrition� RAMS;�

Research� Institute� of� Influenza� RAMS;� Research� Institute� of� Pulmonology� at� the� Federal� Medical� and�

Biological� Agency;� S.� M.� Kirov� Military� Medical� Academy� at� the� Ministry� of� Defense� of� the� Russian�

Federation;� Russian� R.R.� Vreden� Research� Institute� of� Traumatology� and� Orthopaedics;� SEI� HPE�

“Saint-Petersburg� State� I.� P.� Pavlov� Medical� University”� and� other� large� Russian� and� foreign� medical� and�

pharmaceutical� companies� and� scientific� centers.�

We�have�gained� the�unique�set�of� scientific�developments,� knowledge�and�experience.� It� is�how�the� factory�

has� started� the� innovative� development,� successful� modernization� of� manufacture� facilities� and� moved� on�

to� formation� of� modern� pharmaceutical� technologies.

Company� Description� &� Organization

Pharmaceutical� factory�of� St.� Petersburg� is�one�of� the�oldest�manufacturing�enterprises� in� this� sphere.� It�was�

founded� in�1937� in�Leningrad,�as� second�pharmaceutical� factory�named�after�D.M.�Mendeleev.� In� the� future�

it� became� Pharmaceutical� Factory� of� St.� Petersburg,� was� intended� for� providing� people� of� Leningrad� and�

its� region� with� necessary� drugs.� With� the� beginning� of� the� war,� the� enterprise� had� to� deal� with� more�

responsible� and� difficult� tasks.

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부록 2� �전략적 협력사 디렉토리 ❚ 687

During� the�World�War� the�majority�of�pharmaceutical� factories�of�Leningrad,�Moscow�and�other�cities�were�

evacuated.�The�Second�Pharmaceutical� Factory� remained� in� the� city� and�continued� to�work.�During� the�war�

the� factory� continued� to� produce� necessary� for� life� of�millions� people� supplements� and� goods.� The� factory�

staff� packed� medicenal� herbs� and� powders� for� the� Front,� for� city� inhabitants� and� for� wounded� men� in�

hospitals.� It� made� a� big� contribution� to� the� Great� Victory.

Three�months�before� the�end�of� the�War�a�galenical�production�was�started.�Pharmaceutical�medicines�and�

drugs,� produced� from� raw� material� of� natural� origin� were� manufactured� then.

Tinctures,� ointments� and� powders� were� produced� by� the� Leningrad� Galenical� Factory� and� the� range� of�

products� became� bigger� every� year.� At� the� end� of� 1950s� ampoule� production� was� launched.�

� In� January� 1970� the� factory� was� renamed� into� State� Enterprise� “Pharmaceutical� Factory”.

During� its� glorious� history� the� factory�provided� inhabitants� of� the� city� and� country�with� highly� effective� and�

affordable�drugs.�The�product�of� the� famous� Leningrad�Factory�was� considered�as�a� standard� for�quality� and�

has� always� been� in� great� demand.�Many� popular� and�well� known� tinctures� and�medicines�were� developed�

and� manufactured� by� our� factory� experts.�

Employees� of� the� industrial� factories� from� all� over� the� country� came� to� the� Leningrad� enterprise� to� adopt�

the�best�practices,� to� learn� the�principles�of� the�pharmaceutical� industry� structure�and� scientific�organization�

of� labor.�

1994� the� factory� was� privatized� and� became� a� join� stock� company.�

Since� its� foundation� the� company� has� been� working� in� constant� cooperation� with� the� Leningrad�

Chemical-Pharmaceutical� Institute� (now�the�State�Chemical� and�Pharmaceutical�Academy�of�St.� Petersburg).�

Today� the� Pharmaceutical� Company� of� St.� Petersburg� is� cooperating� with� such� renowned� scientific�

establishments,� as:� the�State� Institute�of�Pre-clinical� and�Clinical�Drug�Examination;�with� Institute� of�Human�

Brain�RAS;� Institute�of�Nutrition�RAMS;�SRI�of�Flu�RAMS;�SRI�of�Pulmonology�Federal�Medical� and�Biological�

Agency;�Army�Medical�College�of�Defense�Ministry�of�Russia�named�after� S.M.Kirov;�Russian�R.R.�Vredensky�

Research� Institute� Traumatology� and� Orthopaedics;� SEI� HPE� Sankt-Petersburg� State� I.� P.� Pavlovsky� Medical�

University� and� with� many� other� big� Russian� and� foreign� medical� and� pharmaceutical� establishments.� This�

cooperation� made� it� possible� to� gain� a� unique� collection� of� scientific� developments,� knowledges� and�

experience.� It� is� this� very� experience,� that� helped� the� company� to� survive� the� difficult� years� of� perestroika,�

to�get�on� the� innovative�path�of�development�and� to� successfully� start� the�modernization�of�production�and�

move� on� to� the� creation� of� pharmaceutical� technology� of� new� age.

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688� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

46. GENOSCO

1.� Corporate� General� Information

Corporate� Name GENOSCO

Web-site� Address WWW.GENOSCO.COM

Contact

(Korean� Business)

Name JONG� SUNG� KOH

Address 767C� Concord� Avenue� 2ndFloor

Telephone 617-448-6737

E-mail [email protected]

2.� Description� of� Collaboration�Opportunities

Collaboration�

Opportunities� for�

Out-Licensing

Rheumatoid� Arthritis:� SYK� Project,� Acute� Myeloid� Leukemia:� FLT3� Project,�

Parkinson’s� Disease:� LRRK2� Project:� 공동연구,� Project� Financing,� 지분투자

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부록 2� �전략적 협력사 디렉토리 ❚ 689

47. GEROPHARM

1.� Corporate� General� Information

Corporate� Name GEROPHARM

Head� Office� Address 197022,� Saint� Petersburg,� Akademika� Pavlova� Street,� 5

Web-site� Address http://geropharm.com

Contact E-mail [email protected]

Company� Description� &� Organization

GEROPHARM� is� a� resident� of� a� pharmaceutical� cluster� in� St.� Petersburg� and� Biopharmaceutical� cluster�

"Northern"� in� the�Moscow� District.� During� the� last� two� years� the� company� has� been� rated� by� "TehUspeh"�

in� the� category� of� Russian� high-tech� growth� companies� twice� -� in� 2012� as� the� TOP� 30th� and� in� 2013� as�

the� TOP� -10th.� In� addition,� GEROPHARM� is� a� member� of� the� Russian� Pharmaceutical� Manufacturers’�

Association,� the� Russian� Chamber� of� Commerce� and� a� member� of� Non-Commercial� Partnership� "Medical�

and� Pharmaceutical� Projects.� XXI� Century".

GEROPHARM� develops� and� produces� Russian� innovative� drugs� for� treatment� of� socially� significant� diseases�

as� well� as� some� generics� that� have� priority� in� terms� of� import� replacement.� The� strategic� goals� of�

GEROPHARM�align�with� the�main� tasks� facing� the� industry� today�within� the� framework�of� the� state� federal�

programs� PHARMA-2020� and� BIO� -2020.

GEROPHARM� Group� of� Companies� consist� of:

•� GEROPHARM� Ltd� ­� the� headquarter� company:� defines� the� business� development� strategy,� engages� in�

manufacturing,� as� well� as� responsible� for� sales� and� marketing� of� its� drug� product;

•� GEROPHARM-Bio� (formerly� named� "National� Biotechnology")� ­� the� first� Russian� manufacturer� of� a�

genetically� engineered� human� insulin,� where� the� protein� production� is� done� on� a� full-cycle� basis:� from �

a� scratch� substance� to� a� finished� filled� drug� form;

•�Pharm-Holding� ­� is� a�R&D�core�center:� specializes� in�all� aspects�of�drug�and�pharmaceutical�development�

and� its� industrial� applications.

Detailed� information� about� GEROPHARM:

•� More� than� 12� years� at� the� pharmaceutical� market

•� Investment� projects� in� regional� clusters,� which� have� priority� in� terms� of� import� substitution

•�Creation� of�modern� pharmaceutical� infrastructure� ­� R&D� centre� and� high-tech� production� of� a� full� cycle�

according� to� GMP� standards

•� Some� of� the� projects� in� the� drug� development� are� funded� by� the� federal� programs� from� the� Russian�

Ministry� of� Industry� and� Trade� as� well� as� the� Ministry� of� the� Education� of� the� Russian� Federation

•� The� company� is� registered� in� 13� neighboring� countries,� has� 5� offices� in� CIS� countries

•� Open� dialogue� with� all� target� audiences

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690� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

2.� Additional� Business� Propositions� for� Collaboration

OUR� MISSION� :

-� By� living� up� to� the� latest� advances� in� the� pharmaceutical� technologies� we� develop� and� manufacture�

effective� medicines� thus� create� better� future.�

VALUES� THAT� WE� SHARE� :

-� We� care� about� people`s� health�

-� Quality� above� all�

-� Professionalism� and� shared� responsibility�

-� Development� of� Russian� pharmaceutical� industry�

-� Openness�

To� Partners

General� description� of� the� strategy� and� working� conditions� with� distributors�

General� information� :

“Geropharm”� Ltd.� sells� its�products� in�Russia� through�the� “Club�of�distributors”� -� a�group�of� large�national,�

interregional� and� regional� pharmaceutical� distributors.�

� We� seek� to� create� long-term� partnerships� with� our� distributors,� which� are� based� on� a� mutual� interest�

in� advancing� Geropharm� products.�

Bonus� system� :

For� these� purposes� we� have� created� a� flexible� bonus� system� that� allows� you� to� take� into� account� the�

outstanding� characteristics� of� each� partner.� The� bonus� system� takes� into� account:�

Implementation� of� a� procurement� plan;�

Compliance� with� the� financial� discipline;�

Marketing� efforts� to� promote� Geropharm� medical� products;�

Assistance� in�obtaining� information�on� the� sale�of�Geropharm�medical�products,�which�are�on� the�market.�

To� Potential� distributors� :

“Geropharm”� Ltd� is� interested� in� attracting� partners� who:�

actively� develop� hospital� sales;�

have� strong� positions� in� local� markets;�

have� marketing� resources� for� promoting� medical� products� produced� by� “Geropharm”� Ltd.�

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부록 2� �전략적 협력사 디렉토리 ❚ 691

48. Gramon-Bago de Uruguay S.A.

1.� Corporate� General� Information

Corporate� Name Gramón� -� Bagó� de� Uruguay� S.A.

Head� Office� Address Av.� Joaquin� Suárez� 3359� Montevideo� 11700� Uruguay

Facilities� City� &� Country Uruguay

Web-site� Address www.gramonbago.com.uy

Contact

(Korean�

Business)

E-mail [email protected]

Company� History

Gerardo� Ramón� y� Cía.� S.A.� was� founded� in� 1931� by� Mr.� Gerardo� Ramón,� a� Spanish� immigrant� from�

Barcelona.� It� started� as� an� individual� company,� then� it� became� a� collective� society� and� finally� a� joint-stock�

company.

It�was� situated� in� different� addresses� in�Montevideo,� until� in� 1954�when� it� become�Gerardo� Ramón� y� Cía.�

S.A.�and� settled� in� its�present� location�of�Avda.� Joaquín�Suárez�3359.� From�this� year�on,� it� started�a�growing�

period� that� placed� it� between� the� main� companies� of� the� Pharmaceutical� Market.�

In� 1992,� it� took� place� the� association�with� Laboratorios� Bagó� S.A.� from� Argentina,� a� company� founded� in�

1934;� coincidently,� by� immigrants� from� the� same� origin,� becoming� later� one� of� the� leading� companies� in�

the� Argentinean� pharmaceutical� industry.

From� the� joining�of�both�companies,� since�1992,�Gramón�Bagó�de�Uruguay�S.A.�appeared,�and� it� continues�

locating� itself�between� the� 10�main� companies� of� the�market,� in� spite� of� joints� that�had� taken�place� in� the�

Pharmaceutical� Industry� in� the� last� years.�

Company� Description� &� Organization

The� company� has� its� own�plant�with� areas� for� the�manufacturing�of� tablets,� pills,� capsules,� liquids,� creams,�

and� suppositories,� as� well� as� an� important� Quality� Control� Department� and� a� Department� for� the�

Development� of� New� Products.

Although� it� is� situated� in� Montevideo,� which� is� in� the� south� of� the� territory,� the� sales� force� enables� the�

company� to� visit� the� whole� country,� making� a� fluent� and� permanent� contact� with� physicians,� pharmacists,�

and� medical� centers.�

Gramón� Bagó� de� Uruguay� S.A.� has� more� than� 140� employees,� distributed� over� the� different� areas� of� the�

company,� giving� great� importance� to� the� technical� and� professional� education� of� its� human� resources.

Fifteen�per� cent�of� the�staff�has�a�University�degree�and,�according� to� their� specializations,� they�are�working�

in� the�different�areas�of� the� company.� In�addition,� there� is� a�high�number�of� staff�members� in� intermediate�

ranks� with� university� education� or� equivalent� studies,� who� have� intermediate� degrees� in� different�

specializations.

Gramón�Bagó� is�part�of� the�Bagó�Organization�present� in�all� Latin�America,�which�enables�a� fluent�exchange�

of� scientific� knowledge� and� a� permanent� updating� of� news� of� the� different� markets.

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692� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

49. GlaxoSmithKline

1.� Corporate� General� Information

Corporate� Name GlaxoSmithKline

Web-site� Address www.GSK.com

Contact

(Korean� Business)

Name Ki� Lyong� Bae

Address 9thFloorLSYongsanTower191,Seoul,Korea

Telephone 82� 2� 709� 4155

E-mail [email protected]

2.� Description� of� Collaboration�Opportunities

Collaboration�

Opportunities� for� R&D�

Co-works

GSK� is� looking� for� the� asset� of� oncology,� chronic� disease,� and�

biopharmaceutical� products� in� the� early� stage.� GSK� is� interested� in� advanced�

technologies� as� well.� For� effective� management� of� collaboration,� GSK� set� up�

the�organization,� called�wwBD�Asia� in�China,� looking�after�any�opportunities� in�

Asia� since� 2010.� GSK� is� open� to� all� types� of� collaboration� including� R&D�

co-development.

Collaboration�

Opportunities� for�

In-Licensing

GSK� is� searching� the� collaboration� opportunities� for� in-licensing� of� innovative�

assets� and� technologies

Collaboration�

Opportunities� for�

Out-Licensing

GSK� is� willing� to� discuss�with� any� potential� business� partners� for� collaboration�

opportunities� on� out-licensing� opportunities� if� there� are� any� business� cases.

Collaboration�

Opportunities� for�

Manufacturing

GSK� is� willing� to� discuss�with� any� potential� business� partners� for� collaboration�

opportunities� on� manufacturing

Collaboration�

Opportunities� for� (Co-)�

Marketing� &� Sales

GSK� has� been� managing� various� business� deals� such� as� co-marketing,�

co-promotion,� in-licensing�and�out-licensing.�GSK�has�also�been� looking� for�any�

types� of� deals� with� both� multi-national� company� and� local� company.

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부록 2� �전략적 협력사 디렉토리 ❚ 693

3.�특허분석 결과

GlaxoSmithKline사의 특허분포도를 볼 때 기술 중에 대표적으로 Compounds� Herein� Methods� Calcilytic�

Compouns,� Diseases� Benefiting� Inhibition� Antagonists� Hif� Prolyl� Enzyme� Anemia� Example,� Kinase�

Inhibitors� Containing�Well� Processes�Oxazole�등의 키워드를 가진 기술에 많은 특허가 분포하고 있는 것으로

나타났다.�

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694� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

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부록 2� �전략적 협력사 디렉토리 ❚ 695

50. GUANGDONG BOHONG MEDICINE CO., LTD.

1.� Corporate� General� Information

Corporate� Name GUANGDONG� BOHONG� MEDICINE� CO.,� LTD.

Web-site� Address www.gdbhyy.com

Contact

(Korean� Business)

Name Ms.Lilian� Lo/Ms.Nancy� Zhong/Ms.Melody� Wang

Address2nd� Floor,� #71� LeJia� Road,� BaiYun� District,� GuangZhou,� 510403,�

China

Telephone 0086-20-86342636/86337043

E-mail

[email protected]

[email protected]

[email protected]

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696� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

2.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

GUANGDONG�BOHONG�MEDICINE�CO.,� LTD� is� a�GSP�certified� company,�which� is� an� integrated�enterprise�

with�R&D,�manufacturing,�marketing,�distribution,� importation�&�exportation.� The�products� involve� in�Active�

Pharmaceutical� Ingredients,� Pharmaceutical� Intermediates,� Finished� Products,� Herbal� Extracts,

Excipients,� Medical� Equipments� etc.

BOHONG�was�established� in�2002,�which� is�mainly�committed� to� introduction�of�new�pharmaceuticals� from �

abroad� and� exporting� pharmaceuticals� to� the� world,� as� well� as� developing� and� manufacturing� of� new�

drugs.� Our� goal� is� to� set� up� a� bridge� of� pharmaceuticals� between� China� and� the� world,� and� to� provide�

affordable� and� innovative� medicines� to� our� customers.�

BoHong� has� established� an� extensive� relationship� with� a� majority� of� famous� international� pharmaceutical�

manufacturing� companies� and� local�manufacturers.� Currently,� our�marketing�network� covers�most� parts� of�

China,� with� more� than� 6000� sales� terminals,� and� Bohong� acts� as� an� agency� of� oversea� suppliers� with�

distribution�of�more� than�20� imported�APIs,� and�over�10�products�are�pending� to� IDL� (Import�Drug�License)�

application.

We� have� two� branches,� one� is� JieYang� KangTe� Pharmaceutical� co.,� Ltd.� ,� the� other� is� GuangXi� KeLa�

Pharmaceutical� Technology� Co.,� Ltd.� And� ShanXi� NuoCheng� Pharmaceutical� Co.,� Ltd� is� a� joint� venture� of�

our� company.� Furthermore,� we� are� planning� to� set� up� a� new� API� factory� in� the� near� future.

BOHONG� is� mainly� engaged� in� five� business� areas:

-Importation

-Exportation

-Local� Marketing� and� Distribution

-Formulation� Development� and� Manufacture

-IDL(Imported� Drug� License)� Registration

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부록 2� �전략적 협력사 디렉토리 ❚ 697

Collaboration�

Opportunities� for� R&D�

Co-works

We� offer� R&D� services� in� small� molecules� and� certain� areas� of� biologics.� Given�

to� our� extensive� infrastructure� we� can� provide� any� sort� of� new� and� promising�

platform� or� technology� in� drug� discovery� and� development� area.� We� routinely�

provide� R&D� support� in:

•Chemistry� Services

•Biology�

•Analytical� development

•Process� R&D,� and� Custom� Synthesis

Our� capabilities� include� Synthetic� chemistry,� isotope� labeling� services,� molecular�

biology� through� in� vitro,� ADME,� and� in� vivo� screening� and� profiling.� Besides�

being� a� full� service� CRO� we� also� offer� end� to� end� solutions� in� the� life� sciences�

space.

GVK� BIO� does� not� carry� out� internal� proprietary� research� and� development.�We�

give�utmost�priority� to�maintaining�client� confidentiality� and�the�Project� in�Charge�

will� enforce� stringent� confidentiality� protection�procedures.�Our� effective� project�

management� is� one� of� our� important� features� in� contrast� to� other� service�

providers.� We� have� some� of� the� best� practices� of� the� industry� which� coupled�

with� knowledge� resource� forms� our� strength� and� gives� us� advantage� over� other�

providers.

51. GVK BIOSCIENCES PVT. LTD.

1.� Corporate� General� Information

Corporate� Name GVK� BIOSCIENCES� PVT.� LTD.

Web-site� Address www.gvkbio.com

Contact

(Korean� Business)

Name Piyush� Chahar

AddressGVK� Biosciences� Pvt.� Ltd.,� Plot� No.� 28� A,� IDA� Nacharam,� Hyderabad,�

India-� 500076

Telephone Mob-� +91-9550055544;� Office-� +91-4066929987

E-mail [email protected]� /� [email protected]

2.� Description� of� Collaboration�Opportunities

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698� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Collaboration�

Opportunities� for�

Manufacturing

Our� contract� manufacturing� facility� is� KFDA,� PMDA� and� WHO� audited.� We� are�

collaborating�with�many� companies� in� Korea� and,� are� keen� to� expand�our� client�

base.� Briefly,� we� work� on:

•Bulk� Drug� Manufacturing

•Intermediates� (Pharma/Agro/Electronic)

•cGMP� Manufacturing

•Generic� Drug� Production� Capabilities

•Analytical� Development

•Regulatory� and� QA� support

Collaboration�

Opportunities� for� (Co-)�

Marketing� &� Sales

•Our�geographical� spread� is�across� the�world.� Including,�North�America,�Europe�

and� Asia� Pacific.

•Our� decade� long� experience� with� a� global� clientele� and� dedicated� sales� and�

marketing� teams� for� every� territory� makes� us� a� preferred� partner� for� your�

Marketing� and� Sales� initiatives.

•We�can� take�up� the�projects� related� to�Marketing�and�Sales�of�products� in� the�

areas� of-� pharmaceutical,� biotechnology,� agri-bio,� cosmetics,� fine� chemicals,�

specialty� chemicals� viz.� electronic� chemicals,� nucleosides,� and� radio� labeled�

molecules,� etc.

3.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

We�are�already�a�preferred� partner� for�our�APIs� in� the�Korean�Market.�Being�a�KFDA�audited� company�we�

look� forward� to� having�partners� and�agents�who�can�help� us� build� a� client� base� in� Korea� for� our�Contract�

research� and� development� services.

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부록 2� �전략적 협력사 디렉토리 ❚ 699

Collaboration�

Opportunities� for� R&D�

Co-works

Currently� not� interested� in� meetings� with� CRO's� or� other� service� providers.

Collaboration�

Opportunities� for�

In-Licensing

What� Lundbeck� is� looking� for

Lundbeck� is� looking� for� projects� and� products� that� can� strengthen� our� position�

as� a� leading� global� CNS� company.� Our� strategy� is� to� achieve� this� by� actively�

supplementing� our� internal� development� with� external� opportunities.

Therapeutic� areas

Our� primary� licensing� interest� is� in� projects� and� products� that� expand�our� range�

of� pharmaceuticals� for� the� treatment� of� all� disorders� within� CNS� -� including�

orphan� indications.

- Psychiatry:� mood� disorders,� anxiety� disorders,� psychotic� disorders,� personality�

disorders,� addiction,� development� disorders,� eating� disorders,� etc.

- Neurology:� movement� disorders,� dementias,� cerebrovascular(e.g.� stroke),�

demyelinating� disorders� (e.g.� multiple� sclerosis),� sleep� disorders,� traumatic�

injuries,� pain,� epilepsies,� etc.

Stages

52. H. Lundbeck A/S

1.� Corporate� General� Information

Corporate� Name H.� Lundbeck� A/S

Web-site� Address http://www.lundbeck.com/global�

Contact

(Korean� Business)

Name Pil� Soo� Oh� (Managing� Director)

Address29Fl.� Trade� Tower,� 511,� Youngdong-Daero,

Gangnam-Gu,� Seoul,� Korea

Telephone +82� 2� 431� 6600

E-mail [email protected]

2.� Description� of� Collaboration�Opportunities

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700� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

As�a� fully� integrated�pharmaceutical�company,�Lundbeck� is� active�across�all� stages�

of� a� product’s� development.� Lundbeck� is� therefore� interested� in� products� at� all�

stages:

•Pre-clinical� projects

•Early-stage� development� projects

•Late-stage� development� projects

•Registered� or� marketed� products

In� order� to� develop� new� ground-breaking� therapies,� Lundbeck� is� always�

interested� in� expanding� our� R&D� capabilities� by� establishing� research� and�

development� agreements� with� external� parties.

Types� of� partnerships

Lundbeck� is� currently� engaged� in� all� types� of� partnering� agreements� and� is�

therefore� interested� in:

•In-licensing� opportunities

•Out-licensing� opportunities

•Co-development

•Co-promotion,� cross-promotion� and� co-marketing� agreements

•Strategic� alliances

•Joint� ventures

Territories

By� being� an� EU-founded� company,� Lundbeck� has� historically� had� an� interest� in�

European� rights� for� products� due� to� our� European� strength� and� focus.�We� are,�

however,� expanding�our�business� in�all�markets� including� the�US,�South�America,�

and� Asia.

Geographically�we�are� focused�on�expanding�our�presence� in�all�markets�and�are�

preferably� interested� in� global� or� regional� partnerships,� however� partnerships� at�

a� country� level� may� also� be� of� interest.

Collaboration�

Opportunities� for�

Out-Licensing

Currently� Lundbeck� has� one� product� available� for� out-licensing:

1.� Phase� II� ready� compound� for� Parkinson’s� disease� (global� opportunity)

Lundbeck� is� currently� seeking� global� partner� for� a� phase� II� ready� D1/D2� agonist�

prodrugs� (Lu� 02-750� and� Lu� AE04621)� for� Parkinson’s� disease.

Lu� 02-750� and� Lu� AE04621� are� orally� bioavailable� prodrugs� to� the�

pharmacologically� active� catecholamine� Lu� AA40326.� Lu� AA40326� is� a�

long-acting� compound� in� vivo�with�efficacy�on�par�with�L-DOPA�or�apomorphine.�

Lu� 02-750� and� Lu� AE04621� may� show� the� following� benefits,� compared� to�

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부록 2� �전략적 협력사 디렉토리 ❚ 701

existing� dopamine� replacement� therapies� available� to� patients� with� Parkinson’s�

disease:

•Efficacy� as� good� as� L-DOPA� with� much� improved� potency

•Less� dyskinesia� vs.� L-DOPA

•Improved� duration� of� action� vs.� L-DOPA/apomorphine

•Oral� route� of� administration� over� apomorphine

Based� on� the� above� expected� benefits,� Lundbeck� expects� a� great� potential� for�

the� new� treatment� for� both� early� and� advanced� Parkinson’s� patients.�

Collaboration�

Opportunities� for�

Manufacturing

Currently� not� interested� in� collaboration� opportunities� for� manufacturing.

Currently� not� interested� in� meetings� with� CMO's� or� other� service� providers.

Collaboration�

Opportunities� for� (Co-)�

Marketing� &� Sales

Currently� not� interested� in� meetings� with� CSO's� or� other� service� providers.

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702� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

3.�특허분석 결과

H.� Lundbeck� A/S사의 특허분포도를 볼 때 기술 중에 대표적으로 Negative� Alkyl� Alkenyl� Hydroxy,�

Antagonists� Isoquiolinone� Derivatives� Morpholine� Thiomopholine,� Accetable� Carrier� Provides� Subject�

Suffering� Subject� 등의 키워드를 가진 기술에 많은 특허가 분포하고 있는 것으로 나타났다.

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부록 2� �전략적 협력사 디렉토리 ❚ 703

2006년 01월 01일부터 2012년 12월 10일까지 출원된 H.� Lundbeck�A/S사의 특허의 키워드 분포는 붉은 점으

로 나타난다.

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704� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

53. Janssen Korea Ltd.

1.� Corporate� General� Information

Corporate� Name Janssen� Korea� Ltd.

Web-site� Address www.janssenkorea.com

Contact

(Korean� Business)

Name Shinung� Park

Address26F,�LS�Yongsan�Tower,�Hankangro�2-Ga,�Yongsan-Gu,�Seoul�140-702,�

Korea

Telephone 02-2094-4651

E-mail [email protected]

2.� Description� of� Collaboration�Opportunities

Collaboration�

Opportunities� for�

In-Licensing

Open� for� cardiovascular/metablic� diseases,� infectious� diseases,� immunology,�

oncology� and� CNS/pain

Collaboration�

Opportunities� for� (Co-)�

Marketing� &� Sales

Open� for� cardiovascular/metablic� diseases,� infectious� diseases,� immunology,�

oncology� and� CNS/pain

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부록 2� �전략적 협력사 디렉토리 ❚ 705

3.�특허분석 결과

Janssen사의 특허분포도를 볼 때 기술 중에 대표적으로 Histone� Deacetylase� Inhibiting� Enzymatic� Activity�

Compounds� Meanings� Histone� 등의 키워드를 가진 기술에 많은 특허가 분포하고 있는 것으로 나타났다.�

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706� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

2006년 01월 01일부터 2012년 12월 10일까지 출원된 Janssen사의 특허의 키워드 분포는 붉은 점으로 나타난

다.

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부록 2� �전략적 협력사 디렉토리 ❚ 707

Corporate� Name JURABEK

Head� Office� Address Uzbekistan,� 100003,Tashkent,� 165Almazar� str,

Web-site� Address http://www.jurabek.uz

Contact E-mail [email protected]

Company� History

In� 1994� the� process� of� privatization� and� transfer� of� pharmacies� to� private� property� under� support� of� the�

government� began.� State� Pharmacy� No.� 10,� according� to� decree� No.� 132� of� the� Soviet� of�Ministers� of� the�

Republic� of�Uzbekistan� dated�March�11th� 1994� “About� privatization� and� transferring� to� private� property� of�

pharmacies� included� in� the� system�of�Ministry�of�Health�of� the�Republic�of�Uzbekistan”�was�privatized�among�

the� first� in� the�Republic,� and�acquainted� the� status�of�private�pharmacy�and�was� registered�with�state�bodies�

as� Pharmacy� “Jurabek”.� �

State� Pharmacy�No.� 10�was� named�as� “Jurabek”� in� honour� of� Jurabek� ota� Lutfullaev,�Honoured� Pharmacist,�

who� worked� in� this� pharmacy� for� more� than� 35� years� and� was� respected� by� many� people.� �

1996

State�Pharmacy�No.�10�managed�by� Jurabek�ota�Lutfullaev,� and�consequently�Private�Pharmacy� “Jurabek”�had�

small� intra-pharmacy�production� facility� to�produce� infusion� solutions,�powders�and�other�medicines,�and�the�

management� always� tried� to� increase� the� assortment� and� to� establish� the� manufacture� of� wide� spectrum�

of� medicines.� �

The� Company� made� a� decision� to� open� medicines� manufacturing� facility,� and� in� 1996� jointly� with� Indian�

Company� “Ace� Laboratories� Ltd”,� and� then� with� “Bravo� Medical� Equipment� Trading.� Est.”,� United� Arab�

Emirates� opened� joint� venture.

This� joint� venture� was� named� “Jurabek� Laboratories”.� �

1999

Manufacturing� began� in� 1999� by� launching� capsulated� medicines� production� unit.

Launched� capsulated� medicines� production� unit� became� the� first� not� only� for� the� Company� but� also� was�

the� start� of� manufacturing� of� capsulated� medicines� in� Uzbekistan.� The� first� product� of� this� workshop� was�

54. JURABEK

1.� Corporate� General� Information

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708� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

ampicillin� in� capsules,� which� still� has� increasing� demand� over� the� last� 10� years.

By� 2014� we� plan� to� launch� a� new� capsulated� medicines� production� unit.� �

2001�

In� the� end� of� 2001,� unit� to� produce� tabulated� medicines� was� launched.

Manufacturing� of� tabulated� preparations� was� started-up� in� 2001� jointly� with� Poland� Company� Polfa�

Grodzinsk� that�made� it� possible� to� organise� packaging� of� preparations� purchased� in� form� of� in-bulk� under�

the� license� of� Polfa.� �

By�2014� it� is�planned� to� launch�a� new�modern�production�plant� to�produce� tablets� from�API,� including� the�

process� of� granulation,� tableting,� coating,� blistering� and� packaging.

In� 2001� the� Company� registered� ampicillin� in� capsules� in� the� Republic� of� Kazakhstan� and� makes� its� first�

export� shipment� of� own� products.

2004

One� of� the� greatest� achievements� of� specialists� of� “Jurabek� Laboratories”� became� the� launch� of� unique� for�

the� Republic� of� Uzbekistan,� manufacturing� unit� of� dry� powder� antibiotics� of� cephalosporin� group.� At�

present,� a� sufficient� market� share� of� cephalosporins’� in� Uzbekistan� is� taken� by� antibiotics� of� “Jurabek�

Laboratories”,� which� means� high� trust� of� specialists� from� medical� organisations� and� of� population� in�

medicines� manufactured� by� “JurabekLaboratories”.

2005

Being� the� innovator� in� domestic� pharmaceutical� industry,� “Jurabek� Laboratories”� became� the� first� domestic�

company� that� created� marketing� department� where� now� more� than� 50� doctors� and� other� specialists� are�

working.� Key� function� of� this� department� is� to� increase� awareness� of� our� products� among� the� specialists�

at�medical� institutions.�Medical� representatives�of� “Jurabek�Laboratories”� are� recognized�by�doctors�as� reliable�

consultants,� who� can� give� recommendation� not� limiting� to� the� product� range,� manufactured� by� the�

Company,� always� taking� into� account� interests� of� patients� and� their� health.� “Jurabek� Laboratories”� strictly�

follows� all� the� requirements� of� ethical� marketing� of� medicines.

In� 2005� the� registration� of� dry� powder� antibiotics� of� cephalosporin� group� in� the� Republic� of� Tajikistan�was�

finished,� which� allowed� to� start� export� of� these� products� to� this� country.

2006

Starting� from�2006�projects�of� “Jurabek� Laboratories”�were� included� in�government�program�on� localistation�

of� manufacturing� of� finished� products.� Inclusion� of� projects� in� different� state� programs� on� industry�

development�permitted� “Jurabek� Laboratories”� to� strengthen� its�positions� in� the�market� as� a� leader� not� only�

among� domestic� companies,� but� among� world� manufacturers� operating� in� Uzbekistan� market� as� well.� As�

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부록 2� �전략적 협력사 디렉토리 ❚ 709

a� fact� it� lead� to� the� increase� in� volumes� of� import� substitution.� �

2007

Continuing� investment� activity� in� introducing� new� preparations� into� the� market,� in� 2007� the� Company�

finishes� construction� of� two� new� production� units.

Penicillin� group� antibiotics� dry� powder� fillingunit� made� it� possible� to� increase� the� antibiotics� rangeand�

allowed“Jurabek� Laboratories”� to� be� a� leader� among� suppliers� of� wide� spectrum� antibiotics� in� Uzbekistan,�

as� a� fact,� reducing� the� import� of� analogue� products� from� countries� of� the� near� and� far� abroad.�

The� second�workshop� launched� in� 2007�was� the� ampoule� preparations� production� unit,� which� are� also� in�

great� demand� in� the� market.� “JurabekLaboratories”� is� quickly� taking� leading� position� among� suppliers� of�

ampoule� preparations,� and� within� short� time� achieves� 100� percent� production� capacity.

Efforts�of� specialists�of� “Jurabek� Laboratories”�were�highly�appraised�by� the�Ministry�of�Health�of� the�Republic�

of� Uzbekistan,� and� in� 2007� “Jurabek� Laboratories”� was� awarded� honorary� title� of� “The� best�manufacturing�

enterprise”.

Activity� over� the� expansion� of� export� markets� had� resulted� in� delivery� of� dry� antibiotics� in� the� Islamic�

Republic� of� Afghanistan.�

2008

In� 2008� efforts� of� the� “Jurabek� Laboratories”� to� create� manufacturing� facility� of� high� quality� medicines�

according� to�world� standards,�were� confirmed�by� certificates�by�German�certifying�body�DQS�on� introduction�

of�Quality�Management�System� ISO�9001�and� ISO�13485,�and�Certificate�of� conformance�of�manufacturing�

environment� to� requirements� of� Good� Manufacturing� Practice� (E-GMP)� under� European� directive�

2003/94/EC.

In� that� year� owing� to� the� state� support� the� Company� keeps� on� attracting� investments� for� expansion� of�

production.� Thus,� in� 2008� company� signed� loan� agreement� with� European� Bank� for� Reconstruction� and�

Development� on� financing� of� unique� project� on� manufacturing� of� infusion� solutions� in� polypropylene� vials�

made� of� granules.� Production� of� a� new� workshop� has� a� number� of� advantages� before� analogues� of� such�

solutions,� sold� in� the� Republic� of� Uzbekistan.�

2008� to� 2010

In� this� period� the� Company’s� main� strategy� was� directed� to� the� development� of� export� potential� of� the�

Company� that� has� resulted� in� expansion� of� export� geography� including:� Afghanistan,� Azerbaijan,� Armenia,�

Georgia,� Kyrgyzstan,� Tajikistan,� Turkmenistan,� Kazakhstan.� Today� registration� works� are� continued� in�

Moldova,� the� Ukraine,� and� new� potential� export� markets� are� being� researched.� The� Company� is� opening�

representative�offices� in� countries�of� export�with� the�purpose� to�strengthen�activities� in�products�promotion.� �

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710� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Today�

Today� “Jurabek� Laboratories”� is� a� dynamically� developing� company� with� young� and� energetic� staff� of�

managers�and� specialists� actively�developing�and� introducing�new� technologies�and�methods.�More� than�800�

employees� are� hired� at� the� Company� for� whom� individually� selected� internal� and� external� training� system �

is� developed,� and� who� are� regularly� qualified.� Technical� profile� employees� are� frequently� assessed� for�

conformance�and�are� trained.� �Contacts�with� leading�higher�education� institutions�of�Uzbekistan�have�been�

established� for� job� placement� of� perspective� students.

All� efforts� of� Jurabek� Laboratories� in� development� of� manufacturing� and� widening� the� assortment� are�

directed� “For� the� Health� of� Your� Family”.

Company� Description� &� Organization

Our� Company� was� established� with� the� purpose� to� provide� the� population� of� the� Republic� of� Uzbekistan�

with�domestic�medicine�of�wide�application.� For�15� years�of� activity� in� the�market,� a� team�of�our� specialists�

has� achieved� good� results,� and� our� products� have� recommended� themselves� not� only� at� domestic� but� at�

international� market� as� well.�

Our� achievements� became�possible� owing� to� that�we� are� inspired� by� one�mission:� “To� produce�high-quality�

medicines� distinguished� by� its� effectiveness� and� safety� for� the� health� of� your� family”.� �Making�decisions�we�

are� always� tied� to� five� core� principal� values:� Quality,� Innovation,� Team� work,� Ethic� activity� and� Social�

responsibility.

All� this� helps� us� to� realize� the� development� strategy� which� is� based� on� three� principal� directions:

•� Development� of� medicines� manufacturing� by� investment� in� high-tech� modern� equipment

•� Strengthening� the� position� of� import� substitution� of� medicine� at� domestic� market

•� Widening� and� strengthening� the� Company’s� position� at� international� market

We�are�proud� that�we�could�master� the�manufacture�of�wide�assortment�of�generic�drugs�of�different� forms�

which�are�manufactured�at�our�Company� in�compliance�with� international�directive�on�Good�Manufacturing�

Practice� that� is� confirmed� with� certificates� issued� by� German� certifying� body� DQS.

Our� team’s� slogan� is:� continuous� development� owing� to� which� our� Company� has� an� opportunity� to� make�

its� contribution� to� the� development� of� society� which� we� live� in.

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부록 2� �전략적 협력사 디렉토리 ❚ 711

2.� Additional� Business� Propositions� for� Collaboration

Our� mission� is

To� produce� high-quality� medicines� distinguished� by� its� effectiveness� and� safety� for� the� health� of� your�

family

Our� strategy

The� strategy� of� � "Jurabek� Laboratories"� is� based� on� three� principal� directions:

•� Development� of� medicines� manufacturing� by� investment� in� high-tech� modern� equipment

•� Strengthening� the� position� of� import� substitution� of� medicine� at� domestic� market

•� Widening� and� strengthening� the� Company’s� position� at� international� market

In� order� to� realize� the� tasks� set� in� the� development� strategy,� the� Company� is� actively� attracting� foreign�

investment� into� new� production� lines� using�modern� technologies.� 15� out� 19�manufactured� products� are�

included� in� the� state� program� on� import� substitution.� "Jurabek� Laboratories’s"� share� of� product� in�

Uzbekistan� in�antibiotics�of�cephalosporin�and�penicillin�group� is�more� than�30%.�The�Company� is� actively�

increasing� the� geography� of� export� and� already� present� in� all� countries� of�Central�Asia� and� the�Caucasus�

Region� with� its� products

Our� values�

All� the� Company’s� activities� are� built� up� on� the� following� values:

•� Quality� ­� we� set� the� quality� as� one� of� the� most� principal� indicators� of� both� products� and� processes�

related� to� the� manufacturing� and� customer� satisfaction.

•� Innovation� ­� we� define� innovations� as� driver� of� development� and� perform� any� necessary� analysis� and�

researches� of� tendencies� in� pharmaceutical� development,� any� possible� improvements� of� current�

products,� improvement� of� our� specialists’� knowledge,� and� use� of� new� technologies� within� the�

production� and� other� processes.� �

•� Team�work� ­�we� highly� evaluate� the� contribution�of� every�member� of� our� team� into� general� business,�

appraise� the� results� of�mutual� efforts� and� stimulate� the� culture� of� team�work,� orientations� to� overall�

goal� and� the� involvement� of� each� of� us� in� successful� activity� of� the� Company.

•� Ethic� activity� ­� our� Company’s� managers� in� their� decisions� consider� any� consequences� on� rivals,�

environment� as� well� as� they� adhere� to� ethic� norms� when� negotiating� with� suppliers� and� state�

authorities.�Any�marketing�events�applied�do�not� infringe�upon�consumers’� rights;�promotion�materials�

do� not� bear� any� false� information�with� the� purpose� to� increase� sales� and�other� purposes�whatsoever.

•� Social� responsibility� ­� we� realize� that� we� are� the� integral� part� of� society� whom� we� are� continuously�

striving� to� help.

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712� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name KRKA

Head� Office� Address Krka,� d.� d.,� Novo� mesto,�Šmarješka� cesta� 6,� 8000� Novo� mesto,� SloveniaWeb-site� Address http://www.krka.ru

Contact E-mail [email protected]

Company� History

1954­1964

•� Krka� Pharmaceutical� Laboratory� was� established

•� Krka� Production� Plant� was� established

•� the� first� patent� was� registered�

•� Krka� re-locates� to� Ločna� where� a� major� part� of� production� still� occurs� today�•� Establishment� of� the� Development� Institute�

•� First� cosmetic� products� launched�

•� First� export� ventures�

1965­1974

•� Construction� of� the� new� plant� for� manufacturing� active� ingredients

•� Extension� of� a� new� plant� for� manufacturing� tablets� and� coated� tablets�

•� Construction� of� a� new� plant� for� producing� ointments,� syrups� and� injections�

•� Collection� and� processing� of� medicinal� herbs�

•� Expansion� to� tourist� and� spa� services�

•� Presentation� of� the� first� Krka� Awards

1975­1984

•� registration� granted� by� the� American� FDA� for� the� manufacture� of� antibiotics�

•� the� Dawa� Pharmaceutical� production� plants� began� operation� in� Kenya�

•� fermentation� capacities� were� increased� by� 50� % �

•� construction� of� a� plant� for� converting� pharmaceutical� active� ingredients� into� finished� products�

•� investment� in� preservation� of� clean� waters� and� environment� protection

•� construction� of� the� factory� in� Ljutomer�

•� investment� in� tourist/health-resort� facilities�

55. KRKA

1.� Corporate� General� Information

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부록 2� �전략적 협력사 디렉토리 ❚ 713

1985­1994

•� construction� of� a� plant� producing� insulation� material�

•� building� marketing� network� abroad� (establishment� of� companies� and� representative� offices)�

•� accelerated� development� of� Krka’s� own� generic� drugs,� and� continual� cooperation� with� the� leading�

international� pharmaceutical� companies�

•� ranking� in� the� top� Slovene� companies� and� exporters�

•� modernisation� of� fermentation� production�

•� ensuring� a� highly� qualified� professional� work� force� through� the� project� of� staff� development�

•� increased� investment� in� research� and� development�

1995­2000

•� top-place� ranking�among�pharmaceutical� companies� in�Central� and�Eastern�Europe,�and�penetration� into�

Western� European� markets�

•� investment� in� research� and� development� activities�

•� upgrading� the� Total� Quality� Management� system �

•� restructuring� into� a� joint-stock� company�

2001­2005

•� completion� of� the� construction� of� the� modern� plant� Notol� for� the� production� of� solid� dosage� at� the�

central� Krka� location�

•� expansion� of� production-distribution� network� abroad� (new� production-distribution� plants� in� Poland,� the�

Russian� Federation� and� in� Croatia)

•� a� new� plant� for� the� production� of� solid� dosage� forms� in� Šentjernej•� expansion� of� marketing� and� sales� network�

•� Development� and� Control� Centre� 2

•� Acquisition� of� ISO� 14001� standard� (new� quality� in� environment� protection)�

•� Implementation� of� the� new� SAP� information� system

•�Acquisition�of� the� foodstuff� safety�system�certificate� (HACCP),� safety�and�health�at�work� (OHSAS�18001)�

and� the� certificate� by� the� European� Agency� for� Safety� and� Health� at� Work� (EU-OSHA)�

•� Construction� of� the� plant� for� the� production� of� active� pharmaceutical� ingredients� Synthesis� 4�

2006­2010

•� Expansion� of� the� marketing� and� sales� network

•� Opening� of� Sinteza� 4� API� plant�

•� Introduction� of� no-par� value� shares� (1:10� share� split)

•� Acquisition� of� ISO/IEC� 27001� certificate� for� the� information� security� system �

•�Highest� national� award� for� quality� ­� the� Business� Excellence� Award� of� the� Republic� of� Slovenia� (PRSPO)�

for� 2007.

•� Opening� of� the� new� injection� production� plant

•� A� new� business� centre� for� warehousing� products,� customs� operations� and� marketing� activities� in�

Macedonia�

• Entry� into� a� private� Chinese� pharmaceutical� and� chemical� companies� Zhejiang� Menova� Pharmaceuticals�

Co.,� Ltd.,� Shanghai� and� Anhua� Menova� Pharmaceuticals� Co.,� Ltd.,� Gvande

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714� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

•� Purchase� of� German� company� TAD� Pharma� GmbH� from� Cuxhavna� and� Austrian� company� Alternova�

Arzneimittell� GmbH� from� Vienna

•� New� chemical� development� laboratories

2011­2013

•� Opening� of� a� modern� syrup� production� plant

•� Opening� of� a� plant� for� the� production� of� products� with� a� biocidal� effect�

•� Start-up� of� a� solar� power� station

•� Renovation� and� enlargement� of� high-rack� packaging� material� warehouse

•� Opening� of� the� solid� dosage� forms� production� plant� (OTO)�

•� Development� and� Control� Centre� 3

•� Krka� shares� dual� listed� at� the� Warsaw� Stock� Exchange�

•� Start� of� the� construction� of� Notol� production� plant� ­� the� largest� investment� in� the� history� of� Krka.�

2012

“Sotex”� launched� two� new� medical� brands:� Chondrogard®� and� Nemulex®.

In� the� scope� of� the� agreement� with� FPK� PharmVILAR,� “Sotex”� starts� to� promote� medicinal� products�

Exportal®� and� Angionorm®.

According� to� the� results�of� the� retail� sales�audit� in� the�Russian�Federation� conducted�by�MRC�“Pharmexpert”,�

Chondrogard®� was� recognized� as� the� most� successful� launch� in� ATC-group� level� 1� M� Musculoskeletal�

System.

Company� Description� &� Organization

Mission

Living� a� healthy� life.

Our� basic� task� is� to� enable� people� to� lead� a� healthy,� good� quality� life.� This� we� achieve� through� our� rich�

range�of� products� and� services� ­�with� prescription� pharmaceuticals,� self-medication�products,�with� cosmetic�

and� animal� health� products,� and� with� our� health-resort� services,� with� investment� in� people� and� the�

environment,� and� through� sponsorship� and� donations.

Vision

We� are� continually� consolidating� our� position� as� one� of� the� leading� generic� pharmaceutical� companies�

worldwide.

We�are�achieving� this�on�our�own�by� strengthening� the� long-term�business� connections�and�by�establishing�

partnerships� in� the� fields� of� development,� product� supply� and� marketing.

Values

Speed� and� flexibility

Our� knowledge,� our� abilities,� our� capability� to� innovate,� our� productivity� and�our� ingenuity� enable� us� to� be�

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부록 2� �전략적 협력사 디렉토리 ❚ 715

fast.�We�want� to� be� first.� Not� just� in� sales,� but� in� discovering� the�markets’� new� needs.�We� can� do� this� by�

successfully� shortening� the� development� process,� swift� acquisition� of� registration� documentation� and� our�

harmonised� production� and� distribution.

With� our� responsiveness� and� the� ability� to� adapt� we� overcome� the� obstacles� in� our� path,� be� they� of� a�

marketing� or� legislative� nature.� We� can� cope� with� any� and� all� challenges� ­� regardless� of� the� size� and� the�

site� of� the� project.� Using� flexible� solutions,� we� make� sure� our� partners� can� rely� on� us.

Partnership� and� trust

Krka� helps� create� good� relationships.� We� strive� for� trust-based� relationships� with� our� partners:� our�

customers,�our� suppliers,�our�owners�and�everyone�else�who� surrounds�us.�Only�good�and�open�relationships�

can� help� us� achieve� both� business� success� and� our� primary� mission.

Creativity� and� efficiency

The� only� real� way� to� achieve� first-class� results� is� by� creating� an� atmosphere� that� motivates� our� employees�

to� be� innovative� and� creative.� Therefore,� we� encourage� our� employees� to� speak� freely� of� their� ideas� and�

if� these� ideas�prove� to�be�good� for� the� company,�we�encourage� them� realise� them.�Together,�we� seek�new�

paths� to� make� our� customers� satisfied.�

We�perform�our� tasks� as�well� as�we� can.�We� strive� to� do�what�we�do� in� the� best,�most� efficient�and�most�

time� conserving� way.

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716� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name Kyiv� Vitamin� Factory

Head� Office� Address 38� Kopylivska� Street,� Kyiv,� 04073,� Ukraine

Web-site� Address http://www.vitamin.com.ua

Contact E-mail [email protected]

Company� History

Year� 1937.� The� opening� of� vitamin� juice� drinks� manufacturing.

Year� 1944.� By� order� of� the�Ministry� of� Food� Industry� of� USSR�№� 375� from� 05.12.1944� “Kyiv� vitamin� juice�

factory”� starts� to� function.� The� enterprise� is� subject� to� the� trust� “Ukrvitaminprom”.� The� factory� produces�

vitamins� A,� B1,� B2,� C,� D2� in� the� form� of� pills.

Year� 1954.� The� reorganization�of� the� company� in� “Kyiv� Vitamin� Factory”�with� subordination� to� the�General�

Directorate�of� the�Ministry� of� canning� food� industry�of�USSR.� The�development� of� the� industrial�production�

of� synthetic� vitamin� D3� in� the� form� of� an� oil� concentrate� for� use� in� animal� husbandry.

Year� 1958.� The� production� of� synthetic� vitamin� E� is� created� in� the� Soviet� Union� for� the� first� time.

Year� 1964.�Development� of�manufacturing�of� the�drug� “Videin�D3”�—� a� new�dry� stabilized� form�of� vitamin�

D3� for� veterinary� medicine.

Year� 1976.� “Kyiv�Vitamin� Factory”� becomes� a� part� of� new� created�Kyiv�Chemical-Pharmaceutical� Production�

Association� “Darnitsa”.

Year� 1978.� Launch� of� ascorbic� acid� tablets.

Year� 1994.� Establishment� of� CC� “Kyiv� Vitamin� Factory”� with� legal� and� economic� independence.

Year�1999.�Commissioning�of� the�production� site�of�hard�gelatin� capsules�and� instant� (effervescent)� tablets.�

Accreditation� of� analytical� laboratory� of�medicines� quality� control;� its� equipment� allows� to�make� control� on�

the� level� of� international� requirements.

Year� 2000.� Commissioning� of� the� production� site� (the� only� one� in� Ukraine)� for�manufacturing� soft� gelatin�

capsules.� The� company� gains� an� award� —� an� international� diploma� “Silver� Dolphin”� in� nomination� “XXI�

Century� Enterprise”� in� Brussels.

56. Kyiv Vitamin Factory

1.� Corporate� General� Information

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부록 2� �전략적 협력사 디렉토리 ❚ 717

Year� 2002.� Certification� of� quality� management� system� in� accordance� with� ISO� 9001:2000� (certification�

system� PRIROST)� and� the� SSU� ISO� 9001:2001� (Certification� System� UkrSEPRO).

Year� 2004.�Gaining� an� award� “Charity� Sign”� for� the� quality� and� technical� achievements� in� the� international�

exhibition� “Food� and� life� in� XXI� century”.

Year� 2005.� Recertification� of� the� quality� management� system� in� accordance� with� ISO� 9001:2000�

(certification� system� PRIROST).

Year� 2006.�Certification� of� food� additives� for� Latvia� in� accordance�with� the� requirements� of� the�Regulation�

of� the� European� Parliament� and� Council�№� 852/2004� of� 29.04.2004� on� the� hygiene� of� foodstuffs� (Latvian�

CC).� Commissioning� of� the� production� site� covering� the� tablets.� Validation� of� chemical� analytical� laboratory�

and�microbiological� control� laboratory� of�quality� control�department� (Civil� Service� of�medicines� and�medical�

devices).

Year� 2007.� Recertification� of� the� quality� management� system� in� accordance� with� the� SSU� ISO� 9001:2001�

(Certification� System� UkrSEPRO).� Gaining� the� diploma� for� the� development� of� the� brand� “Kyiv� Vitamin�

Factory”.

Year� 2008.�Changing� the� legal� form�of� a� company� from�CC� to� PC� “Kyiv�Vitamin� Factory”� from�01.01.2008.�

Recertification� of� the� quality� management� system� in� accordance� with� ISO� 9001:2008� (certification� system �

PRIROST).

Year� 2009.� Certification� of� quality� control� department� by� “Ukrmetrteststandart”.

Year�2010.�The�preparation� “Corvalment”�has�become�a�winner� in� its�category� in� the�contest�of�professionals�

of� pharmaceutical� field� in� Ukraine� “Panacea-2010”.

Year� 2011.� Expansion� of� export� markets.� Opening� of� representative� offices� of� PC� “Kyiv� Vitamin� Factory”.

Company� Description� &� Organization

Public� company� “Kyiv� Vitamin� Factory”

is� a� modern� national� pharmaceutical� manufacturer� with� stable� market� position,� competent� team,� broad�

range�of�products� of�high�quality,� transparent� and� responsible�attitude� towards� its� consumers�and�partners.

Today� PC� “Kyiv� Vitamin� Factory”� stands� for:

-� history� of� more� than� 75� years

-� product� portfolio� of� more� than� 130� medical� preparations� and� 10� dietary� supplements

-� high-quality� substances� supplied� from� the� leading� European� countries� and� their� subsidiaries� in�

South-Eastern� Asia

-� the� team�of� professionals� holding� the� same� views� and� having� common� ambitious� aims,�who� are� oriented�

towards� best� results

-� correspondence� of� manufacturing� to� the� standards� of� quality� SSU� ISO� 9001:2009� and� ISO� 9001:2008

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718� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

-� own� certified� QC� laboratory

-� 26� regional� representative� offices� in� Ukraine

-� 6� representative� offices� in� the� near� and� distant� abroad

-� charity� and� humanitarian� aid� for� needy� people

-� social� responsibility� to� the� society� and� to� every� Ukrainian

-� implementation� of� the� mission� stated� in� the� corporate� slogan� —

2.� Additional� Business� Propositions� for� Collaboration

Our� mission

Providing� maximum� availability� of� high-quality� and� safe� medicines,� vitamins� for� the� prevention� and�

treatment� of� wide� range� of� diseases.�

Our� values

-� Reputation� and� trust

Company’s� history� and�high� standards� of� quality� of�medicines,� vitamins� have� formed� trust� and� reputation�

among� customers,� partners� and� competitors.

-� Caring� about� customers

By�maintaining� regular� contact� with� consumers�we� care� for� early� detection� of� their� needs� and�make� our�

best� to� offer� the�most� effective� drugs� due� to� constant� innovation,� updating�product� range,� development�

of� new� areas� of� activities.

-� Staff

We� strive� for� being� the� company� that� our� staff� and� business� partners� are� proud� of.�We� are� the� team� of�

professionals,� talented� and� dedicated� people.� The� focus� of� our� work� is� a� team� work.

-� Quality

The� company� uses� all� the� resources� and� capabilities� to� provide� high-quality� medicines,� vitamins,� while�

focusing�on� the�highest�European� standards,� implementation�and�development�of� innovative� technologies.�

Our� strategy

Strengthening� our� position� in� the� segment� of� vitamins,� forming� of� long-term� leadership� in� the� most�

promising� segments�of�pharmaceutical�market�both� in�Ukraine�and�abroad�through� foremost�dynamics�of�

new� drugs� launch� and� increasing� of� business� profitability.

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부록 2� �전략적 협력사 디렉토리 ❚ 719

57. Laboratorio Dosa S.R.L.

1.� Corporate� General� Information

Corporate� Name Laboratorio� Dosa� S.R.L.

Head� Office� Address Girardot� 1369� C1427AKC� -� Capital� Federal

Facilities� City� &� Country Argentina

Web-site� Address www.laboratoriodosa.com

Contact

(Korean�

Business)

E-mail [email protected]

Company� History

Laboratorio� DOSA� S.A.,� a� company� with� Argentinean� and� Uruguayan� capitals,� � started� its� activities� in�

February� of� 1999� for� the� research,� development,� � marketing� and� promotion� of� oncological,� neuroleptic�

and� AIDS� specialities.

Company� Description� &� Organization

Mission

The� present� commercial� line� is� focused� on� oncology,� AIDS,� psychiatry� and� � pneumology.� Nowadays,�

supplementary� products,� such� as� � immunossuppressant,� high� complex� biotechnological� and�

over-the-counter� � pharmaceutical� products,� are� under� development.

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720� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name � Laboratorio� Dr.� Lazar� &� Cia.� S.A.Q.� e� I�

Head� Office� AddressAv.� Vélez� Sárfield� 5855

CP:� B1606ARI.� Carapachay.� Buenos� Aires.� Argentina.�

Facilities� City� &� Country Argentina

Web-site� Address www.lazar.com.ar

Contact

(Korean� Business)E-mail [email protected]

Company� History

� Assuming,�at� the�beginning,� the� representation�of� imported�products,� some�years� later,� Laboratorio�LAZAR�

began� to� carry� out� the� manufacture� of� its� own� products,� at� its� first� production� plant.� Then,� during� the�

forties,� the�definitive� industrial� plant�was�built� and�put�on�operation� in�Carapachay,� located�at� the�province�

of� Buenos� Aires.� Several� generations� of� Argentine� people� have� grown� up� experiencing� and� collecting� the�

therapeutical� advantages�of�medical� specialities.�With� regard� to� this� issue,� it� suffices� to�mention�Paratropina,�

widely� disseminated� at� the� medical� prescription� pad.

� Throughout� its� history,� Laboratorio� LAZAR� has� grown� up� supporting� the� clinical� and� pharmaceutical�

research,� with� the� development� and� synthesis� of� new�molecules,� incorporating� new� products� to� its� range,�

and� contributing� therapeutical� elements� of� invaluable� importance� at� the� fight� against� several� illnesses.� An�

example� of� that� is� the� introduction� of� Lactulón,� the� first� lactulose� available� at� the� Argentine� market,� an�

irreplaceable� medicine� for� the� treatment� of� portosystemic� encephalopathy� and� extremely� useful� for� the�

treatment� of� constipation.

� With�a�past�of�hierarchy�and�a�modern�and�vigorous�present,� Laboratorio�Lazar�has�an�exemplary� industrial�

plant,� with� manufacturing� areas� meeting� the� most� advanced� and� demanding� international� rules� of� quality�

(GMPc),� which� leads� to� the� development� and� production� of� effective,� reliable� and� high� quality�medicines.

� In� order� to� accomplish� our� goal,� we� have� teams� of� chemists,� doctors,� and� biochemists� working� together�

on� the� development�of�new� formulaes� registering�new�products�at� regulatory� entities,� and�on� the� selection�

and� analysis� of� necessary� scientific� material� for� research� and� development.

Laboratorio� LAZAR� has� an� important� library� with� first� level� national� and� international� publications,�

58. Laboratorio Dr. Lazar & Cia. S.A.Q. e l

1.� Corporate� General� Information

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부록 2� �전략적 협력사 디렉토리 ❚ 721

constituting� a� source� of� relevant� information� available� for� every� inquire� of� doctors.

� Faithful� to� its�philosophy�at� the�service� to� the�doctor�and� the�community,� Laboratorio�LAZAR�has� constantly�

stimulated� the� progress� and� improvement� of� different� medical� specialities,� by� means� of� the� support� to�

correspondent�medical� societies� and� associations� gathering� them;� cooperating� as� in� the� daily� task� as� in� the�

execution� of� scientific� events,� launch� of� permanent� medical� education� programs,� etc.

Company� Description� &� Organization

Our� MISSION� consists� on� the� development� and� the� manufacture� of� high� quality� and� effective� medicinal�

specialities,� in�order� to�offer�other� therapeutical�options� to�health�experts;� that� is,� to�provide�with�high� level�

and� quality� medicines� to� the� national� and� international� community.

Our� VISION� consists� on� the� consolidation� of� the� position� of� Laboratorio� LAZAR� at� the� national�

pharmaceutical� industry� and� the� reinforcing� of� the� presence� worldwide� as� a� “Symbol� of� Confidence”,�

supported�on�genuine� values�as� responsibility,� team�work,� the�constant� search�of�excellence,� the�permanent�

overcoming� and� updating� and� the� respect� for� people.

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722� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

59. Laboratorio Elea S.A.C.I.F. y A.

1.� Corporate� General� Information

Corporate� Name Laboratorio� Elea� S.A.C.I.F.� y� A.

Head� Office� AddressLaboratorio� Elea� SACIFyA� Sanabria� 2353.� C1417AZE� Buenos� Aires� -�

Argentina

Facilities� City� &� Country Argentina

Web-site� Address www.elea.com

Contact

(Korean� Business)E-mail [email protected]

Company� Description� &� Organization

The�main� objective� of� Elea� Laboratories� is� to� increase� its� participation� in� the� local� market� and� its� presence�

in� Latin� America� and� the� rest� of� the� world.

Due� to� the� fact� that� we� have� a� strong� portfolio� of� our� own� and� in-licensed� products� from� leading�

international� companies,� in�addition� to�a� strong�R&�D�Department�and� the� input� from� local�and� international�

academic� centers� providing� world� class� projects,� we� are� in� a� position� to� offer,� license-out,� a� wide� variety�

of� pharmaceutical� products,� covering� diverse� therapeutic� groups.

Our� priority� is� also� focused� on� cooperating� with� multinational� companies� by� means� of� Co-marketing,�

Licensing-in� and� representations.� We� can� offer� the� backing� and� experience� of� specific� business� units� of�

leading� brands,� as� well� as� leadership� positions� in� the� different� business� segments� we� participate� in.� In�

addition,� we� have� a� strong� sales� and� distribution� network,� one� of� the� strongest� in� the� Argentine�

pharmaceutical� market.

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부록 2� �전략적 협력사 디렉토리 ❚ 723

60. LABORATORIOS AC FARMA S.A.

1.� Corporate� General� Information

Corporate� Name LABORATORIOS� AC� FARMA� S.A.

Head� Office� Address Calle� Los� Hornos� 110,� Urb.� Vulcano,� Ate� 349-1986�

Facilities� City� &� Country Peru

Web-site� Address www.acfarma.com

Contact

(Korean�

Business)

E-mail [email protected]

Company� Description� &� Organization

MISSION

To� contribute� in� health� care� by�manufacturing�pharmaceutical� products� that� accomplish� the� highest� quality�

standards

VISION

To� be� recognized� by� health� care� professionals� and� individuals� as� an� organization� that� manufactures� high�

quality� pharmaceutical� products,� that� has� a� well-prepared� team� of� workers� with� solid� ethics,� technology�

innovation�skills�and�special� social�commitment,� so� that�we�achieve� the� leadership�of� the�country�and�region.

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724� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

61. Laboratorios Bago S.A

1.� Corporate� General� Information

Corporate� Name Laboratorios� Bagó� S.A.

Head� Office� Address Bernardo� de� Irigoyen� 248� (C1072AAF)� Capital� Federal

Facilities� City� &� Country Argentina

Web-site� Address www.bago.com.ar�

Contact

(Korean� Business)E-mail [email protected]

Company� History

On� April� 11,� 1934,� this� pioneer� pharmaceutical� company� is� founded� by� Sebastián� Bagó.� Its� expansion� and�

development� started� in�1945,�being� the� first� company� to�manufacture�penicillin-based�products� in�Argentina.�

In� the�early�60’s,� it� extended� its� coverage�area� through� the� first� exports� to�Latin�America.� Later�on,� in�1968,�

it� launches� “Trifacilina”,� the� first� ampicillin� of� the� Argentine� market,� which� significantly� updated� the�

anti-infectious� therapy� available� in� our� country.

Towards� the�end�of� the�60’s,�with� two�pharmaceutical�production� facilities�and�a�Research�and�Development�

center� in� Argentina,� Laboratorios� Bagó� achieved� the� first� position� in� the� Argentine� sales� market,� which� is�

a� remarkable� fact� worldwide� due� to� its� being� an� Argentine� company.� Within� the� scientific� sphere,�

Laboratorios�Bagó�discovered� the�original�molecule�of�Talniflumate,� a�strong�non-steroidal� anti-inflammatory�

drug� with� excellent� gastric� tolerance,� currently� exported� to� South� East� Asia.

Today,�Laboratorios�Bagó� is�present� in�22� countries�of�Latin�America,�Europe�and�Asia,� and� its�products�are�

sold� in� 47� countries.

Company� Description� &� Organization

Laboratorios� Bagó� was� born� in� Argentina� and� it� has� grown� along� with� the� century.� Since� its� foundation,�

in�1934,� it�has�been�permanently�committed� to� its�vision:� to�build�a� state-of-the�art�pharmaceutical�company�

and� to� achieve� excellence� in� health� care.

Our�Products� in�over�47�countries,�11�pharmaceutical�production� facilities�worldwide,�85�patents�developed�

in� 15� countries� under� our� own� research� and� over� 480� products� comprising� 46� therapeutic� lines,� are� some�

of� the� achievements� that� distinguish� us.�

Our� leadership� is�based�on�valuing�and�promoting�a� strong�commitment� to� research�and�development,� thus�

positioning�our�products�ahead�of�modern� therapeutics� and�at� the� level�of� the�highest� international�demands�

and� parameters.�

We� share�with� you� the� outcome� of� eight� decades� of� hard�work,� based� on� enthusiasm� and� effort� to� be� up�

to� our� challenge,� and� to� compete� in� a� world� of� scientific� technology� with� worldwide� quality� and� human�

passion.�

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부록 2� �전략적 협력사 디렉토리 ❚ 725

62. Laboratorios Bernabo S.A

1.� Corporate� General� Information

Corporate� Name Laboratorios� Bernabó� S.A.

Facilities� City� &� Country Argentina

Web-site� Address www.laboratoriosbernabo.com

Contact

(Korean� Business)E-mail [email protected]

Company� History

In� the� 1930s,� national� pharmaceutical� companies� marketed� medicines� imported� as� end� products.� Drugs�

were� prescribed� as�magistral� preparations.� In� 1934,� Laboratorios� Bernabó� joined� a� group� of� less� than� 20�

Argentine� and� international� companies� from� the� National� Pharmaceutical� Industry� that� marketed� their�

products� in� the�country.� From�the�beginning,�we�have�made� important�pharmacological� contributions� that�

were� key� references� in� clinical� therapeutics� with� products� such� as� Dinergol®� (digestive� drug),� Inertil® �

(laxative),� Neurobone®� (sedative),� Benzotrinal®� (mouth-throat� antiseptic),� Opolam®,� Suerobional®;�

Canteol®� and� many� others.

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726� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

63. Laboratorios Fabra S.R.L

1.� Corporate� General� Information

Corporate� Name Laboratorios� Fabra� S.R.L.

Head� Office� Address Carlos� Villate� 5271� B1605AXM� -� Munro

Facilities� City� &� Country Argentina

Web-site� Address www.fabra.com.ar

Contact

(Korean�

Business)

E-mail [email protected]

Company� History

Fifty� years�ago,� in� the�Republic�of�Argentina,� Laboratorios�Fabra�was� conceived�as�a� family�business�venture.�

Today,� with� half� a� century� of� experience,� Laboratorios� Fabra� has� become� a� leading� business� in� the�

production� of� generic� medications.�

A� level� which� was� achieved� thanks� to� a� qualified� and� prestigious� work� team,� state� of� the� art� equipment,�

and� a� common� objective:� improving� people’s� quality� of� life.�

For�us,�commitment� to�quality� is�one�of� the�most� important� foundations�on�which�we�build�our� track� record.�

A� track� record� that� currently� positions� us� as� the� laboratory� with� the� largest� drug� reference� guide� on� the�

market,� from� antimicrobials,� anti-inflammatories,� analgesics,� antihypertensives,� and� antiulceratives,� among�

many� others.�

Our� products� are� distributed� on� the� national� market,� as� well� as� reaching� in� countries� like� Bolivia,� Chile,�

Uruguay,� Paraguay,� Ecuador,� Colombia,� Azerbaijan,� and� Yemen.�

Nevertheless,� none� of� this� could� be� possible� without� the� unity� and� commitment� of� the� family� work� team,�

who� which� constantly� receives� training� and� believes� in� what� they� do;� working� in� a� way� that� is� both�

committed� to� their� workers,� as� well� as� to� the� environment� that� surrounds� them.

Company� Description� &� Organization

Mission�

"Improve� the� quality� of� life� for� people� through� our� commitment� to� health,� manufacturing� excellent�

medications� within� everyone’s� reach."

Vision

"To� be� a� leader� in� the� manufacturing� of� generic� medications,� having� the� largest� drug� reference� guide� on�

the� market,� covering� all� therapeutic� fields� and� ongoing� excellence� in� quality."�

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부록 2� �전략적 협력사 디렉토리 ❚ 727

64. Laboratorios IMA S.A.I.C

1.� Corporate� General� Information

Corporate� Name Laboratorios� IMA� S.A.I.C.

Head� Office� AddressStreet� Palpa� 2862� C1426DPB� Ciudad� Autónoma� de� Buenos� Aires�

Argentina

Facilities� City� &� Country Argentina

Web-site� Address www.laboratoriosima.com.ar

Contact

(Korean� Business)E-mail [email protected]

Company� Description� &� Organization

Mission

Laboratorios� IMA� SAIC,� with� presence� in� the� Argentine� Pharmaceutical� Industry,� since� 1962,� fully�

consolidated,� is� a� company� dedicated� to� the� manufacturing� of� oncological� injectable� medicinal� products�

for� human� use,� in� solution� and� lyophilized� dosage� form.� It� has� the� compromise� to� give� a� reliable� service�

under� most� strict� regulations� based� in� fulfillment� of� the� Good� Manufacturing� Practices� and� Control.

� The�mission� is� to�produce�medicinal�products�with�quality�and� fair�price,� in�order� to�contribute� in�solving�

health� problems.�

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728� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

65. Laboratorios LIOMONT

1.� Corporate� General� Information

Corporate� Name Laboratorios� LIOMONT

Head� Office� AddressAdolfo�López�Mateos�N°�68�Col.�Cuajimalpa,�Cuajimalpa�05000�México,�

D.F.�

Facilities� City� &� Country Mexico

Web-site� Address http://liomont.com

Contact

(Korean� Business)E-mail [email protected]

Company� Description� &� Organization

Mission

Develop,� produce,� and� market� medicines� that� help� heal� human� pain.

Vission

Make� Liomont� synonymous� of� quality� and� trust,� enlarging� the� National� Pharmaceutical� Industry.

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부록 2� �전략적 협력사 디렉토리 ❚ 729

66. Laboratorios Phoenix S.A.I.C. y F.

1.� Corporate� General� Information

Corporate� Name Laboratorios� Phoenix� S.A.I.C.� y� F.

Head� Office� AddressIng.� Torcuato� Di� Tella� 968� -� (B1868BIB)� Avellaneda

� Buenos� Aires,� Argentina

Facilities� City� &� Country Argentina

Web-site� Address www.phoenix.com.ar

Contact

(Korean� Business)E-mail [email protected]

Company� Description� &� Organization

We�are�one�of� the� leading�drug�delivery�companies�specialized� in�development�and�manufacturing�of�oral�

formulations.� We� have� an� experience� of� over� 50� years� bringing� effective� solutions� to� our� customers� by�

combining� formulation�science�with� cutting-edge�processing� technologies�and�highly�qualified�professional�

teams.

Our� company�was� founded� in� Buenos� Aires,� Argentina� as� Diffucap� Eurand� S.A.� and� since� its� inception� it�

focused� on� the� development� and� manufacturing� of� high� value-added� pharmaceutical� formulations.�

Through� its� life,� the� company� constantly� evolved� as� is� evidenced� by� the� introduction� of� several� new�

technologies� and� the� continuous� investment� in� highly-specialized� processing� equipment.�

In�2010�we�changed�our�name�to�Novocap�S.A.�and�we�consolidate�as�an� internationally� renowned�expert�

organization.

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730� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name Laboratorios� Poen� S.A.C.I.F.I.

Head� Office� AddressBermúdez� 1004

CABA� -� República� Argentina.�

Facilities� City� &� Country Argentina

Web-site� Address www.poen.net.ar

Contact

(Korean� Business)E-mail [email protected]

Company� History

Poen� Laboratories� S.A.C.I.F.I.� is� a� domestic� owned� firm� devoted� to� the� manufacture� and� marketing� of�

ophthalmic� medicinal� products.

The� history� began� in� 1933�when� our� company�was� only� a� small� drugstore.�Mr.� Leon�Macchi,� the� founder,�

settled� at� 891� Asamblea� St.,� located� in� Capital� Federal.

Throughout� time,� he� moved� to� a� processing� plant� of� approximately� 750� mts2� in� Madero� St.,� Versailles�

neighborhood,� with� about� 35� people� who� constituted� the� first� founding� group� of� our� company.� At� that�

time,� a� simple� de� facto� business� association� became� a� Corporation.

The�growth�within� the� ophthalmology�market� paid� the�way,� in�November�1964,� for�moving� the� processing�

plant�once�again� to�5120�Gaona�Av.� in�Buenos�Aires� city.� This� building�doubled� the� production� site,� taking�

it� to� almost� 1500� mt2� and� about� 150� employees.�

In� July�1998,� it�was� taken�over�by�Roemmers�Laboratories,�making� the�prestige�of�our�products,� innovation,�

development� and� production� process� technologies� excel.� This� required� running� a� serious,� aggressive� and�

sustained� policy� in� matters� of� capital� assets� investment.�

That� year,� we� also� inaugurated� our� new� and� current� Processing� Plant� in� 1004� Bermudez� St.,� also� located�

in� Buenos�Aires� city.� The�building� is� about� 3500�mt2� and�has� the�most�modern�and� innovative� technology.�

Today,� our� company� is� about� to� be� 80� years� old� and� we� can� proudly� see� that� we� have� reached� absolute�

67. Laboratorios Poen S.A.C.I.F.I.

1.� Corporate� General� Information

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부록 2� �전략적 협력사 디렉토리 ❚ 731

leadership� in� the� local� ophthalmic� market� and� a� relevant� presence� in� more� than� 20� countries� in� America.�

This� required� the� creation� of� team�works,� to� provide� them�with� appropriate� training� and� precise� tools� and�

motivate� them� every� day� in� order� to� reach� the� outlined� objectives.�

It� is� our� wish� to� remain� at� the� leading� edge� of� the� ophthalmic� market,� to� continue� being� the� leaders� in�

research�and� innovation�of�ophthalmic�drugs�and� to�maintain� the� interest�of�physicians�and�patients� through�

a� direct,� honest� and� formal� relationship,� as� we� have� always� done.

Company� Description� &� Organization

Our� Mission

Our� mission� is� to� contribute� to� people’s� health� and� to� improve� their� quality� of� life.� For� this� purpose,� we�

develop� high� quality� medicines,� caring� deeply� about� the� environment.

Vision

To� be� the� leader� company� in� research� and� development� of� ophthalmic� drugs.

Poen�Laboratories�has� implemented�a�Quality� System� in�order� to�elaborate�products�which�meet� the�highest�

national� and� international� requirements� since� our� goal� is� to� reach� the� highest� quality� standards.

Our� Values

•� Respect� for� life

•� Team� Work

•� Excellence�

•� Human� Development�

•� Integral� Quality

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732� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name Lekhim

Head� Office� Address 23,� Shota� Rustaveli� street� 01033� Kiev,� Ukraine

Web-site� Address http://www.lekhim.ua

Contact E-mail [email protected]

Company� History

1992� —� Establishment� of� Lekhim� Company,� City� of� Kyiv.�

1995� —� Establishment� of� Lekhim-Kharkiv,� manufacturing� company,� Kharkiv.�

1995� —� The� production� of� suppositories� ­� a� new� for� Ukraine� medical� form� ­� was� launched� at� the� fully�

automated� line� installed� by� Farmo-Due,� Italian� company.� The� production� capacity� is� 80� million�

pieces� a� year.�

1999� —� The� workshop� for� production� of� solid� dosage� medicines� forms� was� launched� at� Lekhim-Kharkiv.�

1999� —� Lekhim,� JSC� became� the� majority� shareholder� of� the� Technolog� plant� in� the� City� of� Uman.�

2000� —� The� workshop� for� production� of� solid� dosage� medicines� forms� was� launched� at� Technolog�

enterprise.�

2006� —� The� production� volume� of� Technolog,� Private� JSC� reached� 1� billion� tablets� a� year.�

2008�—�The�workshop� for�production�of�medicines� in�ampoules�was� launched�at�Lekhim-Kharkiv�enterprise.�

The� first� phase� capacity� is� 30� million� ampoules� a� year.�

2009� —� Lekhim-Kharkiv� enterprise� received� the� official� confirmation� for� the� correspondence� to� ISO� 9001�

quality� standard.�

2009�—�The�enterprises� Lekhim,� Lekhim-Kharkiv� and�Technolog�merged� in� Lekhim�Group�of�pharmaceutical�

companies.�

2010� —� Lekhim� Group� of� Companies� was� placed� in� the� TOP-10� of� the� best� manufacturers� among� 137�

Ukrainian� pharmaceutical� companies.�

2011� —� At� the� ERP-system� IT-Enterprise� corporate� platform� the� project� for� integrated� automation� was�

started.�

2011� —� Lekhim� Group� of� Companies� was� ranked� the� 7th� regarding� the� rise� of� the� net� annual� income� in�

Ukrainian� pharmaceutical� manufacturers� rating.�

2011�—� Technolog,� Private� JSC� implemented� the� launch�of� a� new�updated�workshop� for�manufacturing�of�

ferment� and� vitamin� medicines.�

2011� —� Lekhim-Kharkiv,� Private� JSC� commissioned� the� powerful� microbiological� laboratory.�

68. Lekhim

1.� Corporate� General� Information

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부록 2� �전략적 협력사 디렉토리 ❚ 733

2012� —� Lekhim-Kharkiv,� enterprise� is� launching� the� second� line� for� the� production� of� injection� solutions.�

2012�—� Technolog� has� obtained� the� Certificate� of� Conformity� of�manufacturing� sites� GMP�No.� 033/2012/�

SAUMP/GMP.�

2013� —� At� the� JSC� "Lekhim-Kharkiv"� put� into� operation� a� new� administrative� complex� and� warehouses.�

2014�—� JSC� "Lekhim-Kharkiv"� received� GMP-certified� in� accordance�with� Good�Manufacturing� Practice� No�

055/2012� /� SAUMP� /� GMP.�

2014�—� JSC�"Lekhim-Kharkiv"�has� received� ISO�9001:�2009� "System�quality�management.�Requirements� "(ISO�

9001:� 2008,� IDT).�

2014� —� At� the� JSC� "Lekhim-Kharkiv"� put� into� operation� a� new� chemical� laboratory.�

Company� Description� &� Organization

Lekhim� Joint� Stock� Company� was� established� in� 1992.

Nowadays� Lekhim�Group� of� Companies� is� powerful�modern� high-tech�manufacturing� company,� one� of� the�

leading� pharmaceutical� Ukrainian� companies� in� the� sphere� of� development,� manufacturing� and� sale� of�

highquality� medicines� at� a� reasonable� price.

Lekhim� Group� of� Companies� includes� the� following� pharmaceutical� companies:

•� Lekhim-Kharkiv,� Private� JSC� (City� of� Kharkiv);

•� Technolog,� Private� JSC� (City� of� Uman);

•� and� management� company� Lekhim,� JSC� (City� of� Kyiv)� with� pharmacies� retail� network.

In� the� course� of� the� years� of� its� activity,� Lekhim� Group� of� Companies� has� taken� leading� positions� among�

manufacturers� of�medicines� at� the�Ukrainian� pharmaceutical�market.�Moreover,�we� are� actively� engaged� in�

export� operations� with� many� countries� of� the� near� and� far� abroad.

The� Group� enterprises� meet� all� the� qualifying� standards� of� the� modern� industrial� production� of� medicines�

and� have� the� relevant� technical,� material,� human� and� scientific� potential.

Lekhim� Group� of� Companies� continues� its� active� development:

•� launches� a� number� of� innovative� projects� to� optimize� all� the� relevant� business� processes;

•� expands� and� updates� its� manufacturing� process;

•� implements� actively� thy� scientific� and� research� work;

•� develops� and� introduces� the� new� direction� of� foreign� economic� activity;

•� is� involved� in� social� programs� of� the� society� health� improvement.

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734� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

69. LS SAVAL

1.� Corporate� General� Information

Corporate� Name LS� SAVAL

Corporate� Ownership Emilio� Saval� Prados

Head� Office� Address Avda.� Presidente� Eduardo� Frei� Montalva� 4600,� Santiago� de� Chile�

Facilities� City� &� Country Chile

Web-site� Address www.saval.cl

Contact

(Korean�

Business)

Name Frank� Wamckel� W.

E-mail [email protected]

Company� History

SAVAL� Pharmaceuticals� history� start� in� the� early� 30’s� in� Spain� to� continue� in� Chile� during� the� 40’s� and� in�

the� latest� decades� in� other� latin� american� countries.

Initially,� SAVAL� Pharmaceuticals� produced� and�marketed� ophthalmologic� products� exclusively� but� expanded�

rapidly� to� other� specialities,� obtaining� leadership� within� the� international� pharmaceutical� industry.�

The�corporate�philosophy�which�has�guided�us� throughout�our� vast� trajectory,�was�born� in� those�early�days:�

to� introduce� into� the�market� innovative�pharmaceutical�products�which� contribute� towards� the� conservation�

of� health,� in� harmony� with� the� enhancement� of� professionals� who� work� in� this� area.�

During� the� last� decade,� SAVAL� Pharmaceuticals� extended� its� activities� successfully� to� various� countries� in�

Latin�America,�carrying� the�same�corporate�message�which�has�been� its� flag� in�every�market:�a�broad� range�

of�products�and� services�which� contribute� to�people’s�well-being.�The�present�meaning�of� its�mission� is�proof�

of� its� commitment� to� develop� innovative� pharmaceutical� products� and� contribute� to� the� improvement� of�

health� under� a� globalized� pattern.

Company� Description� &� Organization

Mission�

To� contribute� towards� the� preservation� of� health,� by� providing� high� quality,� necessary� and� innovative�

pharmaceutical� products,� in� response� to� demands� in� the� markets� in� which� we� operate�

To� contribute� towards� the� satisfactory� fulfillment� of� medical� activities� by� sponsoring� investigation,�

information� and� cooperating� in� the� advancement� of� academic� and� professional� tasks

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부록 2� �전략적 협력사 디렉토리 ❚ 735

Corporate� Name MEGA

Head� Office� AddressNo.� 120,� Moo� 11,� Ample� Tower,� 9th� -10th� Floor,� Bangna-Trad� Road,�

Bangna,� Bangkok� 10260,� Thailand

Web-site� Address http://www.megawecare.com

Contact E-mail [email protected]

Company� History

1982

Mr.�Kirit� Shah� incorporated�our� company�under� the� name�of� “Vikas�Company� Limited”�which�was� reformed�

to� “Medicap� Limited”

1985

“Soi�6,� Samut�Prakran,� Thailand”�Our� first�manufacturing� facility� received�a� license� from�Thai� FDA� to�produce�

medicines� and�GMP� certification.�We�believe� it�was� the� first� and�one� of� the� largest� soft� gel�manufacturing�

facilities� in� Southeast� Asia.

1986

Mr� Vivek� Dhawan,� now� the� Company’s� Chief� Executive� Officer,� joined� the� Company.

1988-89

Increased�our�annual�production� capacity� to�625�million� soft� gel� capsules�by�adding�production� lines� to� our�

manufacturing� capacity.

1990

“Mega� Products� Limited”� was� formed� to� market� and� sell� nutraceutical� products� under� our� own� brands.

1993

Soi� 6� manufacturing� facility� received� GMP� certification� from� the� Australian� TGA

1994

Acquired� the�MedicraftsTM� brand� and� associated� trademarks� for� a� range�of� products;� it� helped� in� growing�

70. MEGA

1.� Corporate� General� Information

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736� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

our� branded� products� and� its� market� acceptance.

1995-96

Established� operations� in� Myanmar� (’95),� Vietnam� (’95)� and� Cambodia� (’96)� to� market� and� sell� our� own�

brands� and� developed� our� distribution� business� as� well

1997

We� become� the� first� pharmaceutical� company� in� Thailand� to� receive� the� ISO� 9002� certification

2000

Launched�our�own�brands� into�developing�markets� including� the�Commonwealth�of� Independent�States�and�

countries� in� Africa� and� the� Middle� East

2001

Mega� We� careTM� registered� as� trademark.

Mega�We� careTM� registered� as� trademark.� Our� manufacturing� facility� in� Soi� 6� obtained� GMP� certification�

from� the� German� health� authority,� the� district� government� of� Arnsberg

First� Thai� pharmaceutical� company� to� export� nutraceutical� and� pharmaceutical� products� to� Germany

2002

Started� manufacturing� facility� in� Dandenong,� Melbourne,� Australia� and� received� a� TGA� licence� for� the�

operations.

2004

Our� Soi� 6� manufacturing� facility� received� GMP� certification� from� the� National� Drug� Authority� of� Uganda.

2005

Changed� our� company� name� from� “Medicap� Limited”� to� “Mega� Lifesciences� Company� Limited”.

2006

Ministry�of�Health�of�Yemen�and�Ukraine�awarded� the�GMP�certification� to�our�Soi�6�manufacturing� facility�

in� Thailand.

Mega� Lifesciences� Company� Limited,� Myanmar� became� the� first� distribution� and� logistics� company� in�

Myanmar� to� receive� ISO� 9001� certification.

2008

Soi� 6� manufacturing� capacity� reached� to� annual� design� capacity� to� 2.1� billion� soft� gel� capsules

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부록 2� �전략적 협력사 디렉토리 ❚ 737

Our� 2nd� manufacturing� facility� was� established� in� Soi� 8� in� samut� prakran,� Thailand� for� manufacturing�

tablets,� hard� capsules� and� packages� commencing� next� year.

GMP�certifications� for�our�Soi�6,�Thailand�and�Australian�manufacturing� facilities� from�United�Arab�Emirates�

ministry� of� health

2009

We� received� GMP� certification� for� our� Soi� 6� manufacturing� facility� from� the� Oman� Ministry� of� Health.

In� the� same� year,� we� received� GMP� certification� for� our� Soi� 8� manufacturing� facility� from:� (i)� the� District�

Government� of� Arnsberg� in� Germany;� (ii)� the� Thai� FDA;� and� (iii)� the� Australian� TGA

2010

We�registered� “Maxxcare”� as�a� trademark� in�2010.�MaxxcareTM� is� the�primary� trademark� for�our�distribution�

business.

We� continued� to� get� GMP� certifications� from� various� countries

GMP� certifications� for� our� Soi� 8� manufacturing� facility� from� the� Ukrainian� Ministry� of� Health

Both� of� our� manufacturing� facilities� in� Thailand� also� received� certification� from� the� Ethiopian� Drug� and�

Administration� Authority

2012

GMP� certification� for� our� Soi� 6� manufacturing� facility� from� the� Ministry� of� Health� of� Sudan

Our�Soi�8�manufacturing� facility� in�Thailand� received�GMP�certification� from� the�Ministry�of�Health�of�Yemen

In� addition,� both� of� our�manufacturing� facilities� in� Thailand� received�GMP� certification� from� the�Ministry�of�

Health� of� Peru

We� received� the�Taxpayers’�Recognition�Award�2011,�an�award� recognizing� taxpayer� responsibility,� from� the�

Thai� Revenue� Department� in� recognition� of� our� being� a� good� corporate� citizen� with� good� corporate�

governance� and� best� practices� in� paying� taxes.

Acquired� the� EugicaTM� brand,� intellectual� property� and� title� documents

According� to� IMS� Health� data� as� of� June� 2013,� a� number� of� our� branded� products� were� ranked� number�

one� in� their� respective� market� categories� in� 2012

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738� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

2013

We� received� GMP� certifications� from� the� Ugandan� National� Drug� Authority� and� the� United� Arab� Emirates’�

Ministry� of� Health� for� our� Soi� 8� manufacturing� facility� in� Thailand

We� relocated�our�manufacturing� facility� in�Australia� from�Dandenong�to�a�newly�constructed�manufacturing�

facility� in� Pakenham,�Melbourne� (“Pakenham� Facility”),� also� received� GMP� certification� from� the� Australian�

TGA.

Transformed� our� Company� into� a� public� company,� we� got� listed� in� Thailand� Stock� exchange� in� November�

2013� and� changed� our� name� to� Mega� Lifesciences� Public� Company� Limited

Company� Description� &� Organization

Established� in� 1982,� Mega� Lifesciences� public� company� limited� is� actively� involved� in� helping� millions� of�

people� have� access� to� safe,� effective,�world� class� quality� nutritional�&� herbal� supplements,�OTC� and� ethical�

products.

From� Thailand� to� the�world,�Mega� is� engaged� in�manufacturing,�marketing,� selling� and� distributing� quality�

pharmaceutical,� nutraceutical� products� and� Fast� Moving� Consumer� Goods� (FMCG).

Headquartered� in� Bangkok,� we� have� our� presence� in� 29� countries� across� the� globe.� Our� manufacturing�

facilities� located� in� Thailand� &� Australia,� have� received� international� accreditation� from� reputed� health�

authorities� around� the� world� with� respect� to� good� manufacturing� practices.� We� export� to� Asia-Pacific,�

Middle� East,� Africa,� CIS-Countries,� Latin� America� and� Europe.

Our� business� activities� across� all� major� stages� of� the� pharmaceutical� industry� value� chain� provide� us� with�

increased� opportunities� to� pursue� growth� by� realizing� potential� synergies� arising� from� coordinating� our�

efforts� across� business� segments� in� our� selected� markets.

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부록 2� �전략적 협력사 디렉토리 ❚ 739

2.� Additional� Business� Propositions� for� Collaboration

Our� Value

Respect

Each� one� of� us� is� different� and� brings� his� or� her� distinct� abilities� to� the� team.� A� team� is� made� up� of�

passionate,� committed� and� caring�people�who�bring�different� views.�We� encourage� respect� amongst� our�

team� members� fostering� a� culture� of� learning� and� changing� together.� Mega� is� an� equal� opportunity�

employer� and� does� not� discriminate� on� Race,� nationality,� religion,� civil� status,� sex� and� sexual� orientation.�

Mega� Respects� a� good� work� &� life� balance.

Freedom

MEGA� insists�on� freedom� to�be�oneself,�encouraging�you�to�do�what�you�are�best� at.�We�believe� in�hiring�

adults� and� believe� them� to� make� responsible� decisions� once� the� freedom� is� given.�We� believe� in� giving�

freedom� to�make�choices� to� lead� their� lives� the�way� they�wish� to,�without�being� judgmental.�As�an�adult,�

you� are� expected� to� value� your� responsibilities� and� maximize� your� freedom,� utilizing� the� existing�

guidelines.

Trust

We� trust�people�as�adults�who�know�what�needs� to�be�done.�We�show�100�percent� trust� in�people�who�

work� at� MEGA,� till� this� trust� is� lost.� We� believe� everyone� is� honest� and� is� here� to� give� their� best.� They�

wish� to� come� to� work� on� time,� contribute� and� want� to� be� respected� for� the� work� they� do.� Our� trust�

extends�beyond�our�own�people� to�our�suppliers� and�partners�who�work� together� to�help�us� create� value�

for� their� customers.

Truth

Being� truthful� in� what� we� do� every� day� is� the� way� of� life� here� at� MEGA.� We� insist� on� truth� in� action�

every� day.�We�will� not�manufacture,�market,� sell,� and�distribute�any�product� that� is� not� safe� for� humans.�

We� will� do� everything� to� report� and� inform� everybody� truthfully� about� our� performance,� successes� and�

failures� and� own� up� to� the� mistakes� we� make.

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740� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Collaboration�

Opportunities� for� R&D�

Co-works

Through� our� Open� Compound� Sourcing� initiative,� Company� invites� potential�

partners� to� submit� their� compounds� to� be� included� in� our� high� throughput�

screening� library� and� utilized� in� efforts� to� identify� new� therapeutics.

We� arer� looking� for� novel� small� organic� chemical� compounds� for� testing� in� our�

screening�campaigns� for�potential� therapeutic� activity.�Many�of� these� compounds�

might� otherwise� never� be� tested� for� potential� therapeutic� benefits.� In� case� of� a�

match,� specific� compounds� could� become� the� next� new� chemical� entity� (NCE)� or�

starting�point� for� further�optimization� in�one�of�our�strategic� therapeutic�areas�of�

focus:� Oncology,� Neurodegenerative� Diseases� and� Rheumatology.

71. Merck Ltd. Korea

1.� Corporate� General� Information

Corporate� Name Merck� Ltd.� Korea

Web-site� Address http://www.merck.co.kr

Contact

(Korean� Business)

Name Young-Joo� Kim

Address 15F,� Haesung-2-building,� Teheran-Ro� 508,� Gangnam-gu� ,Seoul

Telephone 02-2185-3921

E-mail [email protected]

2.� Description� of� Collaboration�Opportunities

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부록 2� �전략적 협력사 디렉토리 ❚ 741

Collaboration�

Opportunities� for�

In-Licensing

For� Korea,�Company� is� keen� to� look� into� the� possibility� of� future� collaboration� to�

address� the� unmet�medical� needs� in� patients�with� cancer,� Cardiovascular�disease,�

or�Metabolic� disorder.� The� collaboration� is� open� to� further� discussion� in� terms�of�

geographic� scope,� which� could� be� a� specific� country� or� global� one,� and� of� the�

development� stage,�which� could�be�co-development�and/or� co-commercialization.

At� Merck� Serono,� we� have� an� enduring� commitment� and� focus� in� our� specialist�

therapeutic� areas� of� oncology,� neurodegenerative� diseases,� fertility� and�

endocrinology,� along� with� rheumatology� as� an� emerging� area� of� expertise.� We�

also� provide� a� portfolio� of� cardio-metabolic� care� and� general� medicine� products,�

especially� in� emerging� markets� where� patient� need� remains� high.

Around� the� world,� teams� of� dedicated� employees� work� to� discover,� develop,�

manufacture� and� commercialize� our� prescription�medicines,� available� in� over� 150�

countries.� We� are� internationally� recognized� as� a� biotechnology� leader,� with�

innovative� and� successful� products� along�with� a� promising� development� pipeline.�

Our� expertise� in� both� biotechnology� and� pharmaceutical� chemistry,� combined�

with�a�profound�understanding�of�disease� in�our� focus� therapeutic� areas,� enables�

us� to� take� a� flexible� approach� to� finding� the� right� compound� to� treat� a� specific�

disease.� The� capability� to� develop� and� manufacture� new� molecular� entities� of�

either� type� with� equal� success� allows� Merck� Serono� to� exploit� the� full� potential�

of� the� biological� and� chemical� spheres� at� every� stage� of� the� drug� development�

process.

We� truly� believe� that� our� focused� expertise� can�make� a� real� difference� to� people�

living� with� serious� diseases.� Not� everything� we� do� leads� to� a� breakthrough,� but�

we� never� lose� sight� of� the� human� need� that� motivates� us.

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742� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

3.�특허분석 결과

Merck� Ltd사의 특허분포도를 볼 때 기술 중에 대표적으로 Cgrp� Headache� Migraine� Cluster� Migraine�

Cluster� Headache,� Alkyl� Hydrogen� Alkoxy,� Protein� Ras� Directed� Transferase� Prenylation� Oncogene�

Protein등의 키워드를 가진 기술에 많은 특허가 분포하고 있는 것으로 나타났다.

Page 746: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

부록 2� �전략적 협력사 디렉토리 ❚ 743

2006년 01월 01일부터 2012년 12월 10일까지 출원된 Merck� Ltd사의 특허의 키워드 분포는 붉은 점으로 나타

난다.

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744� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name MICRO� GEN

Head� Office� Address 10,� 2-nd� Volkonsky� lane,� Moscow,� Russia� 127473

Web-site� Address http://microgen.ru

Company� Description� &� Organization

Federal� State� Scientific-Industrial� Company� MICROGEN� is� the� largest� company� in� Russian� medical� industry�

that� holds� leadership� in� development� and�production�of� immunobiological� preparations,� diagnosticums� and�

drugs.

Consortium�MICROGEN�was� founded� in�May,� 2003� in� order� to� create� a� competitive� enterprise� in� the� field�

of� medical� immunobiology� that� could� ensure� the� implementation� of� national� programs� of� biological� and�

epidemiological� security,�development�of�domestic�biotechnological� industry� in�accordance�with� international�

standards� of� drug� production� and� practical� application� of� new� and� highly� effective� preparations.

Subsidiaries� that�were�amalgamated�within� the�MICROGEN�have�a�history� that� is�more� than�a�hundred� years�

long.�They�were� created�on� the�basis�of�Pasteur�centers�and� laboratories� that� conducted� studies� in� the� field�

of� immunobiology.

The� main� aims� of� the� company� are:

•� complete� provision� of� immunobiological� preparations� for� the� maintenance� of� Russia� epidemiologic� and�

sanitary� welfare,� primarily� vaccines� for� the� National� Vaccination� Schedule� and� vaccines� for� socially� i�

mportant� infectious� diseases;

•�maintenance�and�development�of�efficient�supply�of� immunobiological�preparations� to�Russian�Federation�

subjects;

•� creation� of� a� unified� program� of� development,� funding� and� modernization� of� production� and� research�

development� in� the� field� of� biotechnology;

•� improving� the� international� image� of� the� Russian� science� and� producers� of� immunobiological�

preparations.

At� present� Federal� State� Scientific-Industrial� Company� MICROGEN� is� a� modern� enterprise� that� holds�

leadership� position� in� the� domestic� pharmaceutical� industry.� Production� output� for� MICROGEN� in� the� year�

2013� was� more� than� US$150m.

The� company� steadily�widens� the� shipping� geography� of� its� immunobiological� products:� they� go� to� the� CIS�

countries� (Kazakhstan,� Ukraine,� Byelorussia,� Uzbekistan,� Azerbaijan,� Armenia,� Georgia),� Mexico,� Mongolia,�

Vietnam,� India.� A� number� of� countries� of� Africa,� South-East� Asia� and� Latin� America� are� conducting� talks�

72. MICRO GEN

1.� Corporate� General� Information

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부록 2� �전략적 협력사 디렉토리 ❚ 745

concerning� future� cooperation.

MICROGEN�Consortium� in� active� cooperation�with� leading� Russian� and� foreign� research� centers� is�working�

on� designing� and� application� to� production� development� of� the� unique� innovations� in� immunobiology� and�

biotechnology.

In� collaboration� with� leading� Russian� scientists� the� company� is� striving� to� develop� and� manufacture� new�

high-quality� preparations,� modern� pharmaceutical� forms.

MICROGEN�specialists�participate� in� international� research�projects� including�WHO�programs� for�eradication�

of� natural� smallpox,� measles,� rubella,� tuberculosis,� whooping� cough,� diphtheria,� tetanus,� avian� flu,� etc.

At� present� more� than� 15� novel� preparations� are� being� prepared� for� commercial� production,� e.g.� new�

influenza,� smallpox� and� tick-borne� encephalitis� vaccines,� associated� DTP� vaccine,� hepatitis� B� vaccine,�

hemophilic� infection� vaccine,�mumps,�measles� and� rubella� vaccine,� avian� flu� vaccine,� cell-depleted�pertussis�

vaccine,� staphylococcal-proteus-pseudomonas� aeruginosa� vaccine� (SPPA-vaccine)� and� others.

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746� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name Moscow� Endocrine� Plant

Head� Office� Address 25,� Novokhokhlovskaya� ulitsa,� Moscow,� 109052

Web-site� Address http://endopharm.ru

Contact E-mail [email protected]

Company� Description� &� Organization

The� history� of� operation� of� Federal� State� Unitary� Enterprise� (FSUE)� “Moscow� Endocrine� Plant”� fully� reflects�

the� history� of� the� country:� dreadful� years� of� the� Great� Patriotic� War,� hard� after-war� period,� stable� 1970s�

and� raucous� 1990s...

The� Plant� of� Endocrine�Medicines� at� the� A.I.� Mikoyan�Moscow�Meat� Processing� Factory� (as� the� enterprise�

was� called� then)� was� created� in� April� 1943.� Under� wartime� conditions� the� plant� managed� to� launch�

production� of� insulin,� miol,� thyreoidin� from� raw� materials� derived� from� beef� cattle.

In� 1962,� pursuant� to� the� Resolution� of� the� Council� of� Ministers� of� the� USSR,� “Moscow� Endocrine� Plant”�

became� a� state� enterprise� of� the� union� subordination.

In� 1964� a� new� unit� of� the� plant� with� production� lines� for� manufacturing� intermedin,� adrenalin,� mycoin,�

lydase� and� a� number� of� other� pharmaceutical� products� was� launched.

In� 1968� the� plant� has� become� one� of� the� first� enterprises� in� the� country� to� master� the� production� of�

medicines� in� unit-dose� syringes� and� dropping� tubes.

Also� in� the� 1960s� a� production� section� for� manufacturing� pantocrine,� an� elixir� of� health� and� longevity,�

derived� from� red�deer� antlers�was� created.� Since� then�a� silhouette� of� this� noble� deer� has� become� a� symbol�

of� “Moscow�Endocrine�Plant”�and� later�was�accepted�as�a� logo.�The�enterprise�has�become�one�of� the� largest�

in� the� country�manufacturers� of� pharmaceutical� substances� and� finished� dosage� forms� from�animal-derived�

raw� materials.

The� collapse� of� the� Soviet� Union� and� the� crisis� of� the� early� 1990s� could� not� but� affect� the� enterprise�

operations� —� workshops� for� processing� animal-derived� raw� materials� were� closed,� production� of�

pharmaceutical� substances� of� animal� origin� was� stopped.

Despite� the� difficult� economic� environment,� the� enterprise� launched� new� production� in� 1994� in� order� to�

substitute� for� lost� production� facilities� for�manufacturing� strong�analgesics�which�had� remained�beyond� the�

Russian� border� after� the� collapse� of� the� USSR.� It� is� hard� to� overestimate� the� significance� of� this� event� — �

73. Moscow Endocrine Plant

1.� Corporate� General� Information

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부록 2� �전략적 협력사 디렉토리 ❚ 747

a� brand� new,� own� production� facility� for� manufacturing� painkillers� was� created� in� Russia� almost� from� the�

ground� up.

At� the� moment� Federal� State� Unitary� Enterprise� (FSUE)� “Moscow� Endocrine� Plant”� being� under� the�

supervision�of� the�Ministry�of� Industry�and�Trade�of� the�Russian�Federation� is� a�modern�high-tech�production�

facility.� Its� production� base� includes� four� key� workshops� —� for� manufacturing� medicines� in� ampoules� and�

bottles� (including� sublimates),� tablets� and� capsules� and� workshops� for� manufacturing� medicines� in� PE�

bottles,� unit-dose� syringes� and� ampoules.

The� enterprise� was� one� of� the� first� in� Russia� to� implement� the� international� manufacturing� and� quality�

control� standards�—�Good�Manufacturing�Practice� (GMP).�Quality� control�of� finished�products� is�carried�out�

in� compliance� with� the� international� requirements.

The�enterprise’s�assortment� includes�all� types�of�narcotic� analgesics� required�by� the�Russian�healthcare� sector,�

which�allows� to�satisfy� fully� the�needs�of�medical� treatment� facilities� and�pharmacy�chains� in� these�products.

In� addition� to� analgesics� the� enterprise� manufactures� a� wide� range� of� socially� important� pharmaceutical�

products�applied� in�endocrinology,�gynecology,�ophthalmology,� cardiology,� and�psychoneurological�practice.�

The� plant’s� product� portfolio� includes� 81� pharmaceutical� products� of� eight� pharmacological� classes,� out� of�

which� 60� are� included� in� the� List� of� Vital� and� Essential� Medicines� (VEM)� approved� by� the� Government� of�

the� Russian� Federation.

Product� output� in� accordance� with� the� VEM� list� is� a� social� function� of� the� plant� within� the� framework� of�

the� state� policy� aimed� to� ensure� the� availability� and� affordability� of� medicines� for� the� population.

The� plant’s� specialists� work� in� close� cooperation�with� their� colleagues� from� the� largest� Russian� and� foreign�

scientific� centers.

FSUE� “Moscow� Endocrine� Plant”� is� proud�of� its� history,� its� products� and� its� employees.� The� plant� continues�

its� dynamic� development,� successfully� implementing� for� this� purpose� innovative� programs� and� using�

state-of-the-art� technology.� The� enterprise� is,� by� right,� one� of� the� leaders� of� manufacturing� domestic�

medicinal� products� and� holds� a� strong� position� in� the� Russian� pharmaceutical� market.

High-quality� and� affordable� in� price� products� of� the� plant� are� well� know� both� in� Russia� and� abroad.

2.� Additional� Business� Propositions� for� Collaboration

Our� principles� have� remained�unchanged� for� over� seven�decades�—� to�maintain� top�quality� based�on� the�

latest� scientific� achievements� to� ensure� the� nation’s� health.

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748� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name MosFarma

Head� Office� Address 125239,� Moscow,� Russia,� Pharmacevticheskiy� proezd,� 1

Web-site� Address http://www.mosfarm.ru/

Contact E-mail [email protected]

Company� History

The� Moscow� Pharmaceutical� Factory� was� founded� in� 1932.

The� first�drug� factory�was�established�under� the�Moscow�Municipal�Pharmaceutical�Board.� It�became�known�

as� the� «Galenic� Factory»� because� most� of� the� products� manufactured� at� the� time� were� galenic�

preparations� (tinctures,� extracts� and� drops� obtained� from� herbal� raw� materials).

In� the� 70s� the� company� developed� pharmacopeial� monographs� for� many� medicines� which� became�

traditional,� such� as� Menovasin,� Cindol� and� Fucorcin.� It� also� developed� pharmacopeial� monographs� for� 18�

homeopathic� drugs,� such� as� Calendula� ointment� and� suppositories,� Propolis� ointment� and� Hamamelis�

suppositories.

In� 1976� the� production�was� transferred� to� a� new� site� in� the� north� of�Moscow� in� Koptevo.� Since� then,� the�

plot� of� land� in� the� outskirts,�which� had� been� unremarkable� until� then,�was� named� in� honor� of� the� factory�

­� Pharmaceutical� Lane.

Since� 2005� the� Moscow� Pharmaceutical� Factory� distributes� its� products� under� the� MosFarma� trademark.

In� 2009� the�Moscow� Pharmaceutical� Factory� was� certified� in� compliance� with� GOST� R� 52249-2009� (GMP�

EC� Guide),� applicable� to� the� production� of� soft� non-sterile� dosage� forms� (ointments)� and� solid� non-sterile�

dosed� drugs� (suppositories).

Company� Description� &� Organization

MosFarma� (JSC� Moscow� Pharmaceutical� Factory)� is� a� modern� enterprise� and� one� of� Russia's� leading�

pharmaceutical� manufacturers.

The� company's� product� range� includes� drugs,� both� traditional� and�modern,� of� various� therapeutic� groups,�

including� neurology,� gastroenterology,� pediatrics,� stomatology,� dermatology� and� others.

The�group�of�homeopathic� remedies�and�herbal�medicines� is� still�a� significant�part�of� the�nomenclature.�We�

74. MosFarma

1.� Corporate� General� Information

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부록 2� �전략적 협력사 디렉토리 ❚ 749

also� produce� biologically� active� food� additives,� cosmetics,� incl.� oral� care� products� and� healthcare� products,�

incl.� wipes.� In� 2013� the� company� obtained� a� license� for� production� of� veterinary� drugs.

The� quality,� effectiveness� and� safety� of� MosFarma� products� are� guaranteed� by� its� Quality� Management�

System� implemented� by� the� company.

� MosFarma� pays� great� attention� to� quality� control� and� assurance� system� to� guarantee� its� products'�

compliance� with� national� and� international� standards.

� The� company� Quality� Management� System� was� developed� based� on� modern� standards,� including:

� GOST� R� ISO� 9001� “Quality� Management� System.� Requirements”� and

� GOST� R� 52249-2009� “Rules� for� the� Production� and� Quality� Control� of� Pharmaceuticals”� (GMP).

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750� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Collaboration�

Opportunities� for� R&D�

Co-works

Korea� is� an� increasingly� attractive� destination� of� all� R&D� activities� in� the�

pharmaceutical� and� biotechnology� industry.� During� the� past� 10� years� Korea�

pharmaceutical� and� overall� healthcare� industry� has� proven� its� R&D� abilities� and�

cutting-edge� science.

Global� Pharmaceutical� Industry� is� now� facing� serious� challenges� in� its� operation�

and� innovation�and�trying� to�build� strategies� to�avoid�a� slow-down� in�productivity�

&� innovation.� MSD� Korea� team� also� participate� the� effort� and� need�

unconditionally� participate� in� the� Global� Phase� III� clinical� trials.

Participation� of� clinical� researches� with� global� network� will� also� help� patients� be�

able� to� get� easier� and� faster� access� to� the� new� drug,� also� it� will� increase� the�

capability� and� knowledge� level� of� domestic� clinical� trials.

Luckily,� MSD� Korea� had� been� selected� as� one� of� the� key� emerging� markets� by�

Merck� headquarters� and� promised� for� the� active� support� in� clinical� trials.� It� will�

promote� MSD� Korea's� continuous� growth� and� give� more� opportunity� to�

participate� in� various� global� clinical� researches.� To� support� these� movements,�

MSD� Korea� has� been� expanding� the� investment� as� well.

75. MSD Korea

1.� Corporate� General� Information

Corporate� Name MSD� Korea

Web-site� Address www.msd-korea.com

Contact

(Korean� Business)

Name Don,� Hyun

Address 13Fl.� Seoul� City� Credit� Building,� 168,� Gongduk-dong,� Mapo-Gu,� Seoul

Telephone 02-331-2010

E-mail [email protected]

2.� Description� of� Collaboration�Opportunities

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부록 2� �전략적 협력사 디렉토리 ❚ 751

Collaboration�

Opportunities� for�

In-Licensing

MSD� Korea� had� signed� off� important� license� in� deals� within� Korea� and� one�

example� is� co-developing� and� license� in� collaboration� with� Hanmi� "Cozzar� XQ".�

But� in� reality,� considering� the� heavy� resource� level� needed� to� put� for� external�

license-in,� the�business� case�need� to�be� strong�and� solid�enough,�but�MSD�Korea�

will� keep� eyes� open� to� find� out� external� collaboration� opportunities� through�

product� license� in� and� out.

Collaboration�

Opportunities� for�

Out-Licensing

MSD� Korea� has� historic� relationship� with� local� companies,� inherited� from� legacy�

Schering� Plough� for� out� licensing,� some� OTC� and� ETC� products.� In� future,�MSD�

Korea� will� continue� to� investigate� partnership� models� generating� best� business�

outcome� and� also� social� contribution� and� out� licensing� is� also� one� important�

aspect.

Collaboration�

Opportunities� for�

Manufacturing

Merck� global� strategy� in� terms� of� product� manufacturing� is� consolidating�

manufacturing� facilities� in� combined�hub.� Thus,�manufacturing� facilities� in� Korea�

is� still� uncertain� topic,� but� no� plan� for� now.

Collaboration�

Opportunities� for� (Co-)�

Marketing� &� Sales

The� Business� Development� and� alliance� management� group� in� MSD� Korea� is�

responsible� for� managing� existing� partnerships� to� maximize� their� full� potential.�

For�example,� they�are� responsible� for�managing�Vaccines,�Diabetes,�Osteoporosis,�

Hyper-tension�and�asthma�partnerships� to�ensure�both�parties� successfully� achieve�

the� mutual� goals

Adding� to� the� effort,�MSD� Korea�will� be� strongly� keen� on� finding� co-promotion�

and� co-marketing� type� of� deal� with� local� player� and� other�multi-national� players�

as� well� in� future.

3.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

Due� to� many� aspects,� lower� market� growth� and� declining� profitability� are� expected� over� the� industry� not�

only� for� local� &� multi-national� companies.� To� overcome� these� challenges� and� for� successful� achievement�

of� our�mission� in� delivering� best� health� care� service� to� Korean� people,� I� do� not� think� one� single� company�

can� lead� the� mission.� Through� collaboration� of� each� others,� local� company� help� multi-national� to� localize�

and� multi-national� helps� local� to� globalize,� through� these� strong� bonding� and� collaboration,� I� believe� we�

can� deliver� the� mission

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752� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

4.�특허분석 결과

MSD사의 특허분포도를 볼 때 기술 중에 대표적으로 Indicares� Integer� Ring� Represent,� Oral� Formulation�

Active,� Substituted� Substituted� Substituents�Hydroxy�등의 키워드를 가진 기술에 많은 특허가 분포하고 있는

것으로 나타났다.�

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부록 2� �전략적 협력사 디렉토리 ❚ 753

2006년 01월 01일부터 2012년 12월 10일까지 출원된 MSD사의 특허의 키워드 분포는 붉은 점으로 나타난다.

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754� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name MSP

Head� Office� AddressKPC� “Medservice� Plus”� LLP� 050004,� Republic� of� Kazakhstan,� Almaty,�

Mametovoi� str.� 54

Web-site� Address http://www.medservice.kz

Contact E-mail [email protected]

Company� Description� &� Organization

The� company's� basic� activities� include� distribution� of�medicines� and�medical-purpose� products.� As� of� today�

the� company� is� working� with� products� of� more� than� 280� manufacturers� and� can� offer� a� wide� range� of�

medical,� pharmaceutical� products,� having� constant� assortment� more� than� 4000� items� with� various� brand�

names.� The� company's� personnel� consist� over� 1000� employees� including� Almaty� and� branch� offices.

Our� company's�personnel� are�characterized�by� such�common� features�as�professionalism,� love�of� their�work,�

team�spirit.� Every� year� the�company� carries�out�different�actions� to� improve� its�personnel's�qualification.�The�

corporate� parties,� festivals� and� events� raising� the� team� spirit� have� become� traditional.� Our� company's� top�

managers�devote�a� special� attention� to�each�our�employee,�understanding� that�a�high�professional� level�and�

enthusiasm� for� work� is� the� keystone� of� success� of� "Medservice� Plus".�

The� company� has�an�extended�and�developed�distribution�network� throughout� the�Republic� of� Kazakhstan.�

At� present� the� company's� branch� offices� are� operating� in� 16� cities� such� as� Almaty,� Astana,� Karaganda,�

Aktau,� Aktobe,� Atyrau,� Ust-Kamenogorsk,� Pavlodar,� Shymkent,� Taraz,� Taldykorgan,� Kysyl� -� Orda,�

Semipalatinsk,� Uralsk,� Kokshetau,� Kostanai,� Petropavlosk� which� covers� practically� all� the� regions� of� the�

Republic.�

At�present� time,� the�priority� for� the�company� is�developing�partnership�with�national�distribution� companies.�

Regular� clients�are�more� than�2,500�organizations:�pharmacies,�pharmacy�networks,� and�health�care� facilities�

all� over� the� Kazakhstan.

At� the� time� being,� the� "Medservice� Plus"� group� of� companies� includes� several� companies� such� as:

� KPC� "Medservice� Plus"� LLP,� "MS� Group"� LLP,� "MS� Stock"� LLP

and� also� combines� the� "MS� Help"� brand.

In� 2006,� the� company� introduced� the� standard� ISO� 9000:2000.� KPC� "Medservice� Plus"� LLP� has� been�

successfully� cooperating�with� leading�pharmaceutical� companies�and�selling�quality�medical�products� for� the�

good� of� health� of� the� Kazakhstan� population� for� 15� years� now.� Our� company� takes� an� active� part� in� the�

development� of� the� pharmaceutical� sector� by� establishing� high� standards� of� business� and� facilitating� the�

76. MSP

1.� Corporate� General� Information

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부록 2� �전략적 협력사 디렉토리 ❚ 755

introduction� of� innovation� solutions� and� technologies.

Business� Management� System� was� initiated.� The� implementation� of� SAP� EPR� in� the� Company� allowed�

reducing� the� time� of� preparation� of� the� necessary� information,� as� well� as� provided� the� opportunity� to�

present� the� � full� range� of� information� in� different� analytical� aspects� required� for� management� decision�

making.

Ever� since� 2011� the� Group� of� Companies� '� Medservice� Plus'� has� initiated� an� implementation� of� Good�

Distribution� Practice� GDP� upgrading� the� quality� of� population� drugs� coverage� within� the� territory� of�

Kazakhstan.

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756� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Collaboration�

Opportunities� for� R&D�

Co-works

Collaboration�

Opportunities� for�

In-Licensing

Any� transdermal� and� ODF� products� for� the� US,� Japan,� Europe� Markets

77. NAL Pharmaceuticals Ltd.

1.� Corporate� General� Information

Corporate� Name NAL� Pharmaceuticals� Ltd.

Web-site� Address www.nalpharma.com

Contact

(Korean� Business)

Name Paul� Lai�

Address 7� Deer� Park� Drive,� Suite� G,� Monmouth� Junction,� NJ� 08852,� USA

Telephone 732-329-1388

E-mail [email protected]

2.� Description� of� Collaboration�Opportunities

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부록 2� �전략적 협력사 디렉토리 ❚ 757

Collaboration�

Opportunities� for�

Out-Licensing

Collaboration�

Opportunities� for�

Manufacturing

Any� transdermal� and� ODF� products� for� the� US,� Japan,� Europe� Markets

Page 761: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

758� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

78. Namiki Shoji Co., Ltd.

1.� Corporate� General� Information

Corporate� Name Namiki� Shoji� Co.,.� Ltd.

Web-site� Address www.namiki-s.co.jp

Contact

(Korean� Business)

Name Hiroko� Nakamura

AddressKENSEISHINJUKU� BLDG.� 5-5-3� SHINJUKU,� SHINJUKU-KU,� TOKYO�

160-0022� JAPAN

Telephone +81-3-3354-4026

E-mail [email protected]

2.� Description� of� Collaboration�Opportunities

Collaboration�

Opportunities� for� (Co-)�

Marketing� &� Sales

We� are� a� Japanese� trading� company� involved� in� marketing� pharmaceuticals,�

compounds� for� drug� discovery,� intermediates,� and� health� foods;� and� providing�

various� biological� evaluation� services� of� compounds.� �

We� have� launched� in� 1979� as� a� company� trading� in� raw� materials� of� generic�

pharmaceuticals.

We� later� started� importing� and� marketing� drug-discovery� compounds�

(compounds� for� new� drug� development),� first� time� in� Japan.� We� continue� to�

supply� high-quality� drug-discovery� compounds� and� intermediates� required� at� the�

cutting�edge�of�new�drug�development,� and�we�are�holding�a� firm�position�with�

a� top� share� in� this� field.

With� the� support� of� our� Pharmaceutical� Dept.,� Drug�Discovery� Chemicals� Dept.,�

and� Biological� Research� Dept.,� we� constantly� strive� to� supply� products� and�

services� giving� our� clients� 100%� satisfaction.

We� hope,� by� means� of� these� commercial� activities,� to� play� a� significant� role� in�

radical� new� drug� development,� and� our� satisfaction� lies� in� any� contribution� to�

human� health.

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부록 2� �전략적 협력사 디렉토리 ❚ 759

3.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

We�offer� the� integrated�chemical�database� (SDF)� including�9.5�million� compounds� from�89�suppliers� all� over�

the� world.� � Please� contact� us� if� you� have� any� interests.

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760� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Collaboration�

Opportunities� for� R&D�

Co-works

Nektar� Therapeutics� is� a� clinical� stage� biopharmaceutical� company� developing� a�

pipeline� of� drug� candidates� that� utilize� its� PEGlylation� and� polymer� conjugate�

technology� platforms,� which� are� designed� to� improve� the� benefits� of� drugs� for�

patients.� Its� product� pipeline� consists� of� drug� candidates� across� a� number� of�

therapeutic� areas,� including� oncology,� pain,� anti-infectives,� anti-viral� and�

immunology.�Nektar’s� research�and�development�activities� involve� small�molecular�

drugs,�peptides�and�other�potential�biologic�drug�candidates.� Its�drug�candidates�

are� designed� to� improve� the� pharmacokinetics,� pharmacodynamics,� half-life,�

bioavailability,� metabolism� or� distribution� of� drugs� and� improve� the� overall�

benefits� and� use� of� a� drug� for� the� patients.�

Therefore,� there� are� many� opportunities� for� collaboration� with� NEKTAR� and�

Korean� pharmaceutical� companies� by� applying� any� type� of� drug� candidates� into�

Nektar’s� PEGlyation� and� polymer� conjugate� technology� platforms� to� improve� its�

properties� as� a� drug.

79. NEKTAR Thepeutics

1.� Corporate� General� Information

Corporate� Name NEKTAR� Thepeutics

Web-site� Address www.nektar.com

Contact

(Korean� Business)

Name Business� Development� Team

Address 455� Mission� Bay� Boulevard� South,� San� Francisco,� California,� 94158

Telephone 1-415-482-5300,� 1-885-482-6587

E-mail [email protected]

2.� Description� of� Collaboration�Opportunities

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부록 2� �전략적 협력사 디렉토리 ❚ 761

Collaboration�

Opportunities� for�

In-Licensing

Nektar� Therapeutics’s� strategy� is� to� develop� a� pipeline� of� drug� candidates� that�

utilize� its�PEGlyation�and�polymer�conjugate� technology�platforms,�undergo�early�

stage� clinical� trials� that� demonstrate� the� improvement� upon� applying� our�

technology� platforms,� and� find� a� partnership� for� late� stage� clinical� trials� and�

further.� Therefore,� Korean� pharmaceutical� companies� will� have� many�

collaboration� opportunities� for� In-Licensing� Nektar� drug� candidates.� �

Collaboration�

Opportunities� for�

Out-Licensing

Since� Nektar� is� focused� on� the� development� of� pipeline� of� drug� candidates� and�

Out-licensing� Nektar� drug� candidates,� it� look� like� no� collaboration� opportunities�

for� Out-Licensing� to� Nektar.

Collaboration�

Opportunities� for�

Manufacturing

Nektar�Therapeutics�has�ability� to�produce�high�quality�PEG�(polyetheyleneglycol)�

materials� as� manufacturing� scale.� Currently,� Nektar� collaborate� with� several�

companies� such� as� Baxter� and� Amgen� for� manufacturing.

Therefore,� Korean� pharmaceutical� companies� will� have� many� collaboration�

opportunities� for� manufacturing.

Collaboration�

Opportunities� for� (Co-)�

Marketing� &� Sales

Nektar� Therapeutics� is� a� clinical� stage�biopharmaceutical� company� so� there� is� no�

marketing� and� sales� department.� Therefore,� there� are� no� collaboration�

opportunities

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762� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

3.�특허분석 결과

NEKTAR사의 특허분포도를 볼 때 기술 중에 대표적으로 Receptacle� Packed� Powders� Extraction,� Treatment�

Respiratory� Pulmonary의 키워드를 가진 기술에 많은 특허가 분포하고 있는 것으로 나타남.

Page 766: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

부록 2� �전략적 협력사 디렉토리 ❚ 763

80. NEOLPHATMA

1.� Corporate� General� Information

Corporate� Name NEOLPHARMA

Corporate� Ownership Lic.� Efrén� Ocampo

Facilities� City� &� Country Mexico

Web-site� Address www.neolpharma.com

Contact

(Korean�

Business)

Name Dra.� Edith� Zarate� Rodriguez

E-mail www.neolpharma.com

Company� Description� &� Organization

Mission

We�are�a�Corporate�Group� that� contributes�with� solutions� of�proven�quality� and� innovation� to� improving�

the� health� of� our� patients.� We� stand� out� thanks� to� our� staff,� processes� and� the� services� we� provide.

Vision

The�Neolpharma�Group� shall�be�an� international�competitive�organization,�with�high� impact�on� improving�

the� health� and� quality� of� life� of� our� patients.

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764� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

81. Ningbo Menovo Pharmaceutical Co., Ltd.

1.� Corporate� General� Information

Corporate� Name Ningbo� Menovo� Pharmaceutical� Co.,� Ltd.

Web-site� Address www.menovopharm.com

Contact

(Korean� Business)

Name Tobby� Tang

Address12B-14� Floor,� Building� 1,� Ningbo� R&D� Park,� No.� 999� Yangfan� Road,�

Hi-Tech� district,� 315040,� Ningbo,� China

Telephone 86-574-87352942

E-mail [email protected]

2.� Description� of� Collaboration�Opportunities

Collaboration�

Opportunities� for�

Manufacturing

1.� Menovo:� from� API,� Drug� Product� to� Pharmaceutical� Custom� Service

Founded� in� 2004,� Ningbo� Menovo� Pharmaceutical� Co.,� Ltd� is� a� leading�

pharmaceutical� company� in� China� with� dozens� of� vertically� integrated� products�

of� intermediates,� API� and� formulations.� Headquartered� in� Ningbo,� Zhejiang,� we�

have� state-of-art� R&D� and� GMP� approved� manufacturing� facilities� all� across�

Zhejiang� and� Anhui.�

As� the� leading� global� supplier� of� a� broad� range� of� generic� APIs,� intermediates�

and� pharmaceutical� services,� Menovo’s� market� covers� more� than� 50� countries.�

We� have� deep� knowledge� and� extensive� experience� in� drug� development� and�

GMP� manufacturing.� Our� CMO� team� is� formed� by� the� most� experienced�

scientists� and� engineers� for� process� development,� optimization,� scale-up� and�

analytical�method�development�and�validation.�As�your� full� service�CMO�partner,�

we�deliver� top�quality,� reliability�and�performance� in� the�most� cost�effective�way.�

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부록 2� �전략적 협력사 디렉토리 ❚ 765

2.� � Your� Contract� Manufacturing� Partner

Specialist� Technologies

During� the� years,�we�developed�an� extensive� toolkit�of� specialist� technologies� to�

meet� the� requirement� of� evolving� pharmaceutical� market.� Especially,� we� have�

significant� experience� in� handling� chiral� chemistry,� hazardous� chemistry,�

homogeneous/heterogeneous� catalysts.�We� also� acquired� expertise� in� solid� form �

chemistry,� polymorphism� and� X-ray� crystallography.�

Process� Research� and� Development

We�have�a�brand�new�process� research�and�development� facility�with�more� than�

100� scale-up� labs� and� start-of-art� infrastructure� including�double-jacket� reactors,�

lab� automation� and� parallel� synthesizers.� We� built� chromatography� and�

crystallization�platforms� to�guarantee� timely� isolation�and�purification�of�materials�

from� small� to� large� scale.� With� close� collaboration� of� our� focused� project� team�

and�our� customer,�we�delivered� valuable� innovations� to�our�customers�as�well�as�

high� quality� products.� �

Compliance� and� Quality� Systems

As� a� fully� integrated� pharmaceutical� company,� Menovo� considers� it� the� most�

critical� issue� to� be� fully� compliant� with� regulatory� agencies.� We� have� a� perfect�

track� record� of� inspection� for� agencies� of� different� countries.�We� also� keep�high�

level�of� transparency� to�customer�auditions.�Our�dedicated�quality� and� regulatory�

affairs� specialist�work�hard� to�make� sure� that�all�products�are�made�to�meet�strict�

government� regulations� and� customer� defined� specifications.

The� Right� Contract� Manufacturing� Partner� for� You

We�understand� that� customers�are� facing� increasing� risks�and�pressures.� It’s�more�

and� more� important� to� find� a� reliable� development� and� manufacturing� partner�

to� relieve� your�economic�and� time�pressures.�With�our�extensive�experience,�deep�

knowledge� and� consistent� attention� to� quality� and� cost-competency,� we� believe�

Menovo� is� just� the� right� partner� for� you.� � �

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766� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

82. Novartis AG

1.� Corporate� General� Information

Corporate� Name Novartis� AG

Web-site� Address http://www.novartis.com

Contact

(Korean� Business)

Name Public� Affairs� Team� (Sangwook� Kim,� Dongjun� Park)�

AddressNovartis�Korea,�18F�Yonsei� Severance�Bldg,�84-11,�Namdaemunno�5-ga,�

Joong-� gu,� Seoul,� Korea

Telephone +822� 768� 9325� (Sangwook� Kim),� +822� 768� 9204� (Dongjun� Park)

E-mail [email protected],� [email protected]� �

2.� Description� of� Collaboration�Opportunities

Collaboration�

Opportunities� for� R&D�

Co-works

Our� company� is� interested� in�various� therapeutic� areas�and�a� lot�of�new�products�

are� under� development.� Development� for� oncology� and� specialty� care� such� as�

neuroscience,� ophthalmology,� transplantation,� and� immunology� is� highly�

interesting.

Collaboration�

Opportunities� for�

In-Licensing

Add-on� opportunities� to� therapeutic� areas� where� Novartis� has� been� built�

expertise� and� capabilities�

-� Cardiovascular:� Anti-thrombosis,� Blood� coagulation

-� CNS:� Anti-Parkinson’s� disease,� Anti-epileptics,� Insomnia,� Migraine,� Trigeminal�

neuralgia,� Nociceptive� pain,� Fibromyalgia

-� Tx:� Immune� suppressant�

-� Metabolism:� Anti-diabetes� (e.g.� Human� insulin)

Collaboration�

Opportunities� for�

Out-Licensing

Life�cycle�management� (e.g.� local�development�of�modified�dosage,� formulation)�

to� maximize� the� value� of� mature� products� and� patent-off� products

Collaboration�

Opportunities� for� (Co-)�

Marketing� &� Sales

Any� opportunities� to� compliment� Novartis� and� collaborator’� mutual� needs� and�

capabilities,� especially� for� new� launching� products� and� patent-off� products

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부록 2� �전략적 협력사 디렉토리 ❚ 767

3.�특허분석 결과

Novartis사의 특허분포도를 볼 때 기술 중에 대표적으로 Binding� Cell�Antibodies,� Tyrosine� Serine� Threonine�

Kinase�Mediators,�Alkyl�Aryl�Heteroaryl� Hydrogen,� Plants�Gene� Expression�등의 키워드를 가진 기술에 많

은 특허가 분포하고 있는 것으로 나타났다.

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768� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

2006년 01월 01일부터 2012년 12월 10일까지 출원된 Novartis사의 특허의 키워드 분포는 붉은 점으로 나타난

다.

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부록 2� �전략적 협력사 디렉토리 ❚ 769

Corporate� Name NPO� PETROVAX� PHARM

Head� Office� Address4th� floor,� Suite� В� 4/4,� Global� City� Shopping� and� Office� Centre,� 2�

Dnepropetrovskaya� Street

Web-site� Address http://petrovax.com

Contact E-mail [email protected]

Company� History

1996-2005�

Company� establishment�

2008-2009�

Launch� of� the� GMP� compliant� pharmaceutical� production� and� warehousing� complex� in� Pokrov� (Moscow�

Region)�

2010

Grippol®� Plus� vaccine� produced� for� the� National� Immunization� Schedule� in� Russian� Federation� (11.4m�

doses)�

2011

Partnership� with� Phizer,� a� major� pharmaceutical� company,� to� produce� pneumococcal� conjugate� vaccine� in�

Russia�

2012

Pfizer� and�NPO�Petrovax�Pharm's�13-valent�conjugate�pneumococcal� vaccine� localisation�project� received� the�

Russian� Platinum� Ounce� contest� award� in� the� Project� of� the� Year� nomination�

2013

New� growth� strategy� ­� Vladimir� Potanin,� owner� and� founder� of� Interros,� acquires� a� controlling� stake� in�

Petrovax� Pharm.

Company� Description� &� Organization

NPO� Petrovax� Pharm� develops� and� produces� innovative� medicines� and� vaccines� to� help� improve� people’s�

health� and� quality� of� life.� Our� research� efforts� align� the� latest� scientific� discoveries� with� the� needs� of�

individuals.�

83. NPO PETROVAX PHARM

1.� Corporate� General� Information

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770� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

84. Pfizer Inc.

1.� Corporate� General� Information

Corporate� Name Pfizer� Inc.

Web-site� Address www.pfizer.com

Contact

(Korean� Business)

Name 홍기연

Address 한국 화이자 제약

Telephone 2-317-2368

E-mail [email protected]

2.� Description� of� Collaboration�Opportunities

Collaboration�

Opportunities� for� R&D�

Co-works

Biosimilars� /� Product� enhancement� (advanced� technologies� capabilities� applied�

for� Pfizer� existing� products)

Collaboration�

Opportunities� for�

In-Licensing

Biosimilars� /� Generics

Collaboration�

Opportunities� for�

Manufacturing

Depending� on� cases

3.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

Clinical� trials

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부록 2� �전략적 협력사 디렉토리 ❚ 771

4.�특허분석 결과

Pfizer사의 특허분포도를 볼 때 기술 중에 대표적으로 Alkyl� Substituted� Hydrogen의 키워드를 가진 기술에 많

은 특허가 분포하고 있는 것으로 나타남.

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772� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

85. PHARM SINTEZ

1.� Corporate� General� Information

Corporate� Name PHARM� SINTEZ

Head� Office� Address 8� Vtoroy� Roschinskiy� blvd.,� Moscow,� Russia,� 115419

Web-site� Address � http://www.vertex.spb.ru/en/

Company� History

1997� � —� foundation� of� CJSC� “PHARM-SINTEZ”

1998� � —� registration� of� the� drug� Buserelin� Spray.

1999� � —� registration� of� the� drug� Oktreotid.

2003� � —� registration� of� the� drug� Buserelin-depo.

2004� � —� beginning� of� export� of� drugs� to� Belorussia.

2005� � —� beginning� of� export� of� drugs� to� Ukraine.

2006� � —� registration� of� the� drug� Oktreotid-depo.

2006� � —� registration� of� the� drug� Resorba.

2007� � —� registration� of� the� drug� Oktreotid,� 111In.

2007� � —� beginning� of� export� of� drugs� to� Moldova.

2008� � —� start� of� construction� of� a� new� factory� in� compliance� with� all� the� rules� of� GMP� EU.

2009� � —� registration� of� the� drug� Milanfor.

2009� �—�CJSC�“PHARM-SINTEZ”�occupies�25th�place� in� the�ТОР-30�drug�producers� for� the�LLO�system,�being�

the� first� among� Russian� companies.�

2009� � —� registration� of� the� radionuclide� diagnostics� drug� Rezoscan,� 99mT.

2010� � —� reorganization� of� the� company� to� increase� the� efficiency� of� it’s� operation.�

2011� � —� registration� of� the� drug� Celleks.�

2013� � —� registration� of� the� drug� Imatib.

Company� Description� &� Organization

To� supply� doctors� and� patients�with� essential,� affordable� drugs� for� the� diagnostics� and� treatment� of� heavy�

and� socially� important� illnesses� and� for� improving� the� patient’s� quality� of� life.

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부록 2� �전략적 협력사 디렉토리 ❚ 773

86. PHARMASOFT

1.� Corporate� General� Information

Corporate� Name PHARMASOFT

Head� Office� Address 115280,� Moscow,� ul.� Avtozavodskaya,� 22

Web-site� Address http://www.pharmasoft.ru

Contact E-mail [email protected]

Company� Description� &� Organization

"PHARMASOFT"� is� one� of� the� Russian� leading� producers� of� medications.�

"PHARMASOFT"� has� been� involved� in� innovative� research� in� the� areas� of�medicine� and�pharmacology� for�

many� years.� The� company's� activity� consists� in� development� and� supply� of� consumers� (patients)� with� the�up-to-date,� highly� efficient� and� safe� medications.

Our�mission� is� the�development�and� introduction� into� the� clinical�practice�of�high-tech�and�efficient�drugs�to� safeguard� health� and� improve� the� quality� of� life.

We� value� our� nation's� health� and� work� for� the� people's� benefit!

2.� Additional� Business� Propositions� for� Collaboration

Values

Attitude� to�work.�We�understand� the� importance�of�our�work.�People's� (patients')� lives�and�health�depend�on� it,� that's� why� we� perform� our� duties� with� all� responsibility� and� keep� track� of� our� work's� quality.

Innovation� and� initiative.� Keeping� up�with� the� brand-new� developments� and� trends� of�modern�medicine�

and�pharmacology� lets� us� constantly� improve�and�upgrade� the�quality�of�our�preparations�and� the� results�of� their� effects.

High�ethical�principles�and�reliability.�This� is� the�basis�of�our�activity.�A�human�being's�health� is�our�priority.�

The� whole� of� our� work� is� based� upon� the� firm� medical� principles� and� responsibility.Partnership.�Cooperation� is� the�key� to� successful�development.�We�value�our�partners�and�are�always�open�

to� fruitful� cooperation,� which� is� beneficial� for� our� patients� in� the� first� place.

Staff.�Our�company's� staff� consists�of� the� ranked�specialists,�who� love� their�work�and�never� stop�upgrading�their� skills,� since� they� understand� its� importance� and� their� responsibility.

Reaching� the� goals.� We� are� aimed� at� the� result.� We� define� the� goals� and� reach� them.� This� is� especially�

important� in� the�area�of�medicine,�because�our�work�must� improve�health�and�people's� (patients')�quality�of� life.

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774� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

87. Pharmasset, Inc

1.� Corporate� General� Information

Corporate� Name Pharmasset,� Inc

Web-site� Address www.pharmasset.com

Contact

(Korean� Business)

Name Abel� De� La� Rosa

Address -

Telephone 770-888-9023

E-mail [email protected]

2.� Description� of� Collaboration�Opportunities

Collaboration�

Opportunities� for�

In-Licensing

anti-RNA� virus� compounds

Collaboration�

Opportunities� for�

Out-Licensing

anti-RNA� virus� compounds

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부록 2� �전략적 협력사 디렉토리 ❚ 775

3.�특허분석 결과

Pharmasset사의 특허분포도를 볼 때 기술 중에 대표적으로 Yellow� Fever� Virus� Virus� Rhimovirus� infection�

Virus� Yellow� Fever,� Heterocyclic� Heteroaromatic� Base� Following� Heterocyclic� Heteroaromatic� Suitable�

Protecting의 키워드를 가진 기술에 많은 특허가 분포하고 있는 것으로 나타남.

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776� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

88. PHARMASYNTEZ

1.� Corporate� General� Information

Corporate� Name PHARMASYNTEZ

Head� Office� Address Russia,� 664007,� ul.� Krasnogvardeyskaya� ,� 23,� of.3.

Web-site� Address http://www.pharmasyntez.com

Contact E-mail [email protected]

Company� Description� &� Organization

Founded� in� 1997,� Pharmasyntez� is� now� Russia's� largest� manufacturer� of� anti-TB� drugs.

Since� 2011� Parmasyntez� is� among� the� top� ten� pharmaceutical� companies� in� Russia� in� terms� of� production�

(as� reported� by� Remedium� magazine).

Pharmasyntez� � increases� � its� sales� turnover� every� year.� Our� company� has� the�most� complete� nomenclature�

of� anti-TB� drugs� on� the� Russian� market.� At� three� manufacturing� sites� there� are� available� about� 50� items�

of� drugs� in� different� dosages:� capsules,� tablets,� granules,� infusion� solutions.�

By� 2013� we� are� planning� to� start� manufacturing� ARV� drugs,� anticancer� drugs,� expand� the� range� of�

antibiotics.� The� product� range�will� increase� to� at� least� 70� items� introducing�new�dosage� forms:� vials,� sterile�

dry� powders� and� solutions� for� injection.

Over� the� years� Pharmasyntez� has� gained� enormous� experience� in� building� high-tech� pharmaceutical� plants�

­� there� were� commissioned� two� pharmaceutical� plants� in� Irkutsk� (solid� drugs� production)� and� one� plant� in�

Primorsky� Krai� � (infusion� solutions� production)

To� implement�our�plans� several� investment�projects�have�been�already� started.� The� investments�will� amount�

to� about� 3,1� billion� RUR� (approximately� 100� million� USD).

Together�with� the�Federal� State� Institution�Saint-Petersburg�Research� Institute� for�Phthisiopneumology�of� the�

Federal� Agency� of� High-tech� Medical� Car"� the� company� is� accomplishing� research� of� the� new� innovative�

drug� of� Perhlozone,synthesized� at� A.E.� Favorskiy� Irkutsk� Research� Institute� of� Chemistry.� This� drug� is� an�

important� step� forward� in� tuberculosis� treatment.�

Pharmasyntez� invites� foreign� and� Russian� companies� to� work� together� for� introduction� innovative� drugs� in�

Russia.� Developed� infrastructure� and� professionalism� of� our� employees� allow� us� to� be� confident� in� the�

productivity� of� our� cooperation.�

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부록 2� �전략적 협력사 디렉토리 ❚ 777

2.� Additional� Business� Propositions� for� Collaboration

History� of� development

2012� Launch� of� innovative� drug� Perchlozone®.�

2011� Construction� of� the� plant� for� the� production� of� anticancer� drugs� in� St.� Petersburg.�

2010� Subsidiary� company� RCI� Syntezs� registered� in� St.� Petersburg.�

2009� Launch� of� the� new� production� lines:� two� tablet� lines,� production� scale� and� laboratory� scale�

2005� First� product� (infusion� solutions)� released� at� East� Farm,� Ussuriysk� subsidiary.

2004� Meridian� business� center� opened� in� Irkutsk.

2003� Pharmasyntez� branch� opened� in� Moscow;

� � � � � � R&D� activities� started� to� produce� a� unique� anti-tuberculosis� drug� (Perchlozone®).

2002� Launch� of� anti-tuberculosis� drug� sodium� para-aminosalicylate� (PAS)� granules.�

2000� Drug� supply� to� the� largest� pharmaceutical� distributors� in� Russia� on� regular� basis.

1999� First� drug� (anti-TB� drug� Rifampicin)� released.�

1997� Pharmasyntez� founded� in� Irkutsk.�

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778� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

89. Phs Pharmstandard

1.� Corporate� General� Information

Corporate� Name Phs� Pharmstandard

Head� Office� Address Likhachevsky� travel,� 5b,� Dolgoprudny,� Moscow� region,� Russia

Web-site� Address http://pharmstd.com/

Company� Description� &� Organization

Pharmstandard� JSC,� Russia’s� leading� pharmaceutical� company,� develops� and� manufactures� high-quality�

modern� pharmaceutical� products� which� meet� the� requirements� of� the� healthcare� system� and� the�

expectations� of� patients.

The� most� popular� Pharmstandard� products� today� are� Arbidol®,� Complivit®,� Pentalgin®,� Flucostat®,�

Phosphoglive®,�Amixin®,�Afobazol®,� Rastan®�and�Biosulin®.� The�Company�manufactures�more� than�250�

pharmaceutical� products� including� drugs� for� treatments� of� cardio-vascular� diseases,� diabetes,� growth�

hormone� deficiency,� gastroenterological,� neurological,� contagious� diseases,� metabolic� disorders,� cancer� and�

other� diseases.� More� than� 120� Pharmstandard� products� (taking� into� account� all� forms� and� dosages)� are�

included� in� the� list� of� Vital� and� Essential� Pharmaceuticals.

As� of� 2004� Pharmstandard� developed� more� than� 60� new� pharmaceutical� products� in� co-operation� with�

Russia’s� leading� scientific� centers.� Pharmstandard� JSC� is� a� member� in� a� joint� bio-engineering� project,�

Generium,� whose�main� objective� is� to� development� socially� significant� pharmaceutical� products� within� the�

framework� of� import� substitution� state� program.

The� Сompany’s� total� production� capacity� has� reached� more� than� 1,7� bn� packs� per� year.� Pharmstandard�

production� assets� consist� of� 8� modernized� pharmaceutical� plants:� Pharmstandard-Leksredstva� JSC� (Kursk),�

Pharmstandard-UfaVita� JSC� (Ufa),� Pharmstandard-Tomskhimpharm� JSC� (Tomsk),� Pharmstandard-Biolek� JSC�

(Kharkov,� Ukraine),� Biomed� named� after� I.� I.� Mechnikov� JSC� (Moscow,� Moscow� Region),� Pharmapark� LLC�

(Moscow),� LEKKO� CJSC� (Russia,� Vladimir� region),� medical� equipment� plant� TZMOI� JSC� (Tyumen)� and�

Pharmstandard� LLC� —� a� company� responsible� for� the� purchase� and� supply� of� raw� materials� for�

manufacturing� of� pharmaceutical� products� at� Pharmstandard� production� facilities.

All� Company’s� production� facilities� fully� comply�with� Russian� national� standards,�while� 6� production� lines� at�

JSC�Pharmstandard-Leksredstva�have�already� received� certificates�of� compliance�with� the�EU�GMP�standards.�

All� plants� are� to� be� converted� to� European� GMP� standards� by� 2014,� according� to� the� schedule� approved�

by� Company’s� management.

May� 4,� 2007� —� Pharmstandard� placed� its� shares� during� the� IPO� (Initial� Public� Offering).� Pharmstandard’s�

shares� and� GDRs� are� traded� on� the� RTS-MICEX� and� LSE,� respectively.

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부록 2� �전략적 협력사 디렉토리 ❚ 779

Corporate� Name PIQ� Pharma

Head� Office� Address 125047,� Russia,� Moscow,� Oruzheyniy� pereulok� Str.� 25,� Bld.1

Web-site� Address http://piqpharma.com

Company� History

The� company� was� established� in� 1994� in� Moscow,� and� the� first� product� released� by� the� company� was�

Pantogam®� (hopantenic� acid),� recognized� as� one� of� the� most� balanced� nootropic� drugs.

Pantogam®� tablets�

Pantogam�was�authorized� for�medical�use�by� the�State�pharmacological�committee�back� in�November�1977,�

but� it�was� then�produced� in� limited�quantities.�By�1994�production�of� this� socially� important�drug�has�almost�

stopped.

In� the� mid-90s� with� the� support� from� NPO� Vitaminy� and� participation� of� one� of� its� employees,� doctor� of�

chemistry,� professor� Vyacheslav� Mikhaylovich� Kopelevich,� the� new� pharmaceutical� company� PIQ-PHARMA�

has� practically� brought� Pantogam®� back� to� life� restoring� its� production� in� conformance� to� the� modern�

industry� standards.

1994� Foundation� of� the� Company

1995� Market� launch� of� Pantogam®� tablets

1999� Market� launch� of� Elkar®� oral� solution

2000� Market� launch� of� Pantogam®� syrup

2002� Market� launch� of� Nooklerin®� oral� solution

2003� Market� launch� of� Dibikor®� tablets

2006� Medical� representatives’� service� created.� Market� launch� of� Aksamon®� tablets

2009�Launch�of� its� own� finished�dosage� forms�production�plant� in� the� suburbs�of� Saint-Petersburg.�Market�

launch� of� Pantogam� activ®� capsules,� Elkar®� oral� solution

2010�Production�of�almost�all� range�of�drugs�on� its�own�production� facilities.�Market� launch�of�Karnicetin® �

capsules,� Nicorandil� tablets,� Gabapentin� capsules.

2011�Launch�of� its�own� substances�production�plant� in�Belgorod.�Market� launch�of�Kudevita®�capsules�and�

Orokamag®� capsules

90. PIQ Pharma

1.� Corporate� General� Information

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780� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Company� Description� &� Organization

PIQ-PHARMA� is� one� of� the� first� innovative� pharmaceutical� companies� of� Russia.� Our� activities� are� directed�

towards� development� and� practical� application� of�modern�medical� products� with� the� purpose� of� providing�

doctors� and� patients� with� effective� means� of� treatment� and� prevention� of� diseases.

The� company� includes� departments� for� development,� registration,� promotion� and� sale� of�modern� effective�

medical� products.

Since� its� establishment� in�1994,�PIQ-PHARMA�has�been�working� together�with� research� centers,� supporting�

promising� scientific� research� projects� in� Russian� biochemistry� and� pharmacology.� Basing� on� the� research�

results,� the� company� creates� and� brings� to� the� final� consumer� highly� effective� means� of� treatment� and�

prevention� of� diseases.

The� company�has� its�own�production�base,� conforming� to� the�European�quality� standards� for�pharmaceutical�

production.

PIQ-PHARMA� is� one� of� the� few� Russian� companies� producing� not� only� finished� dosage� forms,� but�

pharmaceutical� substances� as� well,� which� allows� for� assuring� high� quality� of� products� on� all� stages� of�

creation� of� a� drug.

Currently� the�company�has�13�drugs� in� its�portfolio.� These�are�metabolic,� cardiovascular�and�nootropic�drugs�

that�have�proven� in�practice� its� effectiveness� in� treatment�and�prevention�of�a�wide� range�of�diseases.�Over�

10� preparations� of� various� therapeutic� categories� are� on� various� stages� of� development.

Drugs� produced� by� the� company� are� widely� known� and� are� recommended� for� use� by� leading� medical�

specialists� in� pediatry,� psychoneurology,� endocrinology,� cardiology,� neurology.

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부록 2� �전략적 협력사 디렉토리 ❚ 781

Corporate� Name PiSA

Head� Office� Address Av.� España� No.� 1840� Col.� Moderna� 44190� Guadalajara,� Jal.�

Facilities� City� &� Country Mexico

Web-site� Address www.pisa.com.mx

Company� History

February,� 1945

Pisa� is� a� 100%� Mexican� pharmaceutical� company� that� arises� in� the� year� 1945� on� the� initiative� of� our�

founder,� Professor� Don� Miguel� Alvarez� Ochoa,� who� with� the� valuable� collaboration� of� important� health�

professionals� make� Productos� Infantiles� S.A.� in� response� to� the� need� of� that� time:� have� specially� designed�

and� formulated� � medicines� for� children.

Productos� Infantiles� S.A.� was� created

It� began� producing� more� than� ten� different� medicines,� mainly� for� children:� INFRAFEN,� drops� to� treat� colic�

in�babies.� � INFALGINA,�drops�analgesic� and�antipyretic� INFANEUMIL,� cough�syrup,�etc..�which�were� very�well�

accepted.

Quality,� Effort� And� Growth

Everything� was� personally� supervised� by� Professor� Alvarez� Ochoa:� from� procurement� of� raw� materials� and�

materials� for� the� manufacture� of� products� to� distribution,� promotion� and� sale.

Given� their�previous�academic�preparation�and�practical� experience� in�activities� related� to� the�pharmaceutical�

industry�of�our� country,�was�expected� to�determine� the�quality� as� the� first� and�most� stringent� condition� for�

the� development� of� products,� one� of� their� direct� responsibilities.

The�great�effort,�work�and�knowledge�of� those�who� formed�the� company� in� those�days�Productos� Infantiles,�

S.A.�were� reflected� in� their�growth,� solid�growth�that� forced� the�change�and�was�picked�off� ten� years� later,�

to� become� Laboratorios� Pisa� S.A.� de� C.V.

A� Life� Serving� Life� …

70� years� later,� with� more� than� 16,000� employees� in� PiSA� Farmaceutica� we� have� become� the� leading�

Mexican�pharmaceutical� company� thanks� to�our� reputation� and� the� trust� of� the� physicians,� nurses,� patients�

and� institutions,�producing�products� of� the� highest�quality,�meeting� all� national� and� international� standards�

governing� pharmaceutical� production,� while� maintaining� a� youthful� spirit� of� constant� innovation,�

improvement� and� growth.

91. PiSA

1.� Corporate� General� Information

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782� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Company Description & Organization

Our� Quality

To� be� sure� about� the� pharmaceutical� quality�meets� one�of� the�most� important� roles� in� the� production�

and� control� of� pharmaceutical� ordering� to� implement� and� verify� the� good�manufacturing�practices� and�

testing� of� all� bulk� materials,� raw� materials� and� finished� products.

We� recognize� the� importance� of� all� its� products,� facilities� and� services� offered� meet� the� regulations�

and� official� standards� and� health� regulations� establishing� the� Laws.

In� Pisa� Pharmaceutical� currently� have� the� following� certifications:� ISO� 9001:2008� awarded� by� AENOR�

and� IQNet� and� the� Clean� Industry.

From� 2008� Pisa� Group� incorporates� working� philosophy� “LEAN”� in� its� plants� and� Commodity� Plastics�

Injection� solutions� and� small� and� large� volume.

Quality� Policy

We� are� a� 100%� Mexican� company� dedicated� to� the� manufacture,� marketing� and� distribution� of�

medicines,� medical� equipment� and� material� recovery;� committed� to:

1.� Compliance� with� the� requirements� of� our� customers� to� ensure� their� satisfaction.

2.� Compliance� with� legal,� regulatory� and� regulatory� requirements.

3.� The� environmental� care.

4.� The� continuous� improvement� of� our� system� of� administration� through� the� establishment� and�

revision� of� targets.

5.� The� optimal� use� of� resources.

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부록 2� �전략적 협력사 디렉토리 ❚ 783

92. PluriCell Biotech

1.� Corporate� General� Information

Corporate� Name PluriCell� Biotech

Web-site� Address www.pluricellbiotech.com.br

Contact

(Korean� Business)

Name Marcos� Valadares

Address Av� Professor� Lineu� Prestes,� 2242

Telephone 55� 11� 99326� 0056

E-mail [email protected]

2.� Description� of� Collaboration�Opportunities

Collaboration�

Opportunities� for

R&D� Co-works

Our� company�works�with� induced�pluripotent� stem�cell� technology,�which� is� the�

most� promising� technology� in� the� field� of� drug� discovery� and� regenerative�

medicine.� PluriCell�would� be� interested� in� developing� products� directed� to� these�

fields� such� as:

Drug� discovery:� we� have� the� potential� do� derive� in� collaboration� any� kind� of�

human� cell� from� induced� pluripotent� stem� cells� to� be� used� as� a� drug� discovery�

platform� (neurons,� muscle,� MSCs,� etc).

Regenerative�medicine:� the� use� of� heart� cells� in� cardiac� patches� (for� people� that�

suffered� a� Heart� attack),� or� derivation� of� insulin� producing� cells� for� people�with�

type� 1� diabetes.

Collaboration�

Opportunities� for� (Co-)�

Marketing� &� Sales

We�would� like� to� find�a�partner� in�Korea� that�would�be� interested� in�distributing�

our� products� in� Asia� an� Korea.� We� sell� human� adult� cell� types� (currently�

cardiomyocytes,� but� in� the� near� term� skin� and� liver� cells)� for� in� vitro� drug�

discovery.

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784� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name POLYSAN

Head� Office� Address 112� LIGOVSKY� PROSPECT,� SAINT-PETERSBURG,� 191119,� RUSSIA

Web-site� Address http://www.polysan-ru.com

Company� History

1992

Scientific� Technological� Pharmaceutical� Firm� "Polysan"� was� founded� in� Saint-Petersburg

1992

Commencement� of� work� within� the� former� USSR� countries

2002

"Polysan"� enters� an� international� market� (far-abroad� countries)

2004

Russian� Federation� Executive� order

Recipientof� thePrizeof� RussianFederationGovernmentin� thedomainof� scienceandtechniques

Fortheprocessdesign,organizationof� theindustrialoutputandimplementationintomedicalpracticeof�

thedomesticpreparationCycloferon

2005

New� production� complex� was� put� into� action� in� Saint-Petersburg

2006

Russian-Laos� diagnostic� and� treating� viral� infections� Centre� was� established� in� Laos

2006

"Cycloferon"�was�put�on� the�Federal�Standards�of�Ministry�Of�Public�Health�and�Social�Development� for� the�

treatment� of� hepatitis� B,� C,� TB,� HIV� and� influenza,� including� bird� flu

2007

For� the� advances� in�medicinal� production� "Polysan"� was� awarded� International� prize� "Profession�—� Life"� — �

the� highest� public� award� of� honor,� velour,� creation� and� mercy

2009

"Gold� Mercury"� National� Prize� in� the� sphere� of� production� as� a� best� company-exporter

2009

"Polysan"� is� a�Recipient�of� the�Diploma�of� Saint-Petersburg�Government� "Best� exporter�of� Saint-Petersburg"

Company� Description� &� Organization

93. POLYSAN

1.� Corporate� General� Information

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부록 2� �전략적 협력사 디렉토리 ❚ 785

The� Scientific-Technological� Pharmaceutical� Firm� "Polysan,� Ltd"� was� founded� in� December� 1992� by� the�

group� of� specialists� in� biomedical� field� from� different� institutions� of� Saint-Petersburg.� Since� then� Polysan�

gradually�but�quite�precipitant� turned� into� the�Pharmaceutical� Firm,�which�develops�original�preparations�and�

is� capable� to�meet� competition�with�both�domestic� and�foreign� companies.�Nowadays� the�Firm� ranks�among�

the� leaders� of� pharmaceutical� industry� in� Russia� and� takes� constant� care� of� application� of� science� and�

state-of-the-art� technology� achievements� to� production� aiming� further� improvement� of� output� quality.

The� main� goal� of� Polysan� is� development� of� the� original,� high� efficient� medicinal� preparations� with�

reasonable� price� for� patients.

The� uniqueness� of� the� company� consists� of� organization� of� the� whole� preparation� cycle� from� the� idea�

through� the� development� and� registration� to� the� production� and� sale.� In� order� to� fulfill� the� above� task� the�

Firm� possess� the� modern� Scientific� laboratory� Pharmaceutical� production� complex� in� Saint� Petersburg� and�

Substances� Production� Complex� "Polisintez",Ltd� in� Belgorod� (South� of� Russia).

Scientific� Technological� Pharmaceutical� Firm� Polysan� has� two� directions� of� its� activity:� Firstly� —� Polysan� is�

specialized� on� the� development� of� preparations� for� treating� "socially� important"� diseases� that� lead� to� the�

long� disability� and� invalidity:� mass� viral� infections� (hepatitis� B,� C,� flue� infections,� HIV),� bacterial� infections�

and� heavy� diseases� such� as� acute� cerebrovascular� disorder� (brain� infarction),� ischemia� and� others.

The� collective� of� the� Firm� consists� of� Doctors� of� Sciences,� PhD,� who� have� an� impressive� experience� in�

scientific� research� such� as� chemists,� biotechnologists,� biologists,� patent� specialists,� clinicians� of� different�

specialities� and� pharmaceutists.

From� the� very� beginning� as� a�manufacturer� the� Firm� is� developing� and� expanding� its� own� production� line�

subject� to� obligatory� regulation� in� accordance� with� GMP,� resulting� in� high� quality� of� products.

In� June�2005�the�new�Production�complex�equipped�with�present-day�high-tech� facilities� in�accordance�with�

GMP� was� put� into� action� in� Saint� Petersburg.

Special� attention� is� paid� to� product� quality� control� in� accordance� to� up-to-date� requirements� of� Good�

Laboratory� Practice� (GLP).

The� Firm� guarantees� accuracy� and� confidence� of� data� obtained� as� quality� control� laboratory� facilities� are�

being� set�with�up-to-date�analytical� equipment�and�skilled�highly�qualified� staff� is�working� in� the� laboratory.

The� Firms’s� warehouse� meets� the� requirements� of� GLP� also.

� All� the�preparations�of� the�Firm�are� strictly�defended�by�more� than�20�Eurasian,�Russian�and�other�patents�

and� are� licensed� for� application� in� pediatrics.

The�preparations�of�Polysan�are�already� registered� in�Vietnam,� Laos,�Cambodia,�Myanmar�and�Mongolia�and�

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786� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

in� the� countries� of� the� former� USSR.� In� Thailand� and� Indonesia� the� registration� is� in� progress.

At� present� the� preparations� produced� by� "Polysan,� Ltd"� are� in� the� list� of� the�most� demanded� products� on�

pharmaceutical�market� of� Russia� and� some�of� the� ASEAN� countries.� The� product� range� includes� prescribed�

preparations:� correctors� of� the� immune� status� and� antioxidants,� along� with� the� new� prospective�medicinal�

preparations.

Good� sales� are� achieved� on� domestic� market� and� abroad� for� the� following� Firm’s� products:� Cycloferon,�

Reamberin� and� Cytoflavin.� All� of� the� above� products� are� in� the� Firm’s� brand.

The� sales� volume� of� preparations� manufactured� by� the� Firm� is� constantly� growing.� At� the� same� time� the�

distribution� network� is� expanding.� It� covers� virtually� all� regions� of� the� Russian� Federation� and� some�

far-an-near-abroad� countries.

The�Firm’s�distributors�are�working� in�Vietnam,� Laos,�Myanmar,�Cambodia,�Thailand�and�Mongolia�and� some�

countries� of� the� former� USSR.

The� Firm� sets� up� the� network� of� Representative� offices� abroad.� Since�May� 2003� is� functioning� the� officially�

registered�office� in�Vietnam.� It� is� also� responsible� for�presenting� the�Firm� interests� in�South-East�Asia� region�

and� in� ASEAN� countries� in� the� first� place.

The� Russian-Laos� diagnostics� and� treating� viral� infections� center� in� Laos� was� established� and� equipped� by�

modern� diagnostic� equipment� in� 2006�with� the� financial,� technical� and� scientific-methodological� assistance�

of� "Polysan,� Ltd".�All� our�Preparations�are�used� in� the�above�Center.� Two�medicinal� specialists� from�Polysan�

are� currently� working� at� the� Center� and� diagnostic� laboratory� on� the� constant� base.

The� Firm� is� a�member� of� St.Petersburg� Chamber� of� Commerce� and� Industry� and� of� the� Association� of� the�

Pharmaceutical� Companies� of� Russia,� Mongolia� and� Vietnam.

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부록 2� �전략적 협력사 디렉토리 ❚ 787

Corporate� Name PROTEK

Head� Office� Address 22/4,� build.� 7,� Kashirskoye� Schosse.� Moscow,� Russia

Web-site� Address http://www.sotex.ru/

Company� History

Pharmaceutical� company� ”Sotex”� was� established� in� 1999.

Initially,� “Sotex”� was� engaged� in� pre-packing� and� packing� of� finished� drug� products� under� contracts� with�

well-known� western� manufacturers:� Nycomed,� Lek,� Pliva,� KRKA.� This� enabled� the� company� to� gain�

experience� in� production� and� product� quality� control� in� accordance� with� western� standards.

2005�

Injectable�dosage� form�manufacture�with�capacity�of�100�million�ampoules�per� year� is� launched.�The� “Sotex”�

factory� becomes� one� of� the� first� facilities� in� Russia� fully� complying� with� GMP� EU� requirements.

2006�

”Sotex”� launches� production� of� licensed� injectable� medicine� in� cooperation� with� Nycomed.�

”Sotex”� starts� producing� solid� dosage� forms� by� placing� orders� at� European� pharmaceutical� factories.

2007�

“Sotex”� enters� TOP-10� leading� Russian� pharmaceutical� manufacturers.

The� company� starts� selling� products� under� its� own� brands:� Cereton®� and� Angiozil®� Retard.

“Sotex� “PharmFirm”�becomes�a�member�of� the�Association�of�Russian�Pharmaceutical�Manufacturers� (ARPM),�

which� unites� leaders� of� the� pharmaceutical� market.

2008

The� company� acquires� 67%� shares� of� the� biotechnology� company� “Protein� Contour”.

“Sotex”� launches� a� pre-filled� syringe� line� aimed� for� production� of� genetically� engineered� drugs.� The� first�

product�on� this�new� line�was�Eralfon®�(epoetin�alfa)�used� in� such� socially� significant� fields�as�oncology�and�

nephrology.

“Sotex”� product� line� was� replenished� with� new� drug� Amelotex®.�

2009

“Sotex”� starts� exporting� medicinal� products� to� CIS� and� non-CIS� countries.

The� company�continues� to�expand� its� range�of�own�brands�by� launching� the� following�products:�Listab®75,�

CompligamV®,� Flamax®,� Dolomin®.

The� Federal� Antimonopoly� Service� of� the� Russian� Federation� confirmed� the� complete� interchangeability� of�

94. PROTEK

1.� Corporate� General� Information

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788� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Eralfon®� and� its� western� equivalent� based� on� the� material� analysis� and� the� medical� experts� and� clinicians�

opinion.

Production� of� syringes� with� automatic� needle� shielding� system� was� launched.

2010

“Sotex”� launched� two� new� brands:� Neurox� and� Likferr100®.

Company�products� Eralfon®� and�Amelotex®� became� the�winners� of� the� pharmaceutical� Award� “Recipe� of�

the� Year� 2010”.

2011

Eralfon®� became� the� winner� of� two� competitions� at� once:� “Platinum� Ounce� 2010”� and� “Health� Forsyth�

2011”.

“Sotex”� released� the� drug� BloccoC®,� included� in� the� list� of� strategically� important� drugs.

Market� positions� of� “Sotex”� strengthened� by� means� of� perspective� brands� of� Rx-drugs� Anvifen®� and�

Metaprot®.

2012

“Sotex”� launched� two� new� medical� brands:� Chondrogard®� and� Nemulex®.

In� the� scope� of� the� agreement� with� FPK� PharmVILAR,� “Sotex”� starts� to� promote� medicinal� products�

Exportal®� and� Angionorm®.

According� to� the� results�of� the� retail� sales�audit� in� the�Russian�Federation� conducted�by�MRC�“Pharmexpert”,�

Chondrogard®� was� recognized� as� the� most� successful� launch� in� ATC-group� level� 1� M� Musculoskeletal�

System.

Company� Description� &� Organization

“Sotex� “PharmFirm”� is� a� modern� manufacturer� of� medicinal� products,� operating� in� accordance� with� the�

requirements� of�GMP� EU.� “Sotex”� factory� located� in� the� Sergiev-Posad� district� of�Moscow� Region� is� one� of�

the� most� high-technology� and� innovative� pharmaceutical� enterprises� in� Russia.�

The� factory�carries�out�a� complete�cycle�of�production:�preparation�of� injection�solutions,� filling�of�ampoules�

and� syringes� with� further� labeling,� packing� and� shipping� to� a� warehouse.� All� processes� are� carried� out� in�

strict� accordance�with� international� requirements� in� clean� rooms� of� cleanliness� classes� A,� B,� C� and�D� using�

the� equipment� of� leading� European� corporations:� INOVA,� SEIDENADER,� UHLMAN,� BAUSH� &� STROBEL,�

PHARMAPLAN,� IMA.�

“Sotex”� actively� develops� the� portfolio� of� its� own� brands� by� increasing� their� number� from� year� to� year.� The�

extensive� company� product�portfolio� includes� a� lot�of� demanded�drugs,�used� in� different� therapeutic� areas,�

which� have� won� the� trust� of� professionals� and� consumers.

Modern� and� effective� “Sotex”� products� are� not� inferior� to� western� equivalents� in� terms� of� quality� and� are�

much� more� affordable� in� terms� of� price.� The� drugs� affordability� is� explained� by� an� effective� distribution�

network� and� manufacturing� in� Russia.

The�company�also�has�a�unique� for�Russian�market�experience�of�direct� interaction�with� leading� international�

pharmaceutical� manufacturers� in� licensed� production� and� promotion� of� medicinal� products.

“Sotex"� staff� includes� highly� qualified� professionals.� The� company� employees� serving� the� manufacturing�

process� and� controlling� the� product� quality� undergo� a� regular� training� and� improve� their� professional� level.

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부록 2� �전략적 협력사 디렉토리 ❚ 789

95. PTC Therapeutics

1.� Corporate� General� Information

Corporate� Name PTC� Therapeutics

Web-site� Address www.ptcbio.com

Contact

(Korean� Business)

Name Young-Choon� Moon� and� Morgan� Conn

Address 100� Corporate� Court,� SouthPlainfield,NJ07080

Telephone 908-912-9173(Young-Choon),� 908-912-9151(Morgan)

E-mail [email protected],� [email protected]

2.� Description� of� Collaboration�Opportunities

Collaboration�

Opportunities� for� R&D�

Co-works

저희는 화이저,� 로쉬,� 쉐링,� 길리아드,� SMA� foundation,� Welcome� Trust,� FDA,�

Department�of�Defense�등 미국과 유럽의 많은 회사들과 공동연구를 해왔고,�한국의 생

명공학연구원과도 2년간 공동연구를 수행한 경험이있습니다.� �공동연구에 대한 옵션은 언

제든지 열려있지만,�저희는 외부와 공동연구를 수행하는동안 저희 기술을 이용해서 신약

개발을 수행하기 때문에 파트너로부터 공동연구비를 지급받고 수행하고있습니다.� �지금까

지는 한국에서 연구비를 제공받기에는 그 액수가 적어서 공동연구가 활발히 진행되지는

못했습니다.� � 하지만 서로 대화를 통해서 공동연구 수행은 언제든지 가능합니다.� �

우리가 한국에 연구비를 지급하고 공동연구를 하는 경우는 아직 까지는 없었고 당분간 없

으리라 생각합니다.

Collaboration�

Opportunities� for�

In-Licensing

PTC299은 한국에 라이센스인이 가능합니다.� �하지만 지금은 적당한 시간이 아니라 언급

을하지 않고있습니다.� �임상 2상에서 보다 좋은 결과가 나오면 다국적기업및 기타 회사들

과 라이센스를 할 예정입니다.�

Collaboration�

Opportunities� for�

Out-Licensing

아직까지는 아무 회사와도 한국에서 미국으로의 라이센스 아웃을 상의한적이 없습니다.� �

저희가 작은 회사라 현재로는 크게 고려하고 있지는 못합니다.� �일단 현재 임상 3상 진행

중인 것이 시판된 후에는 보다 적극적으로 외국에서 라이센스인을 할 예정입니다.� �아마도

내년도에는 그런 기회가 있을것 같습니다.� �

Collaboration�

Opportunities� for�

Manufacturing

PTC는 자체의 생산 설비시설이 없기때문에 모든 전임상및 임상에 쓰이는 화합물들을 국제

적인 CMO에서 생산하여 임상 전임상을 수행하고 있습니다.� � 지금까지는 유럽회사들이

(스위스 이태리)�저희 물질을 GMP규격에 맞게 생산하고 있습니다.� �아직 한국,�중국,�인도

(중간체는 현재 인도에서 생산하고있음)� 에서 생산하는것은 고려하고 있지 않습니다.� �

Collaboration�

Opportunities� for� (Co-)�

Marketing� &� Sales

물론 가능하지만 아직까지는 수행한 경험이 없습니다.� �현재 저희 회사는시판하는 약이 없

으므로 이 분야는 거론 하기가 이르다고 봅니다.�

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790� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

3.�특허분석 결과

PTC사의 특허분포도를 볼 때 기술 중에 대표적으로 Formulations� Dosage� Forms� Galatamine,� Expression�

Capable�Modulating� Screening,� Splicing� Endonuclease� Trna� Splicing�Componds� Target� Trna의 키워드를

가진 기술에 많은 특허가 분포하고 있는 것으로 나타남.

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부록 2� �전략적 협력사 디렉토리 ❚ 791

The� Benefits� of� Partnering� with� Purdue� Pharma� L.P.

In� today's�competitive�marketplace,�alliances�allow�companies� to� combine� resources�and�expertise� to�advance�

research� and� bring� innovative� products� to� market.� By� building� strong� alliances� with� high-quality,�

research-driven� organizations,� we� provide� new� and� improved� treatments� for� diseases� and� their� symptoms,�

and� deliver� the� best� possible� care� for� patients.

Fully� Integrated� Pharmaceutical� Operations

Purdue� provides� partner� companies� with� extensive� expertise� in� discovery,� clinical� development,� project�

management,� regulatory� affairs,� manufacturing,� marketing,� and� sales.� A� dedicated� Alliance� Management�

function� ensures� that� every� dimension� and� detail� involved� in� our� collaborations� gets� the� attention� required.�

Purdue� has� regulatory� expertise� and� experience� in� gaining� approval� from� the� U.S.� Food� and� Drug�

Administration� (FDA).�Our�national�U.S.� sales�and�marketing�organization�has� the� critical�mass�and�know-how�

to� commercialize� new� products� quickly� and� effectively.

Global� Reach

Purdue� Pharma� and� its� independent� associated� companies� (including� the� Mundipharma/Napp� companies)�

have� a� presence� in� more� than� 30� countries� and� a� staff� of� more� than� 5,000.� � Each� of� these� international�

96. Purdue Pharma

1.� Corporate� General� Information

Corporate� Name Purdue� Pharma

Web-site� Address http://www.purduepharma.com/Pages/default.aspx

Contact

(Korean� Business)

Name -

Addresshttp://www.purduepharma.com/About/Pages/Licensing-Proposal-Form.a

spx

Telephone -

E-mail [email protected]

2.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

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792� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

companies� is� a� leader� within� their� respective� market� for� key� therapeutic� areas.

Expertise� in� Pain� Management

Purdue�has� long-standing�expertise� in�pain�management�and�has� transformed�clinical�practice� to�better� serve�

the� needs� of� patients�with� pain.�We� have� conducted� extensive� research� into� the� development� of� analgesics�

that� provide� safe� and� effective� pain� relief� to� patients.�We�work� extensively�with� physicians,� opinion� leaders,�

and� patient� advocacy� groups� to� ensure� that� pain� is� appropriately� recognized� and� treated.�

Purdue� and� Shionogi� &� Co.,� Ltd.,� one� of� Japan's� largest� research-based� pharmaceutical� companies,� are�

collaborating�on� the�discovery�and�development�of�novel,�non-opioid�medications� to� treat�pain.�The� research,�

which� targets� cellular� receptors� known� to� modulate� pain� responses,� is� being� conducted� jointly� at� Purdue's�

research� center� in� Cranbury,� New� Jersey,� and� Shionogi's� laboratories� in� Osaka,� Japan.�

Purdue� has� an� exclusive� U.S.� licensing� and� co-promotion� agreement� with� Labopharm� Inc.� of� Laval,� Canada�

for� (tramadolHClextended-releasetablets),anextendedreleaseformulationoftramadol.

Expanding� into� Related� Therapeutic� Areas

Purdue� has� an� exclusive� license� and� collaboration� agreement� with� Transcept� Pharmaceuticals,� Inc.� to�

commercialize� Intermezzo®� (zolpidem�tartrate� sublingual� tablet),�a�product� for� insomnia� currently�under� FDA�

review.

Additionally,� Purdue� Pharma� L.P.� and� its� associated� company,� Mundipharma� International� Corporation�

Limited,� entered� into� a� global� strategic� alliance� with� Infinity� Pharmaceuticals,� Inc.� to� advance� the� research,�

development,� and� commercialization� of� Infinity's� discoveries� and� early� clinical� programs� in� oncology� (outside�

the� United� States)� and� neuropathic� pain� (worldwide).

Purdue's� Therapeutic� Areas� of� Interest

Purdue's� licensing� strategy� seeks� to� identify� late-stage� products� within� the� following� therapeutic� areas:

-� Pain� management� -� both� non-opioids� and� opioids

-� Sleep� disorders

-� Gastrointestinal� disorders

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부록 2� �전략적 협력사 디렉토리 ❚ 793

3.�특허분석 결과

Purdue사의 특허분포도를 볼 때 기술 중에 대표적으로 Graft� Tissue� Diseased의 키워드를 가진 기술에 많은

특허가 분포하고 있는 것으로 나타남.

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794� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

97. RANDALL LABORATORIES

1.� Corporate� General� Information

Corporate� Name RANDALL� LABORATORIES

Head� Office� Address Lago� Rodolfo� #� 58� Col.� Granada� 11520� México,� D.F.�

Facilities� City� &� Country Mexico

Web-site� Address www.randall.com.mx

Company� Description� &� Organization

Mision

It� lies�primarily� in� reaching� the�most�sensitive�points�of� the�Mexican�population;�health�economy,�as�quality�

products� consumed� to� reach� the� patient's� confidence� in� being� the� best� option.

Vision

Keep� as� a� pharmaceutical� company� 100%� reliable,� respectable� and� security� our� customers.� Randall�

Laboratories� create� and� distribute� high-quality� products� to� meet� the� medical� needs� that� exist.� Being� a�

company� that� works� for� the� benefit� of� mankind.� Randall� Laboratories� has� over� 50� products� and�

presentations� to� give� our� customers� different� options� according� to� your� needs.

Values

Experience� •� Over� 50� years� in� the� market� precedes� our� knowledge� in� the� pharmaceutical� market.� • �

Honesty� is� the� reason� for� our� reliability� and� permanence.� Confidence� •� Because� we� are� a� link� between�

the� patient� and� health.� Innovation� •� Because� we� are� at� the� forefront� of� technology� in� the� service� of�

health.� Human� Quality� •� Because� we� are� committed� to� health

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부록 2� �전략적 협력사 디렉토리 ❚ 795

98. RC CORP

1.� Corporate� General� Information

Corporate� Name RC� CORP�

Web-site� Address www.rccorp.kr� or� www.rccorp.us

Contact

(Korean� Business)

Name 권태수

Address 경기도 성남시 분당구 정자동 19-6,� 신수빌딩 B1,� 302호

Telephone 010-8753-9717

E-mail [email protected]

2.� Description� of� Collaboration�Opportunities

Collaboration� Opportunities�

for� R&D� Co-worksSister� company� has� the� opportunities:� www.ingenza.com�

Collaboration� Opportunities�

for� In-LicensingSister� company� has� the� opportunities:� www.ingenza.com

Collaboration� Opportunities�

for� Out-LicensingSister� company� has� the� opportunities:� www.ingenza.com

Collaboration� Opportunities�

for� ManufacturingSister� company� has� the� opportunities:� www.ingenza.com

Collaboration� Opportunities�

for� (Co-)� Marketing� &� SalesParent� company� has� the� opportunities:� www.rccorp.us

3.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

- Having�been� in� custom�manufacturing� service�of� pharmaceutical� intermediate� and�API�with�Multinational�

big� pharma� companies� for�more� than�10� years,�we�will� be� able� to� help�Koren�pharma�companies� in� this�

area.

- Our� sister� company,� Ingenza� located� in� Scottland,� is� doing� contract� research� in� biologics.� � So,� there� are�

opportunities� in� R&D� co-work.

- Looking� for� investment� to� develop� biosimilar,� recombinant� Blood� Profactor� VIII� to� market.� �

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796� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Collaboration�

Opportunities� for� R&D�

Co-works

Ricerca� Biosciences� offers� a� comprehensive� suite� of� discovery,� preclinical� and�

development� services� to� support� drug� candidates� from� lead� identification�

through� IND� and� NDA� on� a� global� scale.� Capabilities� include�molecular� through�

in� vivo� screening� and� profiling,� as� well� as� medicinal� chemistry,� radiochemistry,�

IND-enabling� toxicology,� API� process� chemistry� and� cGMP� manufacturing� of�

clinical� and� commercial� API.� Our� experienced� scientists� deliver� world-class�

expertise� and� services� to� help� you� shorten� time� to� IND� and� bring� molecules� to�

the� clinic� faster.

In� addition� to� U.S.-based� facilities� in� Concord,� Ohio,� and� Bothell,� Washington,�

Ricerca� also� has� ISO� 9001-certified� facilities� in� Taipei,� Taiwan,� and� Lyon,� France.�

The�Lyon�facility�also�holds�certification� from� the�Association� for�Assessment�and�

Accreditation� of� Laboratory� Animal� Care� (AAALAC).

� Discovery� Pharmacology

•Molecular� profiling� &� screening

•Functional� pharmacology

•Early� cellular� toxicology

•Cellular� oncology� and� immune� systems

99. Ricerca Biosciences

1.� Corporate� General� Information

Corporate� Name Ricerca� Biosciences

Web-site� Address www.ricerca.com

Contact

(Korean� Business)

Name Namin� Kang

Address 7528� Auburn� Road,� Concord,� OH� 44077

Telephone 1-888-742-3722

E-mail [email protected]

2.� Description� of� Collaboration�Opportunities

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부록 2� �전략적 협력사 디렉토리 ❚ 797

•In� vivo� safety� and� disease� models

•Discovery� DMPK

Chemical� Development

•Medicinal� chemistry

•Analytical� chemistry

•Process� chemistry

•Engineering� and� scale-up

•Radiosynthesis

•API� production� with� cGMP� controls

Drug� Safety� and� Metabolism

•General� toxicology

•Safety� pharmacology

•Continuous� infusion

•Juvenile� toxicology

•DART

•Bioanalytical� services

Page 801: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

798� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name Roemmers� S.A.I.C.F.

Facilities� City� &� Country Argentina

Web-site� Address www.roemmers.com.ar

Contact

(Korean� Business)E-mail [email protected]

Company� Description� &� Organization

Mission

To� renew� the� hope� and� quality� of� life� by� offering� superior� medicines� to� healthcare� professionals.� These�

pharmaceutical� products� are� to� be� the� result� of� research,� product� manufacturing� and� services� provided�

always� with� excellence� in� mind.

Vision

To� expand� the� leading-edge� position� that� Roemmers� holds� in� pharma� in� order� to� provide� a� greater� quality�

of� life� as�well� as� life-expectancy�while� improving� daily� the� research,� diagnosis� and� treatments� performed� in�

the� field� of� Medicine.

Values

Roemmers’� work� is� founded� upon� long-lasting� values� that� support� its� mission� and� allow� the� company� to�

meet� the� goals� set� forth� in� its� vision.

Respect� for� People

This� is� Roemmers’� core� value� and� it� is� applied� to� everyone� the� company� comes� in� contact�with:� employees�

and� their� families,� assistants,� suppliers,� healthcare� professionals� and� the� communities�where�Roemmers� has�

a� presence.

Integrity

Roemmers� is� guided� by� the� highest� ethical� standards� in� both� its� strategic� planning� as� well� as� in� its�

commercial�and�production�processes.�Protection�of� the�environment� is� a�guiding�principle� in�everything�we�

do.

Teamwork

The� strong� relationship� between� teams� is� the� basis� for� the� success� of� our� company.� This� relationship� goes�

beyond� organizational� and� geographical� barriers� seeking� to� correctly� interpret� the� modern� pharmaceutical�

business.� This� sense� of� � teamwork� throughout� the� company� is� strengthened�by�encouraging�mutual� respect�

100. Roemmers S.A.I.C.F.

1.� Corporate� General� Information

Page 802: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

부록 2� �전략적 협력사 디렉토리 ❚ 799

and� the� development� of� individual� talents� so� as� to� tap� employee� skills� and� human� potential� in� the� best�

manner� possible.� Open� dialog� and� information� sharing� is� a� priority� in� this� process.

Excellence

Roemmers’� track� record� is� the� result� of� the� competence� and� integrity� the� company� has� demonstrated� in� its�

conduct.� With� this� idea� in� mind,� Roemmers’� development� is� predicated� upon� paying� special� attention� to�

meeting� its� objectives� and� achieving� the� results� it� has� set� forth.

Concern� for� Life

Roemmers’� motto� expresses� the� desire� to� connect� its� future� to� the� progress� and� well-being� of� our�

community� while� caring� for� and� developing� our� natural� resources.� Because� the� causes� of� diseases,� how�

diseases� occur� and� human� suffering� are� all�multiple� conditions,�we�believe� there� is� no� cure� for� all� of� them�

and�as�a� result�we�will�not� find�a� solution� for� some�of� them.�Despite� this,�Reommers� is�committed� to� finding�

and� offering� therapeutic� solutions� and� progress� in� the� face� of� the� challenges� and� the� changing� needs� in�

the� field� of� healthcare.

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800� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Collaboration�

Opportunities� for� R&D�

Co-works

Sanofi� Collaborates� with� Bioneer� -� Korea’s� first� biotech� ­� to� Develop� Anticancer�

Drug

Sanofi� will� develop� antitumor� candidate� compound� targeted� at� solid� cancers�

including� liver� cancer,� which� is� prevalent� in� Korea,� using� SAMiRNA,� a� next�

generation�nanoparticle� treatment�developed�by� Bioneer� for� the� first� time� in� the�

world.� SAMiRNA� is� a�material� that� dissolves� ribo� nucleic� acid� (RNA)� that� causes�

cancer�by�selectively�attacking� cancer� tissue�only.�Sanofi�plans� to�use� this�material�

for� verifying� effectiveness� of� the� cancer-targeted� gene� it� discovered� and� for�

developing� new� anticancer� drug.

Sanofi� Collaborates� with� LegoChem� Biosciences,� an� Emerging� Biotech� Company�

to� Discover� Lead� Candidates�

LegoChem�will�utilize� the�company’s�unique�synthesis� technology� to� find�possible�

lead� candidates� for� a� high-prevalence� disease� in� the� Asian� demographic� from�

early� stage� hits� provided� by� Sanofi.� This� agreement� has� drawn� considerable�

attention� as� it� incorporates� the� abilities� of� a� multinational� pharmaceutical�

corporation� and� this� startup� company� in� a� win-win� research� collaboration�

agreement.� Sanofi� provides� the� pharmaceutical� target,� and� LegoChemBio�

optimizes� lead� candidates� to� the� selected� target

Pioneer� Network� with� 4� Hospitals

101. SANOFI

1.� Corporate� General� Information

Corporate� Name SANOFI

Web-site� Address www.sanofi.com

Contact

(Korean� Business)

Name SungJoo� Lee� /� Min� Ryoo

AddressSanofi� R&D,� 1001� Dunsan-dong,� Seogu,� Daejeon,� Korea� /� Sanofi�

Korea,� Teheran-ro� 132,� Gangnam-gu,� Seoul,� 135-755,� Korea

Telephone +82� (0)42� 487� 9202� /� +82� (0)2� 527� 5512

E-mail [email protected]� /� [email protected]� �

2.� Description� of� Collaboration�Opportunities

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부록 2� �전략적 협력사 디렉토리 ❚ 801

Sanofi� signed� a� MOU� is� about� establishing� the� ‘Premier� Network’,� a�

comprehensive� networking� program� in� new� drug� development,�with� the� clinical�

trial� centers(�CTCs)�of�4�major�hospitals� (Samsung�Medical�Center,�Asan�Medical�

Center,� Seoul� National� University� Hospital,� and� the� Yonsei� Severance� Hospital).�

The� ‘Premier�Network’� is� Sanofi’s�global�CTC�networking�program� that�devises� to�

improve� efficiency� in� clinical� researches.� The� total� number� of� hospitals�

participated�becomes�20� in� the�world,�which�we�consider�best�of� the�best.� These�

4� hospitals� are� the� first� from� Asia.

Collaboration�

Opportunities� for�

In-Licensing

Sanofi� has� an� open� approach� to� all� biological� and� pharmaceutical� opportunities.�

The� diversity� of� our� business� is� reflected� in� our� interest� in� a� wide� array� of�

therapeutic� areas,� including� but� not� limited� to;

∙Oncology∙Vaccines∙Diabetes∙Immunomodulation� � � � � � � � � � ∙CV� and� Metabolism∙Renal� Diseases∙Rare� Diseases∙Infectious� Diseases ∙Ophthalmology∙Degenerative� Diseases∙Multiple� Sclerosis∙Animal� healthWe� continue� to� look� for� additional� external� opportunities� to� contribute� to� our�

sustainable� growth� from� early� stage� discovery� through� late-stage� development.

Sanofi� is� also� very� interested� in� partnerships� to� advance� emerging� science.� Our�

interests� are� wide� ranging,� including� gene� therapy,� nano-� and�

micro-technologies,� complex� materials,� converging� technologies,� new�

technologies� for� personalized� medicine,� new� classes� of� drugs� and� new�

approaches� to� improve� drug� ability.

Sanofi’s� partnering� brochure� is� available� at;

http://partnering.sanofi.com/sites/all/themes/sanofi/imgs/2/master/sources/index.

htm

Collaboration�

Opportunities� for�

Out-Licensing

Sanofi� has� begun� a� comprehensive� review� of� compounds,� leads,� patents� and�

technologies� in� our� pipeline.

Our� objective� is� to� identify� those� with� potential� for� out-licensing� or� other�

appropriate� forms�of�partnering.�This� is�a�new� initiative� to� create� long-term�value.�

We� are� flexible,� and� as� we� progress� in� our� review,� we� will� be� open� to�

exchanging� ideas� towards� establishing� creative� partnerships.

Currently� 6� opportunities� are� available�

-� multikinase� inhibitor� in� a� novel� eye� drop� formulation� for� the� treatment� of�

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802� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

age-related� macular� degeneration� (AMD)

-� positive� allosteric�modulator� (PAM)� of� the�metabotropic� glutamate� receptor� 2�

(GluR2)�

-� Idrabiotaparinux� -�Unique�once�weekly�anticoagulant�with�best� compliance�and�

tolerance

-� Anti� Factor� IXa/� Xa� (thrombin)

-�PDE7/PDE8� Inhibitor� -�A�novel� cardioprotective�agent� for�preventing� reperfusion�

injury� in� acute� coronary� syndrome

-� P2Y12� receptor� antagonist

Description� of� the� projects� is� available� at;�

http://en.sanofi.com/partners/why_with_us/out-licensing/out-licensing.aspx

Collaboration�

Opportunities� for�

Manufacturing

N/A� for� Korean� territories,� unless� products� in� partnership� require�manufacturing�

service� to� be� provided.�

Collaboration�

Opportunities� for� (Co-)�

Marketing� &� Sales

As� of� 2012,� Sanofi� Korea� has� 4� business� affiliates� of;

∙sanofi� aventis� Korea� (Pharmaceuticals)∙Genzyme� (Rare� Diseases) � � � � � ∙sanofi� pasteur� (Vaccine)∙Merial� (Animal� Health)Sanofi� has� maintained� win-win� strategic� partnerships� with� many� Korean�

companies� from� API,� co-promotion� and� co-marketing� of� Sanofi� products� in�

Korea.

Sanofi� is� also� interested� in� the� local� commercial� collaboration� or� in-licensing�

opportunities� of� innovative� products� developed� by� Korean� pharmaceutical�

companies.�Recently,� Sanofi�has� identified� some�opportunities� already� concluded�

or� currently� ongoing� for� Korea.� Sanofi� seeks� for� the� other� territorial� opportunity�

upon�the� initiation� from�Korea�and�we�believe� this� is� considered�highly�beneficial�

approach� for� Sanofi’s� partnering� as� well� as� extending� the� global� opportunity� of�

Korean� innovative� products.

3.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

Sanofi� is� committed� to� Open� innovation� because�we� recognize� that� inside� and� outside� our� walls,� there� is�

astounding� scientific� discovery� going� on� and� that� it� is� through� collaboration� that� we�will� deliver� the� best,�

the� most� innovative� and� the� most� awaited� solutions� patients� are� hoping� for.�

We� look� forward� to� in-licensing,�out-licensing�and� research�collaborations�with�Korean�biotech,�pharma�and�

academia� from� as� early� as� target� screening� to� promotion� partnership� of� products� already� in� the� market.

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부록 2� �전략적 협력사 디렉토리 ❚ 803

4.�특허분석 결과

SANOFI사의 특허분포도를 볼 때 기술 중에 대표적으로 Gastric� Secretion� 2'� Bishydrazine� Purifying,� Protein�

Coding� Protein� Recombinant� 등의 키워드를 가진 기술에 많은 특허가 분포하고 있는 것으로 나타났다.

Page 807: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

804� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

2006년 01월 01일부터 2012년 12월 10일까지 출원된 SANOFI사의 특허의 키워드 분포는 붉은 점으로 나타난

다.

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부록 2� �전략적 협력사 디렉토리 ❚ 805

102. Serendex aps

1.� Corporate� General� Information

Corporate� Name Serendex� aps

Web-site� Address www.serendex.com

Contact

(Korean� Business)

Name Kaare� Fiala

Address Egernvej� 69,� 2000� Frderiksberg,� Denmark

Telephone +45� 20412363

E-mail [email protected]

2.� Description� of� Collaboration�Opportunities

Collaboration�

Opportunities� for�

In-Licensing

Serendex� is� not� looking� for� In-licensing� opportunities

Collaboration�

Opportunities� for�

Out-Licensing

Serendex� is� looking� for� a� Korean� company� that� which� to� develop� a� specialty�

pharmaceutical� company� in� to� the� US� market� or� supply� own� company� in� USA�

with�a� portfolio� of� development�projects�with� interests� in� the� intensive� care� unit�

therapeutic� area.

Collaboration�

Opportunities� for�

Manufacturing

We� are� predominantly� working� with� recombinant� proteins� an� there� is� thus� an�

opportuinity� to� enter� nto� production� of� one� oo� more� of� these� proteins� that�

Serendex� wishes� to� take� into� clinical� development

Collaboration�

Opportunities� for� (Co-)�

Marketing� &� Sales

The� Serendex� portefolio� of� projects� could� also� be� of� great� interest� for� the� right�

compnay� with� a� seales� force� in� Korea� and� the� ASEA.

3.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

We�are� looking� for�a�partner�who�wishes� to� in-licenses�our�projects�ort�may�be�even� take�over�our� company�

through� a� trade� sale� or� a� merger.

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806� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

103. SERVIER

1.� Corporate� General� Information

Corporate� Name SERVIER

Web-site� Addresswww.servier.com� (Headquarter� in� France)�

www.servier.co.kr� (SERVIER� KOREA)

Contact

(Korean� Business)

Name Frederic� FOUILLOUX� /� Jean-Luc� PICKER

Address5th� fl.� Hong-ik� Univ.� Kangnam-kwan,� #51-12

Banpo� 4-dong,� Seocho-gu,� Seoul,� 137-802,� KOREA

Telephone +82� 2� 3415� 8510� /� +82� 2� 3415� 7901

[email protected]� /

[email protected]

2.� Description� of� Collaboration�Opportunities

Collaboration�

Opportunities� for� R&D�

Co-works

Target� validation,� lead� compound� identification,� in-licensing� development� of�

preclinical� or� early� clinical� development� � Cardiovascular,� Diabetes,� Oncology,�

Neurodegeneration,� Psychiatry

Collaboration�

Opportunities� for� (Co-)�

Marketing� &� Sales

May� look� into� collaboration� opportunities� (contact� F.� Fouilloux)

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부록 2� �전략적 협력사 디렉토리 ❚ 807

3.�특허분석 결과

SERVIER사의 특허분포도를 볼 때 기술 중에 대표적으로 Crystalline� Form� Form� Powder� 등의 키워드를 가진

기술에 많은 특허가 분포하고 있는 것으로 나타났다.

Page 811: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

808� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

2006년 01월 01일부터 2012년 12월 10일까지 출원된 SERVIER사의 특허의 키워드 분포는 붉은 점으로 나타난

다.

Page 812: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

부록 2� �전략적 협력사 디렉토리 ❚ 809

Collaboration�

Opportunities� for� R&D�

Co-works

We� have� some� potential� projects� under� research� and� also� we� are� looking� for�

some� APIs� technology.

Collaboration�

Opportunities� for�

In-Licensing

We�are� looking� for�good�generic�drug� from�Korea�especially� in�psychiatry,�CNS,�

GI� system,�and�cardiovascular� in� some�special� formulation�or�dosage� form.�Also�

we� are� looking� for� bio-pharmceuticals� or� bio� similar� if� there� is.

Collaboration�

Opportunities� for�

Out-Licensing

We� have� one� new� bio-drug� called� aFGF(acidic� fibroblast� growth� factor)� for�

wound� healing� and� skin� care.� It� is� available� for� Korean� for� licensing.

Collaboration�

Opportunities� for� (Co-)�

Marketing� &� Sales

Our� interferon� alpha� 2a� and� 2b� injection� with� competitive� price.� Also�

inter-medium� is� available� for� these� two� product.

104. Shanghai Tenry Pharmaceutical Co., Ltd

1.� Corporate� General� Information

Corporate� Name Shanghai� Tenry� Pharmaceutical� Co.,� Ltd

Web-site� Addresswww.tenry.cc/� www.tenry.com.cn/

www.tenrypharmceutical.com

Contact

(Korean� Business)

Name Ms.� Phoenix� HE

Address 1906� Room,� 2018#� Huashan� Road,� Shanghai,� China

Telephone 086-21-54070055*8265

E-mail [email protected]

2.� Description� of� Collaboration�Opportunities

Page 813: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

810� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Collaboration�

Opportunities� for� R&D�

Co-works

We�have�a�group�of�experts� in�drug�R&D�and�preparation� technology.�We�have�

rich�experiences� in� synthesis�of�compounds�and�preparation�of� insoluble�drugs.�

We� can� provide� technology� evaluation� and� consultation,� solve� difficulties� and�

bring� in�advanced� technology� for�Korean�pharmaceutical�enterprises.�We� invest�

a� R&D� lab� and� establish� platforms� of� synthesis� of� compounds,� insoluble� drugs�

technology,� and� new� pharmaceutical� technology,� which� involves� in� solid�

dispersion,� lipid� some,� nanoparticle,� micro� capsule,� micro� emulsion,� micro�

balloon,� oral� controlled� release� system,� immediate� release� oral� drug� delivery,�

etc..�We�would� like� to� cooperate�with�Korean� companies� to�establish�business.

Collaboration�

Opportunities� for�

In-Licensing

As� long� as� there� is� good� products� and� technology,� SHJNJ� can� in-license� them�

and� transfer� them� to� manufacturer� to� research� and� develop� further� and�

produce� final� products.�

Collaboration�

Opportunities� for�

Out-Licensing

SHJNJ� is� willing� to� out-license� nice� products� and� technology� for� R&D� and�

manufacture� to� Korean� pharmaceutical� companies� which� are� reliable� so� as� to�

develop� Korean� market� together.

Collaboration�

Opportunities� for�

Manufacturing

As�a�good�partner�of� two�manufacturers� in�China,�SHJNJ�provides�an� integrated�

platform�with� “end-to-end”� small�molecule�APIs/intermediates�development�and�

manufacturing� capabilities� from� preclinical� to� commercial� stages.� We� proudly�

support�many�kinds�of� life-science�clients�worldwide�and�manufacture�different�

APIs�per� year.�We� can�provide�and�design� the�products� that�Korean� customers�

need.

Collaboration�

Opportunities� for� (Co-)�

Marketing� &� Sales

SHJNJ� has� close� partners� in� Korea;� we� are� always� co-marketing� and� saling�

products� together�with� them.�And�we�can�help� to� register�Chinese�products� in�

KFDA.�We�would� like� to� establish� new� partnership� on� co-marketing� and� sales�

if� new� customers� in� Korea� wish.�

105. SHJNJ PHARMATECH INC.

1.� Corporate� General� Information

Corporate� Name SHJNJ� PHARMATECH� INC.

Web-site� Address www.shjnj.com

Contact

(Korean� Business)

Name Liu� Yuebin

Address A401,� 271,� Lvke� Rd,� Pudong� District,� Shanghai,� China

Telephone 86-21-50911366

E-mail [email protected]

2.� Description� of� Collaboration�Opportunities

Page 814: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

부록 2� �전략적 협력사 디렉토리 ❚ 811

3.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

Other� services� SHJNJ� can� provide:

1.� CMO,� CRO.

We�provide� the� services�and�assist� to� tackle� technology�problems� for�home�and�abroad�enterprises,� as�well�

as� develop� high-tech� products� covered� by� intellectual� property� rights.

2.� KFDA� Drug� Registration� with� Korean� partners,� and� GMP� training� certification.�

SHJNJ� has� experts� covered� around� the�world,� including� retirement� officials� of� FDA.�We� deeply� understand�

the� policy� of� each� country� and�have� assisted� domestic� enterprises� to� pass� through� inspection�of� USA� FDA,�

Japan� PMDA,� and� Korean� KFDA.� We� successfully� help� them� obtain� the� certificate� licenses� and� export�

products� to� these� countries.

3.� Compile� DMF,� EDMF� files

Our� company�has� skilled� in�compiling�DMF�file� and�assisted�domestic� enterprises� to� compile� tens�of�products�

DMF� files,� and� most� products� succeeded� in� passing� inspection� and� exporting� to� other� countries.

Page 815: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

812� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

106. SibEnzyme

1.� Corporate� General� Information

Corporate� Name SibEnzyme

Head� Office� Address SibEnzyme� US� LLC,� 2� Franclaire� Drive,� West� Roxbury,� MA� 02132,� USA

Web-site� Address http://sibenzyme.com/

Company� Description� &� Organization

SibEnzyme�Ltd.� (Siberian�Enzyme,�SE),� is�a�privately�owned�Russian�company� founded� in�1991.�SibEnzyme�

Ltd.� is� located� in� Academtown� near� Novosibirsk� city� the� capital� of� Siberia� and� a� geographic� center� of�

Russia.

� SibEnzyme�primary� focus� is� production�of� enzymes� and� related�products� for�molecular� biology,� PCR� and�

genetic� engineering.� SE� product� line� includes�more� than�200� enzymes,� several� perfect� DNA� ladders,� high�

quality� dNTPs� and� DNA� preparations.�

SibEnzyme� Ltd.� is� one� of� the� leading� companies� in� restriction� endonucleases� production.

� Sibenzyme� Ltd.� is� a� world� leader� in� research� and� development� of� new� DNA� endonucleases.

� A� first� site-specific� DNA� nickase� � was� found� and� characterized� at� SibEnzyme.

� A� novel� type� of� DNA� endonucleases,� 5-methylcytosine-directed� site-specific� DNA� endonucleases,

� have� been� described� in� SE� laboratories.

� SibEnzyme� Ltd.� manufactures� � more� than� 150� restriction� endonucleases� discovered� at� SE.

� Please� visit� our� � Scientific� Library� Online� for� listing� of� last� SE� publications.�

� SibEnzyme� Ltd� is� ISO� 9001:2008� certified.�

Page 816: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

부록 2� �전략적 협력사 디렉토리 ❚ 813

2.� Additional� Business� Propositions� for� Collaboration

Restriction� endonucleases� -� site-specific� DNA-endonuclease� that� recognizes� a� short� DNA� sequence�

(recognition� site)� and� hydrolyzes� phosphodiester� bond� in� both�DNA� strands� at� definite� position�within� or�

near� this� site

Methyl-directed� DNA� endonucleases� -� site-specific� DNA-endonuclease� that� recognizes� a� short�methylated�

DNA� sequence� (recognition� site)� and� hydrolyzes� phosphodiester� bond� in� both� DNA� strands� at� definite�

position� within� or� near� this� site

Nickases� -� site-specific� DNA-endonuclease� that� recognizes� a� short� DNA� sequence� (recognition� site)� and�

hydrolyzes� phosphodiester� bond� in� one� DNA� strand� at� definite� position� within� or� near� this� site

Other�Enzymes� -�enzymes� that� interact�with�nucleic�acids�and�modify� them� in�a�different�ways:�polymerize,�

hydrolyze,� ligate,� etc.

DNA�methyltransferases� -� site-specific� transferase� that� recognizes�a� short�DNA�sequence� (recognition� site)�

and� transfers� a� methyl� group� from� S-adenosyl-L-methionine� to� adenine� or� cytosine� within� this� site� with�

formation� of� N6-methyladenine,� C5-methylcytosine� or� N4-methylcytosine

DNA� Ladders� -� double-strand� DNA� digests,� designed� to� be� used� as�molecular� weight� standards� for� both�

conventional� and� pulsed� field� gel� electrophoresis

DNAs� -� high� quality� plasmid� and� phage� DNA� preparations

Human� Genomic� DNA� -� DNA� preparations� from� human� cell� lines

dNTPs� -� enzymatically� synthesized�2`deoxynucleotide-5`triphosphates� for� PCR� and�other�molecular� biology�

techniques

10�X�SE-Buffers� -� color-coded�10�X� solutions� for�preparing� reaction�mixtures� to�ensure�optimal� enzymatic�

activity

Page 817: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

814� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name Silanes

Head� Office� Address Amores� 1304,� Col.� Del� Valle� México� D.� F.,� C.� P.� 03100

Facilities� City� &� Country Mexico

Web-site� Address www.silanes.com.mx

Contact

(Korean�

Business)

Name Lic.Gustavo� Gorvoz

E-mail [email protected]

Company� History

In� 1943,� the� world� was� going� through� the� devastations� of� the� Second� World� War� and� the� nascent�

pharmaceutical� industry� established� in� Mexico� was� in� crisis.� The� government,� with� the� goal� of� providing�

better� healthcare� services,� founded� that� year� the�Mexican� Social� Security� Institute� (IMSS)� and� managed� to�

decrease� the�mortality� rates.With� this� background,� a�man�with� vision,�Mr� Antonio� López� de� Silanes� Senior,�

a� Spanish� immigrant,� set� out,� on� 4th� November,� 1943,� a� pharmaceutical� laboratory� which� could� respond�

the� increasing� demands.

Since� the� beginning,� Silanes� Labs� experienced� an� accelerated� growth� through� the� sale� and�manufacture� of�

vitamins� and� painkiller� products.� It� was� in� 1959� when� the� first� combined� medicine� to� treat� diabetes� was�

launched,�being� the� oral� anti-diabetic�products�our�main�product� line�at�present.At� the� same� time,�Antonio�

Silanes� Senior� was� concerned� about� holding� a� close� relationship� with� the� health� authorities,� medical� and�

research� institutes� and� with� the� Medical� Corps,� a� tradition� that� continues� at� the� moment� and� which� has�

been� expanding� to� include� other� countries� and� continents.� � �

Planta� Silanes� Original�

On� the�death�of� its� founder� the� company�was� taken�over�by�his�wife�and�his� six� children�whom,�until� now,�

have� faithfully� preserved� his� legacy.� In� 1995,� Antonio� López� de� Silanes� Junior� assumed� the� control� of� the�

company� and� established� new� strategies.� The� anti-diabetics� line� was� promoted,� as� well� as� the� concept� of�

pharmaco-economy,� thinking�of� the�benefit�of�patients�with� chronic-degenerative� diseases.Thereafter,�more�

innovative�areas�were� inclued.�At� the�outset�of� the�21st� century,� Silanes�opened� its� industrial�plant� in�Toluca�

and� it� is�currently� involved� in�a�globalization,� innovation�and� institutionalization�process� in�order� to�continue�

growing� in� competitiveness� and� production.� �

107. Silanes

1.� Corporate� General� Information

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부록 2� �전략적 협력사 디렉토리 ❚ 815

Company� Description� &� Organization

Values

At�Silanes�we�are� convinced� that� the�observance�of�a�devoted�ethical� sense,� social� responsibility� and�respect�

for�human�dignity� are�our� foundations,�and�help�us�build� trust� among�our� interest�groups.�The�people�who�

work� at� Silanes� are� aware� that� we� faithfully� reflect� the� principles� and� rules� that� govern� us.

Our� source� of� inspiration� is� Health

We� know� that� the� Mission� of� � “Giving� the� world� healthcare� solutions”� � drives� us� � to� practice� the� finest�

balance� between� quality,� innovation� and� ethical� sense� in� pursuit� of� the� public� good.

Our� Vision� to� “Continuously� improve� our� innovation,� globalization� and� institutionalization� strategy”�

encourages�us� to�develop�better�products�and� services�every�day� in�benefit�of�health,� including�new�markets.

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816� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Collaboration�

Opportunities� for� R&D�

Co-works

Our� company� has� our� R&D� center� which� has� adequate� well-equipped� and�

modern� labs� (including� 1� Kilo� lab),� and� also� has� the� production� capability�

ranged� from�gram� to� kg� to�metric� ton� level.�Our�workshop�will� also�be� put� to�

use� in� the� next� year,� the� formulation� of� which� isdesigned� in� strict� compliance�

with� the� international� cGMP� standard.

Advanced� Reactions:� �

Alkylation

Chiral� Separation

Amination

Hlorination

Cycloaddion� (inc� Diels-Alder)

Formylation� (Vilsmerier� reation)

Heterocyclice� formation

Bromination

Carbonylation

Diazotization� (inc� Sandmeyer� reaction)

Hydrogenation

Mannich� reaction

Friedel� Crafts� acylation

Radical� reaction

Metal� hydride

Oxidation�

Stereoselective� synthesis

108. Sinolite Industrial Co., LTD

1.� Corporate� General� Information

Corporate� Name Sinolite� Industrial� Co.,� LTD

Web-site� Address www.china-sinolite.com

Contact

(Korean� Business)

Name Mr.� Michael� Zheng

Address19�Floor,�CIBC�Holley� International,�No.198,�Wuxing�Road,�Hangzhou,�

China,� 310020

Telephone 86-571-86772651

E-mail [email protected]

2.� Description� of� Collaboration�Opportunities

Page 820: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

부록 2� �전략적 협력사 디렉토리 ❚ 817

109. SINTEZ

1.� Corporate� General� Information

Corporate� Name SINTEZ

Head� Office� Address 640008,� Kurgan,� pr.� Konstitutsii,� 7

Web-site� Address http://kurgansintez.ru

Contact E-mail [email protected]

Company� Description� &� Organization

Kurgan� Joint-Stock�Company�«Sintez»� is�one�of� the� largest� enterprises�of�pharmaceutical� industry� in�Russia�

that� meets� modern� standards� of� quality.

The� company� has� produced� pharmaceuticals� since� 1958.� Founded� as� a� plant� for� production� of� substances�

for� pharmaceuticals� manufacture� by� other� plants,� today� JSC� «Sintez»� is� an� innovative� company� that�

operates� in�accordance�with� international� standards�of�pharmaceutical�production�and�manufactures�a�wide�

range� of� high� quality� products.� In� terms� of� the� production� volume� the� plant� is� in� the� top-10� leaders� of�

domestic� pharmaceutical� industry� providing� about� 3%� of� Russian� pharmaceutical� production.

� �

JSC� "Sintez"� is� a� unique� Russian� pharmaceutical� company� that� manufactures� and� substances� for� antibiotic�

production,� and� finished� dosage� forms,� and� articles� for� medical� use� as� well.

� �

Unlike� most� of� Russian� companies� «Sintez»� is� a� self-producer� of� substances� for� manufacture� of� drugs.�

More� than� 30%� of� all� production� the� plant� manufactures� from� its� own� substances,� including� natural� and�

semisynthetic� antibiotics.� The� range�of�output�product� is� represented�by�about�300� items�of�pharmaceuticals�

and� articles� for� medical� use.

Production� areas� of� a� plant� represent� a� modern� pharmaceutical� complex.� It� includes� workshops� on� drug�

production,� research� laboratories,� warehouses� with� finished� products,� auxiliary� facilities� ,� warehouses� with�

raw� materials,� quality� control� laboratories� of� raw� materials� and� finished� products.

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818� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Collaboration�

Opportunities� for� R&D�

Co-works

Somagenics’� Therapeutic� Program� is� based� on� a� proprietary� RNA� interference�

platform� that� can� address� a� wide� range� of� diseases,� including� hitherto�

“undruggable”� therapeutic� targets.� � This� platform,� called� synthetic� short� hairpin�

RNA� (sshRNA),� operates� through� a� mechanism� that� is� distinct� from� that� of� the�

conventional� siRNA� or� shRNA� molecules� that� are� being� developed� by� other�

companies.� � SomaGenics� has� received� legal� opinions� supporting� the� company's�

freedom� to� operate� in� the�RNAi� space.� �We�have� established� a� partnership�with�

a� leading� delivery� company� whose� formulations� can� successfully� deliver� sshRNA�

molecules� into� liver�and�whose� formulated�siRNAs� in�are� currently� in� clinical� trials.�

Our� current� focus� is� on� liver� indications� such� as� hepatitis� C� and� hepatitis� B� viral�

infections� (HCV� &� HBV),� and� hepatocellular� carcinoma� (HCC).� � In� its’� lead�

therapeutic� program,� Somagenics� has� developed� two� highly� potent� sshRNA�

therapeutic� candidates� (SG220� and� SG237)� to� inhibit� HCV� replication.� This�

program� has� achieved� several� important� milestones:

•Enhancement� of� pharmacokinetics� properties� by� improving� serum� stability.

•Elimination� of� immunostimulatory� properties.

•Establishment� of� a� key� partnership� for� formulating� sshRNA� drugs� for� effective�

liver� delivery.

•Demonstration�of� in�vivo�efficacy� in� two�relevant�animal�models,� including�one�

that� supports� HCV� replication� in� human� liver

•Identification� of� partners� for� contract� manufacturing� and� IND-enabling�

toxicology� studies� of� SG220/237.�

Currently,� SomaGenics� is� looking� for� a� pharmaceutical� partner� to� help� advance�

110. SomaGenics, Inc.

1.� Corporate� General� Information

Corporate� Name SomaGenics,� Inc.

Web-site� Address www.somagenics.com

Contact

(Korean� Business)

Name Dr.� Sumedha� Jayasena

Address 2161� Delaware� Avenue,� Santa� Cruz,� CA� 95060

Telephone 831-426-7700� Ext.� 20

E-mail [email protected]

2.� Description� of� Collaboration�Opportunities

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부록 2� �전략적 협력사 디렉토리 ❚ 819

the� HCV� program� into� human� trials.� � This� will� include� the� completion� of�

IND-enabling� toxicology� studies� and� all� clinical� studies.

Collaboration�

Opportunities� for�

Out-Licensing

※SomaGenics’� diagnostic� program� is� focused� on� a� proprietary� platform� (miR-ID)�

directed� towards� the� quantitative� detection� of� microRNAs� (miRNAs).� MiRNAs�

represent� an� emerging� class� of� biomarkers� with� potential� applications� in� major�

therapeutic� areas,� including� cancer,� cardiovascular,� immunology,� and� metabolic�

and� neurological� disorders.� Among� other� characteristics,� the� stability� of�miRNAs�

and� their� presence� in� virtually� all� biological� fluids� as� well� as� archived� tissue�

samples� make� miRNAs� attractive� as� diagnostic� biomarkers.� SomaGenics� has�

positioned� itself� to� provide� the� best� solutions� for� miRNA� detection� because� it�

believes� miRNA� biomarkers� will� play� in� the� emerging� era� of� more� accurate�

diagnoses�and�more� targeted� therapies.�Although�at�present,�microarrays�are� the�

most� frequently� used� technique� for� miRNA� expression� profiling,� RT-PCR-based�

methods� can� provide� greater� sensitivity� and� dynamic� range,� allowing� the� use� of�

very�small�biopsy�samples�and� the�analysis�of� small� subsets�of� cells�or�even�single�

cells.�However,�currently�available�RT-PCR-based�methods�of�miRNA�detection�are�

expensive� and� biased� toward� certain� sequences.� The� small� size� of� miRNAs�

precludes� the� use� of� conventional� RT-PCR� techniques.� Moreover,� miRNA�

sequences�differ� significantly� in�GC-content,�both�among�different�miRNA�species�

and� between� the� 5'� and� 3'� halves� of� individual� miRNAs.� As� a� result,� primers�

binding� to� different� miRNAs� are� not� equally� efficient� under� given� conditions,�

compromising� both� the� sequence-specificity� and� efficiency� of� amplification.� The�

sensitivity�and� specificity�of�miR-ID-based�assays�are�equal� to� those�of� the�current�

“gold� Sstandard”� of� miRNA� detection,� the� TaqMan� miRNA� assay.� � SomaGenics�

has�also�developed�an� isothermal�version�of�miR-ID,� referred� to�as�miRSA.�miRSA�

technology� eliminates� the� requirement� for� cumbersome� equipment� for�

temperature� cycling� that� limits� wide� adaptation� of� the� PCR-based� assays�

especially� for� use� in� point-of-care� diagnostic� applications.� The� sensitivity� and�

specificity�of�miRSA-based�miRNA�detection�assays�are�similar� to� those�of�miR-ID.�

SomaGenics� is� currently� seeking� a� partner� to� either� co-develop� or� � license� the�

miR-ID� technology.

3.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

SomaGenics� is� also� developing� sshRNA-based� anti-HBV� and� anti-HCC� drugs.� � The� company� is� seeking�

partners� to� co-develop� these� early-stage� programs.

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820� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name STADA� CIS

Web-site� Address http://stada.ru

Contact E-mail [email protected]

Company� History

STADA�Group� started� its�activity� in�Russia� in�2001.�One� year� later� in�an�effort� to�make� its�products�available�

for� the� majority� of� Russians� STADA� Group� opened� its� representative� office� in� Moscow.� In� 2005� STADA�

Management� Board� resolved� to� acquire� assets� in� Russia� having� effected� a� transaction� on� purchase� of� one�

of� the� largest� Russian� pharmaceutical� companies� -�NIZHPHARM.� Two� years� later�NIZHPHARM� took� the� lead�

in� transacting� a� deal� on� acquisition� of� the� pharmaceutical� holding� company� MAKIZ-PHARMA� by� STADA�

Group.� In� October� 2008� as� a� result� of� completion� of� business� combination� of� NIZHPHARM� and�

MAKIZ-PHARMA� the� setting-up� of� STADA� CIS� holding� company� was� announced.

Principal� stages� of� development

2009

∙ Start� of� operating� of� STADA� CIS� representative� offices� in� Azerbaijan� (Baku)� and� Armenia� (Erevan)∙ The� large-scale� project� on� process-oriented� SAP� ERP� system� implementation� was� successfully� terminated�in� NIZHPHARM

2008

∙ Foundation� of� STADA� Marketing� and� STADA� PharmDevelopment∙ NIZHPHARM� and� MAKIZ-PHARMA� announced� the� foundation� of� the� first� Russian� STADA� CIS� holding�

company� as� a� part� of� STADA� international� pharmaceutical� group� of� companies.

∙ Integration� of� NIZHPHARM� and� MAKIZ-PHARMA2007

∙ On� the� initiative� of� NIZHPHARM� the� deal� on� acquisition� of� the� company� «MAKIZ-Pharma»� by� STADA�Group� was� made

∙ NIZHPHARM� received� positive� conclusion� of� the� German� certification� bodies� on� conformity� of� the�production� and� quality� management� system� with� the� GMP� ЕС� requirements.� NIZHPHARM� became� the�

first� Russian� pharmaceutical� company�which� received� the�GMP� EC� certificate� of� this� level� and� possibility�

to� produce� goods� for� the� countries� of� European� Community.

∙ SKOPINPHARM�received�positive� conclusion�of� the�WHO�on�conformity�of� the�quality�management�system �

111. STADA CIS

1.� Corporate� General� Information

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부록 2� �전략적 협력사 디렉토리 ❚ 821

with� the� GMP� WHO� requirements

2006

∙ Establishing� of� NIZHPHARM� representative� office� in� Uzbekistan� (Tashkent)2005

∙ Foundation� of� the� subsidiary� «STADA-NIZHPHARM-� Baltics»� in� Lithuania� (Vilnyus)∙ NIZHPHARM� integration� into� the� STADA� structure� in� CIS� countries� and� in� the� Baltics∙ NIZHPHARM� became� part� of� the� International� Group� of� companies� STADA� (Germany)∙ Business� combination� of� SKOPINPHARM� and� MAKIZ-PHARMA2004

∙ Signing�of� the� final� agreement�on� sell� of� the� controlling� interest� in�NIZHPHARM�to� the�Group�of� companies�STADA

∙ Establishing� of� NIZHPHARM� representative� office� in� Kazakhstan� (Almaty)� and� Latvia� (Riga)2002

∙ Establishing� of� NIZHPHARM� representative� office� in� the� Ukraine� (Kyiv)∙ MAKIZ-PHARMA� obtained� the� license� for� medicine� production2001

∙ Termination� of� the� MAKIZ-PHARMA� production� construction2000

∙ Reconstruction� of� the� main� NIZHPHARM� manufacturing� areas� in� conformity� with� the� GMP� standards∙ Development� of� project� on� MAKIZ-PHARMA� production� construction� in� conformity� with� the� GMP�standards

1990-ies� Creation� of� the� modern� high-technology� production

∙ 1998�­� Signing�of� the� Investment�agreement�with� the�European�Bank� for�Reconstruction�and�Development∙ Assimilation� of� capital� investments:� complete� reconstruction� of� the� plant,� equipment� replacement� and�launch�of� new�producing�operations� in� conformity�with� the� international� standards�GMP�and� ISO�9000,�

adoption� of� new�modern� technologies� and� significant� expansion� of� volume� and� range� of� the� released�

products

∙ Launch� of� new� tablet� production∙ Foundation� of� the� closed� joint-stock� company� «Skopinskiy� pharmaceutical� plant»∙ 1996� ­� Start� of�works� on� arrangement� of� conditions� for�medicaments� production� in� conformity�with� the�European� GMP� quality� standards.� Construction� of� the� first� «clean»� premise.

∙ 1994� ­� Privatization� and� transformation� into� a� joint-stock� company� of� NIZHPHARM∙ 1990� ­� Commissioning� of� three� complexes� of� the� plant� at� the� address� 7,� Salganskaya� str.,� developing�

capacities� on� release� of� 132,15� mln.� packages� a� year�

70-80-ies� Technical� upgrading� of� the� plant� primary� production

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822� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

∙ 1981� ­� 1989� ­� Delivery� of� medicaments� in� almost� every� CEMA� country� as� well� as� in� many� African� and�Asian� countries

∙ 1979� ­� The� company� became� the� leading� Russian� enterprise� releasing� soft� medicaments:� ointments,�liniments,� suppositories,� gelatin� capsules

∙ 1971� ­� Reorganization� of� the� testing� laboratory� of� the� plant� into� the� base� applied� research� laboratory∙ 1970� ­� Building� of� the� new� finished-products� storage� area60-� ies� Automation� of� basic� processes,� improvement� in� the� quality� of� NIZHPHARM� production

∙ 1965� ­Elaborating� of� the� overall� plan� on� bringing� the� quality� of� released� products� into� compliance�with�world� standards

∙ 1964� ­�Opening�of� the�biochemical� laboratory�as�a�part�of� the� testing� laboratory.�Cooperation�with� foreign�partners­� Polish� plant� «Polpha»� and� Poznan� chemical� pharmaceutical� plant

40� -� 50-� ies� Modernization� of� NIZHPHARM� production

∙ 1956� ­� opening� of� the� testing� laboratory� with� the� construction� group∙ Work� on� selection� of� new� bases� and� reactors� to� extend� medicaments� expiration� date∙ Start� to� export� soft� medicaments� to� Mongolia,� North� Korea,� Albania,� Iraq∙ 1955� ­� Organization� of� soft� and� solid� capsules� production� plant∙ 1954� ­� Opening� of� a� separate� printing� cardboard� plant∙ 1950� -� Modernization� of� production,� furnishing� with� modern� domestic� and� imported� equipment.�

Switching� over� to� production� of� soft� and� solid� gelatin� capsules,� cachets� and� suppositories

∙ 1945� ­� Opening� of� the� testing� laboratory.� Reorientation� to� pharmaceutical� production.� Launching� the�production� of� dust� materials� and� release� of� denture-base� materials

∙ 1941-1944� ­Release� of� medicine� bags� and� first-aid� kits� for� wounded� soldiers20-30-� ies� Formating� of� NIZHPHARM

∙ 1934� ­� Reorientaion� of� the� chemical� plant� to� production� of� toiletries∙ Presenting� the� chemical� plant�with� the� red� challenge� banner� of� the�medical� pharmaceutical� industry� and�the� Central� Committee� of� the� Trade� Union� of� the� dyed� pharmaceutical� industry

∙ 1936� ­� The� production� of� suppositories� and� ointments� began1919

∙ Foundation�of� the�Chemical� pharmaceutical� plant�№10�based�on� the� chemical� pharmaceutical� laboratory.�∙ Start� of� the� production� of� galenicals� of� plant� raw� and� raw� animal� materials

Company� Description� &� Organization

∙ STADA� CIS� is� a� Russian� holding� company� forming� a� part� of� STADA� Arzneimittel� AG� international� group�that�amalgamated� two� leading�companies�of�domestic�pharmaceutical�market,�namely�NIZHPHARM�and�

MAKIZ-PHARMA.�

∙ STADA�CIS� holding� activities� are� aimed� at� ultimate� revelation� and� satisfaction� of� needs� related� to� gain� in�health� of� the� customers� who� prefer� modern� and� efficient� medications.�

∙ STADA� CIS� holding� company� features� a� diversified� organization� structure� that� embraces� pharmaceutical�

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부록 2� �전략적 협력사 디렉토리 ❚ 823

companies�which� activities� are� associated�with� three� principal� directions:� development,� production� and�

promotion� of� pharmaceutical� products.�

STADA� PharmDevelopment,� R&D� is� a� STADA� CIS� holding� subdivision� that� on� the� basis� of� its� research�

laboratories� works� on� high-technology� medications� development,� commissioning� and� introduction� to� the�

market� being� an� active� participant� of� a� program� intended� for� imported� drugs� replacement� by� high-quality�

domestic� analogs.� In� addition� to� development� of� generic� medications� specialists� of� this� holding� company�

together�with� the� leading� research-and-development� centers� of� Russia� and�CIS� countries� are� occupied�with�

clinical� trials� and� innovative� medicinal� products� development� in� the� most� important� therapeutic� areas� of�

medicine.

Production� facilities� of� NIZHPHARM� (Nizhny� Novgorod),� MAKIZ-PHARMA� (Moscow� city),� SCOPINPHARM �

(Ryazan� region)� with� the� total� production� capacity� of:�

∙ Suppositories:� 360,� 000,� 000� pieces�∙ Ointments,� creams,� gels:� 81,� 120,� 000� pieces�∙ Tablets:� 1� 831,� 900,� 000� pieces�∙ Capsules:� 208,� 100,� 000� pieces�∙ Solutions:� 2,� 160,� 000� pieces�One� of� the� best� quality� management� systems� adopted� in� the� leading� Russian� manufacturers� has� been�

created�and�now� is� successfully� employed�by�manufacturing� companies�of�STADA�CIS�holding.�All�production�

sites� of� the� holding� comply� with� the� GMP� international� standards.� Quality� and� environment� management�

system� is� certified� in� accordance� with� ISO� 9001:2008� and� ISO� 14001:2004� international� standards.

STADA�Marketing,� STADA� Ukraine,� STADA� Central� Asia,� STADA� Azerbaidjan� and� STADA� Armenia� are� the�

companies� responsible� for�marketing�policy� implementation� for� the�purpose�of� the�most�perspective�products�

supporting� within� STADA� CIS’s� key� markets� of� Russia,� Ukraine,� Central� Asia� (Kazakhstan,� Tajikistan,�

Kyrgyzstan,� Uzbekistan)� and� Transcaucasia� countries� (Armenia,� Azerbaijan).

Currently� the� product� portfolio� of� STADA� CIS� holding� company� includes� more� than� 100� medications� of�

various� АТС-classes� and� pharmaceutical� forms.�While� elaborating� the� portfolio� STADA� CIS� places� a� priority�

on� pharmaceuticals� used� in� gastroenterology,� neurology,� gynecology,� cardiology,� urology� as� well� as� those�

administrated� while� musculoskeletal� system� disorders� and� antiviral� medications.

Following� the� policy� of� focusing� on� development� of� modern� drugs� with� unique� properties� needed� in� the�

most� important� and� worthwhile� medicine� areas� and� continuously� investing� in� the� quality� management�

system� and� production� technologies� enhancement,� STADA� CIS� holding� company� seeks� to� achieve� the�

first-priority� strategic� goal,� namely� provision� of� customers� with� high-quality� and� efficient� pharmaceutical�

products� at� acceptable� prices.

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824� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name STENDHAL

Head� Office� Address

Av.� Camino� a� Santa� Teresa� 1040,� Mezzanine� 1

Col.� Jardines� en� la� Montaña,� Delegación� Tlalpan

C.P.� 14210,� México.� D.F.

Facilities� City� &� Country Mexico

Web-site� Address www.stendhal.com.mx

Contact

(Korean� Business)

Name Gerardo� Bachtold� Sotelo

E-mail [email protected]

Company� History

1997:� A� group� of� investors� with� experience� in� the� pharmaceutical� sector� and� a� vision� of� commercializing�

innovative� medicines� and� developing� a� socially� responsible� company� acquired� Stendhal,� a� pharmaceutical�

company� founded� in� Mexico� in� 1974.� Thus,� they� engineered� a� comprehensive� transformation,� with� new�

philosophical� and� business� processes� that� reshaped� the� company.

2003:�We� invested� a� large� amount� of� resources� in� remodeling� our� production� plant,� reaching� the� highest�

world-class� standards� in� good� manufacturing� practices,� conditioning,� storage,� distribution� and� product�

control.� That� same� year,� through� a� strategic� alliance,� we� launched� the� first� product� line� that� would� later�

become� the� backbone� of� treatment� for� patients� with� HIV/AIDS.

2008:� We� entered� the� Neuroscience� area� launching� the� first� monoclonal� antibody� treatment� for� Multiple�

Sclerosis.

2009:�We�merged�with�Pharma�Eicopen�Latinoamérica,�with�whom�we� share�vision�and�values� to�bring�our�

products� to� Central� America� and� the� Andean� countries.� That� is� how� Stendhal� has� grown� into,� a� regional�

leader� in� the� therapeutic� areas� of� HIV� and� Multiple� Sclerosis.

2010� ­�2011:�We�have�become� indisputable� leaders� in�HIV�and�Multiple�Sclerosis� treatment� in�our� territory.�

We� have� also� added� innovative� treatments� in� the� areas� of� critical� care,� and� genetic� diseases� and� disorders.�

Additionally,� we� have� invested� in� the� development� of� new� molecules� for� the� cardiovascular� area.

112. STENDHAL

1.� Corporate� General� Information

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부록 2� �전략적 협력사 디렉토리 ❚ 825

Company� Description� &� Organization

Mission

To� be� a� pharmaceutical� company� offering� the� best� products� for� health� care,� while� ensuring� excellence� in�

research,� development,� production,� and� marketing.

To� be� recognized� by� our� partners,� customers,� competitors,� and� the� general� public� as� a� good� corporate�

citizen� working� with� the� highest� ethical� standards.

To� be� the� best� business� partner,� thanks� to� the� achievement� of� our� objectives� by� implementing� innovative�

and� effective� business� strategies.

To� provide� an� environment� and� opportunities� to� enable� optimal� development� among� our� collaborators� by�

establishing� mutual� commitment� towards� achieving� our� goals.

Vision

To� be� a� world-class� pharmaceutical� laboratory� with� presence� in� Latin� America,� participating� directly� and�

through�partnerships� in� researching�and�developing�products� that�will� provide�quality� health� solutions;�with�

sustained� growth� above� market� average� in� order� to� maintain� leadership� in� all� therapeutic� areas� we�

participate� in,� and� recognition� as� the� best� place� to� work� and� invest.

Values

Integrity:� We� work� with� honesty,� respect� and� responsibility.

Passion� for� excellence:� Our� pursuit,� dedication� and� commitment� to� perfection� are� key� factors� in� what� we�

do.

Open� communication:�We� know� that� the� timely� exchange�of� critical� and� transparent� information� and� ideas�

allow� us� to� meet,� share,� and� grow� together.

Everything� is� possible:� We� think� that� every� dream� can� come� true� and� every� obstacle� can� be� overcome.� If�

we� do� not� find� a� path,� we� will� create� one.

Human� Sense:� People� are� our� reason� for� being.� That� is� why� we� are� a� company� with� sensitivity,� tolerance,�

respect,� and� solidarity.

Sense� of� Urgency:�We�have� great� professional� commitment� that� allows� us� to� address� the� tasks� quickly� and�

on� time.� We� are� always� alert� in� order� to� act� at� the� right� time� and� make� things� happen.

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826� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name TATCHEPHARMPREPARATY

Head� Office� Address http://www.tatpharm.ru/

Contact E-mail [email protected]

Company� History

The� history� of� JSC� "Tatchempharmpreparaty"� originates� from� a� small� company� founded� in� the� end� of� 19th�

century� by� Ferdinand� Grahe.�

1930

� Surgical� suture� (catgut)� factory� was� built� in� Kazan.� �

1931

Chemical-pharmaceutical� plant� was� established.

1941

Special�chemical�workshop�was�built� to�produce�essential�medicines�based�on�urotropine,� crystalline� calcium �

chloride,� barium� sulphate,� sodium� citrate,� etc.� The� product� range� was� expanded� and� new� technological�

processes� were� introduced.

Improvement� of� tabletting� machines� lead� to� increase� in� production� capacity� by� at� least� 30%.� Barium �

sulphate� and� chloroform� production� lines� were� set� up.� Introduction� of� bandage� rolling� machines� allowed�

doubling� the� amount� of� manufactured� bandages.

First�battle� front�brigades�were�assembled�by� the�workers�of� the� factory.� Special� experimental� laboratory�was�

established.�The�production�of� ligatures,�bandages,�ointments,� and�desinfectants�was� increased� to�meet� the�

demands� of� the� Red� Army.�

1944

A� new� technology� was� developed� for� production� of� new�medicines� Adonylene,� Adonizide� and� herb-based�

cardiovascular� remedies.

1946

A� large� group� of� workers� was� honoured� with� the� medal� "For� valorous� labour� during� World� War� II".

113. TATCHEPHARMPREPARATY

1.� Corporate� General� Information

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부록 2� �전략적 협력사 디렉토리 ❚ 827

1947

� The� first� batch� of� Synestrol� obtained.� New� technology� introduced� for� production� of� liquid� remedies� from�

medicinal� herbs� such� as� thermopsis� and� others.� New� method� implemented� for� preparation� of� exracts� of�

spring� adonis.

1948

� The� first� production� line� installed� in� the� workshop� of� prepared� medications.

The� postwar� restructuring� of� the� production� facilities� was� conducted.� The� factory� began� to� specialize� in�

production� of� prepared� medications,� packed� and� ready� for� prescription.

In� order� to� increase� the� overall� production� volume� and� quality� of� the� outputs� the� factory� had� to� abandon�

the� manufacturing� of� bandages,� dental� cement� and� some� other� products.�

1950

Reconstruction�of�workshops�and� factory� sectors� carried�out.�A�number�of� technological�processes�upgraded.

1951

� New�workshop� established� for�manufacturing�of� products� to�meet� demands� of�miners� and� chemists.�New�

tehcnology� was� developed� to� produce� Burov's� fluid.

1952

� A� group� of� workers� was� awarded�with� the�medals� and� orders� of� the� Soviet� Union� for� long-standing� and�

distinguished� performance.� Production� for� export� began.

1954

� 32� workers� were� awarded� with� medals� and� order� of� the� Soviet� Union.

1955

� Production� of� 12� new� medicines� started.

1958

� Substantial� reconstruction� of� the� factory� began.� First� batch� (50.000� vials)� of� new� anti-glaucomatous�

medication� Phosarbine� (Pyrophos).� Production� of� new� antibiotics� and� chemical-therapeutic� agents� started.�

New� research� laboratories�and�construction�bureau� launched.� Introduction�of�new�equipment�and�advanced�

technology�conducted� for�mechanization�of� labour-intensive� tasks.�100.000�packs�of�new�preparation�of�eye�

drops� Armine� produced.

1960

� Production� of� Pas-Sodium,� Phosphakol� eye� drops� and� extract� of� birch� fungi.

1961

� The� first� batch� of� Allokhol� produced.� Introduction� of� continuous� process� of� plant� extracts� evaporation.�

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828� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Vacuum-evaporating� apparatus� of� continuous� action� mounted.

1962

� Construction� of� the� new� plant� started.

1964

� Quality� committee� established.� Shipment� of� the� products� for� export� tripled.

1966

� Relocation� of� the� factory� to� a� new� site.� Manufacturing� of� 12� new� medicines� launched.�

1967

� Biological� laboratory� established.�

1968

Introduction� of� manufacturing� facilities� with� productive� capacity� of� 223� million� packages� of� prepared�

medications� per� year.

1969

Production� of� 9� new� medicines� commenced� -� Euphilline,� Etoxide� and� others.

1971

Shipping� of� the� products� to� Britain,� Iran,� Pakistan,� Iraq� and� all� Socialistic� countries.

1973

� The� factory� was� honoured� with� the� title� "Factory� of� the� highest� production� standards".�

1976

� Based� on� the� chemical-pharmaceutical� and� surgical� sutures� plants� the� consolidated�pharmaceutical� factory�

"Tatchempharmpreparaty"� was� founded.

1978

� New� plant� for� surgical� suture� materials� launched.

1979

� New� site� for� production� of� antibiotics� and� oculentum� opened.

2008

� Launching� of� new� manufacturing� facility� for� tablet� production� in� compliance� with� international� GMP�

standards.

At� present� Joint� Stock� Company� "Tatchempharmpreparaty"� consolidates� state-of-the-art�

chemical-pharmaceutical� and� surgical� suture� plants.

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부록 2� �전략적 협력사 디렉토리 ❚ 829

Our� company�possesses�high� technological� capabilities� and�manufacturing� capacities� allowing�production�of�

more� than�100� items�of�prepared�medications� in� the� form�of� tablets,�ointments,� solutions,�pastes,� tinctures.�

We�produce�medicines�of�30�pharmacological�groups� including�Analgesics,�Antiseptics,�Cardiovascular�drugs,�

Neuroleptics,� Ophtalmological� and� Anticancer� treatments,� Sedatives,� Surgical� Sutures� and� others.

JSC� "Tatchempharmpreparaty"� is� the� only� producer� of� catgut� suture� in� Russian� Federation.� We� export� our�

products� to� Belarus,� Turkmenistan,� Uzbekistan,�Georgia,� Kazakhstan,� Latvia,� Ukraine,� Tajikistan,� Kyrgyzstan.

Company� Description� &� Organization

For� 80� years� Joint� Stock� Company� “Tatchempharmpreparaty”� has� been� responsibly� manufacturing� and�

distributing� pharmaceutical� products� and� surgical� sutures� in� Soviet� Union� and� Russian� Federation.

The�history� of� our� company� originates� from�a� small� firm� founded� at� the� end� of� 19th� century� by� Ferdinand�

Grahe.

In� the� beginning� the� firm� produced� mineral� waters,� lemonades� and� ciders.� Later� on� the� the� range� of�

products� was� extended� and� production� of� medicines� started.

The� catgut� sutures� plant� was� constructed� in� 1930.� Later� chemical-pharmaceutical� factory� was� launched� in�

1931.�

At� present� JSC� “Tatchempharmpreparaty”� consolidates� two� state-of-the-art� plants:� chemical-pharmaceutical�

and� surgical� sutures.

The� company� has� powerful� technological� capabilities,� which� allow� production� of� more� than� 100� items� of�

medications� of� 30� pharmaco-therapeutic� groups.

JSC� “Tatchempharmpreparaty”� is� the� only� producer� of� catgut� sutures� in� Russian� Federation.�We� export� our�

products� to� all� of� the� CIS� countries� (Armenia,� Azerbaijan,� Belarus,� Kazakhstan,� Kyrgyzstan,� Moldova,�

Tajikistan,� Turkmenistan,� Ukraine,� Uzbekistan)� and� Latvia.

Our� research� laboratories�keep�the� range�of� the�products�expanding�by�developing�new�types�of�medications�

and�surgical� sutures.�We�keep�constantly� improving�our�manufacturing�and�packaging� facilities�with�modern�

equipment.�

Our�ongoing�collaboration�with� research� institutes�and�universities� in�Russian�Federation�constitute� the�basis�

of� our� success� as� a� highly� innovative� company.� During� the� period� between� 1993� and� 2000� we� launched�

the� production� of� 56� new� medicines,� including� following:

-� Befungin™� -� natural� drug� based� on� the� birch� fungus� used� as� restorative� remedy� to� treat� gastrointestinal�

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830� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

disorders� and� cancer

-� Cofetamine™� -� migraine� treatment

-� Mebikar™� -� day-time� sedative

-� Glycifone™� -� anticancer� treatment

-� Dimephosphone™� -� regulator� of� metabolism

-� Microiodide™� -� prevention� of� iodine-deficiency

-� Taspir™� -� sparkling� tablets� of� acetylsalicylic� acid

-� Xymedone™� -� � anti-burn� remedy� of� immune� action

-� and� others

JSC� "Tatchempharmpreparaty"� was� awarded� a� prize� for� the� highest� quality� manufacturing.� Recently� we�

expanded�our� collection� of� national� and� international� awardswith� “Golden� award� for� the� best� trade�name”,�

“Golden� arch� of� Europe”,� “Diamond� star� of� the� international� manufacturer’s� association”.

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부록 2� �전략적 협력사 디렉토리 ❚ 831

114. THERAMYT NOVOBIOLOGICS PRIVATE LIMITED

1.� Corporate� General� Information

Corporate� Name THERAMYT� NOVOBIOLOGICS� PRIVATE� LIMITED

Web-site� Address WWW.THERAMYT.COM

Contact

(Korean� Business)

Name SOHANG� CHATTERJEE

Address118/119,�PRASAD�ENCLAVE,�5TH�MAIN,� INDUSTRIAL�SUBURB�PHASE�

II,� YESHWANTPUR,� BANGALORE� 560022,� KARNATAKA,� INDIA

Telephone +91-80-30034600

E-mail [email protected]

2.� Description� of� Collaboration�Opportunities

Collaboration�

Opportunities� for� R&D�

Co-works

i)� Looking� for� partner� to� collaborate� in� development� of� new� mAbs� against�

known� and/or� new� targets� using� our� proprietary� Yeast� Display� Library.�

ii)� Looking� for� Partner� to� collaborate� in� formulation� development� of� peptides�

addressing� half-life� and� delivery� systems.

Collaboration�

Opportunities� for�

Out-Licensing

i)� Looking� for� marketing� partners� for� biosimilars� that� are� ready� for� Phase� III�

Clinical� trials.�

ii)� Looking� for� product� development� companies� interested� in� developing�mAbs�

in� our� proprietary� high� expression� Fucose� Knock-out� (FKO)� cell� line.�

iii)� Looking� for�Discovery�and�Drug�development�company� to� license�our�Fucose�

Knock-out� cell� line�

iv)� Looking� for� partner� to� collaborate� in� development� of� new� mAbs� against�

known� and/or� new� targets� using� our� proprietary� Yeast� Display� Library.�

v)�We� have� already� filed� 5� provisional� patents� on� one� Biobetter,� FKO� cell� line�

and� Yeast� Display� Library.

Collaboration�

Opportunities� for� (Co-)�

Marketing� &� Sales

Looking� for� marketing� partners� for� biosimilars� that� are� ready� for� Phase� III�

Clinical� trials.

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832� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

115. Tuteur S.A.C.I.F.I.A

1.� Corporate� General� Information

Corporate� Name Tuteur� S.A.C.I.F.I.A

Head� Office� Address Encarnación� Ezcurra� 365� 3º� C1107CLA� -� Capital� Federal

Facilities� City� &� Country Argentina

Web-site� Address www.tuteur.com.ar

Contact

(Korean� Business)E-mail [email protected]

Company� Description� &� Organization

TUTEUR� Argentina� is� a� company� with� 40� years� of� experience� in� the� pharmaceutical� industry.

We� focus� on� the� development,� manufacture� and� commercialization� of� pharmaceutical� products,� and�

specialize� in� the� sectors� of� oncology,� hematology,� central� nervous� system� and� orphan� diseases.

Our� products� are� commercialized� in� the� domestic�market� through� a�wide� distribution�network.� �And� also�

in� several� Latin� American� countries� and� worldwide.

In� order� to� provide� for� better� service,� technology,� quality� and� research� in� the� service� of� the� health,� our�

Company�pays� special� attention� to� the� quality�of� raw�materials� and� the� compliance�with� strict� procedural�

regulations.

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부록 2� �전략적 협력사 디렉토리 ❚ 833

116. UNIPHARM

1.� Corporate� General� Information

Corporate� Name grupounipharm

Head� Office� AddressArquímedes�No.�212�Piso�6�Col.�Chapultepec�Morales�Polanco�Delegación�

Miguel� Hidalgo� México,� D.F.11570

Facilities� City� &� Country Mexico

Web-site� Address www.grupounipharm.com

Company� History

We� are� a� multinational� pharmaceutical� laboratory� based� in� Europe� and� focused� on� Latin� America� that� for�

more� than� 48� years� has� offered� quality� products� to� different� segments� of� society.�

·� The� commercialization� of� our� products� started� in� Guatemala� in� 1963,� with� imports� from� Europe.

·� In� 1976,� the� manufacturing� in� Guatemala� started� in� our� facilities� located� in� zone� 1.

·� In� 1981� we� moved� to� our� current� facilities� (Km.� 18� Carretera� al� Pacífico,� Villa� Nueva).

·� In� 1981,� the� expansion� to� Central� America� started.� Honduras� and� El� Salvador� were� the� first� branches.

·� In� 1987� negotiations� with� Nicaragua� started� and� we� established� our� offices� there� in� 1991.

·� Since�1991,�Unipharm’s�growth�and�expansion�has� risen� thanks� to�our�quality�products�and� the�acceptance�

of� the�Medical� and� Pharmaceutical� Profession.� The� expansion� and� acceptance� took� the� Unipharm�Group�

to� commercialize� its�products� in�European�and�South�American� countries,� the�Caribbean,�Egypt�and�other�

African� countries.

·� In� 1994� the� Representation� and� Inventory� Offices� in� Costa� Rica� and� Panama� started� operations.

·� In� 1995,� we� started� operations� in� Mexico� and� in� 1997� we� started� operations� in� our� plant� in� Veracruz.

·� Negotiations� with� Colombia� started� in� 2001.

Company� Description� &� Organization

Mission

We�are�a�multinational� company�based� in�Europe� and�with� a� Latin�America� n� focus� that� offers� the�medical�

profession� and� the� different� segments� of� society,� high� quality� and� innovative� pharmaceutical� and� related�

products;� manufactured� with� cutting� edge� technology,� committed� to� be� the� best� alternative� in� health,�

well-being� and� locations� in� the� countries� were� Unipharm� has� presence.

Vision

In� December� 2016,�we�will� continue� to� lead� Central� America,� venturing� in� the� Caribbean�market� and�with�

growth,� and� substantial� and� sustainabe� profitability� in� Latin� America.

We�will� have� a� presence� and� growth� in� Europe,� Asia� and�Africa,� through� innovative� products� and� creating�

Added� value� for� clients� with� efficiency� in� everything� we� do.

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834� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

117. Unitedmedical

1.� Corporate� General� Information

Corporate� Name Unitedmedical

Head� Office� AddressAv.� dos� Imarés,� 401

Moema� -� 04085-000� -� São� Paulo� -� SP� -� Brasil

Facilities� City� &� Country Brazil

Web-site� Address www.unitedmedical.com.br

Company� Description� &� Organization

United�Medical� represents,� with� exclusivity� in� Brazil,� a� range� of� innovative� and� high� technology� products�

licensed�by�global�R&D� leader� laboratories.� These�drugs�are� vital� for�patients�with� severe�diseases� like�HIV�

infection,� cystic� fibrosis,� cancer� and� systemic� fungal� infection.

Mission

United� Medical� continuously� finds� and� offers� to� physicians� and� hospitals� of� Latin� America� a� range� of�

innovative� drugs,� produced� around� the� world,� designed� for� the� specialized� treatment� of� patients� with�

severe� diseases.

Vision

Building� partnerships,� building� brands

We�want� to� be� the� best� option� for� selling� innovative� products,� because�we� have� expertise,� commitment�

and� full� dedication� to� build� brands� of� high� technology� drugs,� in� hospitals� of� Brazil� and� Latin� America.

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부록 2� �전략적 협력사 디렉토리 ❚ 835

118. Valeant Pharmaceuticals International Inc

1.� Corporate� General� Information

Corporate� Name Valeant� Pharmaceuticals� International� Inc

Web-site� Address www.valeant.com

Contact

(Korean� Business)

Name Alex� Oh

Address 700� Route� 202/206� North,� Bridgewater,� New� Jersey� 08807� USA

Telephone 908-927-1759

E-mail [email protected]

2.� Description� of� Collaboration�Opportunities

Collaboration�

Opportunities� for� R&D�

Co-works

There�might�be�a� limited�opportunities� for� R&D,� since� the� company� only� focuses�

on� speciality� pharmaceuticals

Collaboration�

Opportunities� for�

In-Licensing

There�may�be� some�opportunities� for� in-licensing�on�brand�generics,�dermatology�

and� neurology� products

Collaboration�

Opportunities� for�

Out-Licensing

There� may� be� some� opportunities� for� out-licensing� on� dermatology� and�

neurology� products

Collaboration�

Opportunities� for�

Manufacturing

There�may�be� some�opportunities� for� in-licensing�on�brand�generics,�dermatology�

and� neurology� products

Collaboration�

Opportunities� for� (Co-)�

Marketing� &� Sales

There� might� be� a� limited� opportunities� for� co-marketing&Sales,� since� the�

company� only� focuses� on� dermatology� pharmaceuticals

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836� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Collaboration�

Opportunities� for� R&D�

Co-works

VaxInnate� Inc현재 influenza� vaccine의 연구 개발 및 임상 실험을 전문으로 하고 있는

private� company입니다.�기존의 계란을 이용한 백신과는 달리 유전자 재조합을 통한 새

로운 개념의 백신 platform과 신속한 생산공정을 통해 값싸고 빠르게 백신을 대량 생산

할 수 있다는 장점을 지니고 있습니다.�그간의 기술 개발 노력과 가능성을 인정 받아 얼마

전 차세대 influenza� vaccine의 연구를 위해 미국의 보사부 (U.S.�Department�of�Health�

and�Human�Services� (HHS))로 부터 3년간 약 $120�million의 연구비를 수여 받았습니

다.�작년에 갑자기 발생했던H1N1� flu와 같이 pandemic� influenza� virus를 통한 독감이

갑자기 발생하게 되는 경우 신속하게 효율적으로 다량의 백신 생산을 통해 pandemic� flu

단시간 내에 확산을 방지할 수 있도록 새로운 개념의 백신 연구 개발에 촛점을 마치고 있

습니다.�

이를 위해 현재 많은 seasonal� and� pandemic� influenza백신의 연구 개발 프로젝트가

동시에 수행 중에 있으며,�보다 효율적인 연구 수행을 위해 많은 외부 회사들과 함께 co-work

도 함께 진행 중에 있습니다.�향후에도 좀 더 값싸고 면역 능력이 뛰어난 백신의 연구 개발

및 process� scale-up을 위해서는 기술력 있는 외부 회사들과의 지속적인 협력이 계속 예상되

고 있습니다.�

VaxInnate는 Influenza�vaccine�개발 연구 이외에 Malaria�및 Dengue�vaccine�연구 개

발도 함께 수행 중에 있습니다.�여러가지 strain에 동시에 면역성을 나타내야 하는Malaria�

및 Dengue�vaccine의 백신 특성상,�좀 더 효율적인 백신을 만들기 위해서 여러가지 넘어

야 할 기술적 장벽이 존재하고 있는 상황에 있습니다.�이런 점을 고려해 볼 때Malaria�및

Dengue�vaccine�분야의 많은 전문가들과의 co-work이 필수적일 것으로 예상됩니다.�주

요 연구 co-work�분야로는 단백질 modeling,�process�development,�process� scale-up,� �

formulation� 및 clinical� study� 등이 있습니다.

119. VaxInnate Inc

1.� Corporate� General� Information

Corporate� Name VaxInnate� Inc

Web-site� Address www.vaxinnate.com

Contact

(Korean� Business)

Name Alan� Shaw

Address 3� Cedar� Brook� Drive,� Suite#� 1� Cranbury,� NJ� 08512

Telephone 609-860-2262

E-mail [email protected]

2.� Description� of� Collaboration�Opportunities

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부록 2� �전략적 협력사 디렉토리 ❚ 837

Collaboration�

Opportunities� for�

In-Licensing

현재로는 회사 자체 고유의platform을 이용한 새로운 백신의 개발 및 면역성 향상에 연구

개발 촛점이 맞추어 있는 상태이라 외부 기업에서의 license� in에 상대적으로 적은 관심을

기울이고 있지만 백신의 immunogenicity� improvement�및 백신 공정의 효울성 증가을

위한 제반 관련 기술의 license� in에 대한 기회는 항상 열려있다고 하겠습니다.� �

Collaboration�

Opportunities� for�

Out-Licensing

저희 회사 백신의 platform은 기존의 백신 생산에 비해서 믾은 양의 백신을 값싸고 빠르게

만들 수 있는 장점이 있습니다.�이 때문에 많은 외부 회사 및 미국 및 다른 나라 정부에서

도 많은 관심을 보이고 있는 상태이며 현재 저희 회사 기술의 license� out에 대한 노력은

여러 곳에서 진행되고 있습니다.�앞으로도 자체 platform를 이용한 여러 백신 개발을 통해

얻어지는 vaccine� candidate및 현재 임상 단계에 있는 백신들의 license�out을 통한 타회

사와의 협력 가능성은 계속 이어질 것으로 사려됩니다.� license� out을 체결한 후에 tech�

transfer에 의해 VaxInnate� 고유 기술의 이전이 가능할 것으로 전망됩니다.

Collaboration�

Opportunities� for�

Manufacturing

저희 회사에서 연구 개발된 백신은 이미 여러 CMO를 통해 cGMP�production을 마치고

임상실험에 들어가 있는 상태입니다.�또한 새로운 pandemic� flu백신이 현재 미국에 있는

CMO를 통해서 임상 실험을 위한 백신 생산을 하고 있는 상태입니다.� 매 vaccine�

campaign마다 가격 및 품질면에서 보다 나은 조건의 CMO를 이용하고 있습니다.�앞으로

도 새로 연구 개발되는 vaccine�candidate대량 생산을 위해 기술력과 인지도를 지닌 회사

와의 collaboration이 지속적으로 추진될 것으로 예상됩니다.�향후FAD�승인 후에는 저희

회사 백신의 아시아 및 중남미 시장 개척을 위해 이 지역 백신 수요을 충족할 백신의 대량

생산을 위해서는 타사와의 협력이 필수적일 것으로 전망됩니다.� � �

Collaboration�

Opportunities� for� (Co-)�

Marketing� &� Sales

현재 저희 회사는 R&D�중심회사이므로 marketing�및 sale에 집중하고 있는 단계는 아닙

니다.� 하지만 미래 백신 공급을 위해 한국을 비롯한 아시아 지역 및 중남미 지역에서

marketing�및 sale에 공조가 필요한 만큼 이를 담당할 partner을 찾을 것으로 예상됩니

다.�

3.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

현재 한국의 Pharma그룹 실무진이 저희 회사를 방문하였으며,�현재 저희 회사 기술 책임 담당자와 한국의 Pharma의

technical� team실무 담당자들이 저희 회사 백신 생산 공정에 대한 기술적 논의가 진행되고 있는 단계입니다.�자세한

협력 방안에 대해서는 business�development� team에서 한국의 Pharma�측과 협상 중이니다.�향후 회의를 통해 한국

의 Pharma� 협력 방안이 구체화 될 것으로 예상됩니다.� � � �

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838� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name veropharm

Head� Office� Address 18-9,� 2nd� Yuzhnoportovy� proezd,� Moscow,� 115088,� Russia

Web-site� Address http://www.veropharm.ru

Contact E-mail [email protected]

Company� History

1997

Veropharm� began� to� manage� the� operations� of� Voronezh� Chemical� and� Pharmaceutical� Plant.

Veropharm� acquired� Belgorod� finished� forms� manufacturer.

1999

The� adhesive� bandage� production� of� Voronezh� facility� is� certificated� in� terms� of� conformity� to� the� ISO�

9001:2000� standards.

Construction� of� a� new� GMP� compliant� generic� drug-manufacturing� workshop� started� on� the� basis� of� the�

Belgorod� facility.

2001

Veropharm� acquired� LENS-Pharm.

A� new� generic� drug-manufacturing�workshop� on� the� basis� of� the� Belgorod� facility� is� opened.� The� building�

was� constructed� using� modern� technologies� and� is� fully� compliant� with� the� GMP� standard.

2002

The� decision� about� compliance� to�OST-510� (GMP)� of� the� Commission� of�Ministry� of� Health� of� the� Russian�

Federation�and�the�Ministry�of�Economic�Development�of� the�Russian�Federation� is� received�by�"Veropharm".

2003

Certification� according� to� the� GMP� standards� of� the� Commission� of�World� Health� Organization� has� taken�

place.

Veropharm� adhesive� bandages� awarded� golden� and� silver� marks� of� "100� Best� Goods� of� Russia".

120. Veropharm

1.� Corporate� General� Information

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부록 2� �전략적 협력사 디렉토리 ❚ 839

2004

The� beginning� of� the� publication� of� financial� statements� on� IFRS� (International� Financial� Reporting�

Standards).

New� corporate� brand� "Veropharm"� was� created� with� the� assistance� of� BrаndInstinct.

Veropharm� has� received� "Platinum� Ounce"� the� award� on� pharmaceutical� competition� in� "Company� of� the�

year"� nomination.

The� sales� launch� of� Bilumid� (INN� Bicalutamide)� and� Aprotex� (INN� Aprotinin)� -� the� first� generic� drugs�

produced� in� Russia.

2005

Veropharm�has� received� "Platinum�Ounce"� the�award�on�pharmaceutical� competition� in� "Project�of� the�Year"�

category� (project� "Factive� -� start� of� an� innovative� licensed� preparation").

The� sales� launch� of� Tautax� (INN� Docetaxel)� ­� the� first� generic� drug� produced� in� Russia.

2006

Veropharm� has� conducted� successfully� the� initial� public� offering� (IPO)� of� the� Company’s� shares� on� the�

Russian� stock� market.

2007

Veropharm� has� received� "Platinum� Ounce"� the� award� on� pharmaceutical� competition� in� the� nomination�

"Manager� of� the� Year"� (the� winner� has� been� Ivan� Konoplyannikov,� Director� of� Pharmaceutical� Products�

Business-Unit).

2008

Veropharm�was� included� in� backbone�organizations� list,� approved� by� governmental� commission� on� stability�

increase� development� of� the� Russian� economy.

The� launch� of� Vero-Cladribin� (INN� Cladribine)� ­� the� first� generic� drug� produced� in� Russia.

2009

Quality� Management� System� of� VEROPHARM� and� LENS-Pharm� have� been� certified� compliance� to� ISO�

9001-2008� for� the� first� time.

Veropharm� has� received� "Platinum� ounce"� the� award� on� pharmaceutical� competition� in� "Company� of� the�

year"� and� "Company� of� the� decade"� nominations.

2010

The� sales� launch� of� Verotecan� (INN� Topotecan)� ­� the� first� generic� drug� produced� in� Russia.

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840� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Veropharm� has� been� awarded� "The� most� attractive� employer� 2010"� nomination� due� to� their� long-term �

cooperation� with� Superjob.ru

2011

Construction� has� been� started� of� the� new� plant� building� of� finished� dosage� form� in� Volginsky� township�

(Pokrov� Plant)� and� reconstruction� of� operating� plant� in� Belgorod.

Veropharm� has� been� awarded� "The� most� attractive� employer� 2011"� nomination� due� to� their� long-term �

cooperation� with� Superjob.ru

2012

Veropharm� has� been� awarded� "The� most� attractive� employer� 2012"� nomination� due� to� their� long-term �

cooperation� with� Superjob.ru.

2013

Construction� of� the� FPP� (finished� pharm� product)� new� plant� building� in� the� Volginsky� township� has� been�

completed� and� internal� finishing�works� have� been� carried� out.� The� building� validation� by� State� commission�

and� start� up� in� operation.

Veropharm� has� been� awarded� "The� most� attractive� employer� 2013"� nomination� due� to� their� long-term �

cooperation� with� Superjob.ru

The� sales� launch� of� Anfibra� (INN� Enoxaparin� sodium)� -� the� first� generic� drug� produced� in� Russia.

2014

Veropharm� has� become� a� winner� "Importer� of� the� Year� in� Russia"� category� by� results� of� the� state� rating�

based� on� the� official� reporting� of� 2012-2013� years.

Veropharm� is� the� leading� Russian� pharmaceutical� manufacturer� in� oncological� and� adhesive� bandages�

segments.

Veropharm� has� been� awarded� "The� most� attractive� employer� 2014"� nomination� due� to� their� long-term �

cooperation� with� Superjob.ru.

Company� Description� &� Organization

PSC� VEROPHARM� is� the� leading� Russian� pharmaceutical� producer� known� in� Russia� and� abroad� as� one� of�

Russia’s� largest�manufacturers� of� generic� drugs� (drugs� that� are� identical� to� their� brand�name� counterparts),�

oncological� medications,� and� medical� adhesive� bandages.

VEROPHARM� was� established� on� January� 21,� 1997� by� the� shareholders� of� the� Pharmacy� Chain� 36.6� .�

Organizationally,� the� Company� comprises� three� facilities:� Voronezh� Chemical� and� Pharmaceutical� Plant,�

Belgorod� Plant� for� manufacturing� ready-made� medications,� and� Pokrov� Plant� of� ready-made� medications.�

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부록 2� �전략적 협력사 디렉토리 ❚ 841

The� current� yearly� production� capacity� of� these� enterprises� amounts� to� 591�million� tablets� and� capsules,� 7�

million� ampoules,� 468� million� adhesive� bandages� and� 43� million� vials.

According� to� the� DSM� Group� research� agency,� VEROPHARM� ranks� 4th� by� sales� among� domestic�

manufacturers.� The� Company� is� ranked� 4th� on� list� of� top� ten� manufacturers� of� oncological� medications�

among� domestic� and� foreign� manufacturers.� VEROPHARM� kept� its� leadership� positions� in� the� rating�

compiled� using� the� manufacturers� of� oncological� medications� in� kind.

VEROPHARM,� with� its� cutting-edge,� dynamically� developing� industrial� base� and� a� team� of� highly� skilled�

experts,� confidently� looks� into� the� future,� constantly� improving� its� research,� industrial� and� human� potential�

for� application� of� achievements� of� science� in� its� medications.� Today,� our� portfolio� includes�more� than� 300�

products� used� in� different� areas� of� medicine.� The� Company� has� more� than� 2,000� skilled� employees.

The� VEROPHARM� team� works� effectively� so� as� to� be� able,� using� its� unique� knowledge� and� extensive�

experience,� to�offer� reasonable� solutions� raising� the� level�of�modern�medical� therapy,�and�make�high�quality�

and� affordable� medications� for� millions� of� Russians.

2.� Additional� Business� Propositions� for� Collaboration

Career

The� investment� into� skilled� personnel� forms� the� foundation� for� long-term� success� of� the� Company.� We�

build�a� team�of�professionals�and�always� take�care�of� improvements� in�professional� skills,�motivation,� social�

security,� and� loyalty� to� our� corporate� values.

We� are� interested� in� hiring� purposeful,� self-motivated,� and� responsible� people,�who� could� join� our� team�

and� make� their� contribution� to� the� development� of� the� Company.

We� focus�not�only�on� looking� for�high-quality� experts,�but�also�on� issues�of� their�professional�development�

and�motivation.�Veropharm� is� fully�aware�of� its� responsibility�before� the�people,�who�have�entrusted� their�

career� to� it.� The� Company� does� its� best� to� provide� to� its� employees� all� conditions� needed� for� full�

actualization� of� their� professional� abilities.

We� are� striving� to� create� the� working� atmosphere� of� mutual� respect.

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842� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name Vesalius� pharma� SA

Facilities� City� &� Country Chile

Web-site� Address www.vesaliuspharma.com

Contact

(Korean� Business)E-mail [email protected]

Company� History

began� operations� in� Colombia� in� the� month� of� September� 1999,� aiming� to� position� itself� as� one� of� the�

fastest� growing� pharmaceutical� companies� and� coverage,� first� in� Colombia� and� then� in� Central� and� South�

America� and� the� Caribbean.� The� focus� of� the� company� is� aimed� at� improving� access� to� government� and�

its� people� to� orphan� therapies� and� /� or� high� cost,� providing� human� medicines,� veterinary� medical� and�

surgical� supplies� high� quality� at� competitive� prices.� Providing� solutions� to� specific� diseases� without�

therapeutic� coverage�or� low� availability�of�drugs� for� rare�diseases�be�without� interest� to� the�pharmaceutical�

industry,�he�has�made�us�a�company�with�a�high� social� commitment� in�each�of� the� Latin�American�countries�

where� we� operate.

The�company�began�operations� in�Colombia�as�Hahnemann�Pharmaceutical,�but� in�2007�our�name�changed�

to� Vesalius� Pharma� SAS,� in� order� to� consolidate� in� other� Latin� American� countries.

Vesalius� Pharma� SAS� was� the� first� Colombian� company� to� make� agreements� with� Indian� pharmaceutical�

companies� to�manufacture� drugs� and� that's� how� we� began� operations� with� TB� products�manufactured� in�

India� and� imported� and� marketed� in� several� countries� in� Latin� America� exclusively� by� Vesalius� Pharma� SAS

Later�we�entered� the�veterinary�area,�making�an�exclusive�agreement�with�a� company� in� the�Czech�Republic,�

which� allows� us� to� offer� a� broad� portfolio� of� vaccines� for� pigs,� dogs,� cats� and� rabbits� throughout� Latin�

America.

In�2010�we�obtained� the�Mission�Gazelle�Award� in� the� category�SME�marketing�strategies,� recognition�given�

to� Vesalius� Pharma� SAS� among� 200� companies� nominated� for� this� award.

In� 2011� we� were� prequalified� as� providers� of� the� Pan� American� Health� Organization� (PAHO)� TB� drugs.

In� July� 2012� the� Organization� for� Training� and�Medical� Research� (IOCIM)� gave� us� the� highest� institutional�

discrimination� in� health:� PRIZE� TO� THE� MEDICAL� BY� achivement� FOR� A� BETTER� LIFE� (Award� for� its�

achievements� for� a�Better�Life),� in� recognition�of�our� Institutional�work�and�selfless�performance,� recognizing�

the� best� and� most� professional� Health� year� 2011� -� 2012,� our� specialty,� choosing� only� one� institution� per�

specialty� in�each� country.�Also�we�become�part�of� the�Organization�as�a�Member�Preferential� IOCIM,� taking�

121. Vesalius pharma SA

1.� Corporate� General� Information

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부록 2� �전략적 협력사 디렉토리 ❚ 843

the� opportunity� to� exchange� experiences,� projects,� ideas,� methodologies,� research� and� culture� with� other�

leaders� in� every� field,� from� several� member� countries� and� with� the� same� commitment� to� draw� the� blade�

path� that� will� lead� us� to� achieve� Excellence� in� Health.

In� the�month� of� October� 2012� in� National� Institute� of� Drug� Surveillance� and� Food� INVIMA� granted� us� the�

certification� of� storage� capacity� and� Conditioning� Surgical� Medical� Supplies,� which� allows� us� to� project�

ourselves� as� a� pharmaceutical� international� company�with� a� broad� portfolio� of� products� and� solutions� that�

fit� the� requirements�of� each�of�our� clients�and�ministries�of�health� in� the�different� Latin�American�countries.

Our�portfolio�covers�a�wide� range�of�products� in�different� therapeutic� segments,�especially� for�public�health,�

tuberculosis� and� rare�or� orphan�diseases.�We�are�able� to�meet�all� the� requirements�of� TB� drugs�of� first� and�

second� line� in� Latin�America,� vital�medicines�not�available�and�providing� specialized�surgical�medical� supplies.

We�currently�have�a�presence� in�Argentina,�Chile,�Colombia,�Costa�Rica,�Panama,�Peru,�Dominican�Republic�

and� India.

Company� Description� &� Organization

Mission�

We� are� a� pharmaceutical� company� focused� on� satisfying� the� needs� of� our� customers� and� the� community�

at� large,� providing� solutions� to� institutions,� physicians� and� patients� through� therapeutic� alternatives� for�

human,� veterinary�and� surgical� supplies,� providing�Health�&�Wellness� products�quality� at� competitive�prices.

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844� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

122. WCCT Global, LLC

1.� Corporate� General� Information

Corporate� Name WCCT� Global,� LLC

Web-site� Address http://www.wcct.com

Contact

(Korean� Business)

Name Talia� Nikolao

Address 668� Woodbourne� Rd,� Suite� 110,� Langhorne,PA19047

Telephone (714)� 252-0700� x� 2201

E-mail [email protected]

2.� Description� of� Collaboration�Opportunities

Collaboration�

Opportunities� for� R&D�

Co-works

Korean�Companies�who�are� interested� in� identifying�potential� Phase� I�drugs� they�

may� want� to� license� to� Korea� should� contact� our� senior� management� team� for�

more� information.

3.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

WCCT�Global�has�a�number�of�biotech� sponsors�who�are�often� looking� for�partnerships�or�co-development�

partners.� �Korean�pharmaceutical�companies� interested� in�acquiring�Asian�or�Korean� rights�of�acquiring�NCE�

assets� should� contact� the� WCCT� Global� VP� of� Business� Development.

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부록 2� �전략적 협력사 디렉토리 ❚ 845

Corporate� Name YURiA-PHARM

Head� Office� Address 10,� M.� Аmosova� street,� Кyiv,� Ukraine,� 03680

Web-site� Address http://uf.ua

Contact E-mail [email protected]

Company� Description� &� Organization

� dynamically� growing� company

Pharmaceutical� company� YURiA-PHARM� was� found� in� � 1998.� Today� YURiA-PHARM� is� the� leader�

manufacturer�of� � solutions� for� infusion�not�only� in�Ukraine�but�also� in�CIS.�We� supply�medical� facilities�with�

more� than�100� items�of�bloodand�plasma� substitute� solutions,�original� infusion�drugs,� antibiotics,� fungicidal�

drugs,� syrups,� antiseptics,� parenteral� feeding� preparations,� anti-tuberculosis� drugs,� syringes,� I.V.� sets.� The�

assortment� of� products� fully� covers� the� requirements� of� stationary� curative� establishments� in� infusion�

therapy.�Our�product� line� sums�up� to�more� than�40�preparations.�Annual� turnover�of� the�company�exceeds�

60� mln� bottles� per� year.� �

� confidently� takes� in� the� leading� position� in� the� export� markets

We� deliver� our� products� to� Russia,� Moldova,� Kazakhstan,� Uzbekistan,� Azerbaijan,� Tajikistan,� Kirgizia,�

Turkmenistan� and�Georgia.�More� than� 100� items� are� now�being� registered� for� usage� in� different� countries�

and� the� number� is� continuously� growing.� In� 2008� YURiA-PHARM�Corporation� has� received� a� Certificate� of�

compliance� to� international� quality�management� standards� ISO� 9001� (9001:2009).� In� 2011� YURiA-PHARM �

Corporation� has� complited�WHO-GMP� certification.� Now�we� plan� to� enter� Asia-� Pacific,� African� and� South�

America� markets,� therefore� in� some� countries� we� have� already� started� the� registration� process� for� the�

preparations� planned� to� be� distributed.� YURiA-PHARM� total� headcount� is� constantly� growing� and� at� the�

moment� exceeds� 800,� 2/3� of� them� being� involved� in� production� and� R&D.� �

� a� wide� range� of� popular� original� and� generic� infusion� preparations

Our� company� produces� a� number� of� preparations� (original� and� generic),� which� are� not� produces� in� CIS�

countries� -�Reosorbilact®,�Sorbilact®,�Decasan®,�Horosten®�etc.�For� instance,�Reosorbilact®�(30%�of� total�

distribution�of� the�preparations� included� in�B�05�ATC�code� (B05� -�Blood� substitutes�and�perfusion�solutions)�

and� Sorbilact®� constitute� a� basis� of� infusion� therapy� in� Ukraine.� They� have� completely� replaced�

polyvinylpyrrolidone� preparations� (such� as� Hemodez,� Neohemodez� etc.)� prohibited� in� many� European� and�

other� countries,� and� restricted� dextran� preparations� (Reopolyglucin).� In� our� portfolio� we� also� have� unique�

cosmetological� treatments� -� Hyalual®� (an� anti-age� therapy,� preparation� for� realization� of� procedure� of�

redermalization� -� rejuvenations� by� renewal),� injectional� preparations�modifying� a� cartilage� -� Hyalual®-Artro�

123. YURiA-PHARM

1.� Corporate� General� Information

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846� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

-� unique� innovative� cartilage� protective� preparation� of� new� generation.� It� is� an� effective� combination� of�

hyaluronic�acid�and� sodium�succinate,�which�already�has�showed� the�efficiency� in� treatment�of�patients�with�

osteoarthrosis.�

� appreciated� by� the� physicians� and� the� scientific� medical� community

We� cooperate� intensively� with� many� research� institutions� in� the� field.� For� the� first� time� in� CIS,� in�

collaboration� with� Blood� Pathology� and� Transfusion� Medicine� Institute� of� Ukraine's� Academy� of� Medical�

Science,� we� have� developed� a� group� of� complex� multifunctional� infusion� solutions� -� Reosorbilact®,�

Sorbilact®,�Xylat®,�which� today�make�basis�of�new�direction� in� the� clinic�of� internal�medicine� -� "Low-volume�

infusion� therapy".� Corporation� conduct� an� intensive� research� of� the� new� preparations� and� also� examine�

more�deeply� the� capacity� of� the� existing�ones.�We�make� large� investments� in�Research�&�Development�and�

prove� the� quality� and� efficiency� of� our� preparation� according� to� the� requirements� of� the� “case-based�

medicine”.�

� constant� improvement� of� production� according� to� market� requirements

Keeping� in�mind�constant�enhancing�of�quality� and�accessibility�of� treatment,�we� improve� the�presentations�

and�dosages�of� the�preparations�on�a�permanent�basis.�At� the�moment�our�products�are� released� in�9� forms,�

including� prefilled� syringes,� nebules,� bags� for� irrigation� solutions,� polypropylene� bags,� PVC� bags,� glass�

bottles,� plastic� bottles,� tablets.�

� a� right� hand� of� any� physician

Our� preparations� accelerate� the� patients'� recovery� due� to� their� higher� efficiency,� considerable� decrease� of�

complications� and� minimization� of� side-effects.� Numerous� reputable� medical� investigations� prove� a� visible�

time� saving� in� stationary� treatment� and� higher� therapy� comfort� level.� These� factors� allow� reducing� the�

treatment� cost� and� increasing� an� average� annual� bed� turnover.� �

� a� reliable� and� advantageous� partner

According� to�YURiA-PHARM� long� experience,� practical� usage�of� its� preparations� enhances� an� overall� image�

both� of� a�medical� facility� and� of� the� physician.� Uncompromising� quality� and� reasonable� pricing� have�made�

our� preparations�bestsellers� in�Ukraine� and�CIS� and�we�have� every� reason� to� expect� similar� success� in� other�

countries.� �

� some� short� facts:�

•� leader� in� production� of� solutions� for� infusion;�

•� annually� growth� rate� more� than� 40%;�

•� more� than� 100� items� in� the� product� line;�

•� total� headcount� more� than� 800;�

•� annual� turnover� up� to� 60� million� units;�

•� exports� to� 9� countries;�

•� 80%� of� annual� net� profit� is� invested� in� modernization� of�

� production;�

•� each� year� about� 10� new� medical� preparations� are� delivered;�

•� system� quality� control� ISO� 9001� :� 2009� operates;�

•� GMP� certified.�

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부록 2� �전략적 협력사 디렉토리 ❚ 847

2.� Additional� Business� Propositions� for� Collaboration

OUR� DESIGNATION

Life� is� the� main� global� value!

Our� main� target� is� to� protect� and� improve� it!

OUR� MISSION

•�We� create� unique� medications� for� human� treatment� and� recovery.

•� Through� our� patented� technologies,� we� bring� innovations� in� infusion� therapy� and� set� the� style� in�

pharmaceutical� business.

•� We� achieve� recognition� of� the� Society,� Physicians� and� Patients.

•� We� apply� creative� power� of� our� Employees� and� Partners� and� promote� their� welfare.

OUR� VISION

“Yuria-Pharm”� is� a� leading� innovational� pharmaceutical� corporation� in� Ukraine,� the� best� employer� in�

industry.

OUR� VALUES

•� Our� clients� and� partners� who� trust� us.

•� We� are� ambitious� professional� team� united� with� common� corporate� spirit.

•� The� best� quality� of:

•� our� products;

•� relationships� with� our� Сlients;

•� internal� communications� based� on� high� ethical� standards.

•� Maximum� outcome� and� high� business� profitability.

•� Self-realization� of� every� Employee.

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848� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

124. ZHEJIANG EXCEL PHARMACEUTICAL CO., LTD

1.� Corporate� General� Information

Corporate� Name ZHEJIANG� EXCEL� PHARMACEUTICAL� CO.,� LTD

Web-site� Address http://www.excelpharma.com

Contact

(Korean� Business)

Name Mr.� Fang� Guanxing� � or� � Ms.� Janing

Address9� Dazha� Road,� Huangyan� Economic� Development� Zone,� Taizhou,�

Huangyan,Zhejiang,� China

Telephone +86� 57684160008

E-mail [email protected]

2.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

Zhejiang� Excel� Pharmaceutical� Co.,� Ltd.� is� a� privately-owned� high-tech� company� founded� in� 2000.� It� is�

located� in� a� coastal� scenic� and� convenient� transportation� along� the� coast� of� southeast� China� port� city�

----� Taizhou,� Zhejiang� province.

The� company’s�main� business� is� the� production� and�marketing� of� APIs� and� key� intermediates.�Main� API�

products� include� Gemfibrozil,� Meloxicam,� Fenofibrate,� Amiodarone� HCl� and� Gabapentin.� All� of� the�

company’s� products� meet� USP,� BP,� EP� and� JP� requirements.� Intermediates� are� mainly� sophisticated�

chemicals� contract-manufactured� for�customers.�90%�of� the�company’s�products� are�exported.�Excel�has�

developed� a� product� line� aimed� for� the� higher-end�markets� such� as� the� USA,� EU� and�with� sales� also� to�

the� South� American� and� South-east� Asian� markets.

The� company� has� continuously� improved� its� cGMP� quality�management� systems� and�maintains�multiple�

GMP� compliant� plants.� Since� 2005,� the� company� actively� promotes� the� construction� of� quality�

management� system,� and� obtains� the� GMP� certificate� which� is� issued� by� SFDA� in� December� 2005.� The�

company�past� the� FDA�establishment� inspection� in� January�2009�and� received�EU�CEP�certificate� in�2011.�

The� company� also�maintains� a�multi-purpose� pilot� production� plant�with� a� clean� area� and� a� R&D� center�

thus�providiving� solid� regulatory� support� for� customers.� Excel� Pharma’s�mission� is� to� provide� high�quality�

products� to� customers� and� achieve� sustainable� growth� by� continuously� improving� its� management�

systems.�We� committed� to� learn� from� advanced�management� experience� in� pharmaceutical� production,�

continue� to� promote� and� enhance� the� management� level,� to� promote� cooperation.�

We� warmly� welcome� cooperation� from� all� over� the� world.

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부록 2� �전략적 협력사 디렉토리 ❚ 849

125. Zhiwe Chem-Tech Inc

1.� Corporate� General� Information

Corporate� Name Zhiwe� Chem-Tech� lnc

Web-site� Address www.apichem.cn

Contact

(Korean� Business)

Name Kyree� Fu

Address 3F� .Bul� A2� No� 699� Changhong� Rd� .� Shanghai� � 201202� � China

Telephone 139� 1744� 6399� ,� 86(21)20221225

E-mail [email protected],� [email protected]

2.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

Established� in� 2009,� ZHIWE� Chemical� (APIchemTM� )� is� a� leading� company� focusing� on� Active�

Pharmaceutical� Ingredients� (API)� and� intermediates.

APIchemTM�built�R&D�center� in�Shanghai�as�well� as�manufacturing� facilities� in�Hebei� �province.�The�R&D�

center� has� equipped� with� advanced� instruments� and� machines,� including� high-pressure� tank,�

low-temperature� equipment� (-120℃),� HPLC� and� GC� etc.� APIchemTM� can� offer� products� ranging� from�

milligram� level,� kilogram� level,� up� to� bulk� tons.

Our� clients� widely� spread� from� Europe,� North� America,� and� Asia.

APIchemTM� is� skilled� at� R&D� of� new� drugs,� as� well� as� custom� synthesis� and� contract� research.� “Create�

value� for� clients”� is�our�mission,� and�upon� this�mission�we�cooperate�with� our� clients� to� lower� their� cost�

with� more� efficiency.

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850� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

126. Zodiac

1.� Corporate� General� Information

Corporate� Name Zodiac

Head� Office� AddressEdifício� Berrini� 500� -� Praça� Profº� José� Lannes,� 40� -� 15º� andar� -� Cidade�

Monções� -� São� Paulo� -� SP� CEP:� 04571-100Facilities� City� &� Country Brazil

Web-site� Address www.zodiac.com.br

Contact

(Korean�

Business)

E-mail [email protected]

Company� Description� &� Organization

Mission

We�are�a� company�engaged�with� the�development,�production�and� sales�of�human�pharmaceutical�products.�

We�work� for� physicians� and� patients� to� have� access� to� innovative� and� quality� treatments,� through� a� highly�

motivated� human� staff� and� that� identifies� itself� with� the� company.

Vision

To� be� an� agile� company� in� the� provision� of� quality� health� solutions� and� admired� in� the� market,� growing�

with� sustainability� and� exceeding� the� expectations� of� customers,� employees� and� shareholders.

Values

-� Honesty,� Integrity,� and� Ethics;

-� Credibility,� Reliability,� Transparency,� Consistency� between� thinking� and� saying;

-� Commitment,� Accountability,� Faithfulness,� Loyalty,� Priority� sense;

-� Austerity,� Efficient� use� of� resources;

-� Respect� for� people;

-� To�make� and� have� urgency� sense:� To� understand� how� important� is� to� be� responsible,� responding� in� time�

and� form.

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부록 2� �전략적 협력사 디렉토리 ❚ 851

127. Zuellig Pharma Korea

1.� Corporate� General� Information

Corporate� Name Zuellig� Pharma� Korea

Web-site� Address www.zuelligpharma.com

Contact

(Korean� Business)

Name Edmond� Cho

Address3F.,�Dongwon�Building,�275�Yangjae-dong,� Seocho-gu,�Seoul�137-717,�

Korea

Telephone 82-2-2006-0813

E-mail [email protected]

2.� Description� of� Collaboration�Opportunities

Collaboration�

Opportunities� for� R&D�

Co-works

Zuellig� Pharma� has� a� global� reach� for� clinical� trial� sample� delivery� and� sourcing�

comparators.�As�well,�Zuellig�can�help�Korean�companies� research� the�market� for�

R&D,� through� its� own� global� network.

Collaboration�

Opportunities� for�

In-Licensing

Zuellig� Pharma� can� help� Korean� companies� source� promising� products� through�

its� consulting� service.

Collaboration�

Opportunities� for�

Out-Licensing

Zuellig� Pharma� can� help� Korean� companies� find� business� partners� through� its�

consulting� service.

Collaboration�

Opportunities� for�

Manufacturing

As�Zuellig�Pharma�has� its�own�CMO�facility�outside�Korea,�any� company� can�use�

such� high� quality� production� service.

Collaboration�

Opportunities� for� (Co-)�

Marketing� &� Sales

Zuellig� Pharma� has� very� strong�marketing� and� distribution� network� in� about� 14�

countries.� As� well,� it� has� its� own� Contract� Sales� Organization� service� in� each�

country.

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852� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name zvezda

Head� Office� Address 61010,� Kharkov,� ul.� Gordienkovskaya,� 1

Web-site� Address http://www.zvezda.kharkov.ua

Contact E-mail [email protected]

Company� History

Public� joint-stock� company� "CPP� the� "Red� star"� is� one� of� the� first� pharmaceutical� enterprises� of� Ukraine.� �

� � � � � � � � � � � � � � � � �

History� of� plant� takes� beginning� in� 1923.� Civil� war� made� off� only.� In� Ukraine� Committee� is� created� on� a�

fight� against� unemployment,� the� decision� of� that� is� organize� a� factory� on� packing� of� chemicals.� There� are�

800� workplaces� on� a� factory,� the� name� her� is� given� to� in� a� spirit� that� time� is� the� "Red� star".� By� then� we�

are� a� producer� of� chemical� reagents,� difficult� ethers� and� perfume� products.

Having� in� Kharkiv,� largest� scientific� centre� of� Ukraine,� base� of� scientific� and� research� institutes,� a� plant�

gradually� passes� to� the� production� of� substances� of� medicinal� preparations� (antipyrine,� pyramidonum,�

calcium�gluconate�et�al).�Before�war,� in�1940�year,� substances�already�made�54%�from�the�general�volume�

of� the� produced� products.� The� productive� program� broadened,� the� scales� of� sale� had� increased.

In� October,� 1941� a� plant� was� evacuated� to� Middle� Asia� and� on� Ural� (Chelyabinsk).

After� war� renewal� of� gun-puffed� in� 1943� plant� lasted� 3� years.� The� production� of� substances� of� pre-war�

nomenclature� was� renewed� plus� of� new,� passing� approbation� war� -� norsulfazolum,� white� streptocide,�

ftalazol.� They� defined� specialization�of�plant� -� as� producers�of� antipyretics� and� sulphanilamide�preparations.�

Later� to� them� coumarinic� preparations� (dicoumarin,� neodicoumarin)� were� added.

In�1967�the�pre-war� level�of�production�was�exceeded� in�30� times.�The�products�of�enterprise�were�exported�

in� 23� countries� of� the� world.

1991,�when�Ukraine� got� status� of� the� independent� state,� became� the� critical� stage� in� history� of� plant� -� an�

enterprise� reformed� on� producing� of� the� prepared� medicinal� facilities.

The� first� medical� products� of� PJC� "CPP� the� "Red� star"� was� pills� "Asparkam",� ointments� "Levosin� ",� "Espol"�

and� "Levomekol".

In�1995� the� company�was� transformed� into�a� joint� stock� company,�which�allowed�a� fresh� look�at� its�current�

state� and� prospects.� If� in� 1995� the� plant� annual� mastered� two� drugs,� in� 2000� -� already� 10.� In� the�

pharmaceutical�market� took� pills� diclofenac� and�piroxicam,� "No-Crewe-Sha"� (active� ingredient� -�Drotaverine�

g-chl)� and� "Renalhan"� (analgesic�with� spasmolytic�properties)� as�well� as� the�original�product� -� Thiotriazoline�

ointment� that� proved� to� be� effective� in� bedsores� difficult� healing� wounds� and� catarrhal� gingivitis.

Today� the� assortment� of� products� of� plant� plugs� in� itself� preparations� of� 22� pharmacotherapeutical� groups�

128. zvezda

1.� Corporate� General� Information

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부록 2� �전략적 협력사 디렉토리 ❚ 853

in� that� included:� hard� (pills,� capsules),� soft� (ointments,� gels,� liniments� )� and� liquid� (alcoholatures� and�

solutions)� medicinal� forms.� A� curative� cosmetic� and� additions� dietary� are� similarly� produced.

What� in� assortment� politics� of� plant� in� the� nearest� prospect?� PJC� "CPP� the� "Red� star"� plans� mastering� of�

new� medicinal� facilities� and� continuation� of� series� of� curative� cosmetic.

Basic� work� of� enterprise� assignments� are� further� expansion� of� assortment,� modernisation� of� production�

capacities� and� active� promo� activity.

We� are� proud� of� that� we� work� in� the� sphere� related� to� creation� of� products� for� the� health� of� man� and�

we� adhere� to� unchanging� ideology:� medicinal� preparations� must� be� effective,� safe� and� accessible.

Company� Description� &� Organization

We�take� care�of� the�most� important�and� the�main�value�of�human� life� -�about�his�health.�Public� Joint-� Stock�

Company� "CPP� the� "Red� star"� was� founded� in� 1923� and� is� one� of� the� first� pharmaceutical� companies� in�

Ukraine.� Due� to� the� presence� of� a� large� production� capacity� and� applying� the� new� approach� to� the�

organization�of�production� -�business,�we�create� real�benefits� and�opportunities� for� consumers�and�partners.�

Benefits� and� opportunities� for� consumers� -� it's� affordable� and� quality� medicines.

The�enterprise� is� active�modernization�of�production.�Construction�of�a�new�production� line�of�capsules,� fully�

renovated� shop� for� the� production� of� liquid� dosage� forms.

Benefits� and� opportunities� partners� -� is� to� ensure� quality� service� and� active� the� promotion� activities.

In� the� nearest� plans� of� plant� is� mastering� of� new� pharmacological� groups� and� substantial� expansion� of�

assortment.� The� program� of� preparation� and� active� activity� of� Kames� (Key� Account� Manager)� works� in� all�

metropolises� of� Ukraine.

The� concept� of� strategic� management� of� brand� promotion,� which� includes� a� series� of� specific� commercial�

projects,� proposals� and� programs� of� joint� activities�with� distributors,� pharmacies� and� health� care� providers.

2.� Additional� Business� Propositions� for� Collaboration

Mission

PJSC� "CPP� the� "Red� star"

We� create� high-quality,� efficient,� safe� products� at� an� affordable� price.� We� strive� to� make� every� patient,�

every� doctor,� every� person�who� is� trying� to� quickly� overcome� the� disease,� were� satisfied�with� the� action�

and� the� result� of� our� product.

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854� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

순번 기업명 국가 페이지

1 Afrab-Chem� Limited 나이지리아 856

2 Africa� Medec� Limited� 케냐 858

3 Al� Mojil� Drug� Company 쿠웨이트 859

4 AlfaCure� Pharmaceuticals� 이집트 860

5 atco� pharma� for� pharmaceutical� IND 이집트 861

6 BCN� Limited 나이지리아 862

7 Beta� healthcare 케냐 864

8 Biopharma 케냐 865

9 Cadila� Pharmaceuticals� (EA)� Ltd 케냐 867

10 Carrot-Top� Drugs� Limited 나이지리아 868

11 Chemiron� International� Limited 나이지리아 869

12 Cloriti� Pharmaceuticals� (EA)� Ltd 케냐 870

13 Cosmos� Limited 케냐 871

14 DANADAMS� PHARMACEUTICAL� INDUSTRY� GHANA� LIMITED 가나 872

15 Dawa� Ltd 케냐 873

16 DBK� Pharmaceutical 이집트 874

17 Elys� Chemical� Industries� Ltd 케냐 875

18 Emzor� Pharmaceuticals� Limited 나이지리아 876

19 Entrance� Pharmaceuticals� &� Research� Center 가나 878

20 Ernest� Chemists� Limited� Head� Office 가나 879

21 Escorts� Pharmaceuticals� Ltd 우간다 880

22 Evans� Medical� Limited 나이지리아 881

23 Fidson� Healthcare� Limited 나이지리아 882

24 Gemini� Pharma� Limited 나이지리아 883

【부록 3】� �중동·아프리카 전략적 협력사 디렉토리

본 디렉토리북 수록내용은 해당 기업의 회신 내용을 바탕으로 수록된 내용으로서 신뢰성 여부는 주최측이

보증하지 않음을 유의하시기 바랍니다. 따라서, 글로벌 시장 진출시 본 디렉토리북 내용에 수록된 기업과의

접촉시 업체별로 신뢰성 여부에 대한 사전 조사를 당부드립니다.

■�중동·아프리카 전략적 협력사 디렉토리 수록 기업 리스트 54개사

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부록 3� �중동·아프리카 전략적 협력사 디렉토리 ❚ 855

순번 기업명 국가 페이지

25 Haltons� Pharmacy 케냐 884

26 Harley’s� Ltd 케냐 885

27 Impact� Chemicals� Ltd 케냐 887

28 INRAD 이집트 889

29 Kampala� Pharmaceutical� Industries 우간다 891

30 Kuwait� Saudi� Pharmaceutical� Industries� Co. 쿠웨이트 893

31 Kwality� Afro� Asia 우간다 894

32 Lab� and� Allied 케냐 895

33 Lords� Healthcare� Ltd 케냐 896

34 M&G� Pharmaceuticals� Ltd 가나 897

35 Mansoor� Daya� Chemicals 탄자니아 898

36 Max� Pharmaceuticals� Ltd 케냐 899

37 Medipharm� Industries� (E.A.)� Ltd 우간다 900

38 MTK� Uganda� Limited 우간다 901

39 Neros� Pharmaceuticals� Limited 나이지리아 902

40 Orange� Drugs� Limited 나이지리아 903

41 Oss-Chemie� (K)� Ltd 케냐 904

42 Quality� Chemical� Industries 우간다 905

43 Pharmaken� Ltd� 케냐 906

44 Radiance� Pharmaceuticals� Limited 케냐 907

45 Reals� Pharmaceuticals� Limited 나이지리아 908

46 Regal 케냐 909

47 Rene� Industries� Ltd 우간다 910

48 Skylight� Chemicals 케냐 911

49 Square� Pharmaceuticals 케냐 912

50 Surgilinks� Ltd 케냐 914

51 Universal� Corporation 케냐 915

52 Vacsera 이집트 916

53 Vortex� pharma 이집트 917

54 Zenufa� Limited 탄자니아 918

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856� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name Afrab-Chem� Limited

Head� Office� Address 22,� Abimbola� Street,� Isolo� Industrial� Estate,� Isolo,� Lagos.

Facilities� City� &� Country Nigeria

Web-site� Address www.afrabchem.com

Contact

(Korean�

Business)

Name +234� 1� 452� 2571,� 452� 2777

E-mail [email protected]

Company� History

Afrab-Chem� Limited� was� originally� established� and� registered� in� 1968� under� the� name� Afro� -� Arab�

Techni-Chemicals� Limited� by� a� Nigerian� -� Jordanian� Group� of� Pharmacists,� Chemists� and� Business�

Entrepreneurs� as� Pharmaceutical� Distributors.� In� 1973� the� first� manufacturing� plant� was� established� to�

produce� few� selected� pharmaceutical� products� under� technical� know-how� agreement� with� the� following�

international� companies:

� -� Arab� Pharmaceutical� Manufacturing� Company,� Amman-Jordan.

� -� Zambon� Group� Spa,� Milan,� Italy.

� -� Dr.� Andreu� Laboratories,� Barcelona,� Spain.

� -� OM� Laboratories,� Geneva,� Switzerland.

� At� the� initial� stage,� the� product� range� included� Analgesics� &� Anti-Inflammatory� agents,� Anti-malarias,�

Anti-biotics,�Multivitamins,� Anti� -� rheumatics,�Anti-diabetics,� Anti-spasmodic,� Anti-histamine,� Cough�&�Cold�

mixtures� and� a� range� of� � other� OTC� products.

� Over� the� past� three� decades,� Afrab-Chem� has� recorded� a� steady� growth� and� expansion� in� its� operations.�

Presently,� Afrab-Chem� has� emerged� as� a� respected� leader� in� the� Pharmaceutical�Manufacturing� Industry� in�

Nigeria� with� strong� commitment� to� producing� high� quality� pharmaceuticals.�

� Nevertheless,� Afrab-Chem� in� preparation� for� the� challenges� of� the� emerging� economies� of� the� 20th�

century,� has� embarked� on� plant� expansion� and� improvement� programme.� Presently,� the� main� Factory� and�

the� Laboratories� have� been� modernized� to� comply� with� current� Good� Manufacturing� Practice� (cGMP).

� A� second� ultra� modern� factory� which� will� be� of�World� Health� Organisation� (WHO)� standards� is� currently�

under� construction.

� Today,� Afrab-Chem� as� one� of� the� leading� pharmaceutical� manufacturers� in� Nigeria� serves� the� medical�

1. Afrab-Chem Limited

1.� Corporate� General� Information

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부록 3� �중동·아프리카 전략적 협력사 디렉토리 ❚ 857

professionals� and� patients� in� various� communities� by� providing� dependable� high� quality� pharmaceuticals.�

� The� Company� produces� a� wide� range� of� products� on� contract� for� a� � number� of� institutions� State�

Governments,� Multinational� Pharmaceuticals� Companies,� and� some� foreign� Agencies.

� The� strategic� location�of�Afrab-Chem� in�Nigeria�will� afford� the�Company�easy�access� to�all� important�export�

markets� in�Africa.�We�are�determined�to�develop� the�African�market�particularly�West�Africa�and�at� the� same�

time,� break� into� the� global� export� market.

� Afrab-Chem�recognizes� the� customers’� rights� to�high�quality�products,� integrity� and�service,� the� reason�why�

the� Company� aims� to� operate� at� the� highest� standard� of� ethics� and� integrity� in� both� business� and�

professional� conduct.�

� Afrab-Chem� will� strive� consistently� to� be� among� the� Best� Pharmaceutical� Manufacturing� Company� of�

Choice� in� Nigeria.�

Company� Description� &� Organization

[Mission]

To�delight�our� customers� through� innovative�and�effective�service�delivery� in�providing�essential�products� for�

the� ultimate� benefit� of� all� stakeholders.

[Vision]

To� be� the� foremost� provider� of� essential� pharmaceuticals� and� health� care� products.

Page 861: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

858� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name Africa� Medec� Limited�

Head� Office� Address P.O� Box� 21414,� Nairobi� 00505

Facilities� City� &� Country Kenya

Web-site� Address www.africamedec.com

Contact

(Korean�

Business)

Telephone 0704-418800

E-mail [email protected]

Company� Description� &� Organization

Africa�Medec� is� an�African�distribution� company�with�direct�and� indirect� sales�networks� that�cover� the�whole�

of� East� and� Central� Africa.� Our� direct� locations� are� in� Kenya� and� Uganda� with� additional� partnerships�

throughout� the� whole� region.� We� specialize� in� the� import� and� distribution� of� medical� and� laboratory�

disposables.� Our� African� customers� include:� Clinics,� Private� Hospitals,� Government� Hospitals,� local� retailers�

and� Pharmacies.

Our� team� has� decades� of� experience� in� the� African�market� with�Western,� Eastern� and� local� products.� We�

strive� to� provide� exceptional� service� to� our� local� customers� and� our� international� partners.

2. Africa Medec Limited

1.� Corporate� General� Information

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부록 3� �중동·아프리카 전략적 협력사 디렉토리 ❚ 859

Corporate� Name Al� Mojil� Drug� Company

Head� Office� Address P.O.� Box� 2761� Safat� 13028� Kuwait

Facilities� City� &� Country Kuwait

Web-site� Address www.mojildrug.com

Contact

(Korean�

Business)

Name +� 965� 22923501-4,� 6,10-14

E-mail [email protected]

Company� History

Al� Mojil� Drug� Company� was� established� in� 1964� with� the� intention� of� distributing� pharmaceutical� and�

Nutritional� products� in� a� safe� and� hygienic� manner.

Company� Description� &� Organization

[Mission]

Provide� products� and� services� related� to� pharmaceutical,� nutritional,� consumer,� veterinary� and� medical�

equipments� to� our� customers� that� include� procurement,� custom� clearance,� storage,� distribution,�

maintenance� and� service.

[Vision]

To� be� the� leading� company� providing� innovative� medical� products� and� services� to� Customers� and� achieve�

high� market� share� in� every� business� that� we� engaged� into.

3. Al Mojil Drug Company

1.� Corporate� General� Information

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860� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name AlfaCure� Pharmaceuticals�

Facilities� City� &� Country Egypt

Web-site� Address www.alfacure.com

Contact

(Korean�

Business)

E-mail [email protected]

Company� Description� &� Organization

As� one� of� the� big� pharmaceutical� manufacturers� in� Egypt,� we� strive� to� provide� our� customers� with� top�

quality� medicines� in� most� therapeutic� groups.�

4. AlfaCure Pharmaceuticals

1.� Corporate� General� Information

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부록 3� �중동·아프리카 전략적 협력사 디렉토리 ❚ 861

Corporate� Name atco� pharma� for� pharmaceutical� IND

Head� Office� Address 35� El-Obour� Buildings� ­� Salah� Salem� road� ­� Cairo

Facilities� City� &� Country Egypt

Web-site� Address www.atcopharma.com

Contact

(Korean�

Business)

E-mail [email protected]

Company� Description� &� Organization

We� are� an� Egyptian� human� and� veterinary� pharmaceutical� We� Have� 4� production� lines:Tablets� -� Capsules�

-� solution� ­� suspension-solution-emulsion-powder�

[Vision]

To�be�One�of� the� leading� pharmaceutical� companies� in� Egypt� and� to� become� a� significant� global� player� by�

providing� high� quality,� affordable� and� innovative� solutions� in� Veterinary� &� Human� Pharmaceuticals.

[Mission]

ATCOPHARMA� is� dedicated� to� achieve� better� Human� &� Animal� welfare� through� Human� &� Animal� health�

care� through� developing� &� providing� new� solutions� for� customers� unmet� needs�while� offering� high� quality�

products.

5. Acto Pharma for Pharmaceutical IND

1.� Corporate� General� Information

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862� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name BCN� Limited

Head� Office� AddressPlots� 22/23,� Chief� T.� A.� Doherty� Layout,� Oregun� Industrial� Estate,� Ikeja,�

Lagos.

Facilities� City� &� Country Nigeria

Web-site� Address www.bcnplc.com

Contact

(Korean�

Business)

Name +234� 1� 496� 1765,� 811� 6091

E-mail [email protected]

Company� History

The� boots� Company� (Nig.)� Ltd.� was� incorporated� in� Nigeria� on� 12th� September,� 1960� as� a� wholly� owned�

subsidiary� of� the� Boots� Company� Plc,� Nottingham,� England,� one� of� Britain’s� largest� Pharmaceutical�

Companies� with� large� International� Business� and� considerable� investment� in� Pharmaceutical� research.

The� Company� became� a� Public� Company� on� 14th� February,� 1974� and� in� compliance� with� the� Nigeria�

Enterprises� Promotion� Decree� of� 1972,� 40%� of� the� company’s� equity� capital� was� acquired� by� Nigerian�

citizens� and� associations.� � Later,� in� 1974,� the� company� received� quotation� on� the� Lagos� Stock� Exchange�

(now� The� Nigerian� Stock� Exchange).

With�effect� from�January�1st�1974,�and� in�compliance�with� the�Nigeria�Enterprises�promotion�Decree�1977,�

60%� of� the� company’s� equity� capital� was� acquired� by� Nigerians� and� the� company� became� an� Associate�

Company� of� the� Boots� Company� Plc,� Nottingham,� England.

On� 27th� February� 1981,� the� company� commissioned� its� Pharmaceutical� Manufacturing� Plant� at� Oregun�

Industrial� Estate,� Ikeja,� thus� became� a�Manufacturing� as�well� as� a�Marketing� and�distribution�Organization.

On� 31st� July,� 1991,� the� Company� changed� its� name� from� the� Boots� Company� Nig.� Limited� to� BCN� Plc� to�

reflect� the� new� change� in� the� ownership� of� the� Company� while� still� retaining� foreign� technical� alliances.� �

The� Company� continues� to� enjoy� high� patronage� of� its� product� from� the� trade� and� institutional� business�

(Government� and� other� agencies)

6. BCN Limited

1.� Corporate� General� Information

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부록 3� �중동·아프리카 전략적 협력사 디렉토리 ❚ 863

Company� Description� &� Organization

[Mission]

To�protect� and� enhance� the�quality� of� lives� by�providing� innovative� and� affordable�healthcare�products� and�

services.� By� recognizing� and� rewarding� our� best� people� we� will� ensure� the� best� rate� of� return� for� our�

investors.

[Vision]

1.� To� provide� quality,� innovative� products� and� services,� with� the� aim� of� being� the� leading� Healthcare�

company� with� a� global� footprint.�

2.� To� become� a� leading� Healthcare� company� with� a� global� footprint� by� providing� quality� and� innovative�

products� and� services.�

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864� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

7. Beta Healthcare

1.� Corporate� General� Information

Corporate� Name Beta� healthcare

Head� Office� AddressP.O�Box�42569,�Mogadishu�Road�off�Lunga�Lunga�Road,� Industrial�Area,�

Nairobi.� 00100

Facilities� City� &� Country Kenya

Web-site� Address www.betacare.co.ke

Contact

(Korean�

Business)

Name +254� 20� 265� 2042,� 020� 265� 2089�

E-mail [email protected]

Company� Description� &� Organization

[vision� &� mission]

To�deliver�value� to�all� our� stakeholders�as�a� responsible�corporate�Citizen� that�provides�quality,� affordable�

medicines� &� products� globally.

Page 868: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

부록 3� �중동·아프리카 전략적 협력사 디렉토리 ❚ 865

Corporate� Name Biopharma

Head� Office� Address 7/16,� Block-B,� Lalmatia,� Dhaka-1207,� Bangladesh

Facilities� City� &� Country Kenya

Web-site� Address www.biopharmabd.com

Contact

(Korean�

Business)

Telephone +88-02-58157953,� 58150928,� 58151661

E-mail [email protected]

Company� Description� &� Organization

Biopharma� is� one� of� the� fast� growing� pharmaceutical� companies� in� Bangladesh.� It� is� now� manufacturing�

more� than� 250� products� including� life� saving� drugs� at� affordable� cost� and� committed� to� serving� the� need�

of� ailing� community� with� products� of� excellent� quality,� safety� and� efficacy� complying� the� guideline� of�

regulatory� requirements� of� WHO� cGMP� and� Quality� Management� System.�

[Research� &� Development� (R&D)]

Our� R� &�D� activities� are� based� on� the�motto� striving� for� the� timely� development� of� products� that� responds�

to� and� satisfies� the� customer's� needs.� Our� R� &� D� capabilities� not� only� allow� us� to� provide� you� with� what�

you� need� today,� but� also� provide� us� with� anticipation� and� innovation� to� provide� you�with� what� you� need�

tomorrow.� You� can� trust� our� products� as� we� guarantee� them.�

[Quality� Assurance� (QA)]

QA� Department� consists� of� highly� skilled� and� well� trained� personnel� always� follow� the� guideline� of� WHO�

cGMP� in� all� areas� of� operations� to� ensure� highest� quality� products.� It� is� well� equipped�with� most� modern�

and� sophisticated�equipments.� In�order� to�ensure�highest�quality� in�every� sector,�QA�Department�carries�out�

periodical� inspection� either� internal� (to� all� section� related� to� manufacturing)� and� external� (to� raw�material�

manufacturer).� The�Department� also�monitors� the� quality� of� finished� products� during� the� shelf� life� after� its�

marketing� and� distribution.�

8. Biopharma

1.� Corporate� General� Information

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866� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

[Production]

Our� production� lines� are� designed� to� meet� the� local� and� global� demands.� We� are� now� manufacturing�

products� of� almost� all� the� therapeutic� groups� in� different� dosage� forms� such� as� tablets,� capsules,� syrup¸�

suspension,� dry� powder� for� suspension,� cream,� ointment� and� injectables.�We� combine�machine� technology�

and� skilled� human� resources� to� produce� highest� quality� products.� The� production� lines� are� well� equipped�

with�high� tech�machinery.�All�machines�are�operated�by�well� trained�persons�and� supervised�by�our�experts.�

These�machines� are� also�maintained� and�upgraded� periodically� by� our� trained� and� experienced� engineering�

team� to� ensure� good� running� condition.�

[Mission]

To� serve� mankind�

To� build� customer's� trust� as� a� trusted� company� both� in� products� and� services.�

To� ensure� healthy� and� sustainable� growth� of� each� concern.�

To� maintain� the� quality� in� all� areas� of� operation� by� continuous� development� of� human� resources.�

To� build� strength� carefully� in� important� areas� that� offers� the� resources� for� tomorrow's� business�

opportunities.�

[Vision]

The� vision� of� Biopharma� is� to� play� the� leading� role� in� pharmaceuticals� sector� of� the� country� by� providing�

safe,� effective� and� finest� quality� products� which� will� bring� benefit� to� people� improving� quality� of� life.

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부록 3� �중동·아프리카 전략적 협력사 디렉토리 ❚ 867

Corporate� Name Cadila� Pharmaceuticals� (EA)� Ltd

Head� Office� Address P.O.� Box� 79642,� Nairobi� 00200

Facilities� City� &� Country Kenya

Web-site� Address www.cadilapharma.com

Contact

(Korean�

Business)

Telephone 0722-509988,� 0731-786006

E-mail [email protected]

Company� Description� &� Organization

[Vision]

“Our� vision� is� to� be� a� leading� pharmaceutical� company� in� India� and� to� become� a� significant� global� player�

by� providing� high� quality,� affordable� and� innovative� solutions� in� medicine� and� treatment.”

[Mission]

“We� will� discover,� develop� and� successfully� market� pharmaceutical� products� to� prevent,� diagnose,� alleviate�

and� cure� diseases.

We�shall�provide� total� customer�satisfaction�and�achieve� leadership� in� chosen�markets,�products�and� services�

across� the� globe,� through� excellence� in� technology,� based� on� world-class� research� and� development.

We� are� responsible� to� the� society.� We� shall� be� good� corporate� citizens� and� will� be� driven� by� high� ethical�

standards� in� our� practices.”

9. Cadila Pharmaceuticals (EA) Ltd

1.� Corporate� General� Information

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868� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name Carrot-Top� Drugs� Limited

Head� Office� Address59,� Tapa� Street,� Opp� LSDPC� Housing� Estate� Entrance�Gate,� Ebute-Metta,�

Lagos.

Facilities� City� &� Country Nigeria

Web-site� Address carrottop-ng.com

Contact

(Korean�

Business)

Telephone +234� 1� 720� 4450,� (0)� 803� 304� 6802.

E-mail [email protected]

Company� Description� &� Organization

[Mission]

WE� AIM� TO� HELP� AT� LEAST� 100,000� NIGERIAN� COUPLES� ANNUALLY� achieve� pregnancy,� HAVE� HEALTHY�

BABIES� AND� MAINTAIN� HEALTHY� BALANCED� LIVES.

[Vision]

TO� BE� NUMBER� ONE� FERTILITY� SOLUTION� AND� WELLNESS� COMPANY� IN� NIGERIA

10. Carrot-Top Drugs Limited

1.� Corporate� General� Information

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부록 3� �중동·아프리카 전략적 협력사 디렉토리 ❚ 869

Corporate� Name Chemiron� International� Limited

Head� Office� Address Plot� 12,� Block� B,� Metal� Box� Road,� Ogba,� Lagos.

Facilities� City� &� Country Nigeria

Web-site� Address www.chemiron.org

Contact

(Korean�

Business)

Telephone +� 234� 1� 773� 5817

E-mail [email protected]

Company� Description� &� Organization

Chemiron� International� Limited,� formerly� known� as� Chemech� Laboratories� Nigeria� Limited,� was� established�

in� 1987� and� is� a� household� brand� today.

Our� commitment� and� business� purpose� is� clear;� to� provide� a�medium� of� healthcare,� which� is� quite� simply,�

superior� in� quality� and� delivers� real� health� value� to� our� consumers.

We� envision� being� an� African� market� leader� in� providing� nutritional� healthcare� supplements;� with� the�

demanding�work�and� lifestyle�patterns� today,�we�feel� it� is�crucial� for� supplemental�drugs� to�deliver�noticeable�

differences� to�our� consumers’�health,�drive�and�quality�of� life.�Our� focus�always� remains�on�prominent�health�

epidemics,� such� as� anaemia,� with� a� view� to� delivering� a� difference.

Our�products�are�developed�and�produced� through�extensive�and�careful� research�on� the�physiological�needs�

of� our� customers� base,� using� dedicated� manufacturing� and� logistical� facilities.

Chemiron’s� vision� for� the� next� five� years� will� revolve� around� expanding� our� product� base,� by� continuing�

research� into� ongoing� health� issues,�which� affect� a�wide� range� of� people.� Our� success� stems� from� gaining�

extensive� knowledge� about� a� condition,� before� proceeding� to� develop� formulas� that�make� a� visible� impact,�

quickly� and� effectively.

To� find� out� more� about� us,� working� with� us� or� for� any� other� queries� please� contact� us.

11. Chemiron International Limited

1.� Corporate� General� Information

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870� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name Cloriti� Pharmaceuticals� (EA)� Ltd

Head� Office� Address P.O.� Box� 2753,� Nairobi� 00202

Facilities� City� &� Country Kenya

Web-site� Address www.cloriti.co.ke

Contact

(Korean�

Business)

Name +254� 317871� 020-2597003/4,� 0720-578308

E-mail [email protected]

Company� History

It’s� no� coincidence� that� Cloriti� Pharmaceutical� so� strongly� believes� in� patient-inspired� design� through� true�

collaboration� between� our� experts� and� the� people� who� use� our� products.

Company� Description� &� Organization

We� provide� quality� health� care� products� and� � recognized� as� one� of� the� most� respected� Pharmaceuticals,�

Surgicals,� Veterinary� Medicine� and� Medical� &� Veterinary� Equipment� providers� in� East� Africa� by� both� the�

Health� Care� Community� and� the� families� that� entrust� us� with� servicing� their� healthcare� needs.

� Cloriti� Pharmaceutical� E.A� Ltd� is� a� full� service� provider,� offering� sales,� service� and� installation� of� medical�

equipment.� Our� trained� technical� staff� offer� high� quality� product� installation� and� timely� after� sales� service�

of� all� the� products� we� provide.

[Our� Mission]

To� provide� demonstrably� superior� medical� and� veterinary� products� that� empower� you� and� your� caregivers�

to� confidently� take� control� in� potentially� life-threatening� situations.

12. Cloriti Pharmaceuticals (EA) Ltd

1.� Corporate� General� Information

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부록 3� �중동·아프리카 전략적 협력사 디렉토리 ❚ 871

Corporate� Name Cosmos� Limited

Head� Office� Address P.O� Box� 41433,� GPO� 00100� Nairobi,� Kenya

Facilities� City� &� Country Kenya

Web-site� Address cosmos-pharm.com

Contact

(Korean�

Business)

Telephone +254� 20� 550700-9

E-mail [email protected]

Company� Description� &� Organization

The� importance� of�medicines� can� only� be� realized� if� they� are� readily� available� when� required.�With� that� in�

mind� Cosmos� started� in� 1978�with� the� sole� aim� of�manufacturing� quality�medicines� at� an� affordable� price�

for� Kenyans.

At� Cosmos� we� believe� quality� is� of� paramount� importance� and� there� is� only� 1� quality� when� it� comes� to�

medicines.� Adhering� to� strict� Good� Manufacturing� Practices� we� were� able� to� achieve� this� through� both�

public� and� private� partnerships.

With� over� two� hundred� registered� products,� Cosmos’s� aim� was� to� make� increase� the� quality� of� life,�

convenience�and�compliance�of� the�people.�Cosmos� is�now�a�3rd�generation� family�business�of� technocrats�

that�has�grown� to�have�a�presence� in�9�Sub�Saharan�African� countries�and�employ�400+�people.�Our� latest�

aim� is� to� gain� international� standard� recognition� through� WHO� prequalification� for� the� majority� of� our�

products

[Vision]

Self� sustainable� healthcare� for� East� Africa� driven� by� quality� and� affordability.

[Mission]

To� create� and� facilitate� the� development� of� value-added� Pharmaceutical� manufacturing.

[Strategy]

Use� high� quality�materials� and� production� technology� to� develop� highly� efficacious� products� with� constant�

supply.

13. Cosmos Limited

1.� Corporate� General� Information

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872� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name DANADAMS� PHARMACEUTICAL� INDUSTRY� GHANA� LIMITED

Head� Office� Address 67� Nungua� Link,� Spintex� Road,� Baatsona,� Accra-Ghana

Facilities� City� &� Country Ghana

Web-site� Address www.danadamsgh.com

Contact

(Korean�

Business)

Telephone +233� (0)� 30� 281� 1672� /� 1673

E-mail [email protected]

Company� Description� &� Organization

[Mission]

To�be� the�number�one� leader� in�quality� regional�healthcare� in�West�Africa,�with� the� largest�product�portfolio�

and� biggest� market� share,� using� good� people,� innovative� products� and� world-class� facilities� to� successfully�

create,� produce� and� sell� all� we� do.

[Vision]

Building�a� strong�company� that�will� create�a�healthy�Africa,�where�all�Africans�have�an�opportunity� to�make�

their� own� success� happen.�

14. DANADAMS PHARMACEUTICAL INDUSTRY GHANA LIMITED

1.� Corporate� General� Information

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부록 3� �중동·아프리카 전략적 협력사 디렉토리 ❚ 873

Corporate� Name Dawa� Ltd

Head� Office� Address P.O� Box� 16633-00620,� Nairobi,� Kenya.

Facilities� City� &� Country Kenya

Web-site� Address www.dawalimited.com

Contact

(Korean�

Business)

Telephone +254� 20� 856� 1554/3093/3467/4996;� 020� ­� 3569904

E-mail [email protected]

Company� Description� &� Organization

[Vision]

To� be� a� leading� and�most� respected� pharmaceutical� manufacturing� and� marketing� company� in� Africa� that�

is� renowned� for� supplying� top� quality,� accessible� human� &� veterinary� pharmaceutical� products.

[Mission]

To� enable� people� to� lead� happy,� healthy� and� quality� lives� by� manufacturing� and� supplying� trusted� quality�

healthcare� products� for� human� and� veterinary� use� on� a� sustainable� base.

15. Dawa Ltd

1.� Corporate� General� Information

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874� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name DBK� Pharmaceutical�

Head� Office� Address Zone� 11� block� 12014� Obour� city� industrial� zone,� Cairo,� Egypt

Facilities� City� &� Country Egypt

Web-site� Address www.dbk-eg.com

Company� History

DBK� Pharmaceutical� is� a� leading� integrated� global� pharmaceutical� company� engaged� in� the� development,�

manufacturing,� marketing� and� Sales� of� Pharmaceutical,� Herbal� Brands,� Food� supplements,� High� end�

cosmetics� and� veterinary� products.� Our� products� are� penetrating� in� many� emerging� markets.

DBK� Pharma� is� one� of� the� fastest� growing� Egyptian� Companies� in� the� pharmaceutical� industry� concerned�

with� the� discovery,� development� and� commercialization� of� innovative� medicines� that� have� a� meaningful�

impact� on� improving� the� quality� of� the� products,� driven� by� entrepreneurial� spirit,� commitment� to� integrity�

and� deep� respect� for� people's� health� and� community.

Company� Description� &� Organization

DBK� Pharmaceutical� is� a� leading� integrated� global� Pharmaceutical� Company� engaged� in� development,�

Manufacturing� Marketing� and� sales� of� pharmaceutical

[Vision]

To� be� one� of� the� top� 20� Pharmaceutical� Companies� listed� in� Egypt�within� the� next� five� years,� keeping� our�

focus� on� penetrating� the� International� Pharmaceutical� Markets,� meeting� the� challenges� as� a� Multinational�

Company�within� the�next�decade,� through� the�highest�performance� levels�of�QA,�QC,�R&D�and�professional�

calipers� to� become� Egypt’s� most� valued� Pharmaceutical� company� to� the� patients� ,� costumers,� colleagues,�

shareholders,� business� partners� and� the� communities� where� we� work� and� live� in,� by� development� and�

innovation� to� produce� high� quality� products� with� affordable� prices.

[Mission]

DBK� is� an� Egyptian� pharmaceutical� company.� At� DBK� Pharma,� we� offer� a� diversity� of� pharmaceutical�

products� in� the�Egyptian�market.�DBK�Pharma,�over�decades�of� successes�and�growth,�we�expand�our�scope�

through�a�variety�of� services�within�our�business�portfolio,� and� through�exploring�new� international�markets.

We� are� driven� to� walk� the� extra� mile,� ensuring� that� we� serve� all� our� customers� with� superior� service,� by�

being� their� reliable�partner� to�a�better�healthy� life�with� the�highest�quality�&�affordable�prices.� This�will�only�

be�done�by�utilizing� the�best�marketing�practices� through�our�well� trained�human� resources,�and�our� strong�

network�of� relations�with�multiple� channels� in� the�Egyptian,�African,�Middle�East� and�Balkans�pharmaceutical�

markets.

16. DBK Pharmaceutical

1.� Corporate� General� Information

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부록 3� �중동·아프리카 전략적 협력사 디렉토리 ❚ 875

Corporate� Name Elys� Chemical� Industries� Ltd�

Head� Office� Address P.O� Box� 40411,� Nairobi� 00100

Facilities� City� &� Country Kenya

Web-site� Address www.elyschem.com

Contact

(Korean�

Business)

Telephone +254� 20� 650503-10,� 2334036/7� 2321999/2000

E-mail [email protected]

Company� Description� &� Organization

Welcome� to� Elys� Chemical� Industries� Ltd,� a� Pharmaceutical� manufacturing� company� in� Kenya,� with� origins�

dating� back� to� 1961.� The� company� is� known� for� its� high� technical� standards� and� has� competent� and�well�

equipped� Production� and� Quality� Control� departments� which� adhere� to� the� Good�manufacturing� practices�

(cGMP)� as� laid� down� by� the� Pharmacy� and� Poisons� Board,� Kenya.

The� company� has� a� good� distribution� network� in� the� country� and� also� exports� to� neighboring� countries.�

17. Elys Chemical Industries Ltd

1.� Corporate� General� Information

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876� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name Emzor� Pharmaceuticals� Limited

Head� Office� AddressPlot� 3c,� Block� A,� Aswani� Market� Road,� Isolo/Apapa� Exp.way,� Oshodi,�

Lagos.

Facilities� City� &� Country Nigeria

Web-site� Address www.emzorpharma.com

Contact

(Korean�

Business)

Telephone +234� 1� 452� 3570,� 452� 3721,� 452� 7160

E-mail [email protected]

Company� Description� &� Organization

Emzor�Pharmaceutical� Industries�Limited� is� a�wholly�private� indigenous�pharmaceutical�manufacturing�group�

founded� in� 1984� by� Dr.� Stella� C.� Okoli,� OON.� The� company� is� into� the� manufacture� of� high� quality�

pharmaceutical� products� and� medical� consumables.� Its� holding� company,� Emzor� Chemists� Limited� opened�

for� retail� business� in� January� 1977� in� Yaba,� Lagos.

The� rapid�growth�of� the� retail� business�encouraged�Emzor�Chemists� Limited� to�venture� into� the� importation�

and� wholesale� of� assorted� pharmaceuticals.� The� idea� to� manufacture� locally� came� later� and� this� was�

predicated� on� the� need� to� develop� local� capability,� create� jobs� and� provide� high� quality� pharmaceutical�

products� and� services� to� the� Nigerian� people� at� prices� that� are� not� only� affordable� but� represent� value.

Emzor� Pharmaceutical� Ind.� Ltd.� started� pilot� production� in� 1985.� By� 1988� it� had� become� an� established�

pharmaceutical� manufacturing� company� especially� with� the� introduction� of� Emzor� Paracetamol� which� is�

today� a� leading� brand� of� analgesic� not� only� in� Nigeria� but� across� Sub� Saharan� Africa.

The� company’s� factory� is� located� in� the� Isolo� industrial� area� of� Lagos� with� facilities� to�make� a� wide� variety�

of� high� quality� pharmaceutical� products� that� meet� international� standards� at� affordable� and� competitive�

prices.� All� Emzor� products�meet� the� highest� international� standards� and� are� duly� registered�with� NAFDAC.

The� then� secretary� of� Health� to� the� Interim� National� Government� Dr.� Christopher� Okojie� officially�

18. Emzor Pharmaceutical Limited

1.� Corporate� General� Information

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부록 3� �중동·아프리카 전략적 협력사 디렉토리 ❚ 877

commissioned� the� company’s� factory� in� July� 1993.� The� company� has� since� attracted� foreign� missions,�

scholars,� and� students� of� pharmacy,� microbiology� and� chemistry.� In� April� 1999,� Prof.� Debo� Adeyemi,� the�

Honorable� Minister� of� Health,� commissioned� the� factory� extension.

From� the� modest� beginning� with� four� (4)� products� in� 1987,� we� now� manufacture� in� our� factory� a� wide�

range� of� products� in� the� analgesic,� anti-malaria,� vitamin/haematinics/multivitamin� supplement,�

anti-helmintic,� antibiotics� and� therapeutic� categories.� The� company� has� in� its� stable�more� than� 80� different�

products.

Today,� Emzor� has� become� a� household� name� in� Nigeria� and� a� leader� in� the� pharmaceutical� market� that� is�

known� for�quality�products� at�prices� that�offer� real� value.� These�products� are�widely� distributed� throughout�

Nigeria� and� the�West� African� coast.� Our� commitment� is� to� produce� and� deliver� flawless� products� on� time�

and� every� time.

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878� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name Entrance� Pharmaceuticals� &� Research� Center

Head� Office� AddressNo.� 16� Okpoi� Gonno,� Spintex� Road� Post� office� Box� CT� 10805,� Accra� -�

Ghana,� West� Africa

Facilities� City� &� Country Ghana

Web-site� Address www.entrancepharmaceuticals.com

Contact

(Korean�

Business)

Telephone +233� 507� 067� 750

E-mail [email protected]

Company� Description� &� Organization

Entrance� Pharmaceuticals� and� Research� Centre� is� the� manufacturing� subsidiary� of� Tobinco� Group,�

commissioned� in� the� first� quarter� of� 2014.� The� company� manufactures� non-sterile� preparations,� including�

anti-malarials,� Antiretroviral� and� other� essential� medicines� in� line� with� WHO� recommendations.� Dedicated�

facilities� have� been� provided� for� the� manufacture� of� beta-lactams� (penicillin)� and� non-beta-lactams�

(non-penicillin).

The� company’s� goal� is� to� produce� quality� essential� medicines� in� line� with� national� and� international�

requirements� for� the� local� market� and� for� export.� Entrance� Industries� aims� at�WHO� prequalification�which�

will� enable� the� company� to� participate� in� international� procurement� mechanisms.

With�a�vision� to�build� the�capacity�of� the� local�Pharmaceutical� industry,�Entrance� Industries�has� incorporated�

into� its� set� up� a� Research� centre� in� collaboration� with� the� University� of� Ghana� School� of� Pharmacy.� The�

Research� Centre� is� equipped� with� the� most� modern� equipment� and� facilities� to� help� advance� studies� in�

Pharmaceutics� and� product� development.

[Mission]

To� meet� the� pharmaceutical� needs� of� the� sub-region� by� using� innovative� approaches� to� deliver� premium�

quality� products� through� our� highly� trained� and� dedicated� staff� in� a� qualified� premise.

[Vision]

To� be� the� Premium� Provider� of� quality� pharmaceutical� products

19. Entrance Pharmaceuticals & Research Center

1.� Corporate� General� Information

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부록 3� �중동·아프리카 전략적 협력사 디렉토리 ❚ 879

Corporate� Name Ernest� Chemists� Limited� Head� Office

Head� Office� Address P.O.BOX� 3345,� ACCRA,GHANA

Facilities� City� &� Country Ghana

Web-site� Address www.ernestchemists.com

Contact

(Korean�

Business)

Telephone +233-(0)-302-257-140� /� 141� /� 142

E-mail [email protected]

Company� Description� &� Organization

Ernest�Chemists� started�business� in�1986�as�a� sole�proprietorship�and� in�1993�became�a� limited� liability.� The�

company� is� the� brainchild� of� Ernest� Bediako� Sampong,� a� pharmacist� by� profession.� As� a� mere� one-shop�

business� in� 1986,� Ernest� Chemists� has� grown� very� rapidly� into� a� large� pharmaceutical� entity.�

Ernest� Chemists� has� three� business� structures;� trading,�manufacturing� and� export.� The� company� represents�

some� of� the� world’s� leading� pharmaceutical� brands� and� operates� an� extensive� network� of� distribution�

channels� throughout� the� country.� Inventory� management� is� coordinated� from� a� newly� built� warehouse� in�

Accra� .�

With� the� goal� of� establishing� itself� as� a�major� player� in� the� pharmaceutical� industry� in�Africa,� the� company�

in� 2001� setup� its� own� manufacturing� plant� in� Tema(Ghana)� equipped� with� modern� machinery� and�

equipment.

In� furtherance� of� its� goals� and�objectives,� a� new�penicillin� plant� is� under� construction� to� ensure� production�

activities� are� properly� segregated� to� prevent� the� incidence� of� cross� contamination.�

The� company’s� export� development� programme�which� came� on� stream� in� 2004�with� direct� export� to� Cote�

d’lvoire,� Senegal,� Burkina� Faso� and� Nigeria� to� mention� but� a� few,� saw� the� opening� of� its� first� foreign�

subsidiary� in� Freetown,� Sierra� Leone� in� September� 2009.� On� the� local� scene,� the� company� has� thirteen�

wholesale� and� pharmacy� retails� .

20. Ernest Chemists Limited Head Office

1.� Corporate� General� Information

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880� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name Escorts� Pharmaceuticals� Ltd

Head� Office� Address P.O� Box� 31029,� Kampala,� Uganda

Facilities� City� &� Country Uganda

Web-site� Address escortspharma.com

Contact

(Korean�

Business)

Telephone +256� 706� 169022

E-mail [email protected]

Company� Description� &� Organization

Escort�Pharmaceuticals� � Ltd� is�a�Ugandan�home�grown�company� that� is� an� innovative� sourcing�&�distribution�

company,� involved� in� both� exclusive� representation� and� regional� supply� of� a� wide� range� of� quality,�

affordable� and� accessible� health� care� solutions.

Besides� for�our�core�pharmaceutical�business� in�Uganda,�we�are�an� integrated� supplier�with�strong�presence�

across� the� entire� value� chain� from� key� in� improving� access� and� affordability

With� over� 13� years� of� experience� and� success� in� the� sourcing� and�distribution� of� Health� care� solutions,�we�

have� grown� to� exert� country� wide� reach� in� Uganda� and� our� business� segment� now� includes;�

pharmaceuticals,� diagnostics,� � surgical� equipment� and� Hospital� sundries.

21. Escorts Pharmaceuticals Ltd

1.� Corporate� General� Information

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부록 3� �중동·아프리카 전략적 협력사 디렉토리 ❚ 881

Corporate� Name Evans� Medical� Limited

Head� Office� Address Plot� 6,� Abimbola� Way,� Isolo� P.M.B.� 1120,� Apapa,� Lagos.

Facilities� City� &� Country Nigeria

Web-site� Address www.evansmedicalplc.com

Contact

(Korean�

Business)

Name +234� 1� 790� 1401-8

E-mail [email protected]

Company� History

1.� Evans� Medical� PLC� was� incorporated� in� 1954� under� the� name� Allen� &� Hansbury� [Nigeria]� Limited.

2.� In� 1958,� the� company� was� merged� with� GLAXO� LABORATORIES� LIMITED.

3.� In� 1970� the� name� of� the� company� was� changed� to� GLAXO� NIGERIA� LIMITED.

4.� In� 1976� the� company� name� changed� to� GLAXO� NIGERIA� PLC,� [indigenisation� policy].

5.� In� 1979,� the� company� was� listed� on� the� Nigerian� Stock� Exchange.

6.� 1982� ­� Opening� of� factory� at� Agbara� Industrial� Estate

7.� In� 1994,� the� name� changed� to� EVANS� MEDICAL� PLC.

8.� 1997� -� Developed� EVANSGEL;� 1st� locally� manufactured� Pharma� excipient.

9.� In�2003� -� Forged�a� JV�Alliance�with� India’s�Pharma� Industry�Giant�CIPLA�Ltd� that�gave�birth� to�a�Subsidiary�

company,� CiplaEvans� Nig.� Ltd.� in� 2004.

10.� In� 2007,� we� commissioned� a� purpose� built� plant� for� Penicillin� Antibiotics.

11.� In� 2010� ­� Completed� Factory� Modernization� Programme

12.� In� 2014� ­� A� corporate� identity� change/rebranding� of� the� Strategic� Business� Unit,� Cipla� Evans� to� Evans�

Therapeutics� Limited� took� place.�

Company� Description� &� Organization

[Mission]

To�be� in� the�business�of� improving� the�health�of� the�people,� through� research,�development,�manufacturing�

&� marketing� of� safe� and� effective� pharmaceutical� and� nutraceutical� products� of� sustainable� quality,� caring�

for� our� people� and� creating� reasonable� and� sustainable� wealth� for� shareholders.

22. Evans Medical Limited

1.� Corporate� General� Information

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882� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name Fidson� Healthcare� Limited

Head� Office� Address Olabode� House,� 215/219� Ikorodu� Road,� Obanikoro,� Lagos.

Facilities� City� &� Country Nigeria

Web-site� Address www.fidson.com

Contact

(Korean�

Business)

Telephone +234� 1� 493� 3319

Company� History

Fidson�Healthcare�Plc� is� a� leading�pharmaceutical�manufacturing� company� in�Nigeria.� Founded� in� 1995,�we�

have� relentlessly�pursued�our�goal�of�becoming�a� leading�player� in� the�pharmaceutical� landscape� in�Nigeria.�

Ever� since,� we� have� built� and� cultured� an� organizational� framework� that� has� steadily� helped� us� gain�

ascendancy� in� the� industry.�We�have� crafted� the� pharmaceutical� architecture� of� the� industry� over� the� years�

of� our� existence,� playing� very� defining� roles� in� the� emergence� of� the� new� generation� of� industry� players.�

Innovation,�Excellence,�Passion,� Integrity� and�Ownership...are� five� core� values� that� form� the� substructure�on�

which�we�have�built� a�world-class�company� that�has�earned� the� respect�and�admiration�of�even� the� fiercest�

of� our� competitors.

Our� long� standing� certification� as� an� NIS:ISO� 9001:2008� is� a� good� evidence� of� our� high� standards� of�

processing�and�operations.�We�have� left�no� stone�unturned�to�ensure� that�our�operations� �go�well� together�

with� the� best� of� practices� globally.

Company� Description� &� Organization

[Mission]

To�be� the�preferred� company� that� adds� value� to� life�with�brands� that� deliver� sustainable� profitable� growth.

[Vision]

To� become� the� preferred� leading� healthcare� provider� in� our� sub-region.

23. Fidson Healthcare Limited

1.� Corporate� General� Information

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부록 3� �중동·아프리카 전략적 협력사 디렉토리 ❚ 883

Corporate� Name Gemini� Pharma� Limited

Head� Office� AddressPlot� 13,� Block� A,� Amuwo-Odofin� Industrial� Estate,� Apapa-Oshodi�

Expressway,� Lagos.

Facilities� City� &� Country Nigeria

Web-site� Address www.geminipharmltd.com

Contact

(Korean�

Business)

Telephone +234� 1� 474� 4974,� 790� 1184.

E-mail [email protected]

Company� History

Gemini� Pharmaceuticals�Nigeria� Limited�was� incorporated� in� 1972�by� Bayer�A.G.� Leverkusen,� and�Dr.�M.� B.�

Unuane�with� sole�objective� to�market�and�manufacture�Bayer�AG's�Pharmaceutical� Specialties� in�Nigeria.�At�

the� inception,�60%�of� its� shares�was�owned�by�Bayer�AG�Leverkusen,�West�Germany�and�40%�by�Nigerians.�

In� 1974,� a� Joint� Venture� agreement� was� signed� between� Dr.� M.� B.� Unuane,� Dr.� T.� A.� Odutola� and� Bayer�

AG,� Leverkusen.� The� name� was� changed� to� Bayer� Pharmaceuticals� Nigeria� Limited.� The� then� company�

acquired� 12� acres� of� land� at� Apapa� /� Oshodi� Express� Amuwo-Odofin,� Lagos� for� the� purpose� of� erecting�

Pharmaceutical�Manufacturing�Company.� The�ultra�modern� factory�was� commissioned� in�1982.�Commercial�

activities� also� commenced� the� same� year.�

In� the� late� 80’s,� Bayer� A.G.,� as� part� of� its� global� policy� decided� to� disengage� from� its� activities� in� the� third�

world� countries� to� allow� indigenes� to� own� and�manage� their� subsidiary� companies.� The� share� of� Bayer� AG�

and� Dr.T.� A.� Odutola� was� acquired� by� DR.�M.� B.� UNUANE� and� the� company�was� formally� handed� to� him �

on� 30th� June� 1993.� It� reversed� to� its� original� name� "Gemini� Pharmaceutical� Nigeria� Limited".� With� a�

Franchise�and�Licence�Agreement,� to� continue� to�manufacture�Bayer�AG�Pharmaceutical� Specialist� in�Nigeria�

until� 2002.�

Company� Description� &� Organization

[Mission]

Gemini�Pharmaceuticals� (Nig.)� Ltd�seeks� to�excel� in� the�provision�of�effective�and�dynamic�healthcare�delivery�

through� the� manufacturing� of� high� quality� pharmaceutical� products,� education,� medical� services� and�

research.�

[Vision]

To� be� the� foremost� Manufacturer� of� High� Quality,� Trusted� and� Affordable� Pharmaceutical� Products.

24. Gemini Pharma Limited

1.� Corporate� General� Information

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884� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name Haltons� Pharmacy

Head� Office� Address P.O� Box� 8334,� Nairobi� 00200

Facilities� City� &� Country Kenya

Web-site� Address www.haltons.co.ke

Contact

(Korean�

Business)

Telephone +254� (0)736� 994� 470� +254� (0)737� 994� 450� 0705� 015� 501

E-mail [email protected]

Company� Description� &� Organization

Haltons� Pharmacy� is� a� brand� created� by� Haltons� Limited.� It� is� a� collection� of� pharmacists,� investors� and�

leaders� passionate� about� delivering� accessible� and� affordable� pharmacy� care� of� the� highest� quality� to�

Kenyans� in� a� dignified� manner� wherever� they� are.

Haltons� Pharmacy� is� a� retail� pharmacy� chain� dispensing� prescription� and� non-prescription� pharmaceutical�

products.� The� company� has� retail� outlets� located� mostly� in� high� traffic� residential� estates� capitalizing� on�

volumes� created� by� health� care� medicine� prescribers� to� the� average� Kenyan� consumer.

[Mission]

Establish�Haltons� Pharmacy� as� the� trusted� chain� pharmacies,� that� are� conveniently� located� and�offer� quality�

products� that� support� the� health� care� needs� of� a� growing� City/Nation/Continent� Medium� Term� Plan

•� To� be� the� leading� brand� in� the� retail� pharmaceutical� market� in� Kenya

•� To� be� easily� accessible� and� available� to� meet� our� clients'� needs

[Vision]

A� healthy� and� productive� Kenyan� population� participating� in� National� building� from� access� to� affordable�

pharmacy� &� non� pharmacy� care� that� is� of� highest� quality� and� convenience.

25. Haltons Pharmacy

1.� Corporate� General� Information

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부록 3� �중동·아프리카 전략적 협력사 디렉토리 ❚ 885

Corporate� Name Harley’s� Ltd�

Head� Office� Address P.O.� Box� 42718,� Nairobi� 00100

Facilities� City� &� Country Kenya

Web-site� Address www.harleysltd.com

Contact

(Korean�

Business)

Telephone +254� 3747380/90/91/92,� 0722-202030

E-mail [email protected]

Company� History

Harley's� Limited� is� a� company� registered� in� 1953� that� deals� in� the� sales,� marketing� and� distribution� of�

healthcare� products,� pharmaceuticals,� surgical-equipment,� medical� equipment,� ophthalmic� equipment,�

theatre� equipment� and� OTC� products.� The� volume� of� business� � generated� since� the� current� management�

took�over� from� �1975�has� continued� to�grow�steadily.�At� the� time�of�acquisition�by� the� current�management�

the� company�purely� traded� in�Pharmaceuticals� in�Kisumu�(western�Kenya)�as�a�Wholesale�Dispensing�Chemist�

which� is� still� functional.

In� 1983,�with� the� steady� growth�of� business� and�with�a� view� to� expanding� in� agency� business�&� cover� the�

total� Kenyan� market,� warehouses� and� offices� were� established� in� Nairobi.� Nairobi� being� the� capital� of� the�

country�was� a� center� for� such� business.� Since� then,� till� today,� there� has� been� no� stopping�or� looking�back.�

Due� to� the� growing� market� demand� and� pressing� need� to� excel� in� our� service,� we� have� now� opened� our�

Branch� in�Mombasa.�We� are� happy� to� say� that�we�have� been� appointed� by� 49� International� Companies� as�

their� sole� distributor� in� Kenya.� We� have� been� entrusted� with� the� challenging� job� of� doing� the� Marketing�

&�Distribution� combined�with� Brand� Promotion� and� to�meet� up�with� the�market� requirements.� Apart� from �

the�above�mentioned�Human�Medicines� /�Pharmaceutical� sector,�we�are�also�catering� to� the�veterinary� sector�

with� a� wide� range.

Apart� from�Nairobi,�we�also�have�a� strong�distribution�base� for�pharmaceuticals,� surgical� equipment,�medical�

equipment� and� hospital� furniture� in� Kisumu� as� well� as� in� Mombasa.� With� our� widespread� operation� of�

coverage� of� outlets� and� distribution� network� spread� all� over� the� country,� we� are� also� proud� to� be� the�

sub-distributors� for� many� International� Pharmaceutical� companies� as� well� as� local� manufacturers� operating�

26. Harley's Ltd

1.� Corporate� General� Information

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886� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

in�Kenya.� In�order� to� justify� full�network�of�distribution�and�marketing� throughout�Kenya,�we�have�appointed�

sub-distributors� in� all� major� towns� and� trading� centers.� We� also� are� on� the� approved� list� of� suppliers� of� a�

number�of�N.G.O.'s,�Government�procurement�agencies�and�a�number�of�Private�Procurement�Agents�both�

within� Kenya� and� Internationally.

Over� the� years,� we� have� developed� a� good� relationship� through� committed� services� and� ready� availability�

of� products,�with� all� our� customers� and�most� others� in� the�medical� field.�We� also� cater� to� tender� business�

apart� from� supplying� products� on� quotation� basis� to� all�major� hospitals� and� institution�where� our� business�

is� very� credible.� We� have� been� catering� to� the� government,� private� institutions,� parastatals,� NGO's� and� all�

major� hospitals� and� pharmacies� in� Kenya� for� the� last� 21� years.

We�have� separate� departments�handling�Sales�&�Marketing,�Distribution�&�Dispatch,� Finance,� Imports,�H.R.,�

I.T.,� and�Drug� Registration�&�Regulatory� Affairs.� Each� of� our� Departments� has� a� team� comprising� of� highly�

qualified� and� experienced� professionals� in� the� respective� fields.� We� promote� the� products� of� our� various�

suppliers� through� a� current� vibrant� and� enthusiastic� team� of� 48� medical� representatives� apart� from� the�

marketing� expatriates� from� the� principal� themselves.

We� have� a� good� delivery� system� in� each� of� our� branches� to� deliver� through� our� own� Delivery� vans�

accompanied�by� our� own�delivery� persons� to� provide� personalized� service.� For�Orders� received� from� certain�

remote� customers,� we� have� a� very� good� tie-up� with� the� leading� courier� and� parcel� service� providers� who�

ensure� that� our� customers� get� the� goods� on� time.

Company� Description� &� Organization

[Mission]

Harleys� Ltd.� is� committed� to�ensure� that�both� internal� and�external�customers� satisfaction� that�shall�promote�

socio-economic� progress� in� health� care.

[Vision]

To�be� the� leader� in� the�distribution�and� sales� in�healthcare�and�consumer�products� segments� in�East�Africa.

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부록 3� �중동·아프리카 전략적 협력사 디렉토리 ❚ 887

Corporate� Name Impact� Chemicals� Ltd�

Head� Office� Address P.O.� Box� 3977� Nairobi� 00200

Facilities� City� &� Country Kenya

Web-site� Address www.impactchemicals.co.ke

Contact

(Korean�

Business)

Telephone +254� 552325/651864

E-mail [email protected]

Company� History

JAN� 2000

Impact� Chemicals� was� registered� as� a� business� partnership� by� two� youthful� entrepreneurs� who� would�

eventually� become� its� founding�directors.�At� the� time� the� business� did� not� have� any� operating� premise� but�

conducted� manufacturing� activities� within� the� living� room� of� the� two� partners.� The� company� mainly�

specialized� in� the� manufacture� of� beauty� products� like� body� lotions,� curl� activator� gels,� perfumes,� hair�

shampoos� and� conditioners,� and� to� a� very� limited� extent� a� few� detergents� for� domestic� use.� Impact’s�main�

customers� at� the� time� were� beauty� shops� and� salons.� These� products� were� sold� door� to� door� from� salon�

to� salon� by� the� two� partners� who� at� one� time� also� operated� a� small� distribution� outlet.�

APR� 2004

The� company� was� incorporated� and� became� a� limited� liability� company� with� the� two� partners� as� the�

founding�directors.�At� the� same� time�company�moved�out�of� the�estates� to� their� first� ever� industrial�premise�

which� was� a� single� room� on� the� 1st� floor� of� Laki� house� along� Lunga� Lunga� road.� The� focus� of�

manufacturing� shifted� from� the� manufacture� of� cosmetics� to� pharmaceutical� antiseptics� and� disinfectants.�

Jan� 2005

The�company�acquired� its� first� vehicle�a�Datsun�1200�pick-up�which�became�very�useful� in�making�deliveries�

to� customers.� A� salesman� and� driver� were� employed� to� boost� operations.� This� enabled� Impact� to� expand�

it's� client� base� to� the� larger� Nairobi� area� and� away� from� the� residential� estate.� At� the� same� time,� Impact�

expanded� it's� product� base� from� the� two� main� products� -� methylated� and� surgical� spirit.�

-� Later

27. Impact Chemicals Ltd

1.� Corporate� General� Information

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888� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

The�company’s� sales�activities� spread�out� to� towns� like�Mombasa,�Kisumu,�Bungoma,�Kitale,�Machakos,� etc.�

Fast� forward

Today� Impact� Chemicals� Ltd� stands� tall� among� industry� peers� with� over� 30� highly� valued� products� and� a�

stronger� passion� to� grow.�

Company� Description� &� Organization

[Mission]�

'To� excel� in� our� business� ventures,� through� sound� business� decisions,� dedication� &� commitment,� quality� &�

motivation�of�management�and� staff,� strategic�planning,� in-depth�market� knowledge,� creativity,� continuous�

development� and� a� clear� vision� for� the� future.� We� strive� to� attain:� Healthy� returns� on� our� investments,�

prestige� and� satisfaction� whilst� living� up� to� our� high� moral� values.

[Vision]�

To� be� reliable,� flexible,� responsive� and� to� offer� innovative� products� and� services,� and� to� have� exemplary�

product� knowledge.� Growth� and� financial� success� will� certainly� follow.

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부록 3� �중동·아프리카 전략적 협력사 디렉토리 ❚ 889

Corporate� Name INRAD

Head� Office� Address 14� Saudi� company� building,� 5th� floor,� Heliopolis,� Cairo,� Egypt

Facilities� City� &� Country Egypt

Web-site� Address www.inradcorp.org

Contact

(Korean�

Business)

E-mail [email protected]

Company� History

InRaD�Corporation� is� an� international� enterprise�with� core�competencies� in� the� fields�of�health�care,� applied�

sciences� and� high-tech�materials.� As� an� innovation� company,� it� sets� trends� in� research-intensive� areas.� Our�

products� and� services�are� designed� to� benefit�people� and� improve� the�quality� of� life.�At� the� same� time,�we�

aim� to� create� value� through� innovation,� growth,� and� community� service.�

InRaD� Corporation� exploits� patriot� approaches� towards� offering� a� bundle� of� solutions� to� an� interrelated�

complex� set� of� challenges.� Our� main� is� to� offer� short� term� as� well� as� long� term� sustainable� solutions� to�

Middle-East� and� African� challenges� through� basic� and� applied� science� which� can� provide� both� community�

services� and� develop� new� technologies�which� can� be� used� to� improve� life� standards� of� these� communities.�

InRaD�Corporation�promotes�novel� technologies,�quality� improvement,�cost� reductions,� efficient�energies�and�

access� in� community� development� through� highlighting� the� role� of� innovation� and� technology� through�

atmosphere� of� collaboration.�

InRaD� Corporation� plays� a� key� role� in� manpower� resource� development� through� training,� workshops,� and�

technology� transfer.�

InRaD�Corporation�offers�a�unique�group�of� services� that� include�health,� education,� environment,� innovation�

and� research.� The� landscape� in�which� R&D� can� be� implemented� today� has� changed� significantly� in� the� last�

decade.�

28. INRAD

1.� Corporate� General� Information

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890� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

InRaD� Corporation� has� a� network� of� well-developed� laboratories� carrying� out� research� on� target� sectors� of�

along� with� field� laboratories,� which� serve� as� testing� ground� for� new� technologies� and� help� in� technology�

transfer.�

InRaD� Corporation� is� providing� modules� to� predict� the� emergence� of� relevant� problems.� These� modules�

include� tools� and� scenarios� for� regional� and� global� prevention,� early� warning,� and� surveillance.� These�

advanced� tools� could� have� a� significant� impact� on� the� regional� decision� making� and� policy� development.�

National� and� international� agencies� would� benefit� immensely� from� their� utilization.�

Company� Description� &� Organization

We� are� working� in� the� field� public� health.� We� have� our� own� products� for� malaria� ,� filaria� ,� dengue� fever�

and� zika� virus� vector� control.�

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부록 3� �중동·아프리카 전략적 협력사 디렉토리 ❚ 891

Corporate� Name Kampala� Pharmaceutical� Industries

Head� Office� Address P.O� Box� 7551� Kampala,� Uganda

Facilities� City� &� Country Uganda

Web-site� Address www.kpi.co.ug

Contact

(Korean�

Business)

Telephone +256� 414� 285� 645� /� +256� 752� 285� 645

E-mail [email protected]

Company� History

June� 2002� -� In� collaboration� with� WHO� and� the� Ministry� of� Health� Launched� ‘Homapak’� a� Sulfadoxine�

Pyrimethamine� +� Chloroquine� combination� therapy� formulated� in� age� specific� single� use� dosage� packs� for�

children� between� the� age� of� 2� months� and� 5� years.� This� has� been� the� flagship� brand� in� the� Home� Based�

Management� of� Fever� strategy� launched� in� the� same� year� which� has� resulted� in� an� increase� in� children�

receiving� treatment� within� 24� hours� from� 7.3%� in� 2001� to� 55%� nationally� by� the� year� 2005.

January� 2006� -� Commenced� contract� manufacturing� of� Anti-malarials� and� Injectables

March� 2006� � -� Commissioned� a� Formulation�Development� Laboratory� equipped�with� stability� chambers� for�

accelerated� and� real� time� stability� studies� (First� in� Uganda)

August�2006�-� First� to� Locally�manufacture�and� launch�an�Artemesinin�Combination�Treatment� called�Duact�

(Artesunate� +� Amodiaquine)� in� Uganda

February� 2008� -� Commenced� contract� packaging� of� Medical� diagnostic� devices� and� reagents

March� 2008� -� Launched� the� first� Diabetic� drug� manufactured� in� Uganda:� Formin� (Metformin� Hcl)� for�

treatment� of� Type� II� Diabetes� Mellitus.

September� 2009� -� Launched� the� first� Anti-hypertensive� manufactured� in� Uganda:� Cardipac� (Amlodipine)

29. Kampala Pharmaceutical Industries

1.� Corporate� General� Information

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892� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

January� 2010� ­� Launched� our� official� Code� of� Ethics,� “Producing� medicines� with� integrity”

August�2010�-�Winner�of� the� international� Frost�&�Sullivan�product� leadership�of� the� year�award,�healthcare�

industry,� Uganda

May� 2011� ­� Opened� a� state� of� the� art� secondary� packaging� facility� for� third� party� contract� packaging� of�

medical� products.� Currently� we� carry� out� secondary� packaging� of:� reproductive� health� items� i.e.� Condoms,�

Oral� and� Parenteral� Contraceptives.

Company� Description� &� Organization

[Mission]

To� improve� the� accessibility� of� essential� medicines.

[Vision]

To� be� the� leading� provider� of� affordable� and� quality� healthcare� products� in� East� Africa

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부록 3� �중동·아프리카 전략적 협력사 디렉토리 ❚ 893

Corporate� Name Kuwait� Saudi� Pharmaceutical� Industries� Co.

Head� Office� AddressP.O.� Box:� 5512� Safat� -� Postal� Code:� 13056� Subhan� Industrial� Area,� State�

of� Kuwait

Facilities� City� &� Country Kuwait

Web-site� Address www.kspico.net

Contact

(Korean�

Business)

Telephone +965� 2474� 5012/� 3/� 4

E-mail [email protected]

Company� History

•�KPICO�(Kuwait�Pharmaceutical� Industries�Company)was�established� in�early�80’s� to� supply� the� local�market�

and� it� was� owned� by� the� Kuwait� Govt.

• KSPICO� was� designed� by� the� Swedish� co.� ASTRA� according� to� the� international� standards� for�

Pharmaceutical� Sites.� Unfortunately� when� Iraq� invaded� Kuwait,� the� company� suffered� severe� damages�

and� became� completely� paralyzed.� Many� of� the� machines� and� equipment� were� looted� by� the� Invading�

Iraqi� Army.

•� KSPICO�was� established� in� 1994,� as� a� Kuwaiti/Saudi� joint� venture,� that� took� over� the� ownership.� Saudi�

Shareholders� left� the� company� in� 2005� and� Securities� Group,� Kuwait,� purchased� their� share� since.

Company� Description� &� Organization

[Mission� &� Vision]

•� To� be� a� key� player� in� the� pharmaceutical� industry� in� the� Middle� East� and� North� Africa� with� a� strong�

platform� to� serve�attractive�markets�where�we�are� valued�as�a�highly� competent�and� reliable�health� care�

provider� with� customer� and� quality� focus.

•� To� distinctively� and� competitively� meet� the� ever-changing� demand� in� the� healthcare� with� a� unique�

portfolio� of� quality� medicines� at� well� designed� prices� to� serve� the� welfare� of� community.

•�Building�on�our� scientific,� technical� and� commercial� experiences� to� keep�providing� products� and� services�

with� an� added� value� to� patients,� consumers,� healthcare� professionals� and� stock� holders.

30. Kuwait Saudi Pharmaceutical Industries Co.

1.� Corporate� General� Information

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894� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name Kwality� Afro� Asia

Head� Office� Address Plot� 165,� Kawempe,� Bombo� Road,� Kampala� Uganda

Facilities� City� &� Country Uganda

Web-site� Address www.kaalug.com

Contact

(Korean�

Business)

Telephone +256� 414� 351� 700

E-mail [email protected]

Company� Description� &� Organization

Kwality� Afro� Asia� Limited� Uganda

Kwality� Afro� Asia� Ltd.� was� incorporated� in� Uganda� in� November� 2005.� Shortly� afterwards,� it� acquired� a�

license� from� Uganda� Investment� Authority.� The� manufacturing� of� pharmaceutical� formulations� i.e.� oral�

liquids,� external� preparations� and� topical� preparations� was� its� first� project� in� Uganda.� KAAL� is� a� privately�

held�company� founded�by�Captain�Abhay�Agarwal�with�strong� focus� in�Uganda�and�plans� to�expand� in�East�

Africa� initially� and� later� on� PAN� Africa.

KAAL� is� ranked�among� the� top� five� in�Uganda�and� is� leading� in�selected�position�areas� like�oral� suspensions�

and� syrups� and� external� ointments� and� creams.� Kwality� Afro� Asia� was� started� as� SSI� unit� manufacturing�

pharmaceuticals�and� started� its�commercial�production� in�2007with�only�4�products� registered�with�NDA�for�

manufacture� and� sale.

31. Kwality Afro Asia

1.� Corporate� General� Information

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부록 3� �중동·아프리카 전략적 협력사 디렉토리 ❚ 895

Corporate� Name Lab� and� Allied

Head� Office� AddressMombasa� road,� Opposite� Sameer� Business� Park.� Plot� No.� 209/10349�

Nairobi,� Kenya

Facilities� City� &� Country Kenya

Web-site� Address laballied.com

Contact

(Korean�

Business)

Telephone +254� 20� 8040306,� 2337478,� 8029485/7

E-mail [email protected]

Company� Description� &� Organization

[Mission]

To�acquire�an� innovative,�quality� and�affordable�product�portfolio�pertaining� to�major� therapeutic� segments�

with�dominant�presence� in�all�major�East�African�markets�by�harnessing� the�corporate�strength�of� talent�and�

technology� thus� becoming� a� highly� profitable� organization.�

[Vision]

To� be� the� market� leader� in� the� pharmaceutical� industry� with� ethics,� compassion� and� sensitivity.�

32. Lab and Allied

1.� Corporate� General� Information

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896� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name Lords� Healthcare� Ltd�

Head� Office� Address P.O� Box� 49397,� Nairobi� 00100

Facilities� City� &� Country Kenya

Contact

(Korean�

Business)

Telephone +254� 2717111-15

E-mail [email protected]

Company� Description� &� Organization

In�1977,� Lords�Pharmacy� (Retail)� Limited�was�established�with� the� intent� of� providing� its� immediate�Kenyan�

community�quality�medicinal�products�with�professional�pharmacy� services.�A�decade� later,� realizing� the�dire�

need� for� good� quality� pharmaceutical� products� at� affordable� prices,� the� business� model� was� transformed.�

The� company� then� shifted� its� core� business� towards� importation,� marketing� and� distribution� of�

pharmaceuticals� within� Kenya.

� During� its� 37� years� in� operation,� Lords�has�grown� into�Kenya’s� leading�pharmaceutical�marketing� company�

as�a� standalone�entity.� In�1996,� this�growth�prompted�a� change� in� the� corporate�name� to� Lords�Healthcare�

Limited.� At� the� same� time,� the� company� moved� to� its� present� premises� at� the� prestigious� office� complex,�

Capitol� Hill� Towers� (Ground� Floor),� Cathedral� Road,� Nairobi.

[vision]

To� be� the� trusted� market� leader� in� both� customer� service� and� in� providing� innovative� solutions� for� major�

unmet� medical� needs� in� the� healthcare� industry.

We� aim� to� be� the�most� trusted� and� feared� in� the� healthcare� industry-� trusted�by�our� customers� and� feared�

by� our� competitors.

[mission]

To�deliver�a�unique� contribution� to�better�healthcare.�We�aim� to� reduce�suffering�by�making�medicines�more�

affordable� and� accessible� through� innovation� and� excellent� customer� service,� thus� improving� the� quality� of�

life� of� the� people� around� us.

33. Lords Healthcare Ltd

1.� Corporate� General� Information

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부록 3� �중동·아프리카 전략적 협력사 디렉토리 ❚ 897

Corporate� Name M&G� Pharmaceuticals� Ltd

Head� Office� Address P.O.� Box� 1681,� Accra,� Ghana

Facilities� City� &� Country Ghana

Web-site� Address mgpltd.com

Contact

(Korean�

Business)

Telephone +233-(0)30-266-6868� /� 6613� /� 4758

E-mail [email protected]

Company� Description� &� Organization

The� company�was� established� in� 1989�when� its� current� owners� bought� production� facilities� from�Kingsway�

Chemists� Ghana� Limited,� a� division� of� United� African� Company� Limited� (UAC),� now� known� as� Unilever�

(Ghana)� Limited.�

� The� company� was� restructured� in� July� 1993� with� foreign� equity� under� the� Ghana� Investment� Promotion�

Centre� Act.�

� We� primarily� manufacture� products� on� the� Essential� Drug� List� &� National� Formulary� of� Ghana� published�

by� the� Ministry� of� Health.

34. M&G Pharmaceuticals Ltd

1.� Corporate� General� Information

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898� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name Mansoor� Daya� Chemicals

Head� Office� Address P.O.� Box� 2999� Dar-es-Salaam� Tanzania

Facilities� City� &� Country Tanzania

Web-site� Address mdchemicals.com

Contact

(Korean�

Business)

Telephone +255� 22� 2860130

E-mail [email protected]

Company� Description� &� Organization

Founded� in�1962�by�Mansoor�Daya� the� company� commenced�manufacturing�pharmaceuticals� and�aerosols.�

The�company� is� located� in�Dar-es-� Salaam,�Tanzania’s� largest�city.�The� factory� is� conveniently� located�on� the�

main� road� from� the� city� centre� to� the� international� airport.

Products� manufactured� included� generic� pharmaceuticals� as� well� as� formulations� developed� by� Mansoor�

Daya� (link� to� PRODUCTS).� X-pel� an� aerosol� insecticide� spray� and� No-Bite� an� insect� repellent� have� been�

household� names� in� Tanzania� since� the� company� began� and� continues� to� remain� popular.� X-pel� is� the�

leading� insecticide� spray� in� the� Tanzanian� market� and� is� also� exported� to� all� surrounding� countries.

The� company� is� highly� regarded� in� Tanzania� and� its� products� were� among� the� first� to� be� certified� and�

accredited� by� the� Tanzanian� Bureau� of� Standards.� The� company� has� been� the� recipient� of� several� national�

and� international� awards.� Recently� the� company�was� the� recipient� of� a�UNIDO�grant� to� convert� the�aerosol�

manufacturing�plant� from�using�CFC� (fluorocarbons)� implicated� in�erosion�of� the�Ozone� layer� to�Butane�gas.�

The� company� is� now� the� only� Tanzanian� manufacturer� of� environmental-friendly� aerosols.

35. Mansoor Daya Chemicals

1.� Corporate� General� Information

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부록 3� �중동·아프리카 전략적 협력사 디렉토리 ❚ 899

Corporate� Name Max� Pharmaceuticals� Ltd

Head� Office� Address P.O.� Box� 320,� Mlolongo� 00519

Facilities� City� &� Country Kenya

Web-site� Address www.maxpharmaceuticalsltd.com

Contact

(Korean�

Business)

Telephone 0755-555999,� 0738-772099,� 0715-576884,� 0724-948818

E-mail [email protected]

Company� Description� &� Organization

[Mission]

We� commit� ourselves� to� total� customer� care� by� delivering� world-class� products� and� services.�

[Vision]

To� be� the� leader� in� the� pharmaceutical� industry

36. Max Pharmaceuticals Ltd

1.� Corporate� General� Information

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900� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name Medipharm� Industries� (E.A.)� Ltd

Head� Office� Address P.� O.� Box� 6218,� Kampala� Uganda,� East� Africa

Facilities� City� &� Country Uganda

Web-site� Address medipharm.co.ug

Contact

(Korean�

Business)

Telephone +256� 090� 8888

E-mail [email protected]

Company� History

Medipharm� Industries� (E.A)� Limited�was� founded� in�1971�by�Rogers�Collins�Seguya�and�Mrs.�Rebecca�Seguya�

under� the� name� Overseas� Trading� Company� Limited.� During� that� time,� the� core� business� of� the� company�

was� importation� and� retailing� of� human�pharmaceutical� drugs� and�medical� devices.�However,� the� desire� of�

the� founders� was� to� go� into� manufacturing� of� pharmaceuticals.

In� 1978,� small�mixing� and� compounding�unit�was� started� as�Plot� 5,� Travin�House,�William�Street,� Kampala.�

Within� one� year,� and� due� to� rapid� expansion,� the� manufacturing� unit� was� moved� to� 1.2� acres� at�

Bweyogerere� on� Jinja� Road,� twelve� (12)� Kilometers� from� Kampala.� The� principal� place� of� business� and�

registered� office� is� plot� 65,� Kakajjo� road,� Bweyogerere.

In� the� year�1982,� the�business�name�was�changed�to�Medipharm� Industries� (E.A)� Limited.�The�name�change�

was� registered� with� registrar� of� companies� the� same� year.

Advanced� pharmaceutical� manufacturing� was� not� realized� until� 1984,� when� building� modifications� were�

made�and�procurement�of� critical�production�and�quality� control�were�done.�This�was�made�possible� through�

funding� from� the� International� Development� Agency� (IDA),� through� Uganda� Commercial� Bank.

Company� Description� &� Organization

[Mission]

We� are� a� health� solutions� company� manufacturing� and� distributing� quality� and� affordable� Pharmaceutical�

drugs� in� Uganda,� East� Africa� and� the�wider� COMESA� region.�We� create� an� all� inclusive�work� environment�

that� challenges� and� grows� people� while� providing� a� profitable� return� to� the� shareholders.

[Vision]

A� key� position� in� pharmaceutical� service� delivery� in� Uganda� and� the� wider� COMESA� region.

37. Medipharm Industries (E.A.) Ltd

1.� Corporate� General� Information

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부록 3� �중동·아프리카 전략적 협력사 디렉토리 ❚ 901

Corporate� Name MTK� Uganda� Limited

Head� Office� Address P.� O.� Box� 924,� Kampala.� Uganda�

Facilities� City� &� Country Uganda

Web-site� Address www.mtk.co.ug

Contact

(Korean�

Business)

Telephone [email protected]

E-mail [email protected]

Company� History

MTK�Uganda�Limited�was�established� in�1967�and� specialises� in�Animal�health,�Human�health,�Public�health�

and� Crop� Protection.

MTK� represents�many�prominent�Multinationals� and�has� the� capacity� to� represent�and� sustain�a�stable� supply�

of� allits� products� to� its� customers.

MTK� has� a� reputation� as� an� ideal� partner� for� companies� seeking� to� develop� markets� through� long� term �

business� relationships.� It� can�ease�and�expedite�market�entry�with�unique� combination�of�worldwide�business�

connections,� personal� industry� contacts� and� an� established� marketing� network.

Company� Description� &� Organization

[mission]

To�avail�high�quality�Pharmaceuticals,�equipment�and�chemicals�while�at� the� same� time�offer�maximum�value�

to� all� stakeholders

[vision]

Lead� in� the� provision� of� Innovative� Healthcare� Solutions.

38. MTK Uganda Limited

1.� Corporate� General� Information

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902� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name Neros� Pharmaceuticals� Limited

Head� Office� Address36,� Akin� Adesola� Street� Victoria� Island,� Lagos.� G.P.O.� Box� 7888,� Marina,�

Lagos.

Facilities� City� &� Country Nigeria

Web-site� Address www.nerospharma.com

Contact

(Korean�

Business)

Telephone +234� (0)� 803� 328�7447,� 803� 578�2355� ,� 803�578� 2302,� 803� 356�9048.

E-mail [email protected]

Company� History

NEROS�Pharmaceuticals�Limited�was� incorporated�as�a� limited� liability� company,�on�5th�of�August,�1986�with�

RC�NO�87634�and� she� started�operations�on� JUNE�1989�as� an,� importer� and�distributor� of� pharmaceuticals�

products.

It� is�wholly� an� indigenous� company� founded�by�Dr.�Poly� I.� Emenike,�Ph.D,�MON�who� is� the�Chairman/CEO.

In� the� last� few�years,�NEROS�Pharmaceuticals� Limited�has�maintained�a�steady�growth�and�progress,� in� spite�

of� the�global�economic� recession.� �Today,� the�company�has�more� than�100�branded�products� cutting�across�

different� therapeutic� classes� which� includes:� � Anti-malarials,� Multi-vitamins� (minerals),� Anti-bacterials,�

Anti-fungals,� Anti-hypertensives,� Analgesics,� Anti-diabetics� and�Anti-viral� etc,�with� a� staff� strength� of�more�

than� 100.

Company� Description� &� Organization

[Mission]

Our�Mission� is� to� consistently�deliver�quality�pharmaceutical� solutions� to� the�healthcare� sector�with�a� strong�

commitment� to� creating� value� for� all� stakeholders.

[Vision]

To� be� the� preferred� provider� of� quality� and� affordable� Pharmaceutical� products� that� add� value� to� life.

39. Neros Pharmaceuticals Limited

1.� Corporate� General� Information

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부록 3� �중동·아프리카 전략적 협력사 디렉토리 ❚ 903

Corporate� Name Orange� Drugs� Limited

Head� Office� Address Plot� 66/68,� Town� Planning� Way,� Ilupeju,� Lagos.

Facilities� City� &� Country Nigeria

Web-site� Address www.orangegroups.com

Contact

(Korean�

Business)

Telephone +234� 1� 496� 0036,� 493� 7526,� 493� 7528,� 493� 7507-9

E-mail [email protected]

Company� History

After�working� in�his� family-owned�Chemist� shop—�Eastern� Industrial�Chemist—�for�13� years,� Sir� Tony�Ezenna�

went� on� to� establish� his� own� pharmaceutical� company,� Orange� Drugs� Limited� (ODL)� leveraging� leadership�

and� managerial� skills� he� acquired� from� his� experience�with� Eastern� Industrial� Chemist.� ODL�was� registered�

and� incorporated� on� the� 20th� of� July,� 1988� with� Number� RC.� 115913.� Its� first� office� was� in� Ikenegbu,�

Owerri,� Imo� State� in� 1989� which� later� moved� to� Lagos� State� so� as� to� compete� favorably� locally� and�

internationally.� ODL'S� first� corporate� office�was� located� at� 4B,�Okupe� Estate,�Mende,�Maryland,� Lagos� and�

in� 2001,� the� Company�moved� to� its� present� Head�office� at� 66/68� Town�Planning�Way,� Ilupeju,� Lagos�with�

branches� in� different� parts� of� the� country.�

Orange� Drugs� is� a� limited� liability� company� with� authorized� fully� paid� share� capital� of� N5� million� Naira.� It�

is� involved� in� the� marketing� and� distribution� of� well-tested� drugs,� manufactured� in� Indonesia,� Italy,� India,�

Germany� and� the� United� States� of� America� with� the� Nigerian� consumer� in� mind.� Subsequently,� Orange�

Drugs� Limited� joined� the�beauty� care� industries� through� the� importation�of� soaps,� creams�and�other�beauty�

products.�By�2006,� the�Company� commenced�the� local�production�of�different�brands�of� soaps� in� Lagos�and�

this� was� aimed� at� boosting� the� Nigerian� manufacturing� sector� and� also� creating� jobs� for� the� populace.� In�

order� to�meet� up�with� the� challenges� in� the� global� economy,�Orange�Drugs� Limited� later� diversified� its� line�

of� business� by� the� establishment� of� Orange� Kalbe� ltd� and� Orange� West� Africa� Limited� leading� to� the�

formation� of� Orange� Group.�

Company� Description� &� Organization

[Value]

� Excellence

� Integrity

� TeamWork

� Customer� Focused

40. Orange Drugs Limited

1.� Corporate� General� Information

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904� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name Oss-Chemie� (K)� Ltd

Head� Office� Address P.O� Box� 68502� -� 00622,� Nairobi� Kenya

Facilities� City� &� Country Kenya

Web-site� Address www.osschemie.co.ke

Contact

(Korean�

Business)

Telephone +254-20-823804/� 254-20-2053725

E-mail [email protected]

Company� Description� &� Organization

[Mission]

To� meet� our� customers� dynamic� needs� by� manufacturing� quality� healthcare� products.

[Vision]

To� be� the� leader� in� the� pharmaceutical� industry.

41. Oss-Chemie (K) Ltd

1.� Corporate� General� Information

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부록 3� �중동·아프리카 전략적 협력사 디렉토리 ❚ 905

Corporate� Name Quality� Chemical� Industries

Head� Office� Address P.� O.� Box� 34871,� Kampala,� Uganda

Facilities� City� &� Country Uganda

Web-site� Address www.ciplaqcil.co.ug

Contact

(Korean�

Business)

Telephone +256� 312� 341� 100

E-mail [email protected]

Company� History

The� Government� of� Uganda� reached� out� to� Cipla� Ltd,� one� of� the� world’s� leading� pharmaceutical�

manufacturers,�urging� them� to�partner�with�a� local� firm,�Quality�Chemicals� Ltd� (QCL),� to�enable� the� country�

to� locally� manufacture� antiretroviral� drugs� to� combat� HIV/AIDS� and� anti-malarial� drugs.

This� was� premised� on� the� fact� that� over� 60%� of� HIV/AIDS� and� 80%� of� malaria� cases� are� in� Sub-Saharan�

Africa� yet� it� only�manufactures� 1%�of� the� required�medicines.� The� dependence� on� foreign� pharmaceutical�

imports� comes� with� several� challenges� like� high� costs� of� drugs,� stock-outs� in� health� facilities,� and� risk� of�

counterfeit� drugs.

What� is�more�worrying� is� that� the�World� Trade� Organization’s� (WTO)� Trade� Related�Aspects� of� Intellectual�

Property�Rights� (TRIPS)�agreement�bars�many�developed�pharmaceutical�manufacturing�giants� like� India� from�

supplying�medications� that� are� still� under� patent� at� an� affordable� price.� This� poses� a� great� threat� of� access�

to� lifesaving� medications� such� as� those� for� HIV/AIDS� and� highly� endemic� malaria� for� poor� countries� like�

Uganda.

However,� the� TRIPS� agreement� allows� Least� Developed� Countries� like� Uganda� to� set� up� pharmaceutical�

facilities� and�manufacture�medicines� that� are� still� under� patent.�QCL� took� advantage� of� the� flexibilities� and�

founded�QCIL�which�has�been�approved�by� the�World�Health�Organization� (WHO)�as�an�additional� contract�

manufacturing� site� for� Cipla� Ltd.’s� antiretroviral� and� antimalarial� drugs.

Company� Description� &� Organization

[Mission]

To�sustainably�avail� affordable�and�efficacious�medicines� in�order� to� improve� the�quantity� and�quality�of� life

[Vision]

To� become� a� center� of� excellence� in� the� manufacturing� of� quality,� affordable� and� newer� medicines

42. Quality Chemical Industries

1.� Corporate� General� Information

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906� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name Pharmaken� Ltd�

Head� Office� Address P.O� Box� 95625,� Mombasa� 80106

Web-site� Address www.pharmaken.net

Contact

(Korean�

Business)

Telephone +254� 2040269,� 2343454

E-mail [email protected]

Company� Description� &� Organization

Pharmaken� Ltd� is� a� business� leader� in� the� pharmaceutical� industry� in� Kenya� that� deals� with� the� supply� of�

pharmaceutical� products,� dental� materials� and� equipment.

[MISSION]

Our� mission� is� to� provide� high� quality� products� and� services� to� our� customers.� Pharmaken� ltd� is� also�

committed� to� maintaining� excellence,� respect,� and� integrity� in� all� aspects� of� our� operations� and� our�

professional�and�business� conduct.�We�strive� to� reflect� the�highest� ethical� standards� in�our� relationships�with�

all� health� care� professionals� and� all� our� clients.

[VISION]

Our� vision� is� to� make� a� difference� in� the� lives� of� Kenyans� through� provision� of� affordable� and� quality�

medicine� and� dental� materials.

43. Pharmaken Ltd

1.� Corporate� General� Information

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부록 3� �중동·아프리카 전략적 협력사 디렉토리 ❚ 907

Corporate� Name Radiance� Pharmaceuticals� Limited�

Head� Office� Address P.O� Box� 18947,� Nairobi� 00100

Web-site� Address www.radiancepharma.co.ke

Contact

(Korean�

Business)

Telephone +254� 2509830

E-mail [email protected]

Company� Description� &� Organization

Radiance� Pharmaceuticals� believes� in� availing� the� highest� quality�medicines� at� the� most� reasonable� cost� to�

the� clients.�We� do� this� by� sourcing� products� from� reputable� and� accredited� companies.� The� need� for� high�

quality� affordable� pharmaceutical� products� has� led� to� increased� importation� of� drugs� mainly� from� Asian�

countries� to� meet� the� growing� gap.�

[mission]

We� are� committed� to� being� the� premier� company� offering� a� reliable� link� between� the� manufacturers� and�

the� users� of� pharmaceutical� products.�We� apply� ethical� procedures� in� acquiring,�marketing� and�distributing�

pharmaceutical� products.

[vision]

To�emerge�as�a� leading�pharmaceutical�company� in� the� region�offering�high�quality� and�affordable�products�

and� remain� valuable� partners� to� our� clients� and� suppliers.�

44. Radiance Pharmaceuticals Limited

1.� Corporate� General� Information

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908� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name Reals� Pharmaceuticals� Limited

Head� Office� Address Reals� Plaza,� Plot� 1,� Alhaji� Dosunmu� Street,� CBD� Alausa,� Ikeja� ,� Lagos.

Facilities� City� &� Country Nigeria

Web-site� Address www.realsgroup.com

Contact

(Korean�

Business)

Telephone +234� 1� 774� 1205

E-mail [email protected]

Company� Description� &� Organization

[Mission]

To� be� the� foremost� healthcare� company� in� Nigeria� with� satisfied� stakeholders

[Vision]

To� be� a� leading� provider� of� quality,� certified� and� affordable� Healthcare� products� to� consumers� and� reduce�

mortality� rate� in� West� Africa.

45. Reals Pharmaceuticals Limited

1.� Corporate� General� Information

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부록 3� �중동·아프리카 전략적 협력사 디렉토리 ❚ 909

Corporate� Name Regal

Head� Office� Address P.O� Box� 44421,� Nairobi� 00100

Facilities� City� &� Country Kenya

Web-site� Address www.regalpharmaceuticals.com

Contact

(Korean�

Business)

Telephone +254� 20� 8564211-4

E-mail [email protected]

Company� History

REGAL� Pharmaceuticals� Limited,� a� Kenya-based� company,� is� one� of� the� leading� manufacturers� of� quality,�

essential� pharmaceutical� products� in� Eastern� and� Central� Africa.�

The� firm� was� founded� in� 1981� by� Dr.� Mahendra� K.V.Shah,� a� qualified� pharmacist.

Operations� began� with� the� manufacture� of� oral� syrups/suspension� from� rented� premises� with� a� staff� of�

eight,� followed� two� years� later� with� the� installation� of� tablet� and� capsule� production� lines.� In� 1986,� the�

company� moved� into� a� custom-built� factory� which� led� to� a� significant� increase� in� production� capacity.

In� January�2002,� the� company� transferred�all�manufacturing�activities� to�a�new�factory�at� the�Ruaraka�plant.�

This� state-of� ­the-art� facility� is�designed�to�produce�a�wide� range�of� formulations� in�an�efficient�and�hygienic�

environment.

A� new� factory� meeting� latest� cGMP� specifications� was� commissioned� in� January� 2002� (Unit� II� -�

Non-beta-lactam)and� a� dedicated� Penicillin� (Unit� I)was� refurbished� in� 2006.

Regal� pharmaceutical� has� expanded� rapidly� and� is� continuously� investing� in� order� to� maintain� its� strong�

market� position.� Our� aim� is� to� continue� to� deliver� a� quality� product� at� a� competitive� price� backed� by�

excellent� customer� service.

Company� Description� &� Organization

[Vision]

To� be� the� market� leader� in� the� manufacture� and� provision� of� quality� pharmaceutical� products� in� Africa.

[Mission]

Improve� the�health�and�welfare�of�mankind�by�providing�quality�pharmaceuticals�medicines�at� cost�effective�

prices� with� an� emphasis� on� timely� and� accurate� deliveries.�

46. Regal

1.� Corporate� General� Information

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910� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name Rene� Industries� Ltd

Head� Office� Address P.� O.� Box� 6034,� Kampala.� Uganda�

Facilities� City� &� Country Uganda

Web-site� Address www.rene.co.ug

Contact

(Korean�

Business)

Telephone +256� 41� 4236595� /� 4341416�

E-mail [email protected]

Company� History

[Company� Overview]

The� company� was� founded� in� 1996� by� Mr.� Rishi� Vadodaria� a� MBA� graduate� and� his� wife� Mrs.� Meera�

Vadodaria,� a�qualified�pharmacist.�The�Ugandan�directors� identified� the�urgent�need�for� the� local�production�

of� highly� efficacious� generic� and� branded� medicines,� which� would� fulfill� the� needs� of� Uganda� and� it’s�

neighboring� countries.� Following� registration,� the� commercial� production� began� in� 1999.

[Achievements]

In� 2000� Rene� Industries� was� awarded� the� investors� award.

� Rene� Industries� indigenously� developed� the� anti-malarial� LUMAREN� in� house;� a� duo� therapy� combination�

(Lumefantrine� 120mg+Artemether� 20mg)� for� the� treatment� of� malaria.

� Rene� Industries'� timely� supply� of� drugs� to� meet� the� healthcare� demand� was� recognized� with� the� award�

of� best� supplier� from� National� Medical� Stores� in� 2007.

Company� Description� &� Organization

[Mission]

To� reduce� dependency� on� imported� drugs� by� providing� high� quality� and� efficacious� pharmaceuticals� at� a�

reasonable� cost� hence� improving� the� quality� of� human� life� in� the� local� region.

[Vision]

A�Milestone� to�Golden�Health.� To�achieve�self-sustaining� local�production�of�high�quality�drugs�at� affordable�

prices� in� Uganda.

47. Rene Industries Ltd

1.� Corporate� General� Information

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부록 3� �중동·아프리카 전략적 협력사 디렉토리 ❚ 911

Corporate� Name Skylight� Chemicals

Head� Office� Address P.O� Box� 56739-00200,� Nairobi,� Kenya�

Facilities� City� &� Country Kenya

Web-site� Address skylightchemicals.co.ke

Contact

(Korean�

Business)

Telephone +254� 735� 603� 946

E-mail [email protected]

Company� Description� &� Organization

Skylight�Chemicals� Limited� is� an� established�QA/GMP� compliant�manufacturing� facility� that� is� both� efficient�

and� has� a� high� production� capacity.� On-going� investments� in� new� equipment� and� technologies� enable�

Skylight� Chemicals� Limited� to� incorporate� the� latest� developments� in� top� quality� manufacturing� of�

pharmaceuticals.

The� company�engages�qualified�experts� in� their�areas�of�competence� subjecting� them� to� continuous� training�

in� various� disciplines� to� make� them� more� proficient� in� their� duties.� A� proficient� workforce� is� the� most�

important� resource� in� our� business.

SLC�complies�with� the� relevant� statutory� requirements�within� its� sales� region,� cares� for� the�environment�and�

supports� the� local� communities.

[Mission]

To� provide� high� quality� and� affordable� medicine� for� healthy� nation.

[Vision]

Always� to� remain� the� best� contributor� to� health� care� sector� globally.

48. Skylight Chemicals

1.� Corporate� General� Information

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912� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name Square� Pharmaceuticals

Head� Office� Address P.O.� Box� 19900� Nairobi� 00202

Facilities� City� &� Country Kenya

Web-site� Address www.squarepharma.com.bd

Contact

(Korean�

Business)

Telephone +254� 73� 888� 6985

E-mail [email protected]

Company� History

1958� :� Debut� of� SQUARE� Pharma� as� a� Partnership� Firm.�

1964� :� Converted� into� a� Private� Limited� Company.�

1974� :�Technical�Collaboration�with� Janssen�Pharmaceuticals,�Belgium,�a� subsidiary�of� Johnson�and� Johnson�

International,� USA.�

1982� :� Licensing� Agreement� signed� with� F.� Hoffman-La� Roche� &� Co� Ltd.,� Switzerland.�

1985� :� Achieved� market-leadership� in� the� pharmaceutical� market� of� Bangladesh� among� all� national� and�

multinational� companies.�

1987� :� Pioneer� in� pharmaceutical� export� from� Bangladesh.�

1991� :� Converted� into� a� Public� Limited� Company�

1994� :� Initial� Public� Offering� of� shares� of� SQUARE� Pharmaceuticals� Ltd.�

1995� :� Chemical� Division� of� SQUARE� Pharmaceuticals� Ltd.� starts� production� of� Active� Pharmaceutical�

Ingredients� (API).�

1997� :� Won� the� National� Export� trophy� for� exporting� pharmaceuticals.�

1998� :� Agro-chemicals� &� Veterinary� Products� division� of� SQUARE� Pharmaceuticals� starts� its� operation.

2001� :� US� FDA/UK� MCA� standard� new� pharmaceutical� factory� goes� into� operation� built� under� the�

supervision� of� Bovis� Lend� Lease,� UK.�

2004� :� SQUARE� enlisted� as� UNICEF's� globalsupplier.�

2005� :� New� State-of-the-Art� SQUARE� Cephalosporins� Ltd.� goes� into� operation;� built� under� the� supervision�

of� TELSTAR� S.A.� of� Spain� as� per� US� FDA/� UK� MHRA� requirements.�

2007� :� SQUARE� Pharmaceuticals� Ltd.,� Dhaka� Unit� gets� the� UK� MHRA� approval.�

49. Square Pharmaceuticals

1.� Corporate� General� Information

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부록 3� �중동·아프리카 전략적 협력사 디렉토리 ❚ 913

2009� :� Starts� manufacturing� of� insulin� maintaining� quality� standards� of� US� FDA� &� UK� MHRA.� Dedicated�

hormone�&�steroid�products�manufacturing� facility�complying�with� the� current�Good�Manufacturing�Practice�

(cGMP)� of� WHO,� US� FDA� &� UK� MHRA� starts� operation.�

2012� :� SQUARE� Pharmaceuticals� Ltd.,� Dhaka� Unit� and� SQUARE� Cephalosporins� Ltd.� get� the� Therapeutic�

Goods� Administration(TGA)� of� Australia� approval.�

2015� :� PAI� (Pre� Approval� Inspection)� by� US� FDA� was� successful� for� Dhaka� Site’s� solid� dosage� unit.

� � � � � � :� WHO� approved� Square’s� GMP.

Company� Description� &� Organization

[mission]

Our�Mission� is� to�produce�and�provide�quality�&� innovative�healthcare� relief� for�people,�maintain�stringently�

ethical� standard� in�business�operation�also�ensuring�benefit� to� the� shareholders,� stakeholders�and� the� society�

at� large.

[vision]

We� view� business� as� a� means� to� the� material� and� social� wellbeing� of� the� investors,� employees� and� the�

society� at� large,� leading� to� accretion� of� wealth� through� financial� and�moral� gains� as� a� part� of� the� process�

of� the� human� civilization.

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914� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name Surgilinks� Ltd�

Head� Office� Address P.O.� Box� 14461,� Nairobi� 00800

Facilities� City� &� Country Kenya

Web-site� Address www.surgilinksltd.com

Contact

(Korean�

Business)

Telephone +254� 8058244

E-mail [email protected]

Company� Description� &� Organization

Surgilinks� Limited� is� one� of� the� Leading� Pharmaceutical� Marketing� and� Distribution� companies� in� Kenya�

which� has� been� in� operation� for�more� than� 19� years.� It� was� established� in� 1994�with� a� business�model� of�

Importation,� Marketing� and� Distribution� of� Pharmaceuticals.� Since� then� the� Company� has� grown� from�

Strength� to� Strength� .The� Company� moved� in� 2006� to� its� own� premises� at� “Surgilinks� Building”� along�

Mombasa� Road.

[Mission]

Surgilinks’�mission� is� to�provide� superior� products� and� services� to� the� society,� to� satisfy� customer� needs�and�

to� be� a� leader� in� the� pharmaceutical� industry.

[Vision]

Surgilinks’� vision� is� to� remain� focused�and�committed� to�providing�excellence� in� the�supply�of�pharmaceutical�

products� and� to� maintain� confidence� in� our� customers� by� providing� quality� products.

50. Surgilinks Ltd

1.� Corporate� General� Information

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부록 3� �중동·아프리카 전략적 협력사 디렉토리 ❚ 915

Corporate� Name Universal� Corporation

Head� Office� Address P.O� Box:� 1748-00902,� Kikuyu,� Kenya.

Facilities� City� &� Country Kenya

Web-site� Address ucl.co.ke

Contact

(Korean�

Business)

Telephone +254� 734513075� /� +254� 722207126

E-mail [email protected]

Company� History

Universal� Corporation� Ltd.� (UCL)� got� its� name� from� the� erstwhile� entity� Universal� Pharmacy� (K)� ltd.� (UPKL)�

which� came� into� being� in� 1996� with� a� small� manufacturing� unit� in� Industrial� Area,� Nairobi� ­� Kenya.� UPKL�

started� manufacturing� tablets� initially� and� added� a� syrup� and� suspension� line.� The� sales� have� not� been� a�

problem� as� the� graph� has� always� maintained� an� upward� trend.� This� was� possible� because,� even� with� the�

small� unit,� the� focus� was� always� on� Quality.� However� due� to� lesser� capacity� &� demand,� the� concentration�

was� only� in� Kenya� until� 2003� when� exports� were� made� to� Somalia.

But� the�endeavor�of� the�3� founder�Directors�was�actually� to� set�up�a�bigger,� state�of� the�art�Pharmaceutical�

manufacturing�unit� in�Kenya.� This�dream�came� into� reality� in�2004�with� the�start�of�a� syrup� line�at� the�new�

plant� and� since� then� there� was� no� looking� back.� The� plant� has� been� inspected� by� various� DRAs� from�

different� countries� in� east� and� central�Africa,� Ethiopia� and�was� equivocally� applauded�by� various�NGOs� and�

Health� Groups.

Today�UCL�manufactures�over�100� formulations� including� tablets,� capsules,� syrups�&� suspensions,�ointments�

&� creams.From�2005�onwards�after� the� commissioning�of� the� full� facility,�backed�by� continuously�upgraded�

technical� excellence� and� focus� on� quality� assurance,� UCL� has� spread� its� presence� in� most� of� the� countries�

in� this�Region.�Currently�we�do�business�with�Malawi,�Mozambique,�Zambia,�Burundi,�Rwanda,�Congo,�DRC,�

Sierra� ­Leone,� Somalia,� Angola,� Tanzania� &� Uganda.

The� latest� feather� on� the� cap� is� the� site� approval� from� the�most� stringent�W.H.O,� Geneva.� Since� 2005�we�

are� growing� at� a� very� high� rate� of� almost� 25�%� every� year� despite� the� fact� that� our� first� full� year� business�

activity� as� UCL� was� in� 2006.

Company� Description� &� Organization

[mission]

To� provide� high� quality� health� care� products� affordable� to� more� people.

[vision]

To� be� the� leading� partner� in� providing� quality� and� affordable� health� care� to� africa� and� beyond.

51. Universal Corporation

1.� Corporate� General� Information

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916� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name Vacsera

Head� Office� Address 51� Wezaret� El� Zeraa� St.,� Agouza,� Giza,� Egypt

Facilities� City� &� Country Egypt

Web-site� Address www.vacsera.com

Contact

(Korean�

Business)

Telephone (� +2� )� -� 36711111

E-mail [email protected]

Company� History

VACSERA� was� established� in� 1897� as� a� small� laboratory� by� the� Department� of� Health� for� the� production�

of� cholera� vaccine.

Vaccine� production� in� Egypt� dates� back,� however,� to� V1881� where� smallpox� was� produced� followed� by�

rabies� vaccine� in� 1907.

VACSERA� became� a� holding� company� in� 2002� with� three� affiliate� companies� (EGYVAC,� EGYBLOOD� &�

EGYVET).

VACSERA� is� a� governmental� companyt� related� to� Egyptian� Ministry� of� Health.

Company� Description� &� Organization

[Mission]

To�produce,� import� and�marketing�of� vaccines,� sera�&�biological�products� to� secure� society� requirements�of�

vaccines� &� sera� with� commitment� for� continous� development� of� all� activities.

[Vision]

To�be� recognized�as�a� leader� in� the� international�biophrmaceutical�&�biotechnological� industries,�appreciated�

by� our� customers� and� respected� by� our� competitors.�

52. Vacsera

1.� Corporate� General� Information

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부록 3� �중동·아프리카 전략적 협력사 디렉토리 ❚ 917

Corporate� Name Vortex� pharma

Head� Office� Address 40� Ahmed� Fakhry� st.,� Nasr� city,� Cairo,� Egypt.

Facilities� City� &� Country Egypt

Web-site� Address vortexpharm.com

Contact

(Korean�

Business)

E-mail [email protected]

Company� Description� &� Organization

[Vision]

Within� the� next� 5� years� starting� from� 2015� ,� Vortex� pharma� aims� to� be� one� of� the� top� 50� companies� in�

Egypt� achieving� our� goals� for� Egyptian� society.

[Mission]

To� provide� Nutraceutical� and� Pharmaceutical� market� by� innovative� and� high� quality� products� for� better�

health� care.�

53. Vortex pharma

1.� Corporate� General� Information

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918� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name Zenufa� Limited

Head� Office� Address P.O.Box� 77914,� Dar-Es-Salaam,� Tanzania

Facilities� City� &� Country Tanzania

Web-site� Address www.zenufa.com

Contact

(Korean�

Business)

Telephone +255� 754� 789� 333

E-mail [email protected]

Company� Description� &� Organization

[Mission]

It� is� the� Group’s� primary� objective� for� all� the� companies�within� the� Zenufa� Group� to� provide� products� and�

services� that� are� of� high� quality,� superior� value� and� fair� prices� to� all� its� consumers;� and� to� commit� to� the�

moral� and� social� responsibilities� in� the� communities� where� they� operate.�

[Vision]

With� dedication� to� excellence,� quality� and� innovation,� the� Group's� vision� for� all� the� companies� within� the�

Zenufa� Group� is� to� be� at� the� forefront� of� every� sector� in� which� they� operate� by� becoming� the� renowned�

and� favored� product� and� service� supplier.

54. Zenufa Limited

1.� Corporate� General� Information

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부록 4� �국내 CRO�디렉토리 ❚ 919

순번 분야 기업명 페이지 2015 2016 비고

1 전임상 대구가톨릭대학교 GLP센터 920 ○ ○

기조사양식

2 전임상 메드빌 922 ○ ○

3 전임상 바이오인프라 926 ○ ○

4 전임상 바이오톡스텍 928 ○ ○

5 전임상 산업안전보건연구원 930 ○ ○

6 전임상 한국건설생활환경시험연구원 932 ○ ○

7 전임상 한국화학융합시험연구원 934 ○ ○

8 임상 ADM� Korea� Inc. 937 ○ ○

글로벌조사양식

9 임상 C&R� RESEARCH,� Inc. 944 ○ ○

10 전임상 Chemon� Inc. 952 ○○

(업데이트)

11 임상 DreamCIS� Inc. 957 ○ ○

12 임상 Ginapath,� co,� Ltd 963 ○(신규)

13 임상 ICON� plc 966 ○ ○ 기조사양식

14 전임상 Korea� Institute� of� Toxicology 968 ○ ○

글로벌조사양식

15 임상 LSK� Global� Pharma� Services� Co.,� Ltd 974 ○○

(업데이트)

16 임상 Novotech� Pty� Limited 983 ○ ○

17 임상 PharmaCRO� Inc. 989 ○ ○

18 임상 Quintiles 994 ○ ○

19 전임상 Reference� Biolabs� Inc 1002 ○ ○

20 임상 SCAS-BTT� Bioanalysis� Co.,� Ltd 1008 ○ ○

21 임상 SeoCho� CRO 1014 ○ ○

22 임상 Seoul� CRO� Co.,� Ltd 1017 ○ ○

23 임상 StarTech� Science� LLC. 1024 ○(신규)

【부록 4】� �국내 CRO�디렉토리

본 디렉토리북 수록내용은 해당 기업의 회신 내용을 바탕으로 수록된 내용으로서 신뢰성 여부는 주최측이

보증하지 않음을 유의하시기 바랍니다. 따라서, 글로벌 시장 진출시 본 디렉토리북 내용에 수록된 기업과의

접촉시 업체별로 신뢰성 여부에 대한 사전 조사를 당부드립니다.

■�국내 CRO�디렉토리 수록 기업 리스트 23개사

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920� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

1. 대구가톨릭대학교 GLP센터

Ⅰ.�기업개요

기업명 대구가톨릭대학교 GLP센터 대표자명 소 병 욱

설립년도 (� 2005� )년도 종업원수 (� 10� )명 홈페이지주소 www.glpcenter.co.kr

주 소(본사)우편번호 주소

712-702 경북 경산시 하양읍 하양로 13-13�

기업소개

대구가톨릭대학교 GLP센터는 대학 최초이며 영남지역에서 유일한 GLP기관입니다.�저희 센터는 특허 및 한방제제등의

천연물을 이용한 의약품,�건강기능식품과 기능성화장품 등과 관련한 단회 및 반복투여독성시험 그리고 유전독성시험을

수행하고 있습니다.� 또한 독성시험 뿐 아니라 다양한 기능성 및 효력시험을 수행하고 있는 CRO� 기관입니다.�

보유시설현황

대구가톨릭대학교 GLP�센터는 대학의 부속기관으로 대학 내에서 생명과학과 관련된 분석장비 및 현대화 된 SPF�동물사

육시설을 포함한 장비 및 시설을 보유하고 있습니다.

담당자 연락처성명 부서명

연락처

Tel Fax E-mail

김민희 신뢰성보증부 053.850.3625 053.850.3627 [email protected]

Ⅱ.�수탁시험,�분석 서비스 현황

1. 서비스 영역

영역 전임상 임상1상 임상2상 임상3상 PV PMSData

Management통계분석 인허가대행 컨설팅

해당

여부○ ○

2. 수탁시험/분석 서비스 내용

서비스영역(전임상,� 임상 등) 수탁시험/분석 서비스 세부내용

전임상시험

독성시험 :�단회투여독성시험,�반복투여독성시험,�유전독성시험(복귀돌연변이,�소핵,�

염색체이상)

기능성 및 유효성시험 :� 골관절염,� 비만,� 당뇨병,� 아토피,� 주름,� 미백 등

Page 924: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

부록 4� �국내 CRO�디렉토리 ❚ 9213. 수탁시험/분석 제품영역

신약 생물학적

제제바이오시밀러 천연물의약품 개량신약 제네릭 기타(기재요망)

화합물신약 바이오신약

� ○ � ○

4. 질환영역

골관절염,� 비만,� 당뇨병,� 아토피피부염,� 피부기능성화장품시험

Ⅲ.�보유네트워크 및 공인인증 현황

1. 보유네트워크(제휴/협력기관) 현황

국내 제휴/협력기관명해외 제휴/협력기관명

기관명 국가명

국내 대부분의 CRO� 기관

2. 공인인증현황

국내인증보유현황 해외기관명

보유인증명 인증기관명 보유인증명 인증기관명 국가명

GLP� 독성시험

식품의약품안전청

농촌진흥청

국립환경과학원

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922� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

2. ㈜메드빌

Ⅰ.�기업개요

기업명 ㈜메드빌 대표자명 홍은경

설립년도 (� � 1999� � � )년도 종업원수 (� � 21� )명 홈페이지주소 www.medvill.co.kr

주 소(본사)우편번호 주소

153-801 � 서울 금천구 가산동 60-21,� IT미래타워15층

기업소개

◦㈜메드빌은 1962년에 설립된 실험종양연구소를 모태로 하여 1999년 법인으로 전환된 바이오기업임.

◦출범당시부터 천연물신약개발을 항암제 등의 기술이 제약회사로 기술이전되었음.◦법인 전환 이후 천연물신약을 비롯하여 건강기능식품,�기능성화장품 소재 개발까지 연구의 범위를 확대하여 다양한

국내외 지적재산권을 확보하였음.�

◦2003년 비임상관련 GLP인증을 획득하여 안전성 평가 및 효능 평가를 위한 CRO사업을 진행하고 있음.◦GLP인증항목 --� 8개 항목 (단회,� 다회투여 독성,� 유전독성 3개 항목,� 수생태 독성 3개항목(어류,� 조류,� 물벼룩)

◦2005년부터 자체 연구개발 결과물을 활용하여 제품화에 성공함으로써 현재 건강기능식품 2종,�기능성 화장품 3종을

출시하여 판매하고 있음.◦현재 자체 개발 제품을 일본,� 미국,� 중국으로 수출하기 위한 협상이 진행되고 있음.

◦본 사는 비임상 CRO로서 천연물의약품,�건강기능식품,�기능성화장품 원료 개발부터 판매에 이르기까지 전과정에 대한

컨설팅 및 실제 연구개발,� 상품화 등을 대행하고 있음.◦현재까지 여러 종류의 천연물신약,�건강기눙식품,�기능성 화장품 등이 개발 완료되어 사업화에 성공하여 생산 제품분야

의 매출이 증대되고 있음.� (연간 성장률 30%이상 예상)

보유시설현황 (기업부설연구소 보유)

시설명 활용기능 내용 위치GLP� 동물실험실 일반독성실험 메드빌중앙연구소부검 및 조직병리실 실험동물 부검 및 조직병리 메드빌중앙연구소세포실험실 세포실험 메드빌중앙연구소미생물실험실 미생물실험 메드빌중앙연구소생화학실험실 생화학실험 메드빌중앙연구소분자생물실험실 분자생물학관련실험 메드빌중앙연구소수생태독성실험실 수생태독성실험 메드빌중앙연구소분석실험실 천연물,� 화학물질 분석 메드빌중앙연구소자료보관실 자료보관 메드빌중앙연구소시약조제실 시약조제 메드빌중앙연구소시험물질조제실 시험물질조제 메드빌중앙연구소대회의실 회의용 메드빌중앙연구소사무실 사무지원실 메드빌중앙연구소공조실 공조기기 설치 메드빌중앙연구소발전실 비상발전기 설치 메드빌중앙연구소

담당자 연락처성명 부서명

연 락 처

Tel Fax E-mail

이명수 시험조정 02-2027-5777 02-2027-5776 [email protected]

Page 926: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

부록 4� �국내 CRO�디렉토리 ❚ 923

서비스영역(전임상,� 임상 등) 수탁시험/분석 서비스 세부내용

GLP인증 시험 항목

(8개 항목)

단회투여 독성시험

다회투여독성 시험

유전독성시험 (염색체 이상시험,� AMES� test,� 소핵시험)�

수생태 독성시험(어류,� 조류,� 물벼룩시험)

효력시험

(1)� 당뇨 관련 효능시험

1)� Glucose� incorporation� assay� I

2)� Glucose� incorporation� assay� II

3)� Oral� glucose� tolerance� test� (OGTT)

4)� 1형 당뇨 동물 시험

5)� 2형 당뇨 동물 시험

6)� 알파-glucosidase� activity� assay

(2)� 항암효능 시험

1)� 암세포주에 대한 항암효력 시험

2)� 고형암 세포에 대한 항암효과시험

3)� 복수암 세포에 대한 항암효과 시험

4)� Metastasis

(3)� 간기능 관련 효능시험

1)� 에탄올에 의한 간손상

2)� CCl4에 의한 간손상

3)� D-galactosamine에 의한 간손상

4)� DMN에 의한 간손상 (간경화유발)

(4)� 비만개선효능시험

1)� 지방 조직 감량 시험(in� vivo)

(5)� 안질환 효능시험

1)� Aldose� reductase(AR)� inhibitor� 검색

2)� Lens� culture� 시험

Ⅱ.�수탁시험,�분석 서비스 현황

1. 서비스 영역

영역 전임상 임상1상 임상2상 임상3상 PV PMSData

Management통계분석 인허가대행 컨설팅

해당

여부○ ○

2. 수탁시험/분석 서비스 내용

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924� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

(6)� 지질대사관련 효능시험

1)� 지질 및 콜레스테롤 억제 효력시험

2)� 동맥경화 예방 및 억제 효력시험

(7)� 항산화효능시험

(8)� 항염증 효능시험

1)� 항염증 효력시험

2)� 염증 인자 억제 시험 :� COXs,� NO

(9)� 화장품 관련 효능시험

1)� 여드름 효력 시험

2)� 미백 효력 시험

3)� 자외선 차단 효력 시험

4)� 주름개선 효력 시험 I

5)� 주름개선 효력 시험 II

(10)� 유전독성시험

1)� AMES� test� (GLP)

2)� 염색체이상 시험 (GLP)

3)� 소핵시험 (GLP)

4)� Comet� assay� (Non-GLP)

○� 연구개발 대상 탐색새로운 천연물 소재의 생리활성 물질 분석기술

생리활성 물질 스크리닝 기술

○� 물질분석 및 안정성시험

천연물의 지표물질 설정

분석법 validation

안정성시험

3. 수탁시험/분석 제품영역

신약 생물학적

제제바이오시밀러 천연물의약품 개량신약 제네릭 기타(기재요망)

화합물신약 바이오신약

○ ○ ○ ○ ○ ○ ○

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부록 4� �국내 CRO�디렉토리 ❚ 9254. 질환영역

Cancer, 당뇨, 간질환, 비만, 염증, 안질환, 고지혈증(지질 대사), CNS(치매), 전립선 비대

수탁시험 개발내용 질환영역

� 천연물 항암제 개발 종양학(Oncology)

� 화학물질(합성의약품)� 항암제 개발 종양학(Oncology)

� 치매치료제 개발 CNS

� 아토피 치료제 개발 면역질환

� 다이어트 제품 개발 대사질환(Metabolic� disease)

� 당뇨병 치료제 개발 대사질환(Metabolic� disease)

� 일반 간염 및 간경화 치료제의 연구개발 대사질환(Metabolic� disease)

� 백내장 치료제 개발 안질환

� 골다공증 치료제 개발 골질환

� 관절염치료제 개발 면역관련 질환

� 전립선비대 치료제 개발 비뇨기질환(Urinary� organs� disease)

Ⅲ.�보유네트워크 및 공인인증 현황

1. 보유네트워크(제휴/협력기관) 현황

국내 제휴/협력기관명해외 제휴/협력기관명

기관명 국가명

회원기업/� 제약회사,� 화학물질 관련회사,� 농약회사

� 건강기능식품회사,� 화장품회사,� 컨설팅 회사

� 해외 화학물질 관련 회사 등

기술전문가/�생산기술 연구원,�타 비임상 CRO,�임상 CRO,�화학연구원,�생명

공학연구원 등

산학협력/� 서울대,� 고려대,� 경상대,� 서울여대,� 덕성여대,� 연세대 등

2. 공인인증현황

국내인증보유현황 해외기관명

보유인증명 인증기관명 보유인증명 인증기관명 국가명

비임상시험관리기관지정서

화학물질 유해성시험 연구기관지정서

농약 안전성시험 연구기관

ISO14001

ISO9001

식품의약품안전청

국립환경과학원

농촌진흥청

ICR

ICR

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926� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

3. ㈜바이오인프라

Ⅰ.�기업개요

기업명 ㈜바이오인프라 대표자명 이 상 득

설립년도 (� 2007� )년도 종업원수 (� 36� )명 홈페이지주소 www.bioinfrakroea.co.kr

주 소(본사)우편번호 주소

443-270 경기도 수원시 영통구 이의동 864-1번지 경기바이오센터 3층,� 7층

기업소개

㈜바이오인프라는 미국과 OECD� 기준을 충족시키는 GLP� system에서,� 미국 FDA� CDER� 기준에 적합하게 Validation�

된 분석법을 적용하여 신약,� DDS,� Generic� 의약품의 혈중약물농도 분석 서비스를 국내외 제약회사에 제공

보유시설현황

기업부설연구소 인정 한국산업기술진흥협회 (제20081203호,� 2008년 2월 5일)

보유 장비

-� UPLC-MS/MS� 10대

-� HPLC-UV/FLD� 3대

-� Automatic� Liquid� Handler� 2대

-� Scientific� Data� Management� System� 운영

담당자 연락처성명 부서명

연락처

Tel Fax E-mail

배병선 고객지원팀 031-888-6267 1540-100-6270 [email protected]

Ⅱ.�수탁시험,�분석 서비스 현황

1. 서비스 영역

영역 전임상 임상1상 임상2상 임상3상 PV PMSData

Management통계분석 인허가대행 컨설팅

해당

여부O O O

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부록 4� �국내 CRO�디렉토리 ❚ 9272. 수탁시험/분석 서비스 내용

서비스영역(전임상,� 임상 등) 수탁시험/분석 서비스 세부내용

전임상,� 임상

-� Screening� PK� studies

-� Toxicokinetic� and� Preclinical� PK� studies

-� Micro-dose� PK� studies

-� Clinical� PK� studies

� � � .� Dose� escalation� PK� studies

� � � .� Drug-Drug� Interation� studies

� � � .� Bioequivalence� studies

3. 수탁시험/분석 제품영역

신약 생물학적

제제바이오시밀러 천연물의약품 개량신약 제네릭 기타(기재요망)

화합물신약 바이오신약

O O O

4. 질환영역

-� 생물학적동등성시험 150건 이상 수행

-� PK/TK시험의 검체분석 25건 이상 수행

-� Phase� I� 검체분석 15건 이상 수행

Ⅲ.�보유네트워크 및 공인인증 현황

1. 공인인증현황

국내인증보유현황 해외기관명

보유인증명 인증기관명 보유인증명 인증기관명 국가명

KGLP

(독성동태시험 중 분석시험)식품의약품안전청

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928� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

4. ㈜바이오톡스텍

Ⅰ.�기업개요

기업명 ㈜바이오톡스텍 대표자명 강 종 구

설립년도 (� 2000� )년도 종업원수 (� 176� )명 홈페이지주소 www.biotoxtech.com

주 소(본사)우편번호 주소

363-883 충북 청원군 오창읍 양청리 686-2� 오창과학산업단지내

기업소개

-� 국내 매출 1위의 비임상CRO로 세포나 동물을 대상으로 신물질에 대한 유효성,� 안전성평가를 주사업으로 하고 있음

-� 2000년 설립,� 2002년 비임상시험 관리기관 지정,� 2007년 코스닥 상장,� 2009년 셀트리온과 자본제휴

-� 선진수준의 기술력 확보로 일본에서도 전체의 20%� 매출이 발생

-� 2010년 11월 OECD� GLP� 사찰의 성공적 수검 및 데이터상호인정제도로 해외 진출의 토대가 마련되어 있음

-� 설립 이래로 8,000건 이상의 시험 수행,� 작년 한 해 동안만 1,500건 이상의 시험 수행

-� 2011년 5월 일본과 생체시료분석을 위한 조인트 벤처 설립,� 11월 독일 CRO와 업무 제휴 등 수익 다각화

보유시설현황

-� 6,000의 부지에 5,000평 규모에 선진국 수준에 이르는 3개의 연구동 보유

-� 최신 혈액,� 혈청 분석기기 외에 LC/MS/MS� 등 고가 분석기기 다수 완비

-� 식약청으로부터 국내 민간 최다 GLP� 인증 항목 보유

-� 동시 400건 이상의 시험을 진행할 수 있는 운영시스템

담당자 연락처

성명 부서명연락처

Tel Fax E-mail

정태희 경영관리팀 043-210-7713 [email protected]

m

Ⅱ.�수탁시험,�분석 서비스 현황

1. 서비스 영역

영역 전임상 임상1상 임상2상 임상3상 PV PMSData

Management통계분석 인허가대행 컨설팅

해당

여부○

Page 932: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

부록 4� �국내 CRO�디렉토리 ❚ 9292. 수탁시험/분석 서비스 내용

서비스영역(전임상,� 임상 등) 수탁시험/분석 서비스 세부내용

전임상

-� 비임상시험 :�

� � 독성시험-� 일반독성시험(랫드/마우스/비글),� 생식발생독성(랫드/토끼),� 특수독성시

험 (국소면역독성:기니픽/토끼,� 수생생태독성:조류/물벼룩/송사리/잉

어,� 유전독성:마우스)

� � 안전성약리-�비글/랫드,�조직/임상병리,�동물대체법 시험,�조제물분석,�약물동태 시

-� 약물 스크리닝 및 효능 평가 :� 항암,� 노화,� 당뇨,� 심혈관계,� 면역계 시험 등

-� 시험관련 지원 :� 시험디자인,� 통계분석,� 결과보고서(국문/일문/영문)� 작성

3. 수탁시험/분석 제품영역

신약 생물학적

제제바이오시밀러 천연물의약품 개량신약 제네릭 기타(기재요망)

화합물신약 바이오신약

○ ○ ○ ○ ○ ○ ○

4. 질환영역

-� 종양,� 심혈관계 및 순환계,� 면역계,� 내분비대사계,� 당뇨/비만 분야,� 소화계,� 소염진통,� 발모,� 미백/항노화(주름관련)

Ⅲ.�보유네트워크 및 공인인증 현황

1. 보유네트워크(제휴/협력기관) 현황

국내 제휴/협력기관명해외 제휴/협력기관명

기관명 국가명

셀트리온

안전성평가연구소

크리스탈지노믹스

Iwase� Cosfa� /� CIMIC� /� 스미카분석센터 /� 하이폭스

Beijing� Northland� Biotech

LPT(Laboratory� of� Pharmacology� and� Toxicology� GmbH&Co.KG)

일본

중국

독일

2. 공인인증현황

국내인증보유현황 해외기관명

보유인증명 인증기관명 보유인증명 인증기관명 국가명

GLP

벤처기업 인증

Inno-biz� 인증

식약청/국립환경과학원/농촌진흥청

기술보증기금

중소기업청

AAALACA A A L A C�

International미국

Page 933: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

930� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

5. 산업안전보건연구원

I.�기업개요

기업명 산업안전보건연구원 대표자명 강성규

설립년도 (1989)년도 종업원수 (140)명 홈페이지주소 http://oshri.kosha.or.kr

주 소(본사)우편번호 주소

403-711 인천광역시 부평구 무네미로 478(구산동)�

기업소개

◊설립목적 :�정부는 효율적인 산업재해예방사업을 수행을 위해 사고와 직업병을 조사하고 연구할 기관의 필요성을 인식

하여 산업재해예방에 관한 조사·연구·기술개발 기능을 갖춘 전문 연구기관인 산업안전보건연구원을 1989년 7월 12일

설립

◊조직구성 :� 3실 3센터 1팀

-� 안전경영정책연구실,� 안전시스템연구실,� 직업환경연구실,� 직업병연구센터,� 안전인증평가센터,� 화학물질안전보건센터,�

재해통계분석팀

� � � ※� 상기 조직 중 비임상시험(GLP)은 대전에 소재한 화학물질안전보건센터에서 수행 중

◊주요업무

-� 산업안전보건 제도조사,분석 및 정책 개발 연구

-� 기계,전기,화공,건설안전분야 산업재해예방기술 연구·개발

-� 산업재해예방 기술기준(KOSHA� Code� 등)� 연구

-� 방호장치 및 보호구 검정과 유해위험기계 ·� 기구 및 설비의 안전인증

-� 산업보건위생,� 직업병예방 및 역학조사 산업화학물질 연구

-� 작업환경 개선을 위한 측정,� 평가 및 기술기준 연구,� 개발

보유시설현황

◊비임상시험기관(GLP)� 시설현황(화학물질안전보건센터 독성연구동)

-� 시설 :� 유전독성실험실,�흡입챔버실,� 동물사육실,� 세정실,� 부검실,�분진 및 가스발생실,� 자료보관실,� 환경모니터링실,�

전자현미경실,� 병리 검사실,� 분석실험실 등

-� 인증항목 :� 급성경구독성,� 급성경피독성,� 급성흡입독성,� 아급성흡입독성,� 염색체이상,� 소핵,� 복귀돌연변이 시험

담당자 연락처성명 부서명

연락처

Tel Fax E-mail

박상용 독성연구팀 042-869-0351 042-863-9001 [email protected]

Page 934: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

부록 4� �국내 CRO�디렉토리 ❚ 931

Ⅱ.�수탁시험,�분석 서비스 현황

- 정부 출연연구기관으로서 사업장에서 사용하는 화학물질에 대해 법적 규제수준 및 관리

방안 마련하고 화학물질 정보제공을 목적으로 자체시험(필요시 일부 위탁시험) 위주로

시험을 진행하고 있으며 현재 수탁시험은 진행하고 있지 않음

1. 서비스 영역

영역 전임상 임상1상 임상2상 임상3상 PV PMSData

Management통계분석 인허가대행 컨설팅

해당

여부○

Ⅲ.�보유네트워크 및 공인인증 현황

1. 공인인증현황

국내인증보유현황 해외기관명

보유인증명 인증기관명 보유인증명 인증기관명 국가명

GLP� 인정

-� 급성경구독성시험

-� 급성흡입독성시험

-� 아급성흡입독성시험

-� 염색체이상시험

-� 복귀돌연변이시험

-� 소핵시험

-� 아급성독성시험

-� 급성경피독성시험

국립과학원

-� 단회투여독성시험

-� 반복투여독성시험

-� 복귀돌연변이시험

-� 염색체이상시험

-� 소핵시험

식품의약품안전청

-� 급성경구독성시험

-� 급성흡입독성시험

-� 아급성흡입독성시험

-� 변이원성시험

농촌진흥청

Page 935: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

932� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

6. 한국건설생활환경시험연구원

Ⅰ.�기업개요

기업명 한국건설생활환경시험연구원 대표자명 송 재 빈

설립년도 1971년도 종업원수 445명 홈페이지주소 http://www.kcl.re.kr

주 소(본사)우편번호 주소

153-803 서울시 금천구 가산동 459-28번지

기업소개

○�생활․환경,�의료기기,�비임상시험,�건축자재,�토목관련제품,�녹색산업 등에 대한 시험․ 평가․인증과 연구개발 등을 효율적으로 수행하고,�국내산업의 기술고도화 및 대외성과 유지향상을 도모하여 수출진흥과 소비자를 보호하고,�산업발

전 및 국가경쟁력 제고에 기여함을 목적으로 설립

○� 2010.7.� 한국생활환경시험연구원과 한국건자재시험연구원이 통합하여 한국건설생활환경시험연구원으로 상호 변경

○� 서울 가산동 본원과 7개 시험장,� 11개 지방지원,� 중국 청도 지원을 운영

○� 식약청,� 국립환경과학원,� 농촌진흥청으로부터 GLP� 시험기관으로 인정

-� 의약품․화장품,� 화학제품,� 건강기능성식품,� 농약 등에 대해 연구용역 및 GLP� 시험을 수행

-� 지식경제부 “나노제품의 안전성 확보 플랫폼 기술개발”� 연구용역 등을 수행

보유시설현황

○� 송도 바이오융합단 :� 비임상시험기관 및 의료기기 시험 수행

-� SPF� 소동물실,� 중동물 사육실,� 수술실,� 흡입독성실험실,� 유전독성실,� 생화학분석실,� 임상병리실,� 조직병리실 등

-� 생태독성 실험실,� 어류 사육실,� 어류 실험실 등

-� 혈액분석기 등 41종 142대 장비 보유

담당자 연락처성명 부서명

연락처

Tel Fax E-mail

국원근 안전성평가팀 032-859-4044 032-858-0020 [email protected]

Ⅱ.�수탁시험,�분석 서비스 현황

1. 서비스 영역

영역 전임상 임상1상 임상2상 임상3상 PV PMSData

Management통계분석 인허가대행 컨설팅

해당

여부○

Page 936: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

부록 4� �국내 CRO�디렉토리 ❚ 9332. 수탁시험/분석 서비스 내용

서비스영역(전임상,� 임상 등) 수탁시험/분석 서비스 세부내용

전임상

� •일반독성(설치류․비설치류 단회 및 반복독성)

� •국소독성(피부자극 및 안자극시험),� 감작성 시험

� •유전독성(미생물복귀돌연변이,� 염색체이상시험,� 소핵시험)

� •흡입독성

� •생태독성(어류,� 물벼룩,� 조류성장저해시험)

� •임상병리 및 조직병리

3. 수탁시험/분석 제품영역

신약 생물학적

제제바이오시밀러 천연물의약품 개량신약 제네릭 기타(기재요망)

화합물신약 바이오신약

Ⅲ.�보유네트워크 및 공인인증 현황

1. 보유네트워크(제휴/협력기관) 현황

국내 제휴/협력기관명해외 제휴/협력기관명

기관명 국가명

안전성평가연구소(KIT)

2. 공인인증현황

국내인증보유현황 해외기관명

보유인증명 인증기관명 보유인증명 인증기관명 국가명

비임상시험관리기관

화학물질 유해성시험기관

농약안전성시험연구기관

농약품목등록 시험연구기관

식품의약품안전청

국립환경과학원

농촌진흥청

농촌진흥청

Page 937: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

934� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

7. 한국화학융합시험연구원

Ⅰ.�기업개요

기업명 한국화학융합시험연구원 대표자명 조 기 성

설립년도 (1969)년도 종업원수 (� 608� )명 홈페이지주소 www.ktr.or.kr

주 소(본사)우편번호 주소

150-038 � 서울특별시 영등포구 영등포동 8가� 88-2번지

기업소개

KTR은 기존의 화학,� 환경,� 농약 신약 등 바이오,� 토목 건축 ,� 소재부품,� 인증 등의 분야 이외에 전기전자,� 전자파 및

정보통신까지 다양한 분야의 시험인증 업무를 수행하고 있습니다.�또 기업을 위해 제품 개발과 품질 향상을 위한 기업의

시험실 역할을 하고,�유럽ㆍ러시아ㆍ일본ㆍ미국 등 해외 수출을 위해 주요 교역대상국에서 발행하고 있는 CE,�GOST-R,�

JIS,� NSF,� REACH,� IECEE,� FCC� 등의 인증을 짧은 기간에 저비용으로 받을 수 있도록 직접 지원하고 있습니다.� 또한

의약품,�건강기능식품,�화장품,�농약,�산업용품 및 기타 환경오염물질 등 다양한 제품 및 원료에 대하여 GLP�Guideline

에 따라 독성의 정도와 특성을 신속히 평가하여 고객 만족을 위해 최선을 다하고 있으며,�세계최고수준의 GLP�기관으로

의 도약을 위하여 노력하고 있습니다.�특히 헬스케어연구소에서는 2012년말 준공을 목표로 전남 화순읍 내평리 일대

11,000여 평의 부지에 2,500여 평의 신규 GLP�시설 공사를 진행하고 있습니다.�완공 후에는 김포의 기존 시설과 더불

어 의약품 및 건강기능식품 등에 대하여 원스톱서비스를 할 수 있는 충분한 기반시설을 구축함으로써 Global� CRO에

진입이 가능하게 될 것입니다.�이에 따라 국내 제약 및 바이오기업의 핵심 연구개발 동반자로서 전임상 및 초기 임상분야

에 있어 서로 윈-윈 할 수 있는 진정한 파트너가 될 것으로 확신합니다.

보유시설현황

GLP� 사육시설 및 실험시설(경기도 김포소재)

� � � 실험동[시약조제,� 병리실 등],� 소동물동[청정동물사육실],� 토끼 및 기니픽 사육동,� 중동물동,� 경독성동,� 자료보관실

담당자 연락처성명 부서명

연락처

Tel Fax E-mail

김수현 일반독성팀 031-999-3214 031-999-3006 [email protected]

Ⅱ.�수탁시험,�분석 서비스 현황

1. 서비스 영역

영역 전임상 임상1상 임상2상 임상3상 PV PMSData

Management통계분석 인허가대행 컨설팅

해당

여부○

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부록 4� �국내 CRO�디렉토리 ❚ 9352. 수탁시험/분석 서비스 내용

서비스영역(전임상,� 임상 등) 수탁시험/분석 서비스 세부내용

전임상서비스

� 단회투여독성시험(설치류,� 비설치류),

� 반복투여독성시험(설치류,� 비설치류)

� 생식/발생독성시험(수태능 및 초기배발생시험,

� 출생전후 발생 및 모체기능시험,� 배태자발생시험(설치류,비설치류),�

� 유전독성시험(복귀돌연변이시험,염색체이상시험,소핵시험),

� 항원성시험(아나필락시스쇼크반응시험,� 피부감작성시험)

� 국소독성시험(피부자극시험,� 안점막자극시험),

� 기타독성시험(광독성시험,� 광감작성시험)

3. 수탁시험/분석 제품영역

신약 생물학적

제제바이오시밀러 천연물의약품 개량신약 제네릭 기타(기재요망)

화합물신약 바이오신약

○ ○ ○ ○ ○ ○ ○ 화학물질,� 농약

4. 질환영역

의약품 개발 관련 대부분의 질환

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936� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Ⅲ.�보유네트워크 및 공인인증 현황

1. 보유네트워크(제휴/협력기관) 현황

국내 제휴/협력기관명해외 제휴/협력기관명

기관명 국가명

영남대학교 의료기기임상센터

옥천 참웇라이프케어사업단

(재)바이오장기사업단

안전성평가연구소(KIT)

생물의약연구센터

세명대 임상시험센터

(재)전남 생물산업징흥재단

의료기기산업협회

전북대 임상시험센터

경북바이오산업연구원

대구 T.P.� 바이오산업지원센터

진주시 및 (재)바이오21센터

한국원자력의학원

㈜세이프케미칼

TRC

CERI

MCM

일본

남경 환경과학연구소 중국

DR.Knoell� Consult� GmbH�

B.S.L.� Bioservice�

IBACON�

독일

SIBERSDORF 오스트리아

RGS 터키

2. 공인인증현황

국내인증보유현황 해외기관명

보유인증명 인증기관명보유

인증명

인증

기관명국가명

∙단회투여독성시험(설치류,� 비설치류)∙반복투여독성시험(설치류,� 비설치류)∙생식/발생독성시험� � [수태능 및 초기배발생시험,�출생전후 발생 및 모체기능시험,�배

태자발생시험(설치류,� 비설치류)]

∙유전독성시험(복귀돌연변이시험,� 염색체이상시험,� 소핵시험)∙국소독성시험(피부자극시험,� 안점막자극시험)∙피부감작성시험

식품의약품안전청

국립환경과학원

농촌진흥청

∙항원성시험(아나필락시스쇼크반응시험,� 수동피부아나필락시스반응시험)

∙기타독성시험(광독성시험,� 광감작성시험)식품의약품안전청

∙담수어류에 대한 급성독성시험

∙물벼룩류에 대한 급성유영저해시험

∙조류생장저해시험국립환경과학원

농촌진흥청

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부록 4� �국내 CRO�디렉토리 ❚ 937

Corporate� Name ADM� Korea� Inc.

Corporate� Ownership Private� Company

Head� Office� Address#711,� (Dangju-dong� Royal� Bldg),� 19,� Saemunanro5gil,� Jongro-gu,� Seoul�110-721,� Korea� (Korean� Business� office� is� the� Head� Office.)

Korean� Business� Office#711,� (Dangju-dong� Royal� Bldg),� 19,� Saemunanro5gil,� Jongro-gu,� Seoul�110-721,� Korea

Web-site� Address www.admkorea.co.kr�

No.� of� Employees 74

Financial� Status

Sales� Revenue� in� 2013(US� K$) Capital(US� K$) Dept-equity� Ratio(%)

7,027� K� USD 1,865� K� USD 344%

Contact

(Korean�

Business)

Name Jong-Eon� Lim

Address#711,� (Dangju-dong� Royal� Bldg),� 19,� Saemunanro5gil,� Jongro-gu,� Seoul�110-721,� Korea

Telephone +82� 70� 7119� 0566

E-mail [email protected]

Company� History

Oct� 2003 Founded� as� ADM� Korea� Inc.

Jun� 2005 Initiated� Multinational� Registration� Clinical� Study� between� Korea� and� India

Nov� 2006 Built� Strategic� Partnership� with� EPS� International

Nov� 2007 Established� Data� Management� Team

May� 2008� � � Initiated� Global� Clinical� Study� for� US� FDA� registration

Sep� 2008 Initiated� Pan-Asia(Japan/Taiwan/Korea)� Clinical� Study� for� PMDA� registration

Mar� 2009 Established� Quality� Assurance� &� Regulatory� Affairs� Team

Sep� 2010 Established� Clinical� R&D� Center

8. ADM Korea Inc.

1.� Corporate� General� Information

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938� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Nov� 2010 KOITA� accredit� ADM� Clinical� R&D� Center� as� an� official� corporate� R&D� Center

Got� Certification� of� INNOBIZ� from� SMBA

Got� Certification� of� Venture� Company� from� KOTEC

Mar� 2011 Built� Strategic� Partnership� with� CRScube� Inc.

Aug� 2012 Built� a� e-Learning� System

Apr� 2013 Designated� as� a� company� for� exemption� from� military� service� by� MMA

Jul� 2013 Built� Strategic� Partnership� with� MMS� Holdings� Inc.�

Jun� 2014� � � � � � � � � � � Built� Strategic� Partnership� with� DOT� International� Co.,� Ltd.

Company� Description� &� Organization

ADM� Korea� Inc.� guarantees� to� provide� high� quality� service� in� clinical� research� through� Man� Power� and�

Business�System.�We�value� integrity,� team�work,� commitment,� respect,�and�sincerity� to�our�personnel.�Our�

dedicated�Man� Power� and� efficient� Business� System� will� guide� your� clinical� journey.�We� have� developed�

our� own� Standard�Operation� Procedures� (SOPs)� and� trained�CRAs�with� high� standards.�We� regularly� train�

Clinical� Research� Associates,� Biostatisticians,� and� Data�Managers� to� maintain� the� best� quality� of� services.�

After� all� the� training,� ADM� e-learning� system� verifies� the� results� of� the� training.�

ADM� Korea� Inc.� has� conducted� a� lot� of� clinical� trials� with� global� pharmaceutical� companies� with� good�

partnership,�and� the� results�of�many� clinical� trials�has�been�submitted� to�U.S.�FDA,�PMDA�(Pharmaceuticals�

and� Medical� Devices� Agency)� Japan,� EMEA� (European� Medicines� Agency).� Now,� we� can� conduct�

Regulatory� Affairs,� Clinical� Operation,� Project� Management,� Statistical� Analysis,� Data�Management,� PMS,�

Pharmacovigilance,� and� Quality� Assurance� Services� from� Phase� I� to� IV.� After� the� decades� of� trials� and�

experiences,� now� we� can� proudly� present� ourselves� to� meet� the� global� standards� and� satisfy� our� client’s�

needs.� We� will� continually� strive� to� retain� our� value� and� standards.�

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부록 4� �국내 CRO�디렉토리 ❚ 939

2.� Corporate� Service� &�Business� Area

Corporate� Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

○ ○

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US US US US

Canada Canada Canada Canada

EU EU EU EU

Asia ○ Asia Asia Asia ○

Global Global Global Global

Other Other Other Other

Focusing� Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D

Pre-ClinicalR&D� Strategy

&� ManagementPre-clinical

Test� SamplePhase� I ○ Clinical� Trials ○

Phase� II ○ Clinical� Test

Sample

Finished

Products

Regulatory

Affairs○

Phase� III ○Business

Development○

Finished

ProductPhase� IV ○

Sales� &

Marketing

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940� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

63 19 17 1

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

○ ○

Focusing�

Therapeutic� Area

We�do�have�various�experiences� in�diverse� therapeutic�areas�as� shown� in�pie�chart.�Our�top� three� TAs� are� Endocrinology,� cardiology,� and� oncology.

General� Overview

of� Corporate's� Key

Contract� Services

ADM� Korea� Inc.� provide� services� in� Regulatory� Affairs,� Clinical� Operation,� Project�Management,� Statistical� Analysis,� Data� Management,� PMS,� Pharmacovigilance,� and�Quality� Assurance� Services� from� Phase� I� to� Phase� IV.�

We�established�great� relationship�with� local�and�global�pharmaceutical�companies�and�experienced� in� various� therapeutic� areas.�

With�our� strength,�we�have�submitted� to�U.S.�FDA,�PMDA�Japan,�EMEA,�and�of� course�MFDS.�

Contract� Service�

Capacity� Affordable�

by� Service� Area

1)� Regulatory� Affairs:� Our� experienced� regulatory� professionals� are� committed� to�offering� superior� quality� regulatory� services� to� ensure� product� developments� running�efficiently� and� effectively� and� to� get� clients� maximize� opportunities.�Our� service� portfolio� ranges� from�biological� to� chemical� products� including�NCE� (New�Chemical� Entity),� IMD� (Incrementally� Modified� Drug),� and� Generics.�

2)� Clinical� Operation:� Our� Clinical� Research� Associates� and� Mangers� have� various�experiences� in� global� and� local� studies.�We� also� fully� understand� ICH-GCP� and� KGCP�guidelines.�We�offer� clinical� trial-related� services�within�global� standards� for� the�entire�clinical� trial� process.� ADM� Korea� Inc.� can� help� you� reduce� risks,� expenses,� or� any�

3.� Corporate� Business�Overview

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부록 4� �국내 CRO�디렉토리 ❚ 941

likelihood� of� delays� for� scheduled� timelines,� and� lead� you� success.�

3)� Project�Management:� For� the� best� project� performance�and� fulfilling� client’s� needs,�we�provide�Project�Management�Plan.�Your�success� is�our� success.�Our�passionate�and�talented� teams� of� professionals� assist� you� make� better� and� faster� decisions� on� every�step.

We� put� full� efforts� to� earn� the� high-quality� and� efficiency� in� each� project.�4)� Quality� Assurance/Audit:� Our� QA� Department� respectively� follows� GCP� to� provide�audit� service� to� sponsors.�We�consistently� conduct� self-audit� internally� to�maintain�our�service� quality� and� to� offer� better� service� for� our� valuable� clients.�

5)� PMS:� Our� PMS� experts� provide� the� most� optimized� services� to� satisfy� specific� or�various�client’s�needs� in�accordance�with� the� latest� regulations�and�guidelines� for�PMS.�We� support� clients� to� obtain� reliable� safety� data� by� efficient� study� and� project�management.�

6)�Data�Management:�ADM�Korea� Inc.�provides�high-quality� and�cost-effective�services�to� ensure� successful� management� and� delivery� of� clinical� trial� data./Compliance� with�Regulations� ICH�guideline,� 21� CRF� part� 11� and� KGCP/With� Expert�Data�Manager� and�Database� Programmer,� CRF� Manager,� Data� Coder.�

7)� Statistical� Analysis:� Our� Bio-Statisticians� comply� with� GCP� and� ICH� standards� such�as� ICH� E9,� Statistical� Principles� for� Clinical� Trials,� and�we� have� validated� SAS� Analysis�Result� System.�

8)� EDC� solution:� Solutions� developed� &� provided� by� CRScube� and� ADM� Korea� Inc.

Communication�

with� Clients

Dispositoion� of

Project� Manager

Responsible

Clinical� Research� Manager� (CRM)� is� responsible� for� project�operation,� coordination� and� delivering� deliverables� according�to� the� expected� timeline.� Also,� CRM� coordinates� the� internal�resources� required� to� execute� a� project.� Designated� CRM� is�available�via� telephone,�e-mail�and�mobile�phone�during�office�hours.

Providing� Realtime

Service� Delivery

A� detailed� timeline�Gantt� chart� would� be� developed�with� the�client� at� the� start� of� the� project� as� part� of� the� Project�Management�Plan(PMP).�TMF� including�essential�documents� is�routinely� quality� � checked� against� the� timeline.� For� full� service�projects� the� project� management� function� is� usually� assigned�to� an� experienced� CRM.

Realtime

Feed-back

We�provide�continuous� feedback� to�our�clients� in� real� time�and�are� completely� accessible� at� both� the� account� manager� and�the� Senior� executive� level.� We� meet� needed� deadlines.� We�work� out� a� schedule� which� meets� the� needs� of� the� client.

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942� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

4.� Corporate� Competitiveness

Corporate

Competitiveness

ADM� Korea� Inc.� is� one� of� the� best� CROs� in� Korea� and� has� great� reputation� in�registration� purpose� clinical� trials� (Phase� I,� II� and� III).� We� developed� our� SOPs� in�English� to� meet� the� global� standards� and� our� QA� department� performs� the�periodical� in-house� employees� training� along� with� E-learning� system� that� we� built�exclusively� for� our� workforce.�

We� provide� the� high� quality� services� to� our� clients� and� we� have� been� audited� by�global� and� local� pharmaceutical� companies� and� other� CROs.� Our� project�managers�have�average�of�8�years�experiences�and� they�can�manage� their� team�efficiently� and�handle� the� issues� effectively.�

1.� Specialized� in� registration�purpose� clinical� trials� (Phase� I,� II�and� III)�and�experienced�in� various� therapeutic� areas� in� past� 11� years.

2.�Have�global� standard� system� including�SOPs�and�experienced� in�numerous�global�projects.� (Local� to� Global� projects� ratio:� 40� to� 60)

3.� Built� systematic� training� program� to� have� outstanding� personnel� in� the� field� of�clinical� trials.

4.� Secured� Principal� investigators/Sites� database� and� built� great� relationship� with�them.

5,�CRM�to�CRA�ratios�are� relatively� lower� than�other�competitors� (CRM:�CRA�=�1:6).

6.� Made� strategic� partnership� with� a� lot� of� CROs� in� Asian� region� to� enable�multinational� studies.

No.� of� Regulatory

Inspections

Classification FDA(US) EMA(EU) PMDA(Japan) Others

Pre-Clinical� Area NA

Clinical� Area 23(MFDS)

Manufacturing� Area NA

Others NA

Page 946: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

부록 4� �국내 CRO�디렉토리 ❚ 943

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� toKorea,� Japan,� Germany,� USA

Asian� Clients'

Composition(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

59 21 19 1

No.� of� Asian� Clients

in� recent� 3� years82

Major� Service� Range

with� Asian� Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D

Pre-ClinicalPre-clinical

Test� Sample

R&D� Strategy

&� Management

Phase� I ○ Clinical� Trials ○

Phase� II ○Clinical� Test

Sample

Finished

Products

Regulatory

Affairs○

Phase� III ○

Finished

Product

Business

Development

Phase� IV ○Sales� &

Marketing

Page 947: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

944� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name C&R� Research,� Inc

Corporate� Ownership Private� Company

Head� Office� Address3rd� Floor,� Bunam� B/D� 447,� Samil-daero,� Jongno-gu,� Seoul,� Korea�

110-310

Facilities� City� &� Country Seoul,� Busan(KOREA),� Beijing(CHINA)

Korean� Business� Office

Gangnam� Office:� 3F,� Handong� B/D� 828-7� Yeoksam-dong,�

Gangnam-gu,� Seoul,� Korea� 135-980

Busan� Office:� 18� F,� Gyowon� B/D� 1199-9,� Choryang� 3-dong,�

Dong-gu,� Busan,� Korea� 601-838

Web-site� Address http://www.cnrres.co.kr/

No.� of� Employees 180

Contact

(Korean� Business)

Name Inhyang� Kim

Address3F,�Handong�B/D�828-7�Yeoksam-dong,�Gangnam-gu,� Seoul,� Korea�

135-980

Telephone +� 82-70-4033-3040

E-mail [email protected]

Company� History

C&R� Research� was� founded� in� 1997� in� Seoul� (HQ:� Jongro� office).� In� 2006� and� 2009,� Busan� office� and�

Gangnam� office� in� Seoul� were� established,� respectively.� In� 2010,� for� the� first� time� among� Korean� CROs,�

C&R� Research� established� C&R� Research� China� in� Beijing.�

C&R� Research�was� recognized� and� awarded� as� the� “Korea� Clinical� Research� Organization� of� the� Year”� in�

2008� as� the� part� of� Excellence� in� Healthcare� Awards� by� Frost� &� Sullivan,� which� was� given� to� a� CRO� in�

Korea� for� the� first� time.

To� move� fast,� customize� and� meet� our� clients’� needs,� C&R� Research� has� established� strategic� global�

networks� with� Global� and� Asia� partners� and�made� continuous� efforts� to� expand� and� enhance� long� term�

global� strategic� partnership.� In� 2012,� A-PACT� (Alliance� for� Pac-Asia� Clinical� Trials),� consisted� of� four� top�

local� CROs� in� Japan,�China,� Taiwan,� and� Korea,�was� created�with� one� united� focus� of� clinical� trials� in� the�

Pac-Asia� region.� A-PACT� offers� full-service� portfolios� for� sponsors� interested� in� conducting� studies� in� the�

Pac-Asia� region.

9. C&R RESEARCH, Inc

1.� Corporate� General� Information

Page 948: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

부록 4� �국내 CRO�디렉토리 ❚ 945

Company� Description� &� Organization

As� one� of� the� biggest� CROs� in� Korea�with� the� longest� history� in� the� Korean� CRO� industry,� C&R� Research�

has� been� contributing� significantly� to� the� development� of� clinical� trials� in� Korea.� C&R� Research� possesses�

about� 180� full-time� employees�with� over� 100� PM/CRAs,� all� office-based� in� our� three� offices:� Jongro� (HQ,�

Seoul),�Gangnam�(Seoul),�and�Busan.� In�our�clinical�operations�divisions,�we�have� five� (5)�Clinical�Research�

teams� that� specialize� in� Phase� I-III� studies,� a� Late� Phase� Study� (LPS)� team� that� specializes� in� post� approval�

(Phase� IV,� PMS,� and� observational)� studies,� and� an� Oncology� team� that� specializes� in� Oncology� projects.

C&R�Research�has�been�offering�services� for�all�phases�of�clinical� research� to�over�150�sponsors.�Especially,�

C&R� Research� boasts� its� ample� experience� and� top-notch� services� in� local� regulatory� clinical� trials� with�

conducting� more� than� 700� studies� in� various� therapeutic� areas.

C&R� Academy,� a� CRA� training� organization,� was� established� with� the� vision� to� be� the� clinical� research�

education�hub� in�Asia.�Following� its�vision,�C&R�Academy� received� ISO�9001:2008�qualification� in� “Design,�

Development,� Conduct� and� Service� of� Education�&� Training� for�Clinical� Research� Professionals”� and�offers�

quality� training� program� to� customers� and� C&R� staffs� altogether.

Page 949: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

946� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

2.� Corporate� Service� &�Business� Area

Corporate� Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

○ ○

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US ○ US US US ○

Canada Canada Canada Canada

EU ○ EU EU EU ○

Asia ○ Asia Asia Asia ○

Global ○ Global Global Global ○

Other Other Other Other

Focusing� Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D

Pre-Clinical Pre-clinical

Test� Sample

R&D� Strategy

&� Management○

Phase� I ○ Clinical� Trials ○

Phase� II ○Clinical� Test

Sample

Finished

Products

Regulatory

Affairs○

Phase� III ○Finished

Product

Business

Development

Phase� IV ○Sales� &

Marketing

Corporate� Product� Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

○ ○ ○ ○ ○

Generics APIs Devices Others

○ ○

Page 950: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

부록 4� �국내 CRO�디렉토리 ❚ 947

Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

15.7 71 9.4 3.9

Focusing�

Therapeutic� Area

(%)

Oncologics Lipid� RegulatorsRespiratory�

AgentsAnti-ulcerants

Angiotensin� � � II�

Antagonists

16.3 3.2 3.6 4.1 10.0

AntipsychoticsAutoimmune�

agentsAntidepressants Analgesics Others

2.3 3.4 0.5 2.7 53.9

General� Overview

of� Corporate's� Key

Contract� Services

C&R�Research�has�been�growing�and�expanding�continuously� as�a� leading�CRO�company�

in� Korea� based�on� successful� and�outstanding� performances� in� a� variety� of� areas� in� the�

pharmaceutical,� biotech� and� medical� device� industries� while� providing� a� full� range� of�

services� in� regulatory� affair,� clinical� trial,� PMS,� data�management� and� statistical� analysis�

services� as� well� as� GCP� auditing� service� by� meeting� international� standard� strictly.�

Contract� Service�

Capacity� Affordable�

by� Service� Area

C&R�Research� has� been�offering� full-portfolio�CRO�services� for�over� a� decade�with� high�

satisfaction� and� long-term� business� relations� with� clients.�

To� briefly� describe� our� services:

§ Medical� Writing:� Protocol/CRF/ICF� Development,� ICF� localization,� CSR� Writing�

§ Regulatory� Affairs:� RA� Feasibility� Consulting,� IRB� Submission,� IND� Submission�

§ Clinical� Operations:� Site� Feasibility,� Investigator� Selection,� Project� Management,�

Monitoring,� Medical� Monitoring� (locally),� SAE� Management�

§ Data� Management:� DB� Design,� Paper� CRF� &� EDC-based� Data� Management,� Clinical�

Coding,� Query� Resolution,� Data� QC�

§ Statistical�Analysis:� Sample�Size�Calculation,� Statistical� Programming,�Statistical�Analysis�

Report�

§ Quality� Assurance:� Internal/External� Audit,� Inspection� Preparation�

§ C&R� Academy:� Internal/External� CRA/PM� Training�

§ EDC� System� and� IWRS

*Full� CRO� service� available

From�accumulated� proven� capability,�we� are� the�No.1�CRO� in� the� clinical� research� for�

registration� (IND/NDA)� studies� in� Korea�with� solid� and� successful� global/multi-national�

studies� experiences.� We’ve� built� our� strong� expertise� in� oncology,� cardiovascular� and�

3.� Corporate� Business�Overview

Page 951: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

948� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

metabolism/endocrinology� as� well� as� infectious� disease� therapeutic� areas.� Moreover,�

we’ve� had� numerous� experience� in� various� therapeutic� areas� in� the� last� decades�

including:

Antibiotics,� Cardiovascular,� Dermatology,� Diagnostics,� Endocrinology/Metabolism,� ENT�

(Ear,� Nose,� Throat),� Gastro-intestinal,� Hepatobilliary,� Immunology,� Infectious� Disease,�

Medical� Device,�Musculoskeletal,�Nephrology,� Nervous� System� (CNS,� PNS),�Neurology,�

Obstetrics�and�GYN,�Oncology,�Ophthalmology,�Pain�Killer,�Respiratory,�Rheumatology,�

Urology,� Vaccine,� Others.

Communication�

with� Clients

Dispositoion� of

Project� Manager

Responsible

Project�manager� updates� and� reports� to� the� Sponsor� regarding� any�

study� issues�by� requested� template� and� frequency� for� the�Sponsor’s�

convenience.� Internally,� PM� manages� and� communicates� with� the�

CRAs� through�monthly� or� bi-weekly� internal�meetings� according� to�

the� Project� Management� Plan� and� company� SOP,� in� order� to�

eliminate� unnecessary� work� hours� created� by� miscommunication.

Providing� Realtime

Service� Delivery

In-house� CREPAS� (project� management� system)� is� used� for�

following�up� the�progress�of� projects� accordance�with� the� timeline.

Any� issues� are� immediately� raised� to� project� manager� so� that� they�

can� be� resolved� appropriately.

Realtime

Feed-back

In� addition� to� the� project� manager’s� proactive� communication,�

when� any� issues� regarding� the� budget,� contract,� or� services� arise,�

our� responsible� person� in� BD� team� are� ready� to� assist� the� Sponsor.

Page 952: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

부록 4� �국내 CRO�디렉토리 ❚ 949

Corporate

Competitiveness

Wide� Coverage

Through�A-PACT� (Asia-Pacific�CRO�alliance),�we�are�able� to� conduct� clinical� trials� in�

the�Asia�Pacific� region�with� top�quality�and� local�price.�C&R�Research�China�supports�

Korean� companies� who� aim� to� enter� the� China� market� and� mainly� provides�

consulting,� RA� (market� feasibility,� CTA� submission,� and� NDA� submission),� and�

monitoring� services.�

Project� Management� System�

C&R� Research� has� its� own� electronic� project� management� system� (CREPAS)� which�

contributes� to� systemic� project� management.� It� provides� real-time� updates� on� the�

progress� of� projects� thus� enabling� timely� management� of� human�

resources/workloads�and�any� trial-related� issues,�and� lowering�business� risk� that�may�

arise� by� turnover� of� CRAs.�

Specialized� Therapeutic� Areas� for� Oncology,� and� PV&PMS

To� strengthen� our� value� and� proficiency,� we� have� an� oncology-specialized� clinical�

unit� as�one�of� the�7�clinical�operations�units� in�C&R.�As�a� result,�C&R�Research�was�

selected� by� National� OncoVenture,� a� government-funded� agency,� as� their� only�

partner� CRO� who� manages� and� conducts� every� clinical� trial� that� National�

OncoVenture� is� involved�with.�C&R�Research�also�manages�a� separate�LPS� team�that�

specializes� in� post-approval� projects.

Quality� Management� System

Our�quality�assurance� team� is� responsible� for�quality�assurance�and� risk�management�

activities� in� C&R� Research.

l Investigator� site� audits

l Document� audits

l System� audits

l Pharmacovigilance� audits

l GLP� audits

l GCP� mock� inspection/Gap� analysis

l Competency� check� for� internal� staff

We� have� successfully� passed� all� of� quality� assurance� checks� including� audits� and�

inspections�by� regulatory�agencies� (e.g.�MFDS�(formerly�KFDA))�and�various�sponsors�

without� any� major� findings/concerns.

C&R� Academy� (Training� &� Operations� Practice)

C&R�Academy�provides�professional,� comprehensive�and� “hands-on”� clinical� research�

training� and� continuous� education� programs� to� achieve� our� excellence� in� quality�

within�C&R� Research� and� also� to� provide� excellent� clinical� research� professionals� to�

4.� Corporate� Competitiveness

Page 953: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

950� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

the� industry� and� academia.� C&R� employees� must� complete� 10� credits� (8� hrs� per�

credit)�per� year� to�ensure� their�quality�based�work�and�deepen� their� clinical/medical�

knowledge.�Customized� training� programs� (e.g.�GCP� training,� advanced�monitoring�

practices,� pharmacology,� therapeutic� areas,� etc.)� are� also� available� to� sponsors� as�

well� as� clinical� sites.�

No.� of� Regulatory

Inspections

Classification FDA(US) EMA(EU) PMDA(Japan) Others

Pre-Clinical� Area

Clinical� Area 15(MFDS)

Manufacturing� Area

Others

Current� Status� of

Accredited�

Certification

C&R�Academy�received� ISO�9001:2008�qualification� in� “Design,�Development,�Conduct�

and� Service� of� Education� &� Training� for� Clinical� Research� Professionals”

Page 954: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

부록 4� �국내 CRO�디렉토리 ❚ 951

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� toKorea,� Japan,� USA,� EU

Asian� Clients'

Composition(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

20 66.7 9.4 3.9

No.�of�Asian�Clients

in� recent� 3� years117� (since� Sept.� 2010)

Major� Service�

Range

with� Asian�

Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D

Pre-ClinicalPre-clinical

Test� Sample

R&D� Strategy

&�Management○

Phase� I ○ Clinical� Trials ○

Phase� II ○Clinical� Test

Sample

Finished

Products

Regulatory

Affairs○

Phase� III ○

Finished

Product

Business

Development

Phase� IV ○Sales� &

Marketing

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952� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name Chemon� Inc.

Corporate� Ownership Private� Company

Head� Office� Address15F,�Gyeonggi� Bio� Center,� 147,� Gwanggyo-ro,� Yeongtong-Gu,� Suwon-Si,�

Gyeonggi-DO,� 16229� ,� Korea

Facilities� City� &� Country Yongin,� Chuncheon,� S.Korea

Web-site� Address www.chemon.co.kr

No.� of� Employees 140� employees

Contact

(Korean� Business)

Name Kim� Jung� Rae

Address15F,�Gyeonggi� Bio� Center,� 147,� Gwanggyo-ro,� Yeongtong-Gu,� Suwon-Si,�

Gyeonggi-DO,� 16229� ,� Korea

Telephone +82-31-888-6633

E-mail [email protected]

Company� History

2000� •� Foundation� of� the� company� and� establishment� of� company-affiliated� research� institute�

2001� •� Certification� for� Venture� Business� (Small� and� Medium� Business� Administration)�

2002� •� GLP� certification� for� the� single� dose� toxicity� and� genetic� toxicity� (KFDA)�

2003� •� GLP� additional� certification� for� the� repeated� dose� toxicity,� reproductive� toxicity,� immunotoxicity,�

local� toxicity� (KFDA)�

2004� •� Completion� of� research� institute� in� Yangji

� � � � � •� Approval� of� change� of� GLP� appointment� for� the� research� institute� in� Yangji�

2006� •� GLP� additional� certification� for� Carcinogenicity� (KFDA)�

2007� •� GLP� additional� certification� for� other� toxicities� (KFDA)

� � � � � •� Moved� in� GyeongGi� Bio� Center

� � � � � •� Appointment� as� Chemical� hazard� testing� laboratory� (NIER)�

2008� •� Appointment� as� GLP� certified� Pesticide� safety� testing� laboratory� located� in� GyeongGi� Bio� Center�

(RDA)�

2010� •� AAALAC� Full� accreditation�

2011� •� Completion� of� Nation’s� first� Biologics� 3phase� of� clinical� (U.S.� FDA)

2012� •� INDS� (U.S.� FDA� consulting� agency)� inspection,� domestic� GLP� joint� periodic� inspection

2013� •� Completion� of� Nation’s� first� Natural� substance� 1,2phase� of� clinical� (U.S.� FDA)

2014� •� Expansion� of� research� institute� in� Yangji

� � � � � •� Opened� Chuncheon� Bio� center

10. Chemon Inc.

1.� Corporate� General� Information

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부록 4� �국내 CRO�디렉토리 ❚ 953

Company� Description� &� Organization

ChemOn� Inc.� is� the� first� established�private�CRO� for� the� non-clinical� areas� in� korea,�GLP� (Good� Laboratory�

Practice)� has� been� certified� and� suitable� facilities� and� research� manpower� are� secured.� The� Standard�

Operating�Processes� for� the�procedure�of� each� study�and� the�operation�of� the� facilities� and�equipment�are�

held�and� the�various� tests� that�are� required� in� the�development�of�new�medicines�and�health� supplements,�

cosmetics,� etc.� are� performed.

ChemOn� Inc.� offers� various� analytical� tests� as� well� as� toxicity� test� and� efficacy� test� and� provides� services�

such� as� toxicity� test� with� primates,� efficacy� test,� pharmacokinetics� and� in� vitro� pharmacology� through�

domestic� and� overseas� partners.

Thus� non-clinical� data� on� such� as� recently� studied� new�drug� are� submitted� as� certified� data� to� overseas� as�

well�as� the�domestic�NDA�and� therefore� the�clinical�approval�and� license�of�new�drug�are�achieved�without�

problems.

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954� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

2.� Corporate� Service� &�Business� Area

Corporate� Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US US US US

Canada Canada Canada Canada

EU EU EU EU

Asia ○ Asia Asia Asia

Global Global Global Global

Other Other Other Other

Focusing� Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D

Pre-Clinical ○ Pre-clinical

Test� Sample

R&D� Strategy

&� Management

Phase� I Clinical� Trials

Phase� IIClinical� Test

Sample

Finished

Products

Regulatory

Affairs

Phase� IIIFinished

Product

Business

Development

Phase� IVSales� &

Marketing

Corporate� Product�

Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

○ ○ ○ ○ ○

Generics APIs Devices Others

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부록 4� �국내 CRO�디렉토리 ❚ 955

Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

40 40 10 10

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

General� Overview

of� Corporate's� Key

Contract� Services

We� are� located� near� capital� area� so� that�we� can� visit� our� clients�whenever� they�want�

to� consult� their� project.

We� try� our�best� to�provide� services�with� the�desired� results�within� the� desired� time�at�

reasonable� prices,� thinking� and� worrying� from� the� perspective� of� our� sponsors.

Contract� Service�

Capacity� Affordable�

by� Service� Area

Our� research� center� is� in�Yongin,�Kyeonggi-Do.� This� facility� size� is�909.9㎡�and� is�now�

being� raised� several� kinds� of� animals.

Our� capacities� are�maximum� of� 10,800� rodents,� 220� dogs,� 300� guinea� pigs� and� 120�

rabbits.

We�became� the�organization� to�acquire�accreditation� from�AAALAC� international,�our�

services� are� performed� under� the� highest� standard� for� animal� care� and� use.

Communication�

with� Clients

Dispositoion� of

Project� Manager

Responsible

Our�Project�manager� team� is�composed�of�5�people.� They�each�are�

selected�as� the�contact�man�of� the�project.� �Project�manager� from�

Providing� Realtime

Service� Delivery

Usually� each� project� manager� sends� test� reports,� opinions� and�

Q&A� using� email� or� telephone.�

Realtime

Feed-backProject� managers� contact� with� clients� dialing� or� emailing� directly.

3.� Corporate� Business�Overview

4.� Corporate� Competitiveness

Corporate

Competitiveness

ChemOn� Inc.� work� with� prominent� figures� from� each� academia� as� an� advisory�

board� member� and� have� been� committed� to� continuously� learn� from� them� in�

order� to�perform�and�provide� the�GLP� test� that� can�be� recognized�anywhere� in�

the� world� since� established� in� 2000� so� as� to� meet� the� needs� of� such� market.

we� always� try� our� best� to� provide� services� with� the� desired� results� within� the�

desired� time,� for� the� international� recognition�and�at�competitive�prices,� thinking�

and� worrying� from� the� perspective� of� our� future� sponsors.

Current� Status� of

Accredited� Certification

1.Certified� KGLP� all� items� by� MFDS,� NIER,� RDA

2.Accredited� AAALAC� international

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956� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� to� India,� Thailand

Asian� Clients'

Composition(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

50 0 50 0

No.�of�Asian�Clients

in� recent� 3� years2� company

Major� Service�

Range

with� Asian�

Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D

Pre-Clinical ○Pre-clinical

Test� Sample

R&D� Strategy

&�Management

Phase� I Clinical� Trials

Phase� IIClinical� Test

Sample

Finished

Products

Regulatory

Affairs

Phase� III

Finished

Product

Business

Development

Phase� IVSales� &

Marketing

Page 960: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

부록 4� �국내 CRO�디렉토리 ❚ 957

Corporate� Name DreamCIS� Inc.�

Corporate� Ownership Public� Company

Head� Office� Address Rm.1010,� 130,� Sajik-ro,� Jongno-gu,� Seoul,� 110-756,� Korea

Facilities� City� &� Country<Busan� branch>

Rm.1009,� 176,� Jungang-daero,� Dong-gu,� Busan,� 601-839,� Korea

Web-site� Address http://www.dreamcis.com/

No.� of� Employees 250� employees(only� for� full� time� employees)

Financial� Status

Sales� Revenue� in� 2013

(US� K$)Capital(US� K$) Dept-equity� Ratio(%)

US� K$� 19,796 US� K$� 8,516 105%

Contact

(Korean� Business)

Name Injung� Hwang

Address Rm.1010,� 130,� Sajik-ro,� Jongno-gu,� Seoul,� 110-756,� Korea

Telephone +82-2-2011-4707

E-mail [email protected]

Company� History

2000� :� Established� DreamCIS

2004� :� Started� partnership� with� global� pharmaceutical� companies

2005� :� Set� up� lT� server� room� in� compliance� with� global� standard

2008� :� Received� 2� million� USD� in� grant� from� KDB(Korea� development� bank)

� � � � � � Founded� Biometric� center� specialized� in� DM/Bio-stat.

2009� :� Signed� MSA� with� overseas� partners

� � � � � � Awarded� 2009� national� productive� award(Human� resource� development)

� � � � � � Firstly� introduced� Oracle� clinical� system� in� Korea

2011� :� Set� up� a� Busan� branch�

2012� :� Launched� DreamTrial(EDC� system)

2013� :� Merged� with� Leenos

Company� Description� &� Organization

DreamCIS� is� a� leading� CRO(contract� research� organization)� in� Korea� providing� clinical� research� services� to�

the� pharmaceutical,� biotechnology,� medical� device,� and� functional� food� industries.� Through� the� scientific�

and� systematic� quality� management,� DreamCIS� is� dedicated� to� satisfy� our� clients’� needs� based� on� strict�

ethical� consciousness.

11. DreamCIS Inc.

1.� Corporate� General� Information

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958� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

2.� Corporate� Service� &�Business� Area

Corporate� Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

○ ○

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US ○ US US US ○

Canada Canada Canada Canada

EU ○ EU EU EU ○

Asia ○ Asia Asia Asia ○

Global Global Global Global

Other Other Other Other

Focusing� Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D

Pre-Clinical Pre-clinical

Test� Sample

R&D� Strategy

&� Management

Phase� I ○ Clinical� Trials ○

Phase� II ○Clinical� Test

Sample

Finished

Products

Regulatory

Affairs○

Phase� III ○Finished

Product

Business

Development

Phase� IV ○Sales� &

Marketing

Corporate� Product�

Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

○ ○ ○ ○ ○

Generics APIs Devices Others

○ ○ ○ ○

Page 962: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

부록 4� �국내 CRO�디렉토리 ❚ 959

Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

70 20 5 5

Focusing�

Therapeutic� Area

Oncologics Lipid� RegulatorsRespiratory�

AgentsAnti-ulcerants

Angiotensin� II�

Antagonists

8 2 4 2 2

AntipsychoticsAutoimmune�

agentsAntidepressants Analgesics Others

1 1 1 3 76

Besides� the� above� indication,� we� have� abundant� experience� in� various� types� of�

medicines� such� as� Calcium� Antagonists,� Anticoagulants,� Neurodegenerative� Disease,�

Insulin,� Agents� Affecting� Bone� Metabolism,� Vaccine� herbal� medicine� and� etc.

Please� note� that,� we� are� one� of� the� most� experienced� CRO� in� Vaccine� and� herbal�

medicine� studies.

General� Overview

of� Corporate's� Key

Contract� Services

DreamCIS� is� a� full� scope� of� service� provider� relating� to� clinical� trials� including� RA,�

consulting,� study� designing/protocol� development� including� pk/pd� study� and� bridging�

study,� site�management,�data�management/Bio-stat�and�CSR�writing,�and�we�can�also�

provide� partial� service� according� to� the� sponsor’s� request.

Also,�we�are�able� to�conduct�both�clinical� trials� (P1~P4)�and�non-interventional� studies.�

Especially,�we�have�experts� in� each� job� function� so� that�we�make� sure� to� deliver�high�

qualified� service� to� our� clients.

Contract� Service�

Capacity� Affordable�

by� Service� Area

DreamCIS� is� one� of� the� biggest� CRO� in� Korea.

250� employee� are� working� at� DreamCIS� and�we� have� 160� CRAs,� 35� DM� specialists� ,�

8� Bio-statisticians� and� � � 47� staffs(BD,� QS,� IT,� finance,� HR,� training)

Also,�we�have�MD(medical�director)� in�order� to�provide� the�best� service� for�consulting,�

PT/CSR� writing� and� medical� affairs.�

And,� another� strength� of� our� organization� is� that� we� have� separate� team� for� CR,�

Non-interventional� study,� DM/Bio-stat.� and� each� team� consist� of� qualified� experts� in�

each� job� function.� So�we� can� cover� whole� activities� relating� to� clinical� trials�with� our�

own� resources.

Communication�

with� Clients

Dispositoion� of

Project� Manager

Responsible

In� order� for� effective� communication� with� the� sponsor,� we�

designate� a� person(PM)� who� will� be� responsible� for� whole�

communication� between� two� companies,� and� DreamCIS� regularly�

provides� a� training� relating� to� effective� communication� skill.

Providing� Realtime

Service� Delivery

We�have� our� own� PM� (project�management)� system� and�we� can�

check� the�project� schedule� through�our� intranet.�Also,�PM�(project�

manager)�oversights� the�project� to�make�sure� that� the�data/report�

delivers� to� the� sponsor� in� time.

Realtime

Feed-back

In� order� to� share� sponsor’s� feedback,� we� are� having� a� regular�

project� meeting� (F2F� or� T/C)� with� the� sponsor� and� we� have� a�

regular� internal� meeting� to� share/discuss� any� issues,� sponsor’s�

feedback� and� current� status.

3.� Corporate� Business�Overview

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960� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

4.� Corporate� Competitiveness

Corporate

Competitiveness

1)�DreamCIS� is�one�of� the�pioneers� in�Korea�having�over�14-year�history,� so�we�

have� abundant� experiences� in� various� indications� and� expert� know-how,� too.

2)�Another� competitiveness� is� the� lowest� turnover� rate,� especially� PM’s� turnover�

rate� is� significantly� low�compared� to�other�providers.�To�keep� low�turnover� rate,�

we�provide�better�working�environment�and�excellent� training�programs� in�order�

to� motivate� people� to� stay� at� our� company� and� to� lead� job� satisfaction.� It�

absolutely� leads� our� people’s� satisfaction� and� consequently� better� qualified�

services.

3)� We� have� independently� organized� teams� for� Clinical� trials� (P1~P3),�

non-interventional� studies� including� regulatory� post� marketing�

studies/P4/Functional� food/Medical� device,� and� data� management/bio-stat.� So,�

we� can� provide� specified� services� considering� each� study� type’s� nature� with�

higher� quality.

4)�We� firstly� introduced�global�DM�system�(Oracle�Clinical)� in�Korea� in�2009�and�

have� abundant� experiences� in� DM� of� interventional� studies� (P1~P4),� IITs� and�

non-interventional� studies� (regulatory�Korean�PMS,�OS,�outcomes,�etc.)�Also,�we�

have�our�own�eCRF�system�named�DreamTrial�and� it� is� specially�customized�and�

considered� at� non-interventional� studies’� nature.

No.� of� Regulatory

Inspections

ClassificationFDA

(US)

EMA

(EU)

PMDA

(Japan)

CFDA

(China)

DCI

(India)Others

Pre-Clinical� Area

Clinical� Area MFDS

Manufacturing� Area

Others

Page 964: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

부록 4� �국내 CRO�디렉토리 ❚ 961

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� to

We’ve�worked�with�multinational�pharmaceutical�companies�based� in�USA,�Europe�and�

Asia� and� now� we� are� discussing� with� another� Japanese� pharma� company� for� global�

project.� Other� than� that,� many� other� pharmaceutical� companies� from� India,� Europe�

and� USA� keep� visiting� us� to� discuss� how� to� collaborate� with� us.

Asian� Clients'

Composition(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

50% 35% 10% 5%

No.�of�Asian�Clients

in� recent� 3� years

For� the� last�3�years,�over�60�overseas� clients�have�contacted�us,�and�especially� for�Asian�

client,� � we’ve� conducted� 7� projects� with� 3� Japanese� clients.� Also,� we� are� conducting�

many� global� projects� with� global� sponsors� other� than� Japanese� clients.

Major� Service�

Range

with� Asian�

Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D

Pre-ClinicalPre-clinical

Test� Sample

R&D� Strategy

&�Management

Phase� I ○ Clinical� Trials ○

Phase� II ○Clinical� Test

Sample

Finished

Products

Regulatory

Affairs○

Phase� III ○

Finished

Product

Business

Development

Phase� IV ○Sales� &

Marketing

Page 965: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

962� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

6.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

We� have� worked� and� are� working� with� over� 220� companies� which� include� most� of� Global� pharmaceutical�

companies,� Local� Pharmaceutical� companies� and� bio-ventures� in� Korea.

Also,� we� keep� retaining� existing� clients� at� around� over� 80%� and� the� other� 20%� is� mostly� small� companies�

who� don't� have� enough� pipeline� continuously� conducting� trials.

A� win-win� approach� to� two� parties,� there� are� a� couple� of� collaboration� systems.

1)�Some� sponsors�make� relationship�either� by�Master�Service�Agreement�or�by�nominating�preferred� vendor.�

So,�we�discuss�master� conditions� for� all� contracts�between� two�parties�and�we�only�discuss�outsourcing�work�

for� each� study.�

2)�We� can� provide� dedicated� resources� for� a� certain� sponsor� and� it� can� help� to� be� able� to� provide� effective�

operation� of� its� studies.

3)�We� set-up�working�process� for� a� certain� sponsor� and�develop� a� client-specific�manual� in�order� to� provide�

consistent� and� well-customized� services.

We� are� trying� to� find� new� solution� to� meet� the� sponsor’s� expectation� and� we� will� keep� continuing.

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부록 4� �국내 CRO�디렉토리 ❚ 963

Corporate� Name Ginapath,� Co,� Ltd

Corporate� Ownership Private� Company

Head� Office� Address 1009,�10F,�ZERO�bldg.,�14,� Teheran-ro,�84-gil,� Seoul,�06178,�South�Korea

Facilities� City� &� Country Seoul,� South� Korea

No.� of� Employees 2

Financial� Status

Sales� Revenue� in� 2015

(US� K$)Capital(US� K$) Dept-equity� Ratio(%)

5,000� K� $ - -

Contact

(Korean� Business)

Name Guk-Jin,� Son

Address 1009,�10F,�ZERO�bldg.,�14,� Teheran-ro,�84-gil,� Seoul,�06178,�South�Korea

Telephone +82-10-6405-7493

E-mail [email protected]

Company� History

Ginapath� established� in� end� of� 2014� and� actually� had� 1.5� years’� experience.� But,� more� than� 15� years’�

experience� in� pharmaceutical� field� before� and� after� establishing.

Company� Description� &� Organization

We,� Ginapath,� are� consulting� company� to� support� Korean� pharmaceutical� industry� to� develop� new� molecule� (NCE,�

Biologics,�Biosimilar,�Bio-better,�etc)� for�global� licensing.�Actually,�we�are� supporting�non-clinical,� clinical,�CMO,�Global�

license-In� and� Out.� We� have� strong� partners� in� the� world� for� each� specific� field,� especially� for� FDA� and� EMEA.

12. Ginapath, Co, Ltd

1.� Corporate� General� Information

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964� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

2.� Corporate� Service� &�Business� Area

Corporate�Main�

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing Consulting

○ ○ ○

GeographicalBusiness� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing Consulting

MiddleEast

MiddleEast

MiddleEast

MiddleEast

Africa Africa Africa Africa

US ○ US US US ○

EU ○ EU ○ EU EU ○

Asia ○ Asia Asia Asia ○

Russia&CIS

Russia&CIS

Russia&CIS

Russia&CIS

Cemtral&South�America

Cemtral&South�America

Cemtral&South�America

Cemtral&South�America

ROW ROW ROW ROW

Focusing�Contract

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing Consulting

Research API ○

APIs

R&D ○

Pre-Clinical ○ Pre-clinicalTest� Sample ○

R&D� Strategy&� Management ○

Phase� I ○ Clinical� Trials ○

Phase� II ○ Clinical� TestSample ○

FinishedProducts

RegulatoryAffairs ○

Phase� III BusinessDevelopment

FinishedProduct

Phase� IV Sales� &Marketing

Corporate

Product� Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

○ ○ ○ ○ ○

Generics APIs Devices Others

○ ○ ○ ○

Page 968: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

부록 4� �국내 CRO�디렉토리 ❚ 965

Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

50 20 30 0

3.� Corporate� Business�Overview

Page 969: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

966� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

13. ICON plc

Ⅰ.�기업개요

기업명 ICON� plc 대표자명 Ciaran� Murray

설립년도 (� � 1990� � � )년도 종업원수Global� 약8,300명

Korea� 77명홈페이지주소 www.iconplc.com

주 소(본사)우편번호 주소

- South� Country� Business� Park,� Leopardstown,� Dublin� 18,� Ireland

기업소개

ICON은 제약,�생명공학 그리고 의료기기 산업 분야에 개발 서비스를 제공하는 세계적인 대행업체이다.� ICON은 임상

개발을 지원하는 compound� selection부터 1상에서 4상 임상 시험에 이르기까지 관련 모든 프로그램에 전략적인 개

발,� 관리 그리고 분석을 대행하고 있다.� Dublin에 본사를 두고 있으며,� 아시아 태평양을 포함한 전세계에 38개 국가,�

79개의 사무실을 가지고 있으며 직원수는 약 8,300명이다.

담당자 연락처

성명 부서명연락처

Tel Fax E-mail

이재욱Business�

Development�02-520-5283 02-3463-1346�

[email protected]

om

Ⅱ.�수탁시험,�분석 서비스 현황

1. 서비스 영역

영역 전임상 임상1상 임상2상 임상3상 PV PMSData

Management통계분석 인허가대행 컨설팅

해당

여부○ ○ ○ ○ ○ ○ ○

Page 970: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

부록 4� �국내 CRO�디렉토리 ❚ 9672. 수탁시험/분석 서비스 내용

서비스영역(전임상,� 임상 등) 수탁시험/분석 서비스 세부내용

Clinical� Operations

-� Project� management

-� Clinical� trial� site� management� and� monitoring

-� Regulatory� document� processing

-� Patient� recruitment

-� Contact� management� &� Investigator� reimbursement�

3. 수탁시험/분석 제품영역

신약 생물학적

제제바이오시밀러 천연물의약품 개량신약 제네릭 기타(기재요망)

화합물신약 바이오신약

○ ○ ○ ○ ○ ○ ○

4. 질환영역

� Oncology,� CNS,� cardiovascular,� endocrine&� metabolic� disorders,� gastrointestinal,� infectious� disease

� All� therapeutic� areas� can� be� covered� by� ICON.

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968� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

14. Korea Institute of Toxicology

1.� Corporate� General� Information

Corporate� Name Korea� Institute� of� Toxicology

Corporate� Ownership Public� Company

Head� Office� Address Daejeon� campus

Facilities� City� &� Country P.O.Box� 123,� 141� Gajeongro,� Yuseong-gu,� Daejeon� 305-343,� KOREA

Korean� Business� OfficeJeonbuk� Department� of� Non-human� PrimateGyeongnam� Department� of� Environmental� Toxicology� and� Chemistry

Web-site� Address www.kitox.re.kr

No.� of� Employees 385

Contact

(Korean� Business)

Name Doyon� Cho

Address P.O.Box� 123,� 141� Gajeongro,� Yuseong-gu,� Daejeon� 305-343,� KOREA

Telephone +82-42-610-8106

E-mail [email protected]

Company� History

2012 ▶US� FDA� Inspection2011 ▶Completion�of� third�campus,�Gyeongnam�Department�of�Environmental�Toxicology�and�Chemistry2010 ▶Completion� of� second� campus,� Jeonbuk� Department� of� Non-human� Primate� � � � ▶AAALAC� Re-accreditation2009 ▶Establishment� of� master� plan� for� third� campus2008� ▶Completion� of� Inhalation� toxicology� building� at� second� campus2007� ▶AAALAC� Re-accreditation� � � � � ▶Establishment� of� KIT-ISIS� Biotherapeutics� Development� Center2005� ▶Establishment� of� master� plan� for� second� campus� � � � � ▶United� States� Food� and� Drug� Administration� (US� FDA)� Inspection2004� ▶AAALAC� Re-accreditation2002� ▶GLP� certified� by� the� Korean� Ministry� of� Agriculture� and� Forestry� � � � � ▶Inauguration� of� KIT� (Korea� Institute� of� Toxicology)� affiliated� with� Korea� Research� Institute� of�

Chemical� Technology� (KRICT)2001� ▶Construction� of� the� new� GLP� building2000� ▶OECD� Joint� Visit1998� ▶GLP� certified� by� the� Korean� Ministry� of� the� Environment� � � � � ▶AAALAC� Accreditation� � �1990� ▶GLP� certified� by� the� Japanese� Ministry� of� Agriculture,� Forestry� and� Fisheries1988� ▶GLP� certified� by� the� Korean� Ministry� of� Health� and� Welfare1984� ▶Transferred� from� Korea� Institute� of� Science� and� Technology� (KIST)� to� Korea�Research� Institute� of�

Chemical� Technology� (KRICT)1980� ▶Establishment�of�master�plan� for� research�on�chemical� safety�by� the�Korean�Ministry�of� � � �Science�

and� Technology

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부록 4� �국내 CRO�디렉토리 ❚ 969

Company� Description� &� Organization

Korea� Institute� of� Toxicology,� located� in� Daedeok� Science� Town,� the� center� of� the� state-of-the-art�

biotechnology� in� Korea,� is� a� government-funded� research� institute� to� evaluate� the� safety� of� medicine,�

bio-related� products� and� chemicals� such� as� agricultural� pesticides,� food� additives� and� cosmetics.

Established� in� 1980,� KIT� has� played� a� leading� role� in� improving� advanced� technology� and� bulilding� the�

research� framework� for� the� safety� assessment� in� Korea� ranging� from� the� test� for� general� toxicology� to� the�

test� for� environmental� toxicology.� In� addition,� KIT� serves� as� a� core� infrastructure� in� the� biotechnology�

industry.

KIT� is� a� world-class� prestigious� non-clinical� contract� research� organization� located� in� South� Korea.� KIT’s� GLP�

system� has� been� certified� by� Korean� and� international� regulatory� authorities� based� on� OECD� and� US� FDA�

GLPs.�

Also,� KIT� is� the� first� organization� in� Asia� accredited� by� AAALAC� International� for� humane� laboratory� animal�

treatment.�KIT�offers� a� full� range�of�non-clinical� research�with�high� scientific� standard�and�competitive�price.�

ㆍ� Organization� and� composition� (� as� of� June� 2012)

� � � 3� headquarters,� 6� divisions,� 11� centers,� 11� teams

ㆍ� Manpower� status� :� Total� of� 385� employees� (incl.� 191� non-regular� workers)

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970� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

2.� Corporate� Service� &�Business� Area

Corporate� Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US US US US

Canada Canada Canada Canada

EU EU EU EU

Asia Asia Asia Asia

Global ○ Global Global Global

Other Other Other Other

Focusing� Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research ○ API

APIs

R&D

Pre-Clinical ○ Pre-clinicalTest Sample

R&D Strategy& Management

Phase� I Clinical Trials

Phase� IIClinical TestSample

FinishedProducts

RegulatoryAffairs

Phase� IIIFinishedProduct

BusinessDevelopment

Phase� IVSales &Marketing

Corporate� Product�

Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

○ ○ ○

Generics APIs Devices Others

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부록 4� �국내 CRO�디렉토리 ❚ 971

Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

25% 30% 25% 20%

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

○ ○

General� Overview

of� Corporate's� Key

Contract� Services

Main� Areas� of� Research

•� General� Toxicology� �

•� Carcinogenicity� Study� �

•� Non-human� Primate� Toxicology� �

•� Reproductive� Toxicology� �

•� Genetic� Toxicology� �

•� immunotoxicology� �

•� Pharmacology� �

•� Pharmaco� &� Toxicokinetics� �

•� Toxicologic� pathology�

•� Ecotoxicology� �

•� Environmental� Chemistry� �

•� Toxicogenomics� �

•� lnhalation� Toxicology

Contract� Service�

Capacity� Affordable�

by� Service� Area

<Daejeon� Campus>

•� Facility� Size� :� 21,000� ㎡

-� Toxicology� � :� 17,390� ㎡

-� Pharmacology:� 3,340� ㎡

•� Main� Facilities

-� Regulatory� Toxicology� (IND� and� NAD� enabling� studies)� Laboratory

-� General� Toxicology� � Laboratory

-� Safety� Pharmacology� Laboratory

-� Analysis� Study� Laboratory

-� TK� and� PK� Study� Laboratory

-� Including� Clinical� sample� analysis� Study� Laboratory

-� Drug� Development� Collaboration

<Jeonbuk� Department� of� Non-human� Primate>

•� acility� Size:� Land� area� of� 146.969㎡

•� ain� Facilities

-� Research� Building� 1[Long-term� Toxicity,� Non-human� Primate� Toxicity� Study]

-� Research� Building� for� Testing� Inhalation� Safety

3.� Corporate� Business�Overview

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972� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

-� Dormitory

-� Support� Building

<Gyeongnam� Department� of� Environmental� Toxicology� and� Chemistry>

•� Facility� Size:� Site� 52,674㎡� /� Total� ground� area� 6,493㎡

•� Main� Facilities

-� Ecotoxicology� Study� Laboratory

-� Environmental� Chemistry� Study� Laboratory

-� Physics� &� Chemistry� Syudy� Laboratory

-� Radioactive� lsotope[RI]

-� Toxicology� Study� [Rodent]� Laboratory

-� Genetic� Toxicology� Study� Laboratory

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부록 4� �국내 CRO�디렉토리 ❚ 973

4.� Corporate� Competitiveness

Corporate

Competitiveness

•KIT� is� a� government-funded� research� institute� that� is� specialized� in� the�

assessment� of� toxicity� and� safety� of� bio-industrial� products� including� new�

medicines,� agrochemicals,� and� health� foods.

•KIT� conducts� diverse� overall� pre-clinical� tests� required� in� the� development� of�

new� substances� for� renowned� domestics� and� international� companies� in� the�

field� of� foods,� phamaceuticals� and� agrochemicals.

-� Domestically� the� first� GLP(Good� Laboratory� Practice)� certified� institute

-� 30-year� history� in� the� field� of� Toxicity� and� Safety� Assessment

-� In� Asia,� the� first� AAALAC(Association� for� Assessment� and� Accreditation� of�

Laboratory� Animal� Care)� certified� institute

-� Domestically� the� best� group� of� specialized� personnel� and� first-class�

technologies,� and� the� most� up-to-date� experiment� building�

-� Support� � the� registration� of� the� United� States,� Japan,� and� EU

No.� of� Regulatory

Inspections

ClassificationFDA

(US)

EMA

(EU)

PMDA

(Japan)

CFDA

(China)

DCI

(India)Others

Pre-Clinical� Area ○ ○ ○

Clinical� Area

Manufacturing� Area

Others

Current� Status� of

Accredited� Certification

2012 US� FDA� Inspection2005 US� FDA� Inspection2002 GLP� certified� by� the� Korean� Ministry� of� Agriculture� and� Forestry2000 GLP� certification� by� OECD� Mutual� Joint� Visit�1998 GLP� certified� by� the� Korean� Ministry� of� the� Environment1990 GLP� certified� by� the� Japanese� Ministry� of� Agriculture,� Forestry,� and�

Fisheries1988 GLP� certified� by� the� Korean� Food� and� Drug� Administration� � ㆍKorea�Excellent� Laboratory�Animal�Facility� (KELAF)� (2012,�First� in�GLP� facility�

in� Korea� � ㆍFull� AAALAC� accreditation� in� 1998� (First� in� Asia)�� � � � Accreditation� extensions� in� 2001,� 2004,� 2007,� 2010,� 2013

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974� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

15. LSK Global Pharma Services Co., Ltd.

1.� Corporate� General� Information

Corporate� Name LSK� Global� Pharma� Services� Co.,� Ltd.

Corporate� Ownership Private� Company

Head� Office� Address97� Toegye-Ro,� Coryo� Daeyungak� Tower� 16th� FL.,� Jung-Gu,� Seoul� 04535�

Korea

Web-site� Address www.lskglobal.com

No.� of� Employees 290� Employees

Financial� StatusSales� Revenue� in� 2015(US� K$) Capital(US� K$) Dept-equity� Ratio(%)

14,646,020.19 818,199.9 653

Contact

(Korean� Business)

Name Yong-Bum� Lee�

Address97� Toegye-Ro,� Coryo� Daeyungak� Tower� 16th� FL.,� Jung-Gu,� Seoul� 04535�

Korea

Telephone 82.2.2014.9555

E-mail [email protected]

Company� History

2016� � � 06� Started� Medidata� CTMS� first� among� CROs� in� Korea

� � � � � � � � 06� Started� Medidata� CTMS� first� among� CROs� in� Korea

� � � � � � � � 03� Strategic� Alliance� with� LSK� BioPharma� for� global� clinical� trials� for� Apatinib

� � � � � � � � 03� MOU� with� Konyang� Univiersity� to� develop� the� talents

2015� � � 10� Introduced� Oracle� Health� Sciences� InForm

� � � � � � � � 05� Elected� first� chairperson� of� the� Korean� Association� of� Clinical� CROs�

� � � � � � � � 04� Signed� agreement� with� Clinical� Trial� center� of� Seoul� National� University� Hospital

2014� � � 01� clinical� Afreement

2013� � � 04� President� appointed� as� 'Korean� Society� of� Health� Information� and� Statistics'� Advisor

2012� � � 09� President� appointed� as� ‘Emerging� Medicine� Market� Expansion� and� Consultant’� Expert� Advisor�

� � � � � � � � 05� office� relocated� from� Seocho-dong,� Seoul� to� Myeong-dong,� Seoul

� � � � � � � � 05� Organized� seminar� on� "Outcome� Research"� [Seoul,� Korea]

� � � � � � � � 02� Organized� seminar� on� "Multinational� Clinical� ResearchTrials� &� CDM"� [Seoul,� Korea]

2011� � � 09� Joined� Asia� CRO� Alliance� (Korea,� Japan,� Chaina,� Taiwan,� India,� Malaysia)

� � � � � � � � 09� Signed� alliance� agreement� with� MakroCare

� � � � � � � � 06� Signed� agreement� with� Medidata� Solutions,� Inc

� � � � � � � � 01� Signed� agreement� with� Guro� Hospital,� Korea� University

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부록 4� �국내 CRO�디렉토리 ❚ 975

2010� � � 10� Organized� seminar� on� "Data� Management� &� e*CRF� in� Korea� 2010"

� � � � � � � � 08� Initiated� Electronic� Data� Capture� Service� with� Target� e*Studio

� � � � � � � � 07� Received� certification� from� the� Korea� Industrial� Technology� Association� for� Research� and�

Development� Office

� � � � � � � � 04� Signed� agreement� with� Clinical� Trial� Center,� Dongguk� University

2009� � � 11� Signed� agreement� with� Clinical� Trial� Center,� Dankook� University

2007� � � 11� Office� relocated� from� Yeoksam-dong,� Seoul� to� Seocho-dong,� Seoul

� � � � � � � � 08� Company� name� was� changed� from� Lifecord� Stat-Korea,� to� LSK� Global� Pharma� Service� Co,� Ltd

2006� � � 05� Joined� ACTN� [Asia� Clinical� Trials� Network]

� � � � � � � � 01� Established� partnership� with� Target� Health,� in� Clinical� Research� &� Regulatory� Consulting�

2005� � � 07� Award� for� Appreciation� to� LSK� CEO� by� KFDA

� � � � � � � � 01� Initiated� CDM� System� service� with� DMSys

� � � � � � � � 01� Established� partnership� with� MDS� Pharma� Services� in� Canada

2001� � � 12� Lifecord� and� Westat-Korea� merged� to� form� Lifecord� Stat-Korea,� Inc.

� � � � � � � � 01� Reincorporated� as� Stat-Korea

� � � � � � � � 01� Westat-Korea� was� reestablished

2000� � � 07� Westat� Korea� was� established� [Westat,� Inc.� Korea� branch]

Company� Description� &� Organization

A�full-service�Contract�Research�Organization� (CRO)�established� in�March�2000,�supports� all� aspects�of�Clinical�

Trials,� which� include� phase� I� to� phase� III,� phase� IV,� Investigator� Initiated� Trials,� Post� Marketing� Surveillance�

(PMS),� and� Observational� Studies.

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976� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

2.� Corporate� Service� &�Business� Area

Corporate�Main�

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing Consulting

GeographicalBusiness� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing Consulting

MiddleEast

MiddleEast

MiddleEast

MiddleEast

Africa Africa Africa Africa

US ○ US US US

EU ○ EU EU EU

Asia ○ Asia Asia Asia

Russia&CIS ○ Russia&

CISRussia&CIS

Russia&CIS

Cemtral&South�America

○Cemtral&South�America

Cemtral&South�America

Cemtral&South�America

ROW ROW ROW ROW

Focusing�Contract

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing Consulting

Research ○ API

APIs

R&D

Pre-ClinicalPre-clinicalTest� Sample

R&D� Strategy&� Management

Phase� I ○ Clinical� Trials

Phase� II ○ Clinical� TestSample

FinishedProducts

RegulatoryAffairs

Phase� III ○ BusinessDevelopment

FinishedProduct

Phase� IV ○ Sales� &Marketing

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부록 4� �국내 CRO�디렉토리 ❚ 977

Clients'�Composition

(%)

Big� PharmasMid� or� Small-Size� Pharmas

BiotechCompanies

Start-ups

70% 10% 7% 13%

In-house� Facilities

Research� &Development

Preclinical ClinicalCustom

Manufacturing

Focusing�Therapeutic� Area

Oncologics Lipid� RegulatorsRespiratory�Agents

Anti-ulcerantsAngiotensin� II�Antagonists

19 2 4 1 8

AntipsychoticsAutoimmune�agents

Antidepressants Analgesics Others

1 1 1 1 62

LSK� has� a� clinical� trial� experience� in� 31� therapeutic� area� and� 196� indications.� Among�these� experience� we� have� the� most� experience� in� oncology,� cardiovascular� and�endocrinology.� We� also� have� experience� in� rare� diseases� and� vaccines.

General� Overview

of�Corporate's�Key

Contract� Services

General� Consulting�

ü Regulatory� Strategy� Consulting�

ü Bridging� Study� Strategy�

ü Study� Design� Consulting�

ü Protocol� (Korean,� English)�

ü Product� Development� Consulting

Medical� Writing� &� Research

ü Protocol� Development� (Korean,� English)

ü CSR� Development� (Korean,� English)

RA/SSU

ü Regulatory� Affairs� (IND)

ü Feasibility� (Site� /� Investigator� Selection)

ü PSSV� (Pre-Study� Site� Visit)�

� � � :� Site� Qualification� Visit

ü IRB� Submission

ü CTA� (Clinical� Trial� Agreement)

ü IP� /� non� IP� Import

ü GSP� (Good� Supply� Practice)� Service

Quality� Assurance� (Audit)

ü Audit� (Study,� System,� Qualification)

ü Training

Project� Management�

ü Project� Management� Plan

ü Risk� Mitigation� Plan

ü Budget� /� Timeline� Management� Plan

ü Others

3.� Corporate� Business�Overview

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978� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Monitoring

ü Monitoring� (SIV,� IMV,� COV,� Query� Resolution� etc.)

ü Documentation� (Collection� and� Maintenance� of� TMF� /� ISF� /� PF)

ü Safety� Management�

ü Site� Management

DM� /� STAT� /� CSR

ü Data� Management� (DM)� (EDC� &� paper� ­� based)

ü Statistical� Services

ü Clinical� Study� Report� (CSR)� (Korean,� English)

ü CRF� Development� (Paper� &� e-Contents)

PMS� /� Observational� Studies

ü Post� Marketing� Surveillance� (PMS)�

ü Observational� /� Epidemiological� Studies

Drug� Registration� Service

ü Registration� Strategy

ü NDA� Package� Preparation� /� Submission

ü Reimbursement� Package� /� Submission

Pharmacovigilance

ü Set-up� and� Management� of� a� PV� System

ü PSUR/PBRER� Development

ü RMP� Development

Communication�

with� Clients

Dispositoion� of

Project� Manager

Responsible

•� Project� Planning� -� Planning� and� estimating� are� continuous�

processes�which� shall�be� throughout� the� course�of�a�project.� Project�

Scope,� Project� Time,� Project� Cost,� Project� Schedule,� Quality� Plan,�

Communication� Plan,� Risk� Assessment� Plan

•� Manage� Resources� &� timelines:� Project� scheduling� involves�

preparing� various� graphical� representations� showing� project�

activities,� their� durations� and� staffing.

•�Communication� -� Effective� communication� between� the� projects�

team� members� and� Sponsors.�

•�Work� within� Budgets� -� Ensure� that� the� project� is� completed� on�

time� and� within� budget.�

•�Regular� Follow-up� ­�PM� is� involved� in� the�projects� right� from�the�

beginning� of� the� study� until� the� closure� of� the� project.� Hence,� it’s�

a� continuous� process� to� foresee� Project� Developments� timely�

manner� &� Corrective� action.� Change� the� project� timelines,� adding�

more� resources� etc.

•� Crisis� Management:� Ensure� that� project� risks� are� identified,�

analyzed,� and� responded.�

•�Project�Closure� -�Reporting� the�project� along�with�Achievements�

&� reference� to� objectives,� time� taken� Versus� time� scheduled,� costs�

incurred� Versus� the� budget� etc.

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부록 4� �국내 CRO�디렉토리 ❚ 979

Providing

Realtime

Service� Delivery

•� Maintaining� &� Adhering� to� Project� Specific� timelines

•� Team� &� Vendor� Management�

•� Communication� with� all� project� specific� vendors

� � o� Newsletter

� � o� Scheduling� Teleconference� &� Meetings

•� Project� specific� report� to� Sponsors

•� Assisting� in� Contract� Management

•� Delivering� qualitative� data� &� Ensuring� data� integrity

•� Identifying� risks�and�drawing�up�plans� to�minimise� their� effect�on�

a� project.

•� Ensure� that� these� risks� do� not� develop� into� major� threats.

•�Ensure� that�a�Risk�management�plan� is�prepared�before� the�start�

of� a� clinical� study.�

Realtime

Feed-back

•� Even� though� Global� studies� have� many� vendors,� the� issues� are�

solved� in� timely� manner.

•� One� point� of� Contact� which� sponsors� prefer.

•� Communication� with� all� vendors� which� avoids� confusion

•� Quick� response� to� sponsors� or� vendors� issues.

•� Better� efficiency� in� delivering� services

•� Improved/increased/enhanced� Sponsor� satisfaction

•� Enhanced� effectiveness� in� delivering� services

•� Improved� growth� and� development� within� your� team

•� Opportunities� to� expand� your� services

•� Better� Flexibility

•� Increased� risk� assessment

•� Increase� in� Quality� &� Quantity

•� More� importantly� Good� quality.

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980� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

4.� Corporate� Competitiveness

Corporate

Competitiveness

Experience�

ü 736� Trials� completed� or� ongoing� (Updated� on� Aug.� 2015)

ü Study� experience� in� various� indications

ü Global/local,� large/small� and� early/late� phase� trial� experience

ü Study� issue� analysis/manage� and� escalation

ü Study� rescue� operation� experience�

ü CAPA� competency�

Global� Standard� Quality�

ü ICH� Standard� SOP� in� English

ü Numerous� Assessment� Audits(Multinational� Pharmaceutical� companies� /� CROs)

ü Domestic� sponsor’s� trials� in� the� abroad�

ü Global� standard�DM�System:�e*CRF�of�Target�health�and�Rave�System�of�Medidata�

and� InForm� of� Oracle�

ü High� quality� SAP,CSR�

Strategic� Study� Set-up�

ü Study� consulting� excellence�

ü Study� design� excellence�

ü IRB� DB� Construction

ü Study� set-up� time� contraction�

Specialized� Human� Resource�

ü Native� English� speaking� PMs� (2)� and� CDA� (2)

ü PM� Director� &� CO� Director

ü 10� CRMs

ü Yearly� GCP/SOP� Training

ü Four� yearly� internal� educations

ü Two� or� more� yearly� professional� external� trainings�

The�quality�of�our� study�development�processes�and�operations�has�been�verified�and�

re-verified� through� numerous� global� CRO� and� pharmaceutical� company� assessment�

audits� and�MFDS� inspections.� In�addition,� even�with� the� competition� of� other� global�

CRO's,� LSK� Global� PS,� as� main� CRO,� received� the� global� study� order� from� a� U.S.�

multinational� pharmaceutical� company� to� take� part� in� a� first-in-man� phase� I� clinical�

trial� for� cancer.�Our�global� standard�quality�has�been� recognized� through� leading� this�

clinical� trial.

We� are� initiating� and� conducting� clinical� trials� (2� studies� as� main� CRO)� throughout�

Asia.� We� also� have� received� and� successfully� completed� a� European� study� by� a�

domestic� pharmaceutical� company� through� continuous� QC� monitoring.

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부록 4� �국내 CRO�디렉토리 ❚ 981

No.� of� Regulatory�

Inspections

ClassificationFDA

(US)

EMA

(EU)

PMDA

(Japan)

Russia

&CIS

Central

&� South

America

Middle

EastAfrica Others

Pre-Clinical�

Area○ ○ ○ ○ ○ ○ ○

Clinical� Area ○ ○ ○ ○ ○ ○ ○

Manufacturing�

Area○ ○ ○ ○ ○ ○ ○

Others ○ ○ ○ ○ ○ ○ ○

Current� Status� of

Accredited�

Certification

KoNect� Certificate� about� CRO� system� and� Project� Management� (� expiry� date:�

2018-03-16)

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982� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� to

USA,�Netherlands,�UK,� Israel,�Australia,�Korea,� Japan,� India,�Malaysia,� Taiwan,�Singapore,�

Thailand,� Indonesia,� Cambodia,� Hong� Kong,� Vietnam,� Philippine,� Sri� Lanka

1.� INC� Research,� Inc.� (USA,� North� Carolina)

2.� LSK� Biopartners,� Inc.� (USA,� Utah)

3.� Covance,� Inc.� (USA,� New� Jersey)

4.� Medidata� Solutions,� Inc.� (USA,� New� York)

5.� Target� Health,� Inc.� (USA,� New� York)

6.� Julius� Clinical� Research� (Netherlands,� Zeist)

7.� Chiltern� International,� Ltd.� (UK,� Berkshire)

8.� Cato� Research� Israel,� Ltd.� (Israel,� Tel� Aviv)

9.� MICRON,� Inc.� (Japan,� Kobe)�

10.� Veras� Research� Japan,� Ltd.� (Japan,� Saitama)

11.� MPI,� Inc.� (Japan,� Tokyo)

12.� George� Clinical� Pty� Ltd.� (Australia,� Sydney)

13.� MakroCare� Clinical� Research,� Ltd.� (India,� Andhra� Pradesh)

14.� Sristek� Consulting� Pvt.� Ltd.� (India,� Andhra� Pradesh)

15.� Semler� Research� Center� Pvt.� Ltd.� (India,� Bangalore)

16.� PRA� Taiwan,� Inc.� (Taiwan,� Taipei)

17.� StatPlus,� Inc.� (Taiwan,� Taipei)

18.� Veras� Research� Sdn.� Bhd.� (Malaysia,� Selangor)

Asian� Clients'

Composition(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

74 11 6 9

No.� of� Asian�

Clients

in� recent� 3� years

90� Companies� (From� 2013� to� 2015)

Major� Service�

Range

with� Asian�

Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research ○ API

APIs

R&D ○

Pre-Clinical Pre-clinical

Test� Sample

R&D� Strategy

&�Management○

Phase� I ○ Clinical� Trials ○

Phase� II ○Clinical� Test

Sample

Finished

Products

Regulatory

Affairs○

Phase� III ○Finished

Product

Business

Development○

Phase� IV ○Sales� &

Marketing

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부록 4� �국내 CRO�디렉토리 ❚ 983

16. Novotech (Australia) Pty Limited

1.� Corporate� General� Information

Corporate� Name Novotech� (Australia)� Pty� Limited

Corporate� Ownership Private� Company

Head� Office� Address Level� 3,� 235� Pyrmont� Street� Sydney,� AUSTRALIA

Facilities� City� &� CountryMelbourne,� Brisbane,� Auckland,� Johannesburg,� Taipei,� Manila,� Hong�Kong,� Shanghai,� Singapore,� Kuala� Lumpur,� Bangkok,� Bangalore

Local� AddressCity�Air�Tower�#601,�36,�Teheran-ro�87-gil,�Gangnam-gu,�Seoul�135-973�Republic� of� Korea

Web-site� Address http://www.novotech-cro.com

Contact

(Korean� Business)

Name Novotech� Asia� Korea� Co� Limited

AddressCity�Air�Tower�#601,�36,�Teheran-ro�87-gil,�Gangnam-gu,�Seoul�135-973�Republic� of� Korea

Telephone +82� 2� 567� 7437

E-mail [email protected]

Company� History

Established� in� 1996� with� Head� Office� in� Sydney,� Australia.� �

Novotech’s� operations� provide� access� to� the�most� dynamic� and� fast� growing� clinical� research� hubs� in� the�

region.�Novotech� is�uniquely� embedded� in� the�Asia�Pacific� region.�Our� strategically� selected� locations�help�

cater� to� the� demands� of� our� clients.� In� addition,� through� key� strategic� partnerships� we� offer� worldwide�

reach� to� our� clients,� including� North� America,� Eastern� and� Western� Europe.

Company� Description� &� Organization

Largest� full-service� Australian� based� CRO.� Currently� 18� offices� across� 12� countries� through-out� ANZ,� Asia�

and� South�Africa.�Managed�APAC� component� of� pivotal� trials� for�multiple� FDA,� EMA� registered� products�

since�2001.�Extensive� therapeutic�area�experience�offering� full� services� from�first-in-man�to�Phase� IV�clinical�

studies� for� Regulatory� and� Ethics� submissions,� Clinical� Services,� Biometrics,� Independent� QA� Services� and�

Medical� Writing.

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984� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

2.� Corporate� Service� &�Business� Area

Corporate� Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US US US US

Canada Canada Canada Canada

EU EU EU EU

Asia Asia Asia Asia

Global ○ Global Global Global

Other Other Other Other

Focusing� Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D

Pre-Clinical Pre-clinical

Test� Sample

R&D� Strategy

&� Management

Phase� I ○ Clinical� Trials

Phase� II ○Clinical� Test

Sample

Finished

Products

Regulatory

Affairs

Phase� III ○Finished

Product

Business

Development

Phase� IV ○Sales� &

Marketing

Corporate� Product�

Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

○ ○ ○ ○

Generics APIs Devices Others

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부록 4� �국내 CRO�디렉토리 ❚ 985

Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

5% 6% 89%

Research� &

DevelopmentPreclinical Clinical

Custom

Manufacturing

Focusing�

Therapeutic� Area

Oncologics Lipid� RegulatorsRespiratory�

AgentsAnti-ulcerants

Angiotensin� II�

Antagonists

28 3 9 2 5

AntipsychoticsAutoimmune�

agentsAntidepressants Analgesics Others

1 2 1 5 44

Our� primary� focus� areas� are� oncology,� CNS� and� Respiratory� but� we� emphasize� we�

conduct� studies�across�all�major� indications.�24%�of�our�work� is� in�Phase� I� trials,�34%�

in� Phase� II,� 33%� in� Phase� III� and� the� remaining� 9%� I� Phase� IV� Studies.

General� Overview

of� Corporate's� Key

Contract� Services

Ø Scale� /� Footprint� ­� access� to� 3� billion� people.

Ø Wide� ranging� and� in� depth� therapeutic� experience� having� been� involved� in� almost�

400� trials� across� all� phases� and� therapeutic� areas.

Ø Staff� with� unrivalled� industry� experience�meaning�we� have� huge� support� across� all�

regions� with� expert� country� leaders� in� each� of� our� 12� countries.

Ø Sophisticated� systems� in� place� to� rival� those� of� Global� CROs�

Ø Relationships�with�on�average�85%�of� the� top�50� investigators�and�90%�of� the� top�

20� sites� in� each� of� the� countries� we� are� in.

Ø Quality� ­� FDA� and� EMA� trials� working� under� IND.

Contract� Service�

Capacity� Affordable�

by� Service� Area

•� Novotech� has� access� to� 3� billion� people�

� �Ø Accessible� population� of� 1.3� billion� living� in� urban� centres

•� Novotech� countries� increasingly� important� consumer� markets

� �Ø Asia� expected� to� account� for� 60%� of� middle� class� consumption� by� 2040�

Communication

with� Clients

Dispositoion� of

Project� Manager

Responsible

All� PMs� work� according� to� Novotech’s� own� Project� Management�

Manual� which� provides� a� tool� kit� of� key� processes� and� templates�

designed� to� facilitate�efficient� collaboration�and�project� execution.�

A� study� specific� Project� and�Communication� Plan� is� developed� for�

every� study� we� conduct� at� Novotech.�

The� communication� plan� will� cover� frequency,� methods� and�

pathways� of� communication,� as� well� as� an� issue� escalation� and�

resolution� processes.

3.� Corporate� Business�Overview

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986� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Providing

Realtime

Service� Delivery

Customer� Service� is� a� key� competency� for� all� Novotech� staff.�

Novotech�provide� regular� status� reports� to�all� clients� including�any�

changes� of� scope� and/or� contract.�

Realtime

Feed-back

We� encourage� frequent,� open� and� honest� feedback� at� all� times.

Novotech� uses� a� Clinical� Trial�Management� System� (CTMS)� which�

ensures�all� clients�are�kept�well� informed�of�all� important� issues�as�

they� arise.

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부록 4� �국내 CRO�디렉토리 ❚ 987

4.� Corporate� Competitiveness

•� Novotech� countries� perform� ~60� per� cent� as� many� trials� as� the� US

� � -� Asia� is� only� region� to� have� shown� material� growth� in� clinical� trials

•� Patient� recruitment� in� Novotech� countries� is� competitive� with� the� US

•� Novotech� have� a� very� competent� Clinical� Operations� Department� which� includes:

� � -� Project� Managers

� � -� Clinical� Research� Associates�

� � -� Clinical� Trial� Assistants

� � -� Regulatory� Team�

•� Staff� have� dedicated� line� managers� and� assigned� mentors�

•� Career� development� &� targeted� training� programs

•� Ongoing� performance� assessment� in� line� with� competencies�

•� Below� industry� average� staff� turnover�

•� Ongoing� Novotech� management� oversight:�

� � -� Operations� and� executive� management� oversee� all� projects

� � -� Formal� internal� project� reporting� requirements� assessed� regularly

� � -� Project� review� committee� meets� frequently� to� review� selected� study� progress

No.� of� Regulatory�

Inspections

Classification FDA(US) EMA(EU) PMDA(Japan) Others

Pre-Clinical� Area

Clinical� Area 2 3 14

Manufacturing� Area

Others

Current� Status� of

Accredited

Certification

ISO� 9001:� 2008� Compliant� Quality� Management� System

ICH/GCP� Compliant

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988� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� to

United� States,� Britain,� Switzerland,� France,� Germany,� Italy,� Australia,� Korea,� Taiwan,� Malaysia,�

Philippines

Asian� Clients'

Composition(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

37% 40% 23%

Major� Service�

Range

with� Asian�

Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D

Pre-ClinicalPre-clinical

Test� Sample

R&D� Strategy

&� Management

Phase� I ○ Clinical� Trials

Phase� II ○Clinical� Test

Sample

Finished

Products

Regulatory

Affairs

Phase� III ○

Finished

Product

Business

Development

Phase� IV ○Sales� &

Marketing

6.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

Novotech�signed�a�Memorandum�of�Understanding� (MOU)�with�KDDF� in�2014�to� foster�greater� collaboration�

with� the� Korean� Biopharmaceutical� industry.� �

The� terms� of� the�MOU� are� highly� advantageous� to� Korean� clients� and� Novotech� welcomes� the� opportunity�

to� discuss� potential� collaboration

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부록 4� �국내 CRO�디렉토리 ❚ 989

17. PharmCRO Inc.

1.� Corporate� General� Information

Corporate� Name PharmaCRO� Inc.

Corporate� Ownership Private� Company

Head� Office� Address301#� LordLand� EZ� Tower,� 153� Gumi-dong� Bundang-gu,� Seongnam-si,�463-870,� KOREA

Facilities� City� &� Country Seongnam-si(KOREA)

Web-site� Address www.PharmaCRO.co.kr

No.� of� Employees 13

Financial� Status

Sales� Revenue� in� 2011

(US� K$)Capital(US� K$) Dept-equity� Ratio(%)

2,000.0 500.0 10

Contact

(Korean� Business)

Name James� Kim

Address301#� LordLand� EZ� Tower,� 153� Gumi-dong� Bundang-gu,� Seongnam-si,�463-870,� KOREA

Telephone +82-31-707-1139~40�

E-mail [email protected]

Company� History

2009� Founded� PharmaCRO

2012,� 8� Pharmaceutical� projects,� 7� Health� &� Functional� Foods,� 2� Other� project� ongoing� and� 15�

Governmental� project� are� ongoing�

Company� Description� &� Organization

One�of�domestic�CRO�company� in�Korea�and�we�committed� to�demonstrating� the�strategic�value�of�clinical�

outsourcing� and� the� positive� contribution� to� the� Sponsors� and� Investigators.� As� experts� in� the� clinical�

research�process,�PharmaCRO�comply�with� rigorous�Korean�and� international� regulations�and�Good�Clinical�

Practice� (GCP)�standards.�PharmaCRO� is� leading�clinical� research�organizations� (CROs)� in�Korea� that�provide�

a� full� range� of� clinical� development� services� and� conduct� research� in� Asian� countries� and� approximately�

30� clinical� trials� are� conducted� in� Korea� each� year� sponsored� by� both� industry� and� government.

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990� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

2.� Corporate� Service� &�Business� Area

Corporate� Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

○ ○

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US US US US

Canada Canada Canada Canada

EU EU EU EU

Asia ○ Asia Asia Asia ○

Global ○ Global Global Global ○

Other Other Other Other

Focusing� Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D ○

Pre-Clinical Pre-clinicalTest Sample

R&D Strategy& Management

Phase� I ○ Clinical Trials ○

Phase� II ○Clinical TestSample

FinishedProducts

RegulatoryAffairs

Phase� III ○FinishedProduct

BusinessDevelopment

Phase� IV ○Sales &Marketing

Corporate� Product�

Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

○ ○ ○ ○ ○

Generics APIs Devices Others

○ ○ ○ Nutraceutical

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부록 4� �국내 CRO�디렉토리 ❚ 991

Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

20% 50% 20% 10%

Focusing�

Therapeutic� Area

Oncologics Lipid� RegulatorsRespiratory�

AgentsAnti-ulcerants

Angiotensin� II�

Antagonists

20 20 20 10 0

AntipsychoticsAutoimmune�

agentsAntidepressants Analgesics Others

0 0 10 0 20

Oncology,� Endocrinology,� Cardiovascular,� Urology,� Infectious� disease,� Dermatology,�

Gastroenterology,� Rheumatology,� Immunology,� Hepatology,� ENT,� Ophthalmology,�

Plastic� surgery,� Musculoskeletal,� Metabolism.

General� Overview

of� Corporate's� Key

Contract� Services

<Pharmaceuticals>-� R� &� D� consulting-� Project� Management-� Regulatory� Affairs(IND/IRB)-� Medical� Writing-� Clinical� Trial-� Data� Management-� Statistical� Analysis

<Health� &� Functional� Food>�-� R� &� D� consulting-� Project� Management-� Regulatory� Affairs(IRB/KFDA)-� Medical� Writing-� Clinical� Trial-� Data� Management-� Statistical� Analysis

Contract� Service�

Capacity� Affordable�

by� Service� Area

-� Project� Planning(Consulting,� Design)

-� Protocol/CRF� Development

-� Feasibility� activity

-� Regulatory� Affairs(KFDA,IRB)

-� Site� Contract/Management

-� Monitoring(Initiation,� Routine,� Close-out)

-� Data� Management� &� Statistical� Analysis

-� Report� writing

3.� Corporate� Business�Overview

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992� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Communication

with� Clients

Dispositoion� of

Project� Manager

Responsible

Tel:� +82-31-707-1139~40

e-mail:� [email protected]

Providing

Realtime

Service� Delivery

Tel:� +82-31-707-1139~40

e-mail:� [email protected]

Realtime

Feed-back

Tel:� +82-31-707-1139~40

e-mail:� [email protected]

4.� Corporate� Competitiveness

No.� of� Regulatory�

Inspections

Classification FDA(US) EMA(EU) PMDA(Japan) Others

Pre-Clinical� Area

Clinical� Area ○ ○

Manufacturing� Area

Others

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부록 4� �국내 CRO�디렉토리 ❚ 993

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� toKorea,� Australia,� Japan,� Singapore� and� so� on.�

Asian� Clients'

Composition(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

20% 50% 20% 10%

No.�of�Asian�Clients

in� recent� 3� years15� Clients

Major� Service�

Range

with� Asian�

Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D ○

Pre-Clinical

Pre-clinical

Test� Sample

R&D� Strategy

&�Management○

Phase� I ○Clinical� Trials ○

Phase� II ○Clinical� Test

Sample

Finished

Products

Regulatory

Affairs○

Phase� III ○

Finished

Product

Business

Development○

Phase� IV ○Sales� &

Marketing

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994� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name Quintiles

Corporate� Ownership Public� Company

Head� Office� AddressQuintiles� Transnational� Holdings� Inc.� 4820� Emperor� Boulevard� Durham,�North� Carolina� 27703

Facilities� City� &� Country >100� offices,� >60� countries

Korean� Business� OfficeTransnational� Korea� Co.,� Ltd.� 13th� floor,� World� Tower� Bldg� 7-25�Sincheon-dong� Songpa-gu� Seoul� 138-731,� Republic� of� Korea

Web-site� Address www.quintiles.com

No.� of� Employees Approximately� 30,000

Financial� Status

Sales� Revenue� in� 2013

(US� K$)Capital(US� K$) Dept-equity� Ratio(%)

$3,808,340� (service�revenue)

- -

Contact

(Korean� Business)

Name MiSook� Hyun

Address 13th� floor� World� Tower� Bldg� � 7-25� Sincheon-dong,� Songpa-gu,� Seoul,� 138-731

Telephone +82� 2� 2046� 8805

E-mail [email protected]

Company� History

We� were� founded� in� 1982� by� Dr.� Gillings,� who� was� a� biostatistics� professor� at� the� University� of� North�

Carolina� at� Chapel� Hill.� Dr.� Gillings� and� his� cofounder� pioneered� the� use� of� sophisticated� statistical�

algorithms� to� improve� the� quality� of� data� used� to� determine� the� efficacy� of� various� drug� therapies.� We�

expanded� internationally� into�Europe� in�1987� and� into�Asia� in� 1993.� In� 1994,�we�had�grown� to� over�$90�

million� in� revenues� and� completed

18. Quintiles

1.� Corporate� General� Information

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부록 4� �국내 CRO�디렉토리 ❚ 995

an� initial� public� offering,� or� IPO,� through� Quintiles� Transnational� Corp.,� or� Quintiles� Transnational,� our�

wholly� owned� subsidiary� through�which�we� conduct� our� operations.�As� a� public� company,�we�grew�both�

organically� and� through� acquisitions,� adding� a� variety� of� new� capabilities.� By� the� end� of� 1996,� we�

significantly� expanded�our� service�offerings�by�acquiring�companies� that� added�commercial�and�consulting�

capabilities� to� our� business.� In� September� 2003,�we� completed� a� going�private� transaction,�with�Quintiles�

Transnational� becoming� owned� by� a� group� of� investors� that� included� Dr.� Gillings.

In� January� 2008,� Quintiles� Transnational� engaged� in� what� we� refer� to� as� the� Major� Shareholder�

Reorganization,�which� resulted� in� our� ownership� by� Dr.� Gillings� (and� his� affiliates),� funds� advised� by� Bain�

Capital� Partners,� LLC,� together�with� their� affiliates,� Bain� Capital,� affiliates� of� TPG�Global,� LLC,� or� the� TPG�

Funds� (we� refer� to� TPG� Global,� LLC� as� “TPG� Global”� and� together� with� its� affiliates,� “TPG”),� affiliates� of�

3i�Corporation,�or�3i,�and�certain�other� shareholders�who�participated� in� the�going�private� transaction,�and�

various� members� of� our� management.

In�December�2009,�we�completed�what�we� refer� to�as� the�Holding�Company�Reorganization,�whereby�we�

formed� Quintiles� Transnational� Holdings� Inc.,� or� Quintiles� Holdings,� as� the� parent� company� of� Quintiles�

Transnational.� In� May� 2013,� we� returned� to� the� public� markets� by� completing� an� IPO� on� the� New� York�

Stock� Exchange,� or� NYSE.

Company� Description� &� Organization

Quintiles,� a� Fortune� 500� company,� is� the� world’s� largest� provider� of� biopharmaceutical� development� and�

commercial� outsourcing� services.� � With� a� network� of� more� than� 30,000� employees� conducting� business�

in�more� than�100�countries,�we�helped�develop� or� commercialize�100�percent�of� the� top�100�best-selling�

products� or� compounds� of� 2013.� Quintiles� applies� the� breadth� and� depth� of� our� service� offerings,� along�

with�extensive� therapeutic,� scientific�and�analytics�expertise� to�help�our�customers�navigate�an� increasingly�

complex� healthcare� environment� as� they� seek� to� improve� efficiency� and� effectiveness� in� the� delivery� of�

better� healthcare� outcomes.� � To� learn� more� about� Quintiles,� please� visit� www.quintiles.com

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996� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

2.� Corporate� Service� &�Business� Area

Corporate� Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

○ ○ ○

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US ○ US US ○ US ○

Canada ○ Canada Canada ○ Canada ○

EU ○ EU EU ○ EU ○

Asia ○ Asia Asia ○ Asia ○

Global ○ Global Global ○ Global ○

Other ○ Other Other ○ Other ○

Focusing� Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D ○

Pre-Clinical Pre-clinical

Test� Sample

R&D� Strategy

&� Management○

Phase� I ○ Clinical� Trials ○

Phase� II ○Clinical� Test

Sample

Finished

Products

Regulatory

Affairs○

Phase� III ○Finished

Product

Business

Development○

Phase� IV ○Sales� &

Marketing○

Corporate� Product�

Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

○ ○

Generics APIs Devices Others

○ ○

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부록 4� �국내 CRO�디렉토리 ❚ 997

In-house� Faciliteis

Research� &

DevelopmentPreclinical Clinical

Custom

Manufacturing

Custom

Sale

○ ○

Focusing�

Therapeutic� Area

We� have� product� development� capabilities� across� a� range� of� therapeutic� areas,� with�

a� focus� on� oncology,� cardiovascular,� central� nervous� system,� diabetes� and� internal�

medicine.�

These� five� therapeutic� areas� represented� more� than� 50%� of� the� total�

biopharmaceutical� product� pipeline� in� 2013� and� are� generally� more� complex� and�

require� significant� scientific� expertise� and� global� scale.

General� Overview

of� Corporate's� Key

Contract� Services

We� address� the� needs� of� healthcare� industry� participants� by� providing� product�

development� and� integrated� healthcare� services� to� help� our� customers� navigate� the�

complex� healthcare� environment� and� improve� outcomes.�

We� can� support� our� biopharmaceutical� customers� from� first-in-man� trials� through�

patent� expiration,� from� strategy� through� planning� and� execution.� We� also� offer� a�

growing�number�of� services�designed� to�address� the�outcomes�and�analytical�needs�of�

the� broader� healthcare� industry.�

The� broad� scope� of� our� services� allows� us� to� help� our� customers� rapidly� assess� the�

viability� of� a� growing� number� of� potential� new� therapies,� cost-effectively� accelerate�

development�of� the�most�promising�ones,� launch�new�products� to� the�market�quickly,�

and� evaluate� their� impact� and� appropriate� use� on� patients.

Contract� Service�

Capacity� Affordable�

by� Service� Area

v Product� Development� Services� �Ø Project� Management� &� Clinical� Monitoring� � � � § Study� Design� &� Operational� Planning� � � � § Investigator/Site� Recruitment� � � � § Site� &� Regulatory� Start� Up� � � � § Patient� Recruitment� � � � § Clinical� Monitoring� � � � § Project� Management� � � � § Late� Phase� Interventional� �Ø Clinical� Trial� Support� Services:� � � � § Clinical� Data� Management� � � � § Biostatistical� Services� � � � § Central� Laboratories� � � � § Bioanalytical� Laboratories� � � � § Genomic� Laboratory� � � � § Cardiac� Safety� &� ECG� Services� � � � § Safety� &� Pharmacovigilance� Operations� � � � § Phase� I� Units� �Ø Strategic� Planning� &� Design� � � � § Personalized� Medicine

3.� Corporate� Business�Overview

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998� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

� � � � § Model� Based� Drug� Development� � � � § Planning� &� Design� � � � § Regulatory� Affairs� Services� �Ø Consulting� Services� � � � § Product� Development� Strategy� Consulting� � � � § Regulatory� &� Compliance� Consulting� � � � § Process� &� IT� Implementation� Consultingv Integrated� Healthcare� Services� �Ø Commercial� Services:� � � � § Contract� Sales� � � � § Market� Entry� /� Market� Exit� � � � § Integrated� Channel� Management� � � � § Patient� Engagement� Services� � � � § Market� Access� &� Commercialization� Consulting� � � � § Medical� Education� �Ø Communications� &� Engagement� Services� � � � § Digital� Patient� Services� � � � § Brand� &� Scientific� Communications� �Ø Real-World� and� Late� Phase� Research:� � � � § Observational� Studies� � � � § Product� and� Disease� Registries� � � � § Comparative� Effectiveness� Studies� �Ø Other� Healthcare� Solutions

Communication

with� Clients

Dispositoion� of

Project� Manager

Responsible

Quintiles� has� a� robust� Clinical� Project� Management� (CPM)� group�

in� our� Asia-Pacific� regional� therapeutic� delivery� unit� � with� many�

years� of� experience� in� a� wide� range� of� therapeutic� areas� and�

indications

Providing

Realtime

Service� Delivery

Timelines� are� fundamental� to� any� project� and�we� take� them� very�

seriously.�CPMs�are�closely� involved� in�developing�project� timelines�

and� utilize� the� real� world� clinical� trial� performance� data� that�

Quintiles� has� generated,� from�more� than� 30� years� of� clinical� trial�

research,� to� scale� the� study� appropriately� in� order� to� meet� its�

timeline.

This� enables� us� to� make� realistic� projections� that� assist� in�

managing� our� customers’� and� their� products� timelines.

Realtime

Feed-back

Regular� customer� status� meetings� (usually� teleconferences)� are�

conducted.� These� meetings� are� led� by� the� CPM� and� attended� by�

the� service� line� team� leads.�

Should� a� critical� issue� arise;� the� CPM� will� escalate� problems� by�

alerting� senior� management� at� both� companies,� in� accordance�

with� the� Project� Communications� Plan.

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부록 4� �국내 CRO�디렉토리 ❚ 999

Corporate

Competitiveness

Leadership� and� Global� Scale.�

Based�on� reported�2013�consolidated�service� revenues,�we�are�nearly�1.6� times� the�size�

of�our� closest�public�CRO�competitor.�Our� industry� leading� scale�allows�us� to� leverage�

our� global� capabilities� while� maintaining� customer� confidentiality,� and� our� significant�

technology� and� process� capabilities� enable� the� seamless� transfer� of� data� between�

global� trials� running� simultaneously� to� allocate� resources,� reduce� costs� and� speed� the�

time� to� market.�

Broad,� Deep� and� Diverse� Site� Relationships.�

Under� our� global� prime� site� and� partner� programs,� we� have� broad,� deep� and� diverse�

relationships� with� clinics,� large� hospitals� and� health� systems� through� which� we� have�

access� to� thousands� of� investigators� and� other� providers� worldwide.

Therapeutic� and� Scientific� Expertise.�

Underpinning� our� investments� and� service� delivery� is� a� focus� on� delivering� consistent,�

high-quality� services� to�our�customers�across� all� business�groups� throughout� the�world,�

including�a� centralized�ethics� and�compliance�office�dedicated� to� facilitating�adherence�

to� quality� standards� and� ethical� behavior.�We� have� created� 14� therapeutic� centers� of�

excellence� in� our� company� that� are� designed� to� bring� together� the� scientific� expertise�

across� our� service� lines� as� needed� to� achieve� an� optimal� therapeutic� solution� for� our�

customers.� These� capabilities,� coupled� with� our� biomarker� development� research� labs�

and�assay�development�and�validation�services,�provide�a�comprehensive�set�of� services�

to� support� the� development� of� drug� therapies� across� the� therapeutic� spectrum,�

including� the�emerging� field� of� personalized�medicine.�We�have�product� development�

capabilities� across� a� range� of� therapeutic� areas,� with� a� focus� on� oncology,�

cardiovascular,� central� nervous� system,� diabetes� and� internal� medicine.� These� five�

therapeutic� areas� represented�more� than�50%�of� the� total� biopharmaceutical� product�

pipeline� in� 2013� and� are� generally� more� complex� and� require� significant� scientific�

expertise� and� global� scale.

Integrated�Services� to�Enable�Better�Decision-making� in� the�Broader�Healthcare�Market.�

Our� core� market� is� product� development,� and� we� have� deep� and� global� expertise�

across� the� phases� of� this� market� from� first-in-man� trials� through� post-marketing�

studies.� Our� services� are� designed� to� provide� integrated� solutions� that� address� the�

complex� challenges� faced� by� a� broad� range� of� healthcare� industry� participants.� We�

believe� that�our� significant�capabilities� in�analytics,�clinical� science�and� real-world�data,�

combined� with� our� broad� commercial,� consulting� and� post-launch� expertise,� will�

enable�us� to�meet� the� research�and�analytical�needs�of�healthcare� industry�participants�

from� the� development� and� commercialization� organizations� within� traditional� and�

emerging�biopharmaceutical�companies� to�payers,�providers� and�other� stakeholders.�As�

the� healthcare� market� continues� to� demand� greater� accountability� for� outcomes� and�

value� for� money,� we� intend� to� increasingly� deploy� our� capabilities� in� the� broader�

healthcare�market� to�help�healthcare� industry�participants� rapidly�assess� the�viability�of�

new� drugs,� cost-effectively� accelerate� development� of� the� most� promising� drugs,�

4.� Corporate� Competitiveness

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1000� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

launch� and� promote� drugs� to� the� market� effectively,� evaluate� their� impact� on�

healthcare,� and� make� better� reimbursement� and� prescription� decisions.

Experienced,� Highly� Trained� Management� and� Staff.�

Our� senior� management� team� includes� executives� with� experience� from� inside� and�

outside� the�biopharmaceutical� and�biopharmaceutical� services� industries�who�use� their�

decades� of� experience� to� serve� our� customers� and� grow� our� company.� Our� founder,�

Dennis� Gillings,� CBE,� Ph.D.,� a� pioneer� of� the� biopharmaceutical� services� industry,�

continues� to� serve� as� our� Executive� Chairman.� Thomas� H.� Pike,� our� Chief� Executive�

Officer,� joined� us� with� 30-plus� years� of� strategic� and� operational� experience� in�

healthcare� and� technology,� much� of� it� gained� in� leadership� positions� at� Accenture.�

Each� of� our� other� executive� officers� has� more� than� 25� years� of� experience� in� large,�

multinational� organizations.� Our� management� and� staff� are� comprised� of�

approximately� 30,000� employees� worldwide,� of� whom� more� than� 950� are� medical�

doctors� and�more� than�900�possess� a�Ph.D.�or� equivalent.�As�of� the�end�of�2013,�we�

have�over�5,600�contract�medical� sales� representatives,�a� sales� force� that� is�comparable�

in� size� to� the� sales� forces� of� many� large� biopharmaceutical� companies.� In� 2013,� we�

were� named� as� one� of� the� 25� best� multinational� places� to� work� by� the� Great� Place�

to� Work®� Institute� for� the� third� consecutive� year.

Technology� Solutions� and� Process/Data� Capabilities.�

For� over� 30� years,� we� have� focused� on� investment� in� quality� data,� including�

de-identified� electronic� health� records,� or� EHR,� and� we� currently� have� access� to� EHR�

data� representing�more� than�60�million� patient� lives.� In� addition,�we�have� established�

a�substantial�digital�network�of� registered�users�with�whom�we�communicate� regularly.�

More� than� 3�million� people� are� registered� users� of� these� digital� services� that� provide�

opportunities� to� seek� information� and� participate� in� clinical� trials� and� observational�

studies.�Because�data�are�only�as�good�as� the�analytics�used� to�analyze� them,�we�have�

also� invested� heavily� in� data� analytics� products,� services� and� professionals.� As� part� of�

this� investment,�we� created�our�proprietary�data� integration� tool,�Quintiles� Infosario®,�

which� is� a� suite� of� services� that� integrates� data� from� across� multiple� source� systems�

to� provide�us�and�our� customers�with� current,�quality� and� comprehensive� information�

regarding� clinical� trials,� allowing� decisions� to� be� made� quickly� and� efficiently.� In�

addition,� we� have� developed� a� planning� and� design� platform� and� other� software�

solutions� to� enable� improvements� to� the� drug� development� process� and� to�

demonstrate� the� value� of� biopharmaceutical� products� in� the� real� world.� We� have�

obtained�or� applied� for�more� than�60�patents� in� connection�with� the�development� of�

our� proprietary� technology,� systems� and� processes.

Current� Status� of

Accredited

Certification

We� maintain� our� standard� operating� procedures� in� accordance� with� regulations� and�

guidelines� appropriate� to� the� region� where� they� will� be� used,� to� help� ensure�

compliance�with�all�applicable� standards�of�GxP� including�but�not� limited� to�GCP,�GDP�

and� GLP.

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부록 4� �국내 CRO�디렉토리 ❚ 1001

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� to

As� of� 2013,� we� have� 28� offices� in� 15� markets� in� Asia� Pacific,� with�more� than� 6,700�

employees.� Quintiles� has� worked� with� a� multitude� of� Asian� customers� in� the� last� 3�

years� ­� working� with� them� locally� in� individual� markets� and� helping� them� enter� new�

countries� and� regions.

No.�of�Asian�Clients

in� recent� 3� years

As� of� 2013,� we� have� 28� offices� in� 15� markets� in� Asia� Pacific,� with� more� than� 6,700�

employees.� Quintiles� has� worked� with� a� multitude� of� Asian� customers� in� the� last� 3� years�

­� working� with� them� locally� in� individual� markets� and� helping� them� enter� new� countries�

and� regions.�

Major� Service�

Range

with� Asian�

Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D ○

Pre-ClinicalPre-clinical

Test� Sample

R&D� Strategy

&�Management○

Phase� I ○ Clinical� Trials ○

Phase� II ○Clinical� Test

Sample

Finished

Products○

Regulatory

Affairs○

Phase� III ○

Finished

Product

Business

Development○

Phase� IV ○Sales� &

Marketing○

6.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

With� the� Korea� National� Enterprise� for� Clinical� Trials� (KoNECT),� we� are� producing� educational� events� for�

investigators,� local� and� multinational� biopharma� companies� and� relevant� government� officials� to� enhance�

clinical� research� standards� and� expand� clinical� research� capacity.� And� to� increase� our� clients’� bioanalytical

capabilities,� we� forged� an� exclusive� alliance� with� South� Korea’s� premier� provider,� BioCore.

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1002� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

19. Reference Biolabs Inc

1.� Corporate� General� Information

Corporate� Name Reference� Biolabs� Inc

Corporate� Ownership Private� Company

Head� Office� Address 9Fl.,� Hanhwa� Biz� Metro� Bldg.,� 242� Digital-ro,� Guro-gu

Facilities� City� &� Country seoul(KOREA)

Korean� Business� Office 9Fl.,� Hanhwa� Biz� Metro� Bldg.,� 242� Digital-ro,� Guro-gu

Web-site� Address www.rbiolabs.com

No.� of� Employees 50

Financial� Status

Sales� Revenue� in� 2012

(US� K$)Capital(US� K$) Dept-equity� Ratio(%)

1,100 2,390 134.6%

Contact

(Korean�

Business)

Name Myung� Ryurl� Oh

Address 9Fl.,� Hanhwa� Biz� Metro� Bldg.,� 242� Digital-ro,� Guro-gu,� Seoul,� KOREA

Telephone +82-2-6006-7642,� Fax.� +82-2-2621-7050

E-mail [email protected]

Company� History

Feb.� 2009� Established� R&D� Institute

Dec.� 2009� Acknowledged� as� a� '� Venture� Company� '� by� Korea� Finance� Corporation

Aug.� 2010� Acquired� INNO-BIZ� by� Small� &� Medium� Business� Administration

Sep.� 2010� Acquired� ISO� 9001� certification

Jan.� 2013� Investment� promotion� by� Korea� Investment� Partners� Co.,� Ltd.�

Feb.� 2013� Investment� promotion� by� NAUIV� Capital

April� 2013� Moved� to� HanWha� Biz� Metro� Bldg.

Approved�as� the�Center� for�Molecular�Genetics�Analysis�by�Korea�Centers� for�Disease�Control�&�Prevention

Approved� as� the� organization� to� operate� IRB� by� Korea� Centers� for� Disease� Control� &� Prevention

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부록 4� �국내 CRO�디렉토리 ❚ 1003

Company� Description� &� Organization

On� April� 16,� 2007,� Reference� Biolabs� Inc.� (RBL)� was� established� as� a� bio-pharmaceutical� company� aims� to�

develop�novel�biologics�and�diagnostics�of�unmet�medical�need.�RBL�has�been�working�as� the�pathology� core�

facility� of� Seoul� National� University� and� provided� high� quality� pathology� analysis� services� to� researchers� and�

drug� development� companies.� In� addition,� RBL� also� provides� diverse� diagnosis� services� to� domestic� hospitals�

based� on� our� fully� integrated� molecular� genetics� analysis� system.

The� Clinical� &� CRO� Center� offers� diverse� biological� analysis� and� diagnosis� services� based� on� histology,�

molecular� genetics� and� immunology� to� customers� from� academia,� hospitals,� pharmaceutical� companies� and�

national� R&D� institutes.� RBL� also� supports� the� development� of� customized� diagnostic� systems.

The�Clinical�&�CRO�Center�provides�GLP/non-GLP�grade� services.�RBL� is�one�of� the�premium�service�providers�

of� the� Global� Standards.

Page 1007: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

1004� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

2.� Corporate� Service� &�Business� Area

Corporate� Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

○ ○ ○ ○

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US US US US

Canada Canada Canada Canada

EU EU EU EU

Asia Asia Asia Asia ○

Global ○ Global ○ Global ○ Global

Other Other Other Other

Focusing� Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research ○ API ○

APIs

R&D ○

Pre-Clinical ○ Pre-clinical

Test� Sample○

R&D� Strategy

&� Management○

Phase� I Clinical� Trials ○

Phase� IIClinical� Test

Sample

Finished

Products○

Regulatory

Affairs○

Phase� IIIFinished

Product

Business

Development○

Phase� IVSales� &

Marketing○

Corporate� Product�

Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

○ ○ ○

Generics APIs Devices Others

○ ○ ○ ○

Page 1008: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

부록 4� �국내 CRO�디렉토리 ❚ 1005

Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

33% 33% 34% 0%

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

○ ○ ○

General� Overview

of� Corporate's� Key

Contract� Services

-� Histopathology� Analysis� Service:� Tissue� Cross� Reactivity� Analyses,� FFPE/Frozen�

Tissue/Cell� Block� Hematoxylin� &� Eosin� Staining,� Immunohistochemistry� (IHC)�

Staining,� Special� Staining,� TUNEL� &� BrdU� Assay,� Tissue� Microarray� (TMA),� Laser�

Micro-Dissection� (LMD)� and� FISH/IF� Test� and� Diagnoses.

-� Molecular� Diagnosis� Service:� Nucleic� Acid� (DNA/RNA)� Isolation-� Blood,� Cell,� Tissue�

(FFPE/Frozen/TMA),� DNA� Quantification� (qPCR),� RNA� Quantification� (RT-qPCR),�

RNA�Validation� (QC),�Micro� RNA-�miRNA� Isolation�&�miRNA�RT-qPCR,�Quantitative�

Methylation-Specific� PCR,� PK� Analysis� for� siRNA� Therapeutics,� Gene� Mutation�

Sequencing,� Microarray� -� Expression� Array� (1� or� 2� color),� � Array� CGH� &� miRNA�

Expression,�Next�Generation� Sequencing,� Cell� Line� Authentication� -� STR�Analysis� &�

Mycoplasma� Tests

-� Immunology�Diagnosis� Service:�ELISA�Analyses,�Customized�ELISA�Kit�Development�&�

Validation� -�Direct/Indirect�Kit,�Direct�Sandwich�Kit�&� Indirect�Sandwich�Kit,�Animal�

TK,� Human� PK� Analysis� for� Protein� Therapeutics

-� Drug� Discovery� Service:� Antibody� Drug� Discovery� Services� &� siRNA� Drug� Discovery�

Services

Contract� Service�

Capacity� Affordable�

by� Service� Area

CRO� center� has� cutting-edge� equipments� (IQ-OQ-PG)� in� GLP� facilities� as� follows;�

Simens�Microlabstar� system,�Hamilton�Microlab�STAR,�Roche� LC480,�Agilent�Microarray�

Scanner,� Life� technologies� Ion� Proton,� Roche� Ventana� Discovery� XT� System,� Rotary�

Microtome,� Dissection� Microscope� (SMZ� 1000),� Laser� Micro� Disection� (ION� LMD),�

Fluorescence� Microscope,� Image� Scanner,� TMA� MASTER,� LEICA� Paraffin� Embedding�

Station,� LEICA� Automatic� Tissue� Processor,� LEICA� Cryostate,� TECAN� Genesis�

Workstation,� BIO-RAD� Bioplex� (Luminex)� and� so� on.

3.� Corporate� Business�Overview

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1006� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Communication�

with� Clients

Dispositoion� of

Project� Manager

Responsible

1.� To� interpret� scan� results� with� the� Chief� Prosecutor� against�

inspection� results� to� client� clinical� advice� and�discussion� should�

be� provided.

2.� Program� planning� and� training� of� quality� control� and�

management

3.� If� necessary,� development� of� new� tests� as�well� as� research� and�

staff� training� plans� and� shall� be� enforced.

4.� Should� be� actively� involved� in� the� management� of� CRO.

Providing� Realtime

Service� Delivery

Domestic:� EMS

International� :� UPS�&� FedEx� by� ISTA�5B� (International� Safe� Transit�

Association)

Realtime

Feed-backLIMS� and� E-mail�

4.� Corporate� Competitiveness

Corporate

Competitiveness

RBL� has� well-trained� technicians,� cutting-edge� equipments� (IQ-OQ-PG)� &� GLP�

facilities,� experiences� in� managing� diverse� human� &� animal� specimens� and�

produce� high� quality� data.�

RBL� has� SOP� for� molecular� genetics� service� of� DNA/RNA� from� FFPE� by� full�

automation� system� and� LIMS.

No.� of� Regulatory

Inspections

ClassificationFDA

(US)

EMA

(EU)

PMDA

(Japan)

CFDA

(China)

DCI

(India)Others

Pre-Clinical� Area

Clinical� Area KIGTE

Manufacturing� Area

Others ISO9001

Current� Status� of

Accredited� Certification

-� Acquired� ISO� 9001:2008

-� Approved� as� the� Center� for� Molecular� Genetics� Analysis� by� Korea� Centers� for�

Disease� Control� &� Prevention

-� Approved� as� the� organization� to� operate� IRB� by� Korea� Centers� for� Disease�

Control� &� Prevention

-� Preparatory� stage� for� Approval� of� GLP� by� Korean� FDA

-� Preparatory� stage� for� Accreditation� of� ISO15189� (Medical� Laboratory)

Page 1010: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

부록 4� �국내 CRO�디렉토리 ❚ 1007

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� to� Japan� and� China

Asian� Clients'

Composition(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

50 25 25 0

No.�of�Asian�Clients

in� recent� 3� years10

Major� Service�

Range

with� Asian�

Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research ○ API ○

APIs

R&D ○

Pre-Clinical ○Pre-clinical

Test� Sample○

R&D� Strategy

&�Management○

Phase� I ○ Clinical� Trials ○

Phase� II ○Clinical� Test

Sample

Finished

Products○

Regulatory

Affairs○

Phase� III ○

Finished

Product

Business

Development○

Phase� IVSales� &

Marketing○

6.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

RBL� has� made� close� relationships� with� most� of� Korean� major� pharmaceutical� and� biotech� companies� in�

drug� development.

Page 1011: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

1008� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

20. SCAS-BTT Bioanalysis Co., Ltd

1.� Corporate� General� Information

Corporate� Name SCAS-BTT� Bioanalysis� Co.,� Ltd

Corporate� Ownership Private� Company

Head� Office� AddressOchang� Scientific� industrial� Complex,� 686-2,� Yangcheong-ri,� Ochang-eup,�

Cheongwon-gun,� Chungcheongbuk-do,� 363-833,� Korea

Facilities� City� &� Country Ochang(KOREA)

Korean� Business� OfficeGyeonggi�Bio-Center,�864-1,� Iui-dong,�Yeongtong-gu,�Suwon,�Gyeonggi-do,�

443-270,� Korea

Web-site� Address www.scas-btt.com

No.� of� Employees 40� people

Financial� Status

Sales� Revenue� in� 2011

(US� K$)Capital(US� K$) Dept-equity� Ratio(%)

4� mil� US� dollar 0.55� mil� US� dollar -

Contact

(Korean�

Business)

Name Sung� ho� (Daniel),� Yoon

AddressGyeonggi�Bio-Center,�864-1,� Iui-dong,�Yeongtong-gu,�Suwon,�Gyeonggi-do,�

443-270,� Korea

Telephone 82-31-888-6451

E-mail [email protected]

Company� History

May,� 2000 Analysis� department� of� Biotoxtech�

Dec,� 2007 Start� Biological� material� analysis� (GLP� standards)

Dec,� 2008 Bioanalytical� Center� of� Biotoxtech

May,� 2011 SBB� founded

Jul,� 2011 GLP� certificate� (KFDA)

Company� Description� &� Organization

SCAS-BTT� Bioanalysis(SBB)� is� the� bioanlytical� CRO� established� by� Sumika� chemical� analytical� service(SCAS)�

which� is� the� largest�analysis� company� in� Japan�and�Biotoxtech(BTT)�which� is�Korean� leading�non-clinical�CRO.

SBB� has� the� expertise� from� experience,� analytical� skill� and� the� latest� equipment� as� the� analytical� CRO.� Our�

mission� is� that� we� dedicate� to� develop� new� drugs� for� welfare� and� health� of� human.� For� our� mission,� SBB�

will� serve� high� quality� analytical� study� rapidly� under� sponsor’s� budget.

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부록 4� �국내 CRO�디렉토리 ❚ 1009

2.� Corporate� Service� &�Business� Area

Corporate� Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US US US US

Canada Canada Canada Canada

EU EU EU EU

Asia ○ Asia Asia Asia

Global ○ Global Global Global

Other Other Other Other

Focusing� Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D

Pre-Clinical ○ Pre-clinical

Test� Sample

R&D� Strategy

&� Management

Phase� I ○ Clinical� Trials

Phase� II ○Clinical� Test

Sample

Finished

Products

Regulatory

Affairs

Phase� IIIFinished

Product

Business

Development

Phase� IVSales� &

Marketing

Corporate� Product�

Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

Generics APIs Devices Others

Page 1013: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

1010� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

20 45 35 0

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

○ ○ ○

General� Overview

of� Corporate's� Key

Contract� Services

<Bioanalytical� Method� Development&� Validation>

n Small� molecule

-� The� latest� Equipment� (LC/MS/MS)

-� Service

1.� Method� Feasibility

2.� Method� Development

3.� Method� Validation

4.� Method� transfer

n Large� molecule

-� ELISA� (Synergy� Mx)

-� Service

1.� Method� Feasibility

2.� Method� Development

3.� Method� Validation

4.� Method� transfer

<BioAnalysis>

n Non-clinical� TK/PK

-� Pharmacokinetics

-� Toxicokinetics� under� GLP

n Clinical� PK� analysis

-� Measurement� of� Drug� concentration

in� Phase� Ⅰ,Ⅱ,Ⅲ,Ⅳ

n Bio� Equivalence� studies

3.� Corporate� Business�Overview

Page 1014: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

부록 4� �국내 CRO�디렉토리 ❚ 1011

Contract� Service�

Capacity� Affordable�

by� Service� Area

SBB� is� the� Analytical� CRO� founded� by� SCAS� in� Japan� and� Biotoxtech� in� Korea.� So� we�

can� provide� our� high� quality� analytical� service� to� customers� in� Japan� and� Korea� now.�

And�we�keep�going� to�make� the� contract�with�other�CROs� in�Europe�and�US.�So� in� the�

near� future� sponsors� in� any� countries� can� get� SBB’s� competitive� service.

Communication�

with� Clients

Dispositoion� of

Project� Manager

Responsible

For� the� rapid� response,� our� researchers� have� a� double� role� as� a�

project� manager� and� a� performer� of� the� study.

Providing� Realtime

Service� Delivery

Before�a� contract,� SBB’s� analytical� team�provides�a� study�schedule� to�

sponsor.� And� we� will� report� the� result� of� every� step.� So� we� are�

punctual� for� the� project.

Realtime

Feed-back

Through� realtime�communication�with� sponsor,�we�can�move� swiftly�

for� a� successful� outcome.� And� for� project� management,� internal�

communication� system� between� analytical� team� and� marketing�

team� is� built� up� firmly.

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1012� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

4.� Corporate� Competitiveness

Corporate

Competitiveness

<Environment>

Our� sponsor� can�get� the� best� service� and� the� rapid� response� from�SBB.� To� achieve�

this� mission,� we� applied� technically� trained� staffs� and� the� latest� equipments.

<Total� service>

SBB� build� the� total� service� relationship�with� BTT� and� SCAS� for� the� successful� drug�

development.� We

can� give� “non-stop� service”� to� our� sponsors.� Through� this� process,� you� can� get�

efficient� and�

expeditious� data� from� non-clinical� to� clinical� study.

Current� Status� of

Accredited� Certification

<BTT>

2002.12� � � Preclinical� (drug)� all� of� items� � � � � � � � � � � � by� KFDA

2003.01� � � Preclinical� (chemical)� all� of� items� � � � � � � � by� NIER

2003.12� � � Preclinical� (pesticide)� all� of� items� � � � � � � � by� RDA

2007.11� � � Ecotoxicology� (chemical)� � � � � � � � � � � � � � � by� NIER

2008.12� � � All� of� items� � � � � � � � � � � � � � � � � � by� AAALAC

2008.10� � � Safety� Pharmacology by� KFDA

2010.11� � � OECD� GLP� Audit� � � � � � � � � � � � � � � � � � � � � by� OECD

2011.10� � � Replacement� test� of� animal� � � � � � � � � � � by� KFDA

<SCAS>

1998.07� � � Toxicokinetics� � � � � � � � � � � � � � � � � � � � � � � by� MHLW

2000.08� � � Pesticide� test� &� Residue-prone�

agricultural� chemical� � � � � � � � � � � � � � � � � by� MAFF

<SBB>

2011.07� � � Toxicokinetics� � � � � � � � � � � � � � � � � � � � � � � by� KFDA

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부록 4� �국내 CRO�디렉토리 ❚ 1013

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� toKorea,� Japan

Asian� Clients'

Composition(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

35 35 30 0

No.�of�Asian�Clients

in� recent� 3� yearsTotal� 39� clients,� 33� clients� in� Korea,� 6� clients� in� Japan

Major� Service�

Range

with� Asian�

Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D

Pre-Clinical ○Pre-clinical

Test� Sample

R&D� Strategy

&�Management

Phase� I ○ Clinical� Trials

Phase� II ○Clinical� Test

Sample

Finished

Products

Regulatory

Affairs

Phase� III

Finished

Product

Business

Development

Phase� IVSales� &

Marketing

6.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies

SBB� conduct� the� bioanalysis� service� of� non-clinical,� clinical� study� and� BE.� And� we� will� set� up� to� analysis�

the� biomedicine� and� CMC� in� the� near� future.�

SBB� promise� that� we� will� be� one� of� the� most� experienced� and� customer� focused� analytical� CRO� in� the�

world.

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1014� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

21. SeoCho CRO

1.� Corporate� General� Information

Corporate� Name SeoCho� CRO

Corporate� Ownership Private� Company

Head� Office� Address 89� Bangbae-ro,� SungJi� BLDG� 3th� Fl.,� SeoCho-gu,� Seoul� 137-842� Korea

Facilities� City� &� Country Seoul(Korea)

Korean� Business� Office 89� Bangbae-ro,� SungJi� BLDG� 3th� Fl.,� SeoCho-gu,� Seoul� 137-842� Korea

Web-site� Address www.sccro.co.kr

No.� of� Employees 5� people

Financial� Status

Sales� Revenue� in� 2011

(US� K$)Capital(US� K$) Dept-equity� Ratio(%)

320,000 - -

Contact

(Korean�

Business)

Name Joon� Chul� Park

Address 89� Bangbae-ro,� SungJi� BLDG� 3th� Fl.,� SeoCho-gu,� Seoul� 137-842� Korea

Telephone 82� 2� 582� 5781

E-mail [email protected]

Company� History

2005� � Establishment

2006� � GS� Medics� and� five� other� companies.� Development,� Clinical,� Licened,� GMP� apply

2007� � Medical� Estetic� and� five� other� companies.� Development,� Clinical,� Licened,� GMP� apply

2008� � Mundi� Pharma� and� five� other� companies.� Development,� Clinical,� Licened,� GMP� apply

2009� � SJ� Medical� and� five� other� companies.� Development,� Clinical,� Licened,� GMP� apply

2010� � GM� Botanical� and� five� other� companies.� Development,� Clinical,� Licened,� GMP� apply

2011� � KCL� and� three� other� companies.� Development,� Clinical,� Licened,� GMP� apply

2012� � CG� Bio� and� four� other� companies.� Development,� Clinical,� Licened,� GMP� apply

Company� Description� &� Organization

SeoCho�CRO�agency�will� research� the� regulations� related� to� product�development,� professionalism,�morality,�

and� the� spirit� of� service� worth� pursuing,� pharmaceuticals,� medical� devices,� health� supplements,� cosmetics,�

etc.� (generic� pharmaceutical� research,� clinical� monitoring,� clinical� trials,� human� testing)

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부록 4� �국내 CRO�디렉토리 ❚ 1015

2.� Corporate� Service� &�Business� Area

Corporate�

Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US US US US

Canada Canada Canada Canada

EU EU EU EU

Asia Asia Asia Asia

Global Global Global Global

Other ○ Other Other Other

Focusing�

Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D

Pre-ClinicalPre-clinical

Test� Sample

R&D� Strategy

&� Management

Phase� I Clinical� Trials

Phase� IIClinical� Test

Sample

Finished

Products

Regulatory

Affairs

Phase� III ○

Finished

Product

Business

Development

Phase� IV ○Sales� &

Marketing

Page 1019: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

1016� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

3.� Corporate� Business�Overview

Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

0 50 0 50

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

Focusing�

Therapeutic� Area

(%)

Oncologics Lipid� RegulatorsRespiratory�

AgentsAnti-ulcerants

Angiotensin� II�

Antagonists

20

AntipsychoticsAutoimmune�

agentsAntidepressants Analgesics Others

80

General� Overview

of� Corporate's� Key

Contract� Services

pharmaceuticals,� medical� devices,� health� supplements,� cosmetics,� etc.� (generic�

pharmaceutical� research,� clinical� monitoring,� clinical� trials,� human� testing)

Communication�

with� Clients

Providing� Realtime

Service� DeliveryCG� Bio� Clinical� Monitoring

4.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Major� Service�

Range

with� Asian�

Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D

Pre-Clinical Pre-clinical

Test� Sample

R&D� Strategy

&� Management

Phase� I Clinical� Trials

Phase� IIClinical� Test

Sample

Finished

Products

Regulatory

Affairs

Phase� III ○Finished

Product

Business

Development

Phase� IV ○Sales� &

Marketing

Page 1020: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

부록 4� �국내 CRO�디렉토리 ❚ 1017

22. Seoul CRO Co.,Ltd.

1.� Corporate� General� Information

Corporate� Name Seoul� CRO� Co.,Ltd.�

Corporate� Ownership Private� Company

Head� Office� Address

2FL,� Noveltech� Bd.� 201-6

Nonhyeon-Dong,� Kwangnam-Gu,

Seoul,� Korea

Korean� Business� Office

2FL,� Noveltech� Bd.� 201-6

Nonhyeon-Dong,� Kwangnam-Gu,

Seoul,� Korea

Web-site� Address www.seoulcro.co.kr�

No.� of� Employees 45

Financial� Status

Sales� Revenue� in� 2011

(US� K$)Capital(US� K$) Dept-equity� Ratio(%)

$� 953,129 $� 1,077,805 333.10%

Contact

(Korean�

Business)

Name Mi-Jin� Choi

Address 2FL,� Noveltech� Bd.� 201-6� Nonhyeon-Dong,� Kwangnam-Gu,� Seoul,� Korea

Telephone +82-70-4027-3012

E-mail [email protected]

Company� History

Feb,� 2011� � Reorganized� the� Medical� Team�

Aug,� 2010� � Reorganized� and� system� updated� for� DM/STAT� business.�

May,� 2010� � Reorganized� the� Clinical� Research� Department

Apr,� 2010� � Moved� the� headquarter� office� to� current� address

Apr,� 2009� � Founded� Seoul� CRO� Co.,� Ltd.�

Company� Description� &� Organization

Seoul� CRO� is� a� contract� research� organization� for� clinical� trial� co-founded� in� April� 2009� through� the�

partnership�of� the�CHA�medical�group,�a�KOSDAQ� listed�medical�group�and� the� Japanese�conglomerate� JGC�

Pharma� Services� Co.,� Ltd.� (Previously� known� as� Tokyo� CRO).�

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1018� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

2.� Corporate� Service� &�Business� Area

Corporate� Main�

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

○ ○

Geographical

Business� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

US ○ US US US ○

Canada Canada Canada Canada

EU ○ EU EU EU ○

Asia ○ Asia Asia Asia ○

Global ○ Global Global Global ○

Other ○ Other Other Other ○

Focusing� Contract

Service� Area

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D

Pre-ClinicalR&D� Strategy

&� Management○

Pre-clinical

Test� SamplePhase� I ○ Clinical� Trials ○

Phase� II ○Clinical� Test

Sample

Finished

Products

Regulatory

Affairs○

Phase� III ○Business

Development○

Finished

ProductPhase� IV ○

Sales� &

Marketing

Corporate� Product� Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

○ ○ ○

Generics APIs Devices Others

Page 1022: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

부록 4� �국내 CRO�디렉토리 ❚ 1019

Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

39 18 41 0

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

Focusing�

Therapeutic� Area

(%)

Oncologics Lipid� RegulatorsRespiratory�

AgentsAnti-ulcerants

Angiotensin� II�

Antagonists

9 0 4 0 15

AntipsychoticsAutoimmune�

agentsAntidepressants Analgesics Others

2 0 0 1 69

Indication Total Phase� I Phase� II Phase� III Phase� IV IIT Device ETC

Cardiovascular 13 6     4 1 1 1

Dentistry 1           1  

Dermatology 7     1     5 1

Endocrinology 3 1   2        

Gastroenterology 4 2   2        

Internal Medicine 1 1            

Nephrology 1         1    

Neurology 5   1 1   1 1 1

Obstetrics & Gynecology 4     1     3  

Oncology 8 4   2   1 1  

Ophthalmology 5 2     1   2  

Orthopedics 7   1 1     5  

Otorhinolaryngology 4     1     3  

Plastic Surgery 11           11  

Pulmonology 4   2   1     1

Transplant 2         1   1

Urology 3 1     1   1  

ETC 2     1       1

TOTAL 85

General� Overview

of� Corporate's� Key

Contract� Services

Supporting� full-package� service� of� Clinical� Trial

ü Strategic� Consulting

ü Regulation� of� KFDA� (from� IND/IDE� to� NDA/MDA)

3.� Corporate� Business�Overview

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1020� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

ü Clinical� Trial� in� Korea/Japan/China

ü Project� Management

ü Protocol� &� CRF� Development

ü Site/Investigator� Identification� &� Qualification

ü Monitoring

ü Data� Management

ü Statistical� Analysis

ü Clinical� Study� Reporting

ü Inspection/Audit

ü PMS� &� Pharmacovigilance

ü Epidemiology� Study

Contract� Service�

Capacity� Affordable�

by� Service� Area

Regulatory� Affairs

ü Support� strategic� plan� for� KFDA� approval�

ü Product� Development�

ü Regulation� of� PMDA� &� SFDA� (CMC,� IND,� NDA)

ü Clinical� Trial� in� Japan� &� China

ü Regulation� of� FDA

Medical� Writing

ü Protocol� development

ü Clinical� study� report� development�

ü Sample� size� &� analysis� method� design

ü Informed� consent� development

ü CRF� development

Clinical� Research� Services

ü Project� strategic� planning

ü Project� management

ü Feasibility� study

ü Investigator/Site� identification� &� qualification

ü Pre-study� visit

ü Investigator� meeting

ü IRB� submission

ü Initiation� activities

ü Site� personal� training�

ü Site� monitoring� activities

ü Safety� management

ü Close-out� activities

Data� Management

ü CRF/� e-CRF� development

ü Data� management� plan� (DMP)

Page 1024: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

부록 4� �국내 CRO�디렉토리 ❚ 1021

ü DB� structure

ü Data� validation� specification� (DVS)

ü Data� entry� screen� (DES)

ü Double� entry�

ü Medical� coding

ü DataBase� quality� check

ü DataBase� lock

ü Data� transfer

ü Archiving

Statistic

ü Randomization� code� generation

ü Sample� size� &� power� calculation

ü Statistical� analysis� plan

ü Statistical� analysis� &� reporting�

Communication�

with� Clients

Dispositoion� of

Project� Manager

Responsible

Every� issues� are� reporting� to� project�manager� and� project�manager�

takes� responsibility� of� the� project.

Providing� Realtime

Service� DeliveryDepends� on� the� project� timeline

Realtime

Feed-backResponse� by� email� or� phone� within� 1� day�

Page 1025: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

1022� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

4.� Corporate� Competitiveness

Corporate

Competitiveness

[Global�network]�With�our�strategic�overseas�network,�we�provide�a�Total�Clinical� Trial�

Service� encompassing� customized� strategic� consulting� for� Asian� study� as� well� as�

Global� study.� We� closely� work� with� our� group� companies� (JGC-pharma� services,�

Beijing-CRO)�and�will� further�expand�partnership� in�Asia.�Our� vision� is� to�become� the�

No.� 1� CRO� for� Asian� clinical� studies

[Clinical� Strategy]� Our� team� members� who� provide� professional� medical� writing�

services� are� qualified� with� Ph.D.� and� M.D.� degrees� and� have� numerous� experiences�

in�DM,� STAT�and�CRA.�Based�on� the�broad� experiences� in� the�R&D� field,�we� support�

the� best� strategic� plan� for� FDA,� KFDA,� PMDA,� SFDA� approval� and� marketing� of�

pharmaceuticals� and� medical� devices.� Also,� through� our� great� correspondence� and�

interactive� communication� skills� with� sponsor,� investigators� and� Drug� administration,�

we� provide� optimal� protocols� and� clinical� study� reports.

No.� of� Regulatory

Inspections

Classification FDA(US) EMA(EU) PMDA(Japan) Others

Pre-Clinical� Area

Clinical� Area 7

Manufacturing� Area

Others

Current� Status� of

Accredited�

Certification

Compliance� with� ICH-GCP� and� KGCP� guild� lines

Page 1026: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

부록 4� �국내 CRO�디렉토리 ❚ 1023

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� toIsrael,� Korea,� Japan,� U.S.A�

Asian� Clients'

Composition(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

39 18 41 0

No.�of�Asian�Clients

in� recent� 3� yearsNone

Major� Service�

Range

with� Asian�

Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API

APIs

R&D

Pre-ClinicalPre-clinical

Test� Sample

R&D� Strategy

&�Management○

Phase� I ○ Clinical� Trials ○

Phase� II ○Clinical� Test

Sample

Finished

Products

Regulatory

Affairs○

Phase� III ○

Finished

Product

Business

Development○

Phase� IV ○Sales� &

Marketing

Page 1027: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

1024� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Corporate� Name StarTech� Science� LLC.

Corporate� Ownership Private� Company

Head� Office� Address No.� 9112,� 9F,� Myeongsong� 2-gil� 34,� Jung-gu

Facilities� City� &� Country Seoul,� South� Korea

Web-site� Address www.startechscience.com�

No.� of� Employees 7

Contact

(Korean� Business)

Name Yeonyeu� Goo,� CEO

Address No.� 9112,� 9F,�Myeongsong� 2-gil� 34,� Jung-gu,� Seoul,� South� Korea� 04535

Telephone +82� 70� 4136� 8186

E-mail [email protected]

Company� History

In� Feb� 2016,� StarTech� Science� started� Clinical� Research� Business.� Currently� Big� Pharma� Company,� Global�

Pharmaceuticals,� BioTech� Companies,�Medical� Device� and� Food� &�Nutrition� are� conducting� in� Clinical� Trials.�

Also�with�US� and� EU� collaboration�partners,� IND/NDA�Regulatory�Affairs� Consulting� and�Activities� are� doing�

well.� BioTeh�Companies� are� supported� to� submit� FDA� and� EU� IND/NDA� applications�with� strategic� planning�

and� approaches� proactively.� Recently� we� are� working� with� global� partners� as� well.

Company� Description� &� Organization

StarTech� Science� is� a� Full� Service� CRO,� and� also� specialized� clinical� study� start-up� Clinical� Research�

Organization� (CRO)�and� led�by�a�management� team�with�profound�clinical� research�experience� in�Korea�and�

Asia�Pacific�Region.�We�presently�provide�clinical� trials� services� in�Korea�with�across�Asia,� including�Singapore,�

Hong� Kong,� Malaysia,� Taiwan,� the� Philippines,� Vietnam,� Australia� and� India,� the� US� and� the� EU.� Through�

our�experience� from�working� in�multinational�pharmaceutical� companies�and�CROs� in�Asia,�we�offer�a�unique�

advantage� of� having� a� deep� understanding� of� the� clinical� research� and� regulatory� environment� within� the�

region,� the� cultural� and� social� diversity� and� the� expectations� of� quality� standards� of� our� clients.

StarTech� Science� provides� a� range� of� clinical� study� start-up� services� to� support� phase� I� ­� IV� studies� in� Asia�

Pacific� Region,� the� US� and� the� EU.� These� include� feasibility� studies� and� site� selection,� project�management,�

regulatory� submissions/approvals,� IRB� submission/approval,� Site� contract/investigator� Payments,� Site� Start-up,�

Investigational� Product� (IP)/Non-IP� Custom� Clearances,� Site/Document� Management� and� so� on.� StarTech�

Science�partners� to�provide� site� initiation� visits� to� site�close-out�visits,� site�data�management,�biostatistics�and�

medical�writing� capabilities.� This� partnership� allows� StarTech�Science� to�provide� strong�expertise,� end-to-end�

service� capabilities,� as� well� as� cost� effectiveness� to� our� clients.

Our� team’s� extensive� experience� and� our� complete� range� of� clinical� services� enables� StarTech� Science� to�

provide� our� clients� with� comprehensive,� high� quality� and� cost� effective� clinical� trial� solutions,� with� the�

flexibility� to� provide� specific� functional� services� or� full� service� outsourcing� solutions� tailored� to� the� needs� of�

our� clients.

23. StarTech Science LLC.

1.� Corporate� General� Information

Page 1028: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

부록 4� �국내 CRO�디렉토리 ❚ 1025

2.� Corporate� Service� &�Business� Area

Corporate�Main�

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing Consulting

○ ○

GeographicalBusiness� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing Consulting

MiddleEast

MiddleEast

MiddleEast

MiddleEast

Africa Africa Africa Africa

US ○ US US US ○

EU ○ EU EU ○ EU ○

Asia ○ Asia Asia Asia ○

Russia&CIS

Russia&CIS

Russia&CIS

Russia&CIS

Cemtral&South�America

Cemtral&South�America

Cemtral&South�America

Cemtral&South�America

ROW ○ ROW ROW ROW ○

Focusing�Contract

Service� Area

Contract� Research&� Development

ContractManufacturing

Contract� Sales� &Marketing Consulting

Research API ○

APIs

R&D ○

Pre-Clinical Pre-clinicalTest� Sample

R&D� Strategy&� Management ○

Phase� I ○ Clinical� Trials ○

Phase� II ○ Clinical� TestSample

FinishedProducts

RegulatoryAffairs ○

Phase� III ○ BusinessDevelopment

FinishedProduct ○

Phase� IV ○ Sales� &Marketing

Corporate

Product� Area

New� DrugBiologics

Herbal

MedicineBiosimilars

NCE NME

○ ○ ○ ○ ○

Generics APIs Devices Others

○ ○ ○ ○

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1026� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Clients'�

Composition

(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

25 25 25 25

In-house� Facilities

Research� &

DevelopmentPreclinical Clinical

Custom

ManufacturingCustom� Sales

○ ○

Focusing�

Therapeutic� Area

(%)

Oncologics Lipid� RegulatorsRespiratory�

AgentsAnti-ulcerants

Angiotensin� � � II�

Antagonists

21.2 0 27.3 0 0

AntipsychoticsAutoimmune�

agentsAntidepressants Analgesics Others

0 0 0 0 51.5

General� Overview�

of� Corporate's� Key�

Contract� Services

StarTech� Science� is� a� Full� Service� Clinical� Research� Organization(CRO),� which� provides�

SMART� -� Clinical� Study� Start-Up� Services� with� IT� Integrated� Services� to� pharmaceutical�

companies,� biotech� companies� and�medical� device� companies.� StarTech� Science� creates�

new� value� in� clinical� trials,� as� exploring� our� re-invention� and� adjusting� the� 2nd� IT�

evolution� with� people.� Our� first� brand� StarSys� Version� 1.0.� Clinical� Study� Start-Up�

Database� will� be� applied� with� dedicated� and� various� experienced� services,� which� be�

contributed� to� pharmaceutical� industries.� StarTech� Science� provides� specialized� Clinical�

Study� Start-Up� Services� with� IT� Integrated� solutions� to� ensure� clinical� trial� outcomes,�

which� includes� Project� Management,� Study� Study-Up� Plan,� Regulatory� and� IRB�

Management,� Site� Document� Collections,� Monitoring� Services� etc..�

Also,�our�Services� create�new�value� in� clinical� trial� environments,�as�well� as�we�shall�offer�

dedicated� and� qualified� services� with� paperless,� IT� Re-Inventional� Soultions� and� Echo�

Services.

Contract� Service�

Capacity� Affordable�

by� Service� Area

Also�with�US�and�EU�collaboration�partners,� IND/NDA�Regulatory�Affairs�Consulting�and�

Activities� are� doing� well.� BioTeh� Companies� are� supported� to� submit� FDA� and� EU�

IND/NDA� applications� with� strategic� planning� and� approaches� proactively.� Recently� we�

are� working� with� global� partners� as� well� and� provides� very� reliable� services� with� the�

reasonable� price� to� our� clients.

StarTech� Science� provide� various� specialized� service� to� support� and� submit� API�

registration,� DMF� or� medical� device� in� the� US� and� EU� with� our� partners.� Currently� we�

are� working� with� global� pharmaceutical� companies� and� also� set-up� china� registration�

process� with� Taiwan� Translation� company.

Also�we�connect� to� the�EU�consulting� firm�with�business/development,� sales,�marketing�

in� Denmark� and� Germany� and� as� well� as� Chinese� Pharmaceuticals� to� support� and�

explore� China� Big� Markets.

3.� Corporate� Business�Overview

Page 1030: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

부록 4� �국내 CRO�디렉토리 ❚ 1027

4.� Corporate� Competitiveness

Corporate

Competitiveness

StarTech� Science� provide� a� full� service� CRO� and� a� specialized� clinical� study� start-up�

activities� within� 4.9� months� to� clients� proactively.� Also� we� are� doing� strong�

regulatory� activities� with� our� partners.� We� can� say� more� profound� and� expertized�

services� to� clients� as� much� as� global� pharmaceutical� services.�

We�have� almost� 17� years� experiences� in�Clinical�Research� and� Extensive� knowledge�

of� regulatory� framework,� best� KOLs� and� sites� across� the� region.� Our� experience� in�

Asia� pacific� following� regions� -� Korea,� Singapore,� Hong� Kong,� Thailand,� India,�

Taiwan,� China,� Malaysia,� the� US� and� the� EU.

Current� Status� of

Accredited�

Certification

GCP� Certification

Project� Manager� Certification

Program� Registration� -� Intellectual� Property� (StarSys,� Clinical� Trial� Management�

System)

5.�Collaboration�Experiences�with�Asian�Pharmaceutical�&�Biotech�Companies�in� recent� 3� years

Countries� which

clients� belong� toKorea,� Singapore,� Hong� Kong,� Thailand,� India,� Taiwan,� China,� Malaysia

Asian� Clients'

Composition(%)

Big� PharmasMid� or� Small

-Size� Pharmas

Biotech

CompaniesStart-ups

30 30 40 0

No.� of� Asian� Clients

in� recent� 3� years10

Major� Service� Range

with�Asian�Companies

Contract� Research

&� Development

Contract

Manufacturing

Contract� Sales� &

MarketingConsulting

Research API ○

APIs

R&D ○

Pre-Clinical Pre-clinical

Test� Sample

R&D� Strategy

&�

Management

Phase� I ○ Clinical� Trials ○

Phase� II ○Clinical� Test

Sample

Finished

Products

Regulatory

Affairs○

Phase� III ○Business

Development○

Finished

Product○

Phase� IV ○Sales� &

Marketing○

Page 1031: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

1028� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Manama� Medical Enaltec� � Labskaiping� � genuine� biochemical

pharmaceutical

Elarabipharma� � Group SHJNJ� Modern� Pharmaceutical kaiyuan� hengtai� pharmaceutical

The� Arab� � Drugstore Anyang� Jiuzhou� Pharmaceutical kunshan� microchem� specialties

Middle� East� � Scientific� Bureau Zhejiang� Kangle� Pharmaceutical kunshan� yalong� trading

BAHER� HGFBeijing� Oriental� Friendship

Advertising

langfang� gaobo� jingband

pharmaceutical

Sawa� Pharma Ruibang� Laboratories lanshen� special� resin

Gulf� Generic� � General� Trading Ningxia� Tairui� Pharmaceutical leping� safety� pharmaceutical

Alfahealthcare Ningxia� Kingvit� Pharmaceutical lianyungang�debang� fine� chemical

Taiba� Pharma� � LLC Jubangpharmlianyungang� hengyang�

pharmaceutical

PHARMAZONE� � SAUDI� ARABIA Beijing� Lunarsun� Pharmaceutical lianyungang� klt� pharmaceutical

King� Saud� � Medical� CityZhejiang� Warrant

Pharmaceutical

lianyungang� wantai

pharmaceutical� material

saudi� german� � hospital Tosun� Pharmaceuticalliaoning� dongyuan�

pharmaceutical

Al-Hayat� � Pharmaceuticals Yantai� Justaware� � Pharmaceutical liaoning� hongtai� � pharmaceutical

Dabur� � International� Ltd Zhejiang� Jinhua�Conba�Bio-Pharm liaoning� senrong� � pharmaceutical

stratgurus aasenbo liaoyang� oxirano� material

Alphamed� -� Abu� � Dhabi Fuan� Pharmaceuticalliaoyuan� city� baikang�

pharmaceutical

RACS� General� � Trading� LLCSichuan� Intercontinental

Pharmaceutical

liaoyuan� silver� eagle�

pharmaceutical

Global� Pharma Yangzhou� Liberty� Pharmaceutical lifecome� biochemistry

Al� Hayat� � Pharmaceuticals Zhejiang� Haisen� Pharmaceutical linshu� huasheng� chemical

VishwamitraBeijing� Gaobo� Pharm-Chemicals

Techlivzon� pharmaceutical� group

Blue� River� � Medical� Equipment

TradingLanxite jiangsu� zhuxi� activated� carbon

New� BridgeChongqing� carelife� �

Pharmaceuticalhuohe� nanjiecun� pharma

ONCO� Pharma Hebei� Lianao� Pharmaceutical luoyang� desheng� bio-tech

VITANE� � Pharmaceuticals� Inc. Sichuan� Xieli� Pharmaceutical huzhou� dazhou� chemical

CHAN� CHAO� � International Hunan� Jiudian� Pharmaceutical masteam� bio-tech

【부록 5】� �주요 아웃소싱 그룹 현황 리스트

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부록 5� �주요 아웃소싱 그룹 현황 리스트 ❚ 1029

Taiwan�Bio� � Industry�OrganizationZhejiang� Xianju� Junye

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Page 1033: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

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HEALTHCARE� SDN� BHDZhejiang� Hisoar� Pharmaceutical PHEXCOM

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Page 1034: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

부록 5� �주요 아웃소싱 그룹 현황 리스트 ❚ 1031

Clinical� � Development� Services

Agency

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Page 1035: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

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Page 1036: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

부록 5� �주요 아웃소싱 그룹 현황 리스트 ❚ 1033

RUNDO-CRONOVA chengdu� shengnuo� biopharm shanghai� twisun� bio-pharm

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Page 1037: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

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Page 1038: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

부록 5� �주요 아웃소싱 그룹 현황 리스트 ❚ 1035

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Page 1039: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

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Page 1042: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

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Page 1043: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

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Page 1044: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

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Page 1046: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

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Page 1047: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

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Page 1048: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

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Page 1049: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

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Arlenda� Sterigenics�

AsepticTechnologies� StratexConsulting�

B&CGroupS.A.� VegobConsult�

Bio.be(Ipg)� Bio.be(Ipg)�

CIDE-SOCRAN� DNAVisionS.A.�

CROPHASprl� I.P.B.M.-InternationalProject&BusinessManagementSPRL�

DNAVisionS.A.� ProbioxS.A.�

I.P.B.M.-InternationalProject&BusinessManagementSPRL� ProgenosisSA�

IDDI� AepodiaS.A.�

KeyrusBiopharmaSA� DNAVisionS.A.�

NextPharma� Arlenda�

PecherConsultantsSPRL� KeyrusBiopharmaSA�

ProbioxS.A.�

■�미국 생명공학산업협회 회원사(유럽지역 포함 업데이트)�리스트 :� 143개사

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부록 5� �주요 아웃소싱 그룹 현황 리스트 ❚ 1047

Charles� � River ALTANA� � AG IQ� � Corporation

Copenhagen� � Capacity Arecor� � Ltd. MC2� � Biotek� Group

Cygnus� � Technologies,� Inc Arrow� � Therapeutics,� Ltd Med� � Discovery� SA

D2� � Pharma� Consulting� LLC Athera� � Biotechnologies� AB Neovacs� � SA

Deloitte� � Recap� LLC Baliopharm� � AG Neusentis

Dow� � Pharmaceutical� Sciences,� Inc Bavarian� � Nordic,� A/S Newron� � Pharmaceuticals,� SpA

Dyadic� � International,� Inc Beta-Cell� � NV Novozymes

EBD� � Group BIO� � Deutschland One� � Nucleus� Ltd

EquipNet,� � Inc BIOCAT Pepscan� � Therapeutics� BV

Exemplar� � Genetics,� LLC BioFarmind PEPTONIC� � Medical� AB

FOB� � Synthesis,� Inc Bionature� � E.A.� Ltd. Pergamum� � AB

Gallus� � Biopharmaceuticals,� LLC Biopeople Phosphate� � Therapeutics� Limited

Genoptix,� � Inc BP� � Biofuels Plastid� � AS

greenovation� � Biotech,� GmbH BP,� plc Profibrix,� � BV

HistoRx,� � Inc Cambridge� � Antibody� Technology�Group� plc

Prosidion,� � Ltd

HTD� � BioSystems,� Inc Cancer� � Research� Technology� Limited Redx� � Pharma� Ltd

Insight� � Genetics,� Inc Cellectis� � SA ReNeuron

JDJ� � Bioservices� Pty� Ltd Celonic� � AG Reverdia

Keygene� � Inc. Celonic� � GmbH Royal� � Nedalco

Laureate� � Biopharma CEVEC� � Pharmaceuticals� GmbH Scottish� �Development� International

Life� � Technologies� Corporation Clavis� � Pharma� ASA Selexis� � SA

Logopharm,� � GmbH Cluster� � Industrial� Biotech� E.V. Solvay� � Pharmaceuticals� SA

Luitpold� � Pharmaceuticals,� Inc. Covagen� � AG SuppreMol,� � GmbH

MacDougall� � Biomedical�Communications

Crucell Swissaustral� � Biotech� SA

Martek� � Biosciences� Corporation Cyclacel� � Pharmaceuticals,� Inc Symphogen,� � A/S

McDonnell� � Boehnen� Hulbert� &�Berghoff� LLP

DA� � VOLTERRA Technologiepark� � Heidelberg,�GmbH

Medicago� � Canada,� Inc Danisco� � A/S TechnoPhage,� � SA

Molecular� � Probes,� Inc Delphi� � Genetics� SA Thrombotargets� � Europe� SL

MPI� � Research df-mp UBIFrance

PharmaBioSource,� � Inc Domantis,� � Ltd UCB� � Pharma� SA

Protein� � Sciences� Corporation DSM� � Bio-Based� Products� &� Services uniQure� � BV

ProteoNic� � BV EBE� -� European� Biopharmaceutical�Enterprises

Venture� � Valuation

PsychoGenics,� � Inc Elan� � Drug� Technologies Wiborg� � ApS

Radford Endotis� � Pharma,� SA Xenetic� � Biosciences� Plc

Research� � &� Diagnostic� Antibodies Epitarget� � AS ZF� � BIOTOX

Royalty� � Pharma�Management,� LLC Evercyte� � Gmbh

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1048� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Aceto� � Corporation Hi-Tech� Pharmaceuticals

ACIC Huahai� US� Inc.

Actavis� Inc. Impax� Laboratories

A.J.� Renner Ind-Swift� Laboratories,� Inc.

ALTA� SCIENCE Interchem� Corporation

All-Pak� Inc. Lachman� Consultants� Services,� Inc.

Amerigen� Pharmaceuticals� Inc. Mckesson� Corporation

Amneal Midlothian� Laboratories

Anapharm,� Inc. Momenta� Pharmaceuticals

Anchen� Pharmaceuticals,� Inc. New� chemic� Inc.

ANDA� Inc. Novel� Laboratories,� Inc.

Apicore� LLC Novum� Phramceutical� Research

APP� Pharmaceuticals� Inc. Pharma� Medica� Research� Inc.

Ben� Venue� Laboratories� Inc. Qualitest� Pharmaceuticals

Biddle� Sawyer� Corporation Ren-Pharm� International

Bioniche� Pharma� Group� Limitied RTI� Health� Solution

Capsugel Sagent� Pharmaceuticals

Caraco Sandoz� Inc.

Cetero� Research Sovereign� Pharmaceuticals

ChemWerth� Inc. Strides� Inc.

DAVA� Pharmaceuticals,� Inc. Synomics� Pharmaceutical� Services

Dr.Reddy's� Laboratories� Inc. Synthon� Pharmaceuticals

Eagle� Pharmaceuticals Taro� Pharmaceutical

ETHEX� Corporation Tedor� Pharma� Inc.

Fougera TevaPharmaceutical�

Gedeon� Richter TOLMAR,� Inc.

Great� Southern� Laboratories VersaPharm,� Inc.

Harris� Pharmaceutical Vijuk� Equipment

Hartmann� Pharmaceutical Vinchem� Inc.

Heritage� Pharmaceuticals Zydus� Pharmaceuticals

■�미국제네릭협회 회원사 :� 60개사

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부록 5� �주요 아웃소싱 그룹 현황 리스트 ❚ 1049

Access� Technologies Chemical� Solution� Ltd.(CSL) Maxxan� Analytics� Inc.

Advinus� Therapeutics� Limited ChemRisk,� Inc. Medline� Industries,� Inc.

Advion� BioServices,� Inc. CIRION� Clinical� Trial� Services� Inc. Metabolon,� Inc.

Aegis� Technologies� Group CIT MolTox

Almac Comparative� Bioscience,� Inc,(CBI) Mouse� Specifics,� Inc.

Alpha� Genesis,� Inc.(AGI) Contract� Pharma MPI� Research

Alturas� Analytics,� Inc. CorDynamics MultiCase

Analytical� Bio-Chemistry� Labs,�

Inc.(ABC)

CPCClinic,Medipolis� Medical NAMSA

Ani� Lytics,� Inc. CXR� Biosciences� Limited National� Research� Center� for�

NewDrug

ANILAB,� LLC Data� Science� International(DSI) NeuroScience� Associates(NSA)

Antech� Diagnostics Definiens� Inc. Neuroservice

Apredica Dermal� Technology� Laboratory�

Ltd(DLT)

Nucro-Technics� Incorporated

Argutus� Medical EMD�Millipore Numira� Biosciences

Art's� Way� Scientific ENVIRON� International� Corp. Pharmatek� Laboratories,� Inc.

Aushon� BioSystems,� Inc. EPL� Archives,� Inc. PhoenixBio� Co.,� Ltd.

AVA� Biomedical,� Inc. EPL,� Inc(Experimental� Patholgy�

Laboratories)

Phylonix� Pharmaceuticals� Inc

AVANZA� Laboratories,� LLC Evotec(UK)� Limited Porsolt

BASF� SE Experimur Pre-Clinical� Research� Services,�

Inc.(PCRC)

BASi(Bioanalytical� Systems,� � Inc) Exponent,� Inc PreLabs

Bio� Medic� Data� Systems,� Inc. Fraunhofer� ITEM Premier� Laboratory,� LLC

Bio-Serv,� Inc. Fulcrun� Pharma� Development,� Inc. Purina� Mills� LabDiet

Bioagri� Phrama GE� Hearlthcare PWG� Genetics

Biobide Gentronix,� Limited QPS-Taiwan

BioChemed� Services H&T� Corporation Quansys� Biosciences

Bioculture(Mauritius)� Ltd Hamiltion� Thorne,� Inc. Quotient� Bioresearch

Biological� Test� Center(BTC) Harlan� Laboratories,� Inc. ReachBio

Biologics� Consulting� Group,� � Inc. HistoTox� Labs,� Inc. Regularatory� Science�

Asocciates(RSA)

Bioo� Scientific Huntingdon� Life� Sciences Research� Essential� Services� LLC

Biopredic� International ICF� International Ricerca� Biosciences,� LLC

Biopta� Ltd IDEXX� Laboratories,� Inc. Sequani� Limited

BioReliance� Corporaion In� Vitro� ADMET� Laboratories Seventh� Wave

BioScience� Laboratories Ina� Research,� Inc.(INA) SkinEthic� Lboratories

■�국내외 행사 및 학회 참가 리스트(2012� BIOKOREA,� 2011� ToxExpo)� :� 152개사

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1050� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

BioSTAT� Consultant,� Inc INDIGO� Biosciences,� Inc. Smithers

BioStorage� Technologies,� � Inc. InSphero� AG SOLVO� Biotechnology

BioTox� Sciences IPO Spring� Vally� Laboratories,� Inc.

BioVendor,� LLC Integrated� Laboratory� Systems,�

Inc.(ILS)

SRI� International

Boston� BioProducts Intellicyt� Corporation STEMCELL� Technologies� Onc

Bruker� Daltonics� Inc. INTOX� Pvt.� Ltd. Tandem� Labs

Burdock� Group IPS� Therapeutique,� Inc. Thermo� Scientific

Buxco� Research� Systems ITR� Laboratories� Canada,� Inc. TNO

C3-B� Alliance Jai� Research� Foundation toXcel,� LLC

Calibrate,� Inc JCL� Bioassay� USA Toxicology� Regulation� Services(TRS)

Caliper� Life� Science,� Inc KCAS,� LLC ToxServieces� LLC

Care� Research Kinder� Scientific� Company Veritox,� Inc

Cayman� Chemical Lampire� Biological� Laboratories,� Inc. Vimta� Labs� Limited

CeeTox,� Inc Litron� Laboratories VRL� Laboratories

Cerep� Inc. Lonza� Bioscience WIL� Research� Company,� Inc

ChanTest� Corp. Luminex� Corporation Wildlife� International� Ltd.

Charles� River Maccine� Pte� Ltd MatTek� Corporation

Marken Biologics� Consulting� Group

AAIPharma� Services� Corp. CreapharmOso� BioPharmaceutical� �

Manufacturing� LLC

Abbott� Laboratories Cyanta� Analytical� Services Pace� Analytical� Life� Sciences

ABC� Laboratories DataCeutics,� Inc. Particle� Technology� Labs

Accupac Diteba� Research� Laboratories Patheon,� Inc.

Akrimax� Manufacturing DSM� Pharmaceuticals PDI,� Inc

Algos� Preclinical� Services Elan� Drug� Technologies PharmaZell,� Inc.

Alliance� Medical� Products Eurofins� Pharma� Services Pilgrim� Software

Almac Federal� Equipment Pillar5� Pharma� Inc.

Alphora� Research,� Inc. Fleming� Pharmaceuticals PrePak� Systems,� Inc.

Althea� Technologies,� Inc. Florida� Biologix Quintiles� Transnational

AMRI Formatech Randox� Laboratories� Ltd.

Anderson� Packaging,� Inc. Fresenius� Kabi� Product� Partnering Recipharm

AndersonBrecon� Clinical� � Services Grand� River� Aseptic� Manufacturing Ricerca� Biosciences,� LLC

Apotex� Fermentation� Inc. Groupe� Parima,� Inc. Ropack� Packaging

ATL Haemtech� Biopharma� Services Rottendorf� Pharma� GmbH

Avema� Pharma� Solutions Harlan� Laboratories� Ltd. Ruger� Chemical

■�ContractPharma�관련 업체 리스트 :� 115개사

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부록 5� �주요 아웃소싱 그룹 현황 리스트 ❚ 1051

BASF� Pharma� (Evionnaz)� SA Harmony� Labs,� Inc. Sandoz� GmbH

BASi� (Bioanalytical� Systems,� � Inc.) Haupt� Pharma SCM� Pharma

Beckloff� Associates Hisun� Pharmaceuticals� USA,� Inc. SGS� Life� Science� Services

Ben� Venue� Laboratories,� Inc. HollisterStier� Pharma� Solutions Sharp� Corporation

Bilcare� Global� Clinical� � Supplies,�

AmericasHospira� One� 2� One Sheffield� Pharmaceuticals

Boehringer� Ingelheim HTD� Biosystems� Inc. Siegfried� Ltd

Boston� Analytical,� Inc. Impact� Analytical Sigma-Tau� PharmaSource� Inc.

Cangene� Biopharma Importfab� Inc. SL� Pharma� Labs,� Inc.

Catalent� Pharma� Solutions Integral� BioSystems� LLC Smithers� Viscient

Cellular� Technology� Ltd. JHP� Pharmaceuticals,� Inc. Stason� Pharmaceuticals,� Inc.

Cetero� Research Lancaster� Laboratories Therapex,�Div�E-Z-EM�Canada,� Inc.

Chartwell� Pharma,� LLC LSNE� Contract� Manufacturing ThermoSafe� Brands

Chemic� Laboratories,� Inc. Lyne� Laboratories,� Inc. TraceLink� Inc.

Clinical� Research� Management,� � Inc. Lyophilization� Technology,� Inc. Unigene� Laboratories,� Inc.

CMC� Biologics� A/S Merck� BioManufacturing� NetworkUniversity�of� Iowa�Pharmaceuticals�

(UIP)

Coating� Place� Inc. Meridian� Life� Science,� Inc. UPM� Pharmaceuticals,� Inc.

Coldstream� Laboratories Metrics,� Inc. Velesco� Pharmaceutical� Services

Compliance� Insight,� Inc. Micron� Technologies,� Inc. Vetter�Pharma� International�GmbH

Confab� Laboratories Mikart,� Inc.WellSpring�Pharmaceutical�Canada�

Corp.

Congenix� LLP MPI� Research West-Ward� Pharmaceuticals

Consumer� Product� Testing� Co.,� � Inc. Myoderm Xcelience� LLC

Corden� Pharma� Group Norwich� Pharmaceuticals,� � Inc.

CoreRx,� Inc. Octagon� Research� � Solutions

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1052� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Manama� � Medical chengdu� � huayi�medicinal� accessary�

material

shanxi� � yunpeng� pharmaceutical

Elarabipharma� � Group chengdu� lier� pharmaceutical shenyang� syndy� pharmaceutical

The� Arab� � Drugstore chengdu� longquan� high-tech� �

natural� pharmaceutical

shenyang� yi'an� medical� �

supplements

Middle� East� � Scientific� Bureau chengdu� shengnuo� biopharm shenzhen� salubris� � pharmaceutical

BAHER� HGF chengdu� xindu� kuixing� bio-chem� �

factory

shijiazhuang�baiqi�chemical� � industry

Sawa� Pharma chifeng� yingfa� pharmaceutical� � &�

chemical

shijiazhuang� concorde� �

pharmaceutical

Gulf� Generic� � General� Trading china� resources� zizhu� �

pharmaceutical

shijiazhuang� haili� � pharmaceutical

Alfahealthcare chongqing� chunrui� pharm-chem shijiazhuang� haosheng� chemical

Taiba� Pharma� � LLC chongqing� ensky� chemical shijiazhuang� hengrun� science� � &�

technology

PHARMAZONE� � SAUDI� ARABIA chongqing� quanxinxiangsheng� �

bio-pharmaceutical

shijiazhuang� lixin� � pharmaceutical

King� Saud� � Medical� City chongqing� shenghuaxi� �

pharmaceutical

shijiazhuang� polee� � pharmaceutical

saudi� german� � hospital dalian� toyounger� chemical shijiazhuang� wuyue� pharmaceutical�

factory

Al-Hayat� � Pharmaceuticals dandong� yichuang� � pharmaceutical shijiazhuang� yongyuan� chemical

Dabur� � International� Ltd datong� tongxing� antibiotic shouguang� nuomeng� chemical

stratgurus dingkang� pharmaceutical sichuan� guanghan� sanxingdui� �

natural-chemical

Alphamed� -� Abu� � Dhabi donggang� hongda� pharmaceutical sichuan� hongmao� � pharmaceuticals

RACS� General� � Trading� LLC dongming� huiren� bio-product sichuan� jiexiang� herb� material

Global� Pharma dongming� shengyuan� � bio-chemical�

technology

sichuan� jinshan� pharmaceutical

Al� Hayat� � Pharmaceuticals dongtai� baoshun� �

orgarisms-manufactures

sichuan� long�march� �pharmaceutical

Vishwamitra dongtai� xinyuan� chemical sichuan� neijiang� huixin� �

pharmaceutical

Blue� River� � Medical� Equipment�

Trading

dongying� heyi� chemical sichuan� xicheng� pharmaceutical

New� Bridge dongying� huakang� chem sichuansheng� shifangshi� � huakang�

medicine� raw� material� factory

【부록 6】� �주요 전략적 협력사 현황 리스트

■�중국,�인도,�동남아 지역 전략적 협력사 :� 873개사

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부록 6� �주요 전략적 협력사 현황 리스트 ❚ 1053

ONCO� Pharma yuchengshi� haihe�biological� � agents sichuan� zhonghong� natural� �

pharmaceutical

VITANE� � Pharmaceuticals� Inc. enantio� tech� corporation sinopharm

CHAN� CHAO� International farmasino� pharmaceuticals sinopharm�weiqida� � pharmaceutical

Taiwan� Bio� Industry� Organization fujian� fukang� pharmaceutical sinopharm� zhijun� suzhou� �

pharmaceutical

biotechcorp fushun� shunte� chemical starlake� bioscience

J.B.� PHARMACY� �GROUP�SDN�BHD futaste� pharmaceutical strand� bioscience

AIN� MEDICARE� � SDN� BHD guan� enkang� chemical success� int'l� logistics

CANAAN� ALPHA� � SDN� BHD guangdong� bohong� medicine sung� wun� pharmacopia

DOLPHIN� � HEALTHCARE� SDN� BHD guangdong� dilikang� medicine sunny� group� sel� biochem

GAMAT� EMAS� SDN� � BHD guangdong� leawell� � pharmaceutical sunresin� new� materials

HOVID� BERHAD guangdong�tongde� �pharmaceutical sunrise� group� corporation

XORIX� SDN� BHD guangxi� changzhou� natural� �

pharmaceutical

suzhou� ausun� chemical

BIO-SCIENCE� � MARKETING� SDN�

BHD

guangzhou� bairui� medicine suzhou� bec� biological� � technology

BIOVALENCE� SDN� � BHD guangzhou� standard� pharma suzhou� dawnrays� pharmaceutical

EMPIRE� � CARRIAGE� SDN� BHD guanguangzhou� hanfang� �

pharmaceutical

suzhou� homesun� pharmaceutical

IDAMAN� PHARMA� �

MANUFACTURING� SDN� BHD

guilin� pharmaceutical suzhou� huihe� pharmaceutical

IDAMAN� PHARMA� � SDN� BHD haimen� bestfine� chemical lianyungang� ningkang� chemical

IIUM� TRADING� � SDN� BHD hanhangzhou� liren� � pharmaceutical suzhou� kaiyuan� minsheng� sci� � &�

tech

MALAYSIAN� � VACCINES� AND�

PHARMACEUTICALS� SDN� BHD

hanzhong� trg� biotechnology suzhou� lanxite� biotechnology

NOVA� � LABORATORIES� SDN� BHD harbin� aolin� pharmaceutical suzhou� lixin� pharmaceutical

PHARM-D� SDN� � BHD harbin� pharmaceutical� group suzhou�no.5�pharmaceutical� � factory

PHARMANIAGA� �

MANUFACTURING� BERHAD

hebei� changshan� biochemical� �

pharmaceutical

suzhou� qichuang� business� �

consulting

PRIME� � PHARMACEUTICAL� SDN�

BHD

hebei� huachen� pharmaceutical suzhou� synthetic� chemical

RANGE� PHARMA� � SDN� BHD hebei� huaxu� chemical suzhou� tailida� technology

SANTIS� PHARMA� � SDN� BHD hebei� huaxu� pharmaceutical suzhou� tianlu� � bio-pharmaceutical

Y.S.P.� � INDUSTRIES� (M)� SDN� BHD hebei� jianmin� starch� glucose suzhou� tianma� pharma� group

YENHER� � AGRO-PRODUCTS� SDN�

BHD

hebei� jiheng� pharmaceutical suzhou� wellfair� chemicals

CCM� � PHARMACEUTICALS� SDN�

BHD

hebei� jingye� chemical suzhou� wugan� pharmaceutical

ACE� ADVERTRADE� � SDN� BHD hebei� shengxue� dacheng� �

pharmaceutical

suzhou� xingye� chemical

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1054� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

AVERROES� PHARMACEUTICALS�

SDN� BHD

hebei� veyong� animal� �

pharmaceutical

taicang� puyuan� pharmaceutical

DYNAMIC� � PHARMASHOPPE� &�

HEALTHCARE� SDN� BHD

hebei� xiecheng� biotechnology taicang� xintal� alcohol

EURO� � CHEMO-PHARMA� SDN�

BHD

hebei� xingang� pharmaceutical taishan� xinning� pharmaceutical

NASMIR� HARD� � GELATIN�

CAPSULES� SDN� BHD

hebei� xingtai� metallurgy� �

magnesium

taixing� yangzi� pharmaceutical� �

industry

PROFOUND� � KESTREL�

LABORATORIES� SDN� BHD

hebei� yinuo� animal� husbanory� �

science� and� technology

taizhou� bolon� pharmachem

CAMBRIDGE� � HERBAL� SDN� BHD hebei� yuxing� bio-engineering taizhou� highsun� pharmaceutical

Transmedic� Pte� � Ltd hebei� zhaozhou� limin� glucose taizhou� xingming� � pharmaceutical

Antah� � Healthcare� Group hebei� tianxu� natural� pigment taizhou� xinyou� pharmaceutical

Summit� Company henan� huashang� pharmaceutical taizhou� yojoy� pharmaceutical

zuellig� pharma henan� huifeng� pharmaceutical the� united� laboratories� � limited

DKSH henan� jiushi� pharmaceutical tianjin� bokelin� medical� � packaging�

technology

LF� Asia henan� lihua� pharmaceutical tianjin� J&K� limited

Hoang� Vu� � Trading� Engineering� &�

Services� Company� Limited

henan� purui� pharmaceutical tianjin� jingye� fine� chemicals

Nanogen� � Biopharma� Co� Ltd henan� sunny� industry tianjin� jinhuitaiya�chemical� � industry

Jebsen&JessenChemicalsVietnamCo

Ltd�

henan� topfond� pharmaceutical tianjin� kingyork� group

STADA-VNJointVentureCo.,Ltd� henan� xinxiang� huaxing� �

pharmaceutical� factory

tianjin� pacific� pharmaceutical

GlomedPharmaceuticalCo.,Inc� henan� xinyi� medicine� group� � fine�

chemical� industry

tianjin� zhongjin� � pharmaceutical

VINAPHARM henan� yuchen� fine� chemical tianjin� zhongrui� � pharmaceutical

Mekophar henan� zhenghong� pharmaceutical� �

adjuvant

tipr� pharmaceutical

Alcare� � Pharmaceuticals� Pte� Ltd hengshui� changhao� � biotechnology titan� pharmaceutical

Veredus� � Laboratories yunnan� pharmaceutical� industry tonghua� maoxiang� pharmaceutical

KINGSTON��MEDICAL�SUPPLIES�PTE�

LTD

huakang� pharmaceutical� science� �

and� technology

tpsh� technology

Global� Trade� � Linkages� Private�

Limited

huanggang� luban� pharmaceutical vitalpharms� company� limited

Ecron� acunova huanggang�saikang� �pharmaceutical shenzhen� voosong� technology

AMRI� Global� � smartsourcing huanggang� wellman� biosciences weifang� shengtai� medicine

C-CAMP huanghua� jinhua� additives weihai� disu� pharmaceutical

Clinical� � Development� Services�

Agency

huangshan� tianmu� menthol� �

pharmaceutical

weilian� fine� chemical

GVK� BIO MFCI wenzhou� opal� chemical� industry

Page 1058: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

부록 6� �주요 전략적 협력사 현황 리스트 ❚ 1055

DR.� REDDY'S huazhong� pharmaceutical wenzhou� xiaolun� coating� �

technology

VEENA� TAMTA� � BHATIA hubei� danjiangkou� kaitai� � hormone wuhan� sinocon� new� chemical� �

materials

Ministry� of� � Science� &� Technology�

Government� of� India

hubei� fangtong� pharmaceutical wujiang� bolin� industry

ABLE hubei� lansun� biochemistry� �

pharmaceutical

wujiang� yongxiang� alcohol� �

manufacturing

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Pharmaceuticals

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pharmaceuticals&chemicals� share

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Pharmexcil hubei� qianjiang� siwei� amino� � acid xi'an� honson� biotechnology

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development

xiangyang� yuchang� fine� � chemical

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supreempharma hubei� yitai� pharmaceutical xinxiang� kexin� chemical

Aaranya� � BioSciences hubei� zhongmu� anda� �

pharmaceutical

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gongsi

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materials

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Assistance� Council

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intermediate

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jiangsu

Criyagen� Agri� � &� Biotech� Private�

Limited

hunan� dibo� tragacanta xiuzheng� pharmaceutical� group� �

liuhe� pharmaceutical

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Technology� Institute

hunan� Er-kang� pharmaceutical xuancheng� baicao� pharmaceutical

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dnr� � Distribution hunan� warrant� pharmaceutical xuzhou� hengkai� ginkgo� products

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PENTA� VALENT IMCD� china yabang� chemical

PT.� PARIT� � PADANG� GLOBAL improve� medical� technology yabao� pharmaceutical� group

Kalbe inner� mongolia� lantai� � industrial yancheng� kale� new� matericals

Sanbe jiangsu� SMK� pharmaceutical yancheng� kangqiang� farm

Dexa Ji'an� hairui� natural� plant yancheng� shengda� chemical

Soho� Group jiangsu� nhwa� pharmaceutical yangzhou� pharmaceutical

PT� Tempo� Scan� � Pacific� Tbk jiangsu� qinfen� pharmaceutical yangzhou� tianhe� pharmaceutical

Beijing�Pharma� �And�Biotech�Center jiangsu�chemical� information� �center yangzhou� winsome� aba� pharmacy

Changshu� New� � Venture jiangsu� chengyi� pharmaceutical yantai� dongcheng� biochemicals

Hunan� Dongting� � Pharmaceutical jiangsu� chiatal� fengchai� �

pharmaceutical

yantai� luyin� pharmaceutical

Shenzhen� Boda� � Biopharm jiangsu� dafeng� city� tiansheng� �

pharmaceutical

yanzhou� shengbao� � pharmaceutical

CHARIOTEER jiangsu� dawning� pharmaceutical yichang� tianren� pharmaceutical

Page 1059: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

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CHANGZHOU� � SUNLIGHT�

PHARMACEUTICAL

jiangsu� grand� xinyi� � pharmaceutical yicheng� goto� pharmaceutical

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PHARMACEUTICAL

jiangsu� hengsheng� � pharmaceutical yingcheng�wuhan� organic� �material

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chemicals

Hangzhou� � utanpharma� biology jiangsu� huachang� chemical yixing� jiangshan� bio-tech

Shanghai� � Record� Pharmaceuticals jiangsu� huaxu� pharmaceutical yonghe� chemical

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pharmaceutical

중국의약그룹총회사 jiangsu� jiujiujiu� technology yueyang�xinzhang's� �pharmaceutical�

industry

광주의약그룹유한회사 jiangsu� jubang� pharmaceutical yuhuan� huanglong� zibuye� �

guanjiangchang

천진시의약그룹유한공사 jiangsu� kangheng� chemical yunan� forever� bright� � cyclodextrin

산동동아아교그룹유한책임회사 jiangsu� renhang� pharmaceutical yunnan� linyuan� spice

화북제약그룹유한책임회사 jiangsu� senxuan� pharmaceutical� � &�

chemical

yunnan� sansheng� pharmaceutical

태지그룹유한회사 jiangsu� shenhua� pharmaceutical yuwei� biological� pereparation

신화로항약업그룹유한회사 jiangsu� swellxin� bio-pharm. zhejiang� apeloa� kangyu� �

pharmaceutical

중경의약주식유한회사 jiangsu� tiansheng� � pharmaceutical zhejiang�apeloa�medical� � technology

석가장제약그룹 jiangsu� yizhenghe� � biotechnology zhejiang� chemsyn� pharm

동북제약그룹유한책임회사 jiangsu� yongda� pharmaceutical zhejiang� dongcheng� �

pharmaceutical

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상해뢰윤상약업유한회사 jiangxi� chibang� pharmaceutical zhejiang� excel� pharmaceutical

천진중신약업그룹주식유한회사 jiangxi� dexing� parchn� sodium� �

isovitamin� c

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절강해정그룹유한회사 jiangxi� ganliang� � pharmaceutical�

material

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pharmaceutical

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material

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동북제약총공장 jiangxi� huitong� pharmaceutical zhejiang� kinglyuan� � pharmaceutical

길림수정약업그룹 jiangxi� gold� lotus� � pharmaceutical zhejiang� langhua� � pharmaceutical

중국(항주)청춘보그룹유한회사 jiangxi� kangshengtang� �

pharmaceutical

zhejiang� limin� chemical

심천만기약업유한회사 jiangxi� new� ganjiang� �

pharmaceutical

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하북성고영기업그룹회사 jiangxi� renqi� pharmaceutical zhejiang� shaxing� pharm� &� � chem

이군제약유한책임회사 jiangxi� rongxing� � pharmaceutical zhejiang� shenghua� biok� biology

Page 1060: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

부록 6� �주요 전략적 협력사 현황 리스트 ❚ 1057

사천과륜실업그룹유한회사 jiangxi� shengdian� S&T zhejiang� shengshi� � bio-technology

청두지오그룹 jiangxi� shenli� pharm&chem zhejiang� sixian� pharmaceutical

정대청춘보약업유한회사 jiangxi� synergy� pharmaceutical zhejiang� tiantai� fuda� medical� �

chemistry

산시동성그룹유한회사 jiangxi� uniqmol� pharmaceutical zhejiang� xianfeng� technology

천사력제약주식유한회사 jiangyin� yuecheng� jiangnan� � fine�

chemical

zhejiang� xianju� xianle� �

pharmaceutical

복건동춘약업주식유한회사 jiaxing� junkang� �

commerce&industrial

zhejiang� yatai� pharmaceutical

AlputonInc� jiayi� pharmaceutical zhejiang� yongning� � pharmaceutical

OmnicareClinicalResearch� jilin� changqing� ginseng zhejiang� yongtai� technology

GlobalMedicalConsultingServices(Sh

anghai)Co.Ltd.�

jiangcheng� oil� chemical zhejiang� changming� �

pharmaceutical

MedkeyMed-TechDevelopmentCoLt

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jilin� jiufeng� biotechnology zhengzhou� fuyuan� chemical� �

industry

ProswellMedicalCorporation� jinan� chenghui� shuangda� � chemical zhengzhou� ruikang� � pharmaceutical

BeijingMedpaceMedicalScience&Tec

hnologyLtd�

jinan� huimeng� biotech zhenjiang� dera� medical

ExcellenceFutureInternationalConsul

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chemistry

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H&JMedinforConsultantsLtd� jinan� kehui� pharmaceutical zhenjiang� kangfu� biological� �

engineering

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CoLtd�

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ShanghaiLoudonMarketingConsulta

ntCoLtd�

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chemical� industry

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MacroStatChinaClinicalResearchCoL

td�

jinan� taifei� science� &� � technology YanTai� HengYuan� Bioengineering� �

Co.,LTD

BeijingJoinnPharmaceuticalCenter� jingdezhen� kaimenzi� medicinal� �

chemistry

Suzhou� Highfine� Biotech� � Co.,Ltd.

BeijingBionovoMedicineDevelopme

ntCoLtd�

jingzhou� hongda� biotechnology Shandong� Fangming� �

Pharmaceutical� Group� Co.,Ltd.

CHINDOCPharmaServices� jining� liujia�pharmaceutical� �adjurant�

limited� company

Tairui� Pharmaceutical� Co.,� Ltd

BeijingMedSeptMedicalConsultingC

oLtd�

jintan� qianyao� pharmaceutical� � raw�

material� factory

HUZHOU� ZHANWANG�

PHARMACEUTICAL� � Co.,Ltd.

BeijingCRO,Inc.� jintan� sanfang� pharmaceutical� �

material

SINOPHARM� JIANGSU� CO.,� LTD.

VivoDevelopmentLtd� jinzhou� jiutai� pharmaceutical ANHUI� SUNHERE�

PHARMACEUTICAL� � EXCIPIENTS�

CO.,� LTD.

Page 1061: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

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ClindaMedicineStudy� jizhou� city� huayang� chemical Shandong�Kaisheng�New� �Materials�

Co.,� Ltd

ShanghaiCaresBiotechCoLtd� jqc� pharmaceutical Er-kangpharmaceuticalco.,LTD�

GleneaglesCRC(China)PteLtd� jubilant� organosys Zhejiang� Qiming� Pharmaceutical� �

Co.,� Ltd.

TigermedConsultingCoLtd� kaiping� genuine� biochemical� �

pharmaceutical

Wudi� Reaction� � Pharma&Chemical�

Co.,Ltd

BeijingZhongweibichengInternation

alMedicineResearchCenter�

kaiyuan� hengtai� pharmaceutical Jinlong�Technology�Group�Co.,� �Ltd.

BeijingDMSPharmaLtd� kunshan� microchem� specialties Qilu� Pharmaceutical� Co.,� Ltd.

ShanghaiSLGCoLtd� kunshan� yalong� trading Huangshan� Bonsun� �

Pharmaceuticals� Co.,Ltd.

ShanghaiPharmaEngineCoLtd� langfang� gaobo� jingband� �

pharmaceutical

changzhou�wujin� linchuan� �chemical�

co.,ltd.

ShanghaiNewsummitBiopharmaCoL

td�

lanshen� special� resin Xuchang�Ruida�Biology� �Technology�

Co.,Ltd.

ShanghaiGenomics,Inc.� leping� safety� pharmaceutical Dawnrays� Pharmaceutical� �

(Holdings)� Limited

CCBRBeijingCenter� lianyungang� debang� fine� � chemical ANGEL� YEAST� CO.,LTD

InCROMChina� lianyungang� hengyang� �

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Hubei� Gedian� Humanwell� �

Pharmaceutical� Co.,Ltd.

Accelovance(China)CorpLtd� lianyungang� klt� pharmaceutical Huanggang� Yinhe� Aarti� �

Pharmaceutical� Co.,Ltd.

Shanghai� � Medicilon� Inc. lianyungang�wantai� �pharmaceutical�

material

maceutical� Co.,� Ltd.� Shenzhen� �

YOUPUHUI

Convance� Inc.� � Beijing liaoning� dongyuan� � pharmaceutical Hangzhou� Heta� pharm� &� Chem� �

Co.,Ltd

GiantMed-PharmaServices,Inc.� liaoning� hongtai� � pharmaceutical Shanghai� Yuking� Water� Soluble� �

Material� Tech� Co.,� Ltd

GuangzhouBojiClinicalResearchCent

er�

liaoning� senrong� � pharmaceutical AnhuiBiochemUnitedPharmaceutical

Co.,LTD�

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gCoLtd�

liaoyang� oxirano� material Hebei� Chengxin� Co.,� Ltd

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pharmaceutical

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CO.,� LTD.

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CO.,� � LTD

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ghai)CoLtd�

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Pharmceutical� Co.,Ltd.

BioDuroBeijingCoLtd� linshu� huasheng� chemical SHANDONG�FENGYUAN�CHEMICAL� �

CO.,� LTD.

Xi'anNewDrugEvaluationandResearc

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livzon� pharmaceutical� group Chengdu� CSHPHARM� Co.,Ltd.

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부록 6� �주요 전략적 협력사 현황 리스트 ❚ 1059

ChangzhouWujinYabangPharmaceu

ticalChemicalCoLtd�

jiangsu� zhuxi� activated� carbon JINAN�DEXINJIA�BIO&TECH��CO.,LTD

AutekBio(Beijing),Inc.� huohe� nanjiecun� pharma FOSHAN� NANHAI� ZHONGNAN� �

PHARMACEUTICAL� FACTORY

SinoGenoMaxCoLtd� luoyang� desheng� bio-tech Guangzhou� Hanpu� Pharmaceutical� �

Co.,� Ltd.,

ShanghaiGenePharmaCoLtd� huzhou� dazhou� chemical Henan� Lingxian� Scientific� and� �

Technical� Pharmaceutical� Co.,Ltd

FrontageLaboratories(Shanghai)CoL

td�

masteam� bio-tech Ji'nanOrgachemPharmaceuticalCo.,

Ltd�

BiotechPharmaceuticalCoLtd� medicalchem� manuf ShaanxiHuikeBotanicalDevelopment

Co.,Ltd�

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d�

meggle� group Greenutra� Resource� Inc.

Ascenta(Shanghai)R&DCenter� ningbo� menovo� pharmaceutical NingboDekangBiochemCo.,Ltd.�

BeijingUnion-GeniusPharmaceutical

TechnologyDevelopmentCoLtd�

nanchang� baiyun� pharmaceutical Huzhou� City� Linghu� Xinwang� �

Chemical� Co.,� Ltd

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Technology� Co.,Ltd.

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hCoLtd)�

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Biotechnology� Co.,Ltd

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aluationofDrugs�

nanjing� guochen� chemicals Jiangsu� Baosheng� Longcheng� �

Pharmaceutical� Co.,� Ltd

VitalBridge(China),Inc.� nanjing� harmony� pharmtech Jizhou� Huaheng� Biological� �

Technology� Co.,Ltd

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Co.,Ltd

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SundiaMediTechCoLtd� nantong� menthol� factory SAVANT� PHARM

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Vector� Gene� � Technology� Co� Ltd nexchem� pharmaceutical Waigaoqiao� Liantong

HuaxipharmCoLtd� ningbo� double� sun� � pharmaceutical sacren� snow

Page 1063: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

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ShanghaiChemPartnerCoLtd� ningbo� team� pharmaceutical Zhejiang� Tiantai� Pharm

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ShanghaiLeadDiscoveryPharmaceuti

calCoLtd�

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Chemizon,Inc.� pharmaceutical� co.,� ltd.� Shenzhen� �

youpuhui

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Bio� Lab� � Co.,Ltd. qingdao� kangyuan� � pharmaceutical Beijing� Oriental� Friendship� �

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Page 1064: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

부록 6� �주요 전략적 협력사 현황 리스트 ❚ 1061

www.mps.org.my/ shaanxi� haixinqinghua� �

pharmaceutical� And� chemical

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Pharmaceutical

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http://www.prema.or.th/ shaanxi� huaqi� medical� � technology Zhejiang� Haisen� Pharmaceutical

http://www.vnpca.org.vn shaanxi� sciphar� hi-tech� � industry Beijing� Gaobo� Pharm-Chemicals� �

Tech

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bio-technology

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Anhui� Benma� � Pioneer� Technology shandong� fangxing� technology� �

development

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biotechnology

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Chemindustry

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Page 1065: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

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beijing� sun-novo� � pharmaceutical�

reseach

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industry

shandong�zhongke�taidou� �chemical Wuxi� Fortune� Pharmaceutical

beijing� yingmao� pharmaceutical shandong�zouping�huiyuan�chemical�

factory

In� Sung� Trading

beijing�zhongliantianhong� �chemical�

information� center

shanghai� acebright� pharmaceutical�

group

Taizhou� Waigaoqiao� Liantong� �

Pharmaceutical

bengbu� bbca� tushan� �

pharmaceutical

shanghai� colorcon� coating� �

technology� limited

Shenyang� Tonglian� Medicines

bidlink� E-Biz� tech shanghai� fenghong� pharmaceutical�

excipient� and� technology

Tianxin� Pharmaceutical

binzhou� holly� pharmaceutical shanghai�haodeng�organic� �chemical Quobang� Pharmachem

biocompounds� pharmaceutical shanghai� honest� chem Minsheng� Group� Shaoxing� �

Pharmaceutical

bys� chem-pharm shanghai� jinban� pharmaceutical ZHP

cangzhou� senary� chemical� � S.&T. shanghai� jinhe� bio-technology Shandong� Liaocheng� Ehua� �

Medicine

changshu� yikang� chemical� � industry shanghai� jinjinle� industries Valiant� Fine� Chemicals

changshu�huagang� �pharmaceuticals shanghai� jinshan� � pharmaceutical Zhejiang� Hisoar� Pharmaceutical

changshu� fushilai� medicine� � &�

chemical

shanghai� modern� hasen� �

pharmaceutical

ECHEM� Pharmaceutical

changzhou� bihai� environmental� �

protection� technology

shanghai� nanxiang� reagent Hubei� Hongyuan� Pharmaceutical

changzhou� carbochem shanghai�nuocheng� �pharmaceutical Guangzhou� Baiyunshan� Chemical� �

Pharmaceutical� Factory

changzhou� hubin� medicine� raw� �

materials

shanghai� pharmaceutical� � holding China� Sinopharm� International� �

Corporation

changzhou� jiaerke� � pharmaceutical�

group

shanghai� puyi� chemical Huahengshengwu

changzhou� kaiyi� chlorine� &� � alkali�

chemical

shanghai� qiao� chemical� science Tianjin� Minxiang� � Pharmaceutical

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부록 6� �주요 전략적 협력사 현황 리스트 ❚ 1063

7TM� Pharma� � A/S� NeuroVive� � Pharmaceutical� AB�

ACADIA� Pharmaceuticals� AB� NicoNovum� AB�

Action� Pharma� A/S� NsGene� A/S�

Active� � Biotech� AB� Orphazyme� ApS�

Adenovir� Pharma� AB� Prozymex� Pharmaceuticals� A/S�

Alligator� Bioscience� AB� Respiratorius� AB�

AnaMar� (R&D)� AB� RhoVac� ApS�

Aros� Pharma� ApS� Rose� Pharma� A/S�

Ascendis� Pharma� A/S� Sanos� Bioscience� A/S�

Bavarian� Nordic� A/S� Santaris� Pharma�

BioInvent� International� AB� Santaris� Pharma� A/S�

BKG� Pharma� Sentinext� Therapeutics� Aps�

Camurus� AB� Serendex�

CMC� Contrast� Stevia� aps�

Cortendo� AB� Symphogen� A/S�

DanDrit� Biotech� A/S� Topotarget� A/S�

Dermagen� AB� Valderm� ApS�

DuoCort� Pharma� AB� Veloxis� Pharmaceuticals� A/S�

Egalet� Ltd.� Vicore� Pharma� AB�

Eldon� Biologicals� A/S� ViroGates� A/S�

Enkam� Pharmaceuticals� Zealand� Pharma� A/S�

Epitherapeutics� ApS� ZGene� A/S�

Essentys� AB� Zymenex� A/S�

Evolva� A/S� ALK�

FluimediX� Alkalon� A/S�

Forward� Pharma� A/S� AstraZeneca� R� &� D� Lund�

Genmab� A/S� AstraZeneca� R&D� Mölndal�

Hansa� Medical� AB� Bifodan� A/S�

INAGEN� ApS� Biogen� Idec� (Denmark)� Manufacturing� ApS�

Laccure� AB� Bioglan� AB�

Lica� Pharmaceuticals� Ferring� Lægemidler� A/S�

LIDDS� AB� Genzyme� A/S�

LiPlasome� Pharma� ApS� LEO� Pharma� A/S�

MC2� Biotek� Group� Lundbeck� (H.� Lundbeck� A/S)�

Mirrx� Therapeutics� A/S� McNeil� AB�

Nensius� Research� A/S� Nordic� Drugs� AB�

Neobiotics� AB� Novo� Nordisk� A/S�

Neoloch� ApS� Syntese� A/S�

NeuroSearch� A/S�

■�메디콘밸리(북유럽)�입주기업(2012�업데이트)� :� 77개사

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1064� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Abbott Addex

Alexion ARD

BASF Bayer

Biomarin Clariant� Produkte� GmbH

Cryo� Save� Group Deinove

DSM Eli� Lilly

Evonik GlaxoSmithKline

Ineos� Bio KWS

Merck� Serono MLP� � Vision� Biotech� S.L

MSD� Europe Novamont

Novo� Nordisk Pamgene

Prosensa� Therapeutics Purac

Shire Solvay

Syngenta Transgene

Actogenix Ajinamoto

Amgen Areta� International

Baxter BioAmber

Biosciences� KTN Crucell

CSL� Behring Dow� AgroSciences

DuPont� de� Nemours Erytech� Pharma

Genzyme GOMBORI� S.L.

Keygene Limagrain

Metabolix� Explorer Monsanto

NatureWorks Novartis

Novozymes Pfizer

Product� Life� Group� BVBA Roquette� Frères

Swedish� Orphan� Biovitrum Sucrerie� de� Tirlemont

Tigenix

Actavis Helm

Alkaloid Hospira

AlfredE.Tiefenbacher JadranGalenskiLaboratorij

ApotexEurope Medochemie

ArrowGenerics Mylan

■�유럽 바이오협회 회원사 :� 55개사

■�유럽 제네릭의약품협회 회원사 리스트 :� 24개사

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부록 6� �주요 전략적 협력사 현황 리스트 ❚ 1065

CombinoPharm NobelPharmaceuticals

ConsilientHealthLtd RanbaxyEurope

EGISPharmaceuticals Sandoz

Farmoz SopharmaAD

FreseniusKabi Stada

GedeonRichter TEVAEurope

GoldshieldGroupplc Zentiva

AepodiaS.A.� KitoZyme�

Baxter� R&D� Europe� SCRL MaSTherCell�

BiotechToolsFactoryS.A.� ProgenosisSA�

Cefochim� PrometheraBiosciences�

DNAVisionS.A.� RommelConsultingPartnersScrl�

EuroscreenSA� StraticellSA�

GalepharM/F� UCL-CentredeTechnologiesMoléculairesAppliquées�

GlaxoSmithKlineBiologicals� ULG­GemblouxAgro-BioTech�

Henogen-Novasep� ZentechSA�

ITEOS� AMDSA�

LaboLifeBelgiumSPRL� AnalisR&DDiag�

MithraPharmaceuticalsS.A.� ArtialisSA�

PfizerGlobalManufacturing� BelgianVolitionSA�

PharmaInsight� Bio.be(Ipg)�

PrometheraBiosciences� CorisBioConcept�

PropharexSA� Diagam�

RommelConsultingPartnersScrl� DiasourceImmunoassays�

Trasis� DNAVisionS.A.�

UCBPharmaS.A� DNAlytics�

UCL-DépartementdePédiatrie� D-TEK�

ULB-LaboratoryofInstrumentalAnalysisandBioelectrochemistry�

EppendorfArrayTechnologiesS.A.�

ULg-UnitédePharmacologieFMV� Eurogentec�

AnalisR&DDiag� I.P.B.M.-InternationalProject&BusinessManagementSPRL�

AraponicsSA� I.R.E(InstitutNationalRadioElement)�

Beldem,divisionofPuratosNV.-PuratosGroup� ImmunoDiagnosticSystem�

BoneTherapeutics� MDSNordion�

Cardio3BioSciences� MDxHealth(OncomethylomeSciences)S.A.�

CorisBioConcept� NYXOAH� � S.A

■�덴마크 대사관 리스트 :� 79개사

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1066� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Aastrom� � Biosciences,� Inc Forma� � Therapeutics,� Inc Rigel� � Pharmaceuticals,� Inc

ACADIA� � Pharmaceuticals,� Inc Furiex� � Pharmaceuticals Sanaria,� � Inc

Acceleron� � Pharma,� Inc Galectin� � Therapeutics� Inc. SanBio,� � Inc

Access� � Pharmaceuticals,� Inc GENEIUS,� � Inc Sandoz� � Austria

Acetylon� � Pharmaceuticals,� Inc Genelux� � Corporation Sangamo� � BioSciences,� Inc

Achaogen,� � Inc Genfit� � Corporation SciClone� � Pharmaceuticals,� Inc

Achillion� � Pharmaceuticals,� Inc GenSpera,� � Inc Scifluor� � Life� Sciences,� Inc

Aciont� � Inc GenVec,� � Inc Seaside� � Therapeutics,� Inc.

Acucela� � Inc. Geron� � Corporation Seattle� � Genetics,� Inc

Adamas� � Pharmaceuticals,� Inc Gilead� � Sciences,� Inc Shield� � Therapeutics

Advanced� � Cancer� Therapeutics Gliknik� � Inc Sierra� � Sciences,� LLC

ADVENTRX� � Pharmaceuticals,� Inc GlycoMimetics,� � Inc SIGA� � Technologies,� Inc

Aegerion� � Pharmaceuticals,� Inc Glycos� � Biotechnologies,� Inc Sirius� � Genomics,� Inc

Affymax,� � Inc Halozyme� � Therapeutics,� Inc SomaGenics,� � Inc

Afraxis,� � Inc Halsa� � Pharmaceuticals,� Inc Somaxon� � Pharmaceuticals,� Inc

Agennix� � AG Heat� � Biologics,� Inc Sunesis� � Pharmaceuticals,� Inc

Akebia� � Therapeutics,� Inc HemaQuest� � Pharmaceuticals,� Inc Sutro� � Biopharma,� Inc

Aldagen,� � Inc Hematech,� � Inc. Symphogen,� � A/S

Alder� � BioPharmaceuticals,� Inc Hepregen� � Corporation Syndax� � Pharmaceuticals,� Inc

Aldevron Human� � Genome� Sciences SynDevRx,� � Inc

Alethia� � Biotherapeutics,� Inc Hydra� � Biosciences,� Inc Synereca� � Pharmaceuticals,� Inc

Alexion� � Pharmaceuticals,� Inc iCeutica,� � Inc Tacere� � Therapeutics,� Inc

Alexza� � Pharmaceuticals,� Inc Ichor� � Medical� Systems,� Inc Tactical� � Therapeutics,� Inc

DelphiGenetics� ProbioxS.A.�

EppendorfArrayTechnologiesS.A.� ULB-LaboratoryofInstrumentalAnalysisandBioelectrochemistry�

EurobiotecBrusselsSA� UMONS-Dép.deChimiegénérale,OrganiqueetBiomédicale

Eurogentec� Valibio�

EuroscreenSA� ZentechSA�

FenwalEurope� 4Clinics(All4it)�

GlaxoSmithKlineBiologicals� Arlenda�

Henogen-Novasep� Cetic�

IMCYSESA� EgeminAutomationN.V�

ImmunoDiagnosticSystem� KeyrusBiopharmaSA�

IPRATECHSA� ULg-DépartementdeModélisationetSystèmes�

IxemelSA�

■�미국 생명공학산업협회(유럽지역 포함 업데이트)�회원사 :� 462개사

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부록 6� �주요 전략적 협력사 현황 리스트 ❚ 1067

Algenol� � Biofuels� Inc iCo� � Therapeutics,� Inc Takeda� � San� Diego,� Inc

Allegro� � Diagnostics Idera� � Pharmaceuticals,� Inc Takeda� � San� Francisco

Allon� � Therapeutics� Inc. Ikaria Taligen� � Therapeutics,� Inc

ALTANA� � AG IMBcom� � Pty,� Ltd Targacept,� � Inc

Altravax ImClone� � Systems,� Inc Target� � Discovery,� Inc

Alvine� � Pharmaceuticals Immune� � Design� Corporation TCA� � Cellular� Therapy,� LLC

Ambit� � Biosciences� Corporation ImmunGene,� � Inc Telik,� � Inc

Amgen� � Inc ImmunoCellular� � Therapeutics,� Ltd Terapio� � Corporation

Amicus� � Therapeutics,� Inc ImmunoGenes� � AG TESARO,� � Inc.

Aminex� � Therapeutics,� Inc Immunomic� � Therapeutics,� Inc Tessarae,� � LLC

Amunix,� � Inc Immuron� � Ltd The� Dow� � Chemical� Company

Amylin� � Pharmaceuticals,� Inc ImmuRx,� � Inc Theravance,� � Inc

Anadys� � Pharmaceuticals,� Inc ImmuVen Theron� � Pharmaceuticals� Inc

Anaphore,� � Inc Impel� � NeuroPharma Threshold� � Pharmaceuticals,� Inc

AnaptysBio,� � Inc. Implicit� � Bioscience� Inc Thrombotargets� � Corporation

Anchor� � Therapeutics,� Inc. Incyte� � Corporation Tigris� � Pharmaceuticals,� Inc

Angion� � Biomedica� Corporation Infinity� � Pharmaceuticals,� Inc. Titan� � Pharmaceuticals,� Inc

Anthera� � Pharmaceuticals,� Inc Inimex� � Pharmaceuticals,� Inc Tobira� � Therapeutics,� Inc

Apexigen,� � Inc Inovio� � Pharmaceuticals,� Inc Topaz� � Pharmaceuticals,� Inc

Aphios� � Corporation INSERM-TRANSFERT Tragara� � Pharmaceuticals,� Inc

Apogee� � Biotechnology� Corporation Insmed,� � Inc Transcept� � Pharmaceuticals,� Inc

Apricus� � Biosciences,� Inc. Intellikine Transition� � Therapeutics,� Inc

APT� � Therapeutics,� Inc Intra-Cellular� � Therapies,� Inc. Trevena,� � Inc

AptaMatrix,� � Inc InVasc� � Therapeutics,� Inc Triangle� � Pharmaceuticals,� Inc

Aradigm� � Corporation Inviragen,� � Inc Trillium� � Therapeutics,� Inc

Arog� � Pharmaceuticals,� LLC Ischemix,� � LLC Valeritas,� � Inc

ArQule,� � Inc Isis� � Pharmaceuticals,� Inc Vapogenix,� � Inc

Array� � BioPharma,� Inc Jazz� � Pharmaceuticals,� Inc VBI� � Vaccines

Arrowhead� � Research� Corporation JDP� � Therapeutics� Inc VentiRx� � Pharmaceuticals,� Inc

Artificial� � Cell� Technologies,� Inc Johnson� � &� Johnson� Ventrus� � Biosciences,� Inc.

Artisan� � Pharma,� Inc KAI� � Pharmaceuticals,� Inc Verastem

Asklepion� � Pharmaceuticals,� LLC KaloBios� � Pharmaceuticals,� Inc Versartis,� � Inc

Athersys,� � Inc KemPharm,� � Inc Virdante� � Pharmaceuticals,� Inc

Auspex� � Pharmaceuticals,� Inc Kineta,� � Inc VitaPath� � Genetics,� Inc

Avanir� � Pharmaceuticals,� Inc Kolltan� � Pharmaceuticals,� Inc Vivamab� � LLC

Avid� � Radiopharmaceuticals,� Inc Koronis� � Pharmaceuticals,� Inc VLST� � Corporation

Avila� � Therapeutics,� Inc Kowa� � Company,� Ltd. Wintherix� � &� Epitherix,� LLC

Axerion� � Therapeutics,� Inc. Kyowa� � Hakko� Kirin� California,� Inc X-BODY,� � Inc

Axial� � Biotech,� Inc Ligand� � Pharmaceuticals,� Inc Xcovery� � Vision

BioCryst� � Pharmaceuticals,� Inc Lipont� � Pharmaceuticals� Inc. XDx� Inc

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1068� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

BioDak,� � LLC Lixte� � Biotechnology� Holdings,� Inc Xenerex� � Biosciences

BioLeap,� � Inc MabVax� � Therapeutics,� Inc. XOMA� � Ltd.

BioMarin� � Pharmaceutical,� Inc MacroGenics,� � Inc YM� � BioSciences� Inc.

BioMarker� � Strategies,� LLC Madeira� � Therapeutics,� LLC YM� � BioSciences� USA� Inc.

BioMimetic� � Therapeutics,� Inc Marina� � Biotech,� Inc ZIOPHARM� � Oncology,� Inc

BioSante� � Pharmaceuticals,� Inc MaRS� � Innovation Allinky� � Biopharma

Biotron� � Limited MaxCyte,� � Inc Alnylam� � Pharmaceuticals� Europe,�

AG

BioXcel� � Corporation Maxygen,� � Inc Amakem� � NV

bluebird� � bio Med� � Discovery� SA Arecor� � Ltd.

Bradley� � Pharmaceuticals,� Inc Memgen,� � LLC Arrow� � Therapeutics,� Ltd

BrainCells,� � Inc Mentrik� � Biotech� LLC AstraZeneca,� � Plc

BRL� � Screening,� Inc Mersana� � Therapeutics,� Inc Athera� � Biotechnologies� AB

CalciMedica,� � Inc. Metabolex,� � Inc Baliopharm� � AG

Canadian� � Arthritis� Network Micell� � Technologies,� Inc Bavarian� � Nordic,� A/S

Cancer� � Prevention� Pharmaceuticals,�

Inc

Micromet,� � Inc Bayer� � Schering� Pharma

Cancer� �Research�Technology�Limited Mirna� � Therapeutics,� Inc Beta-Cell� � NV

Cara� � Therapeutics,� Inc Momenta� � Pharmaceuticals,� Inc BIO� � Deutschland

Carolus� � Therapeutics,� Inc Montreal� � Invivo BIOCAT

Catabasis� � Pharmaceuticals,� Inc Mucosis BioFarmind

Catalyst� � Biosciences,� Inc Napo� � Pharmaceuticals,� Inc Bionature� � E.A.� Ltd.

Catalyst� �Pharmaceutical�Partners,� Inc Nativis,� � Inc Biopeople

Celator� � Pharmaceuticals� Inc. Nektar� � Therapeutics,� Inc Boehringer� � Ingelheim

Cell� � Therapeutics,� Inc Neoprobe� � Corporation BP� � Biofuels

Celldex� � Therapeutics,� Inc Nerve� � Access,� Inc BP,� plc

Cempra� � Pharmaceuticals,� Inc Neuraltus� � Pharmaceuticals Cambridge� � Antibody� Technology�

Group� plc

CeNeRx� � BioPharma,� Inc Neurocrine� � Biosciences,� Inc Cellectis� � SA

Centella� � Therapeutics,� Inc. Neurokos,� � Inc Celonic� � AG

Cequent� � Pharmaceuticals,� Inc NeuroPhage� � Pharmaceuticals,� Inc Celonic� � GmbH

Ceregene,� � Inc Neurotech� � USA,� Inc CEVEC� � Pharmaceuticals� GmbH

Cerenis� � Therapeutics,� SA Newron� � Pharmaceuticals,� SpA Cluster� � Industrial� Biotech� E.V.�

(CLIB2021)

Cerulean� � Pharma,� Inc NexGenix� �Pharmaceuticals�Holdings,�

Inc

Crucell

CG� � Pharmaceuticals,� Inc Nexmed� � USA Danisco� � A/S

Chelsea� � Therapeutics,� Inc NextWave� � Pharmaceuticals� Inc Delphi� � Genetics� SA

ChemoGenics� � Biopharma,� LLC NGM� � Biopharmaceuticals,� Inc df-mp

Chimerix,� � Inc Nile� � Therapeutics,� Inc Domantis,� � Ltd

CIMA� � Labs,� Inc NovaBay� � Pharmaceuticals,� Inc DSM��Bio-Based�Products�&�Services

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부록 6� �주요 전략적 협력사 현황 리스트 ❚ 1069

Cipher� � Pharmaceuticals,� Inc Novabiotics� � Ltd European� Biopharmaceutical�

Enterprises

Clavis� � Pharma� ASA Novadigm� � Therapeutics,� Inc Elan� � Drug� Technologies

Cleveland� � BioLabs,� Inc Novavax,� � Inc Endotis� � Pharma,� SA

Clovis� � Oncology,� Inc Novici� � Biotech Epitarget� � AS

Codevax,� � Inc Novira� � Therapeutics,� Inc Finnish� � Bioindustries

Colby� � Pharmaceutical� Company Nurelief� � Pharma� Ltd. BIOCAT

Collateral� � Therapeutics� Inc. Nuron� � Biotech Genopole

CoLucid� � Pharmaceuticals,� Inc Odyssey� � Thera,� Inc Geron� � Bio-Med,� Ltd

Conatus� � Pharmaceuticals,� Inc Omniox,� � Inc Gist-brocades� � International� BV

Corridor� � Pharmaceuticals� Inc OMT,� � Inc. Glaxosmithkline

Covagen� � AG Oncolix,� � Inc greenovation� � Biotech,� GmbH

Critical� � Outcome� Technologies,� Inc Oncolytics� � Biotech� Inc. Grifols� � International� SA

CSL� � Limited OncoMed� � Pharmaceuticals,� Inc Healthcapital� � SA

CuraGen� � Corporation Onconova� � Therapeutics,� Inc IDA� � Ireland

Cyclacel� � Pharmaceuticals,� Inc Oncosec� � Medical� Incorporated InDex� � Pharmaceuticals� AB

Cytogel� � Pharma,� LLC Ontario� � Genomics� Institute Integrated� � Biologix� Gmbh

Cytokinetics,� � Inc Opexa� � Therapeutics IQ� � Corporation

CytomX� � Therapeutics,� Inc. Orphagen� � Pharmaceuticals,� Inc Lilly� � Turkey

CytRx� � Corporation OSI� � Pharmaceuticals,� Inc MC2� � Biotek� Group

DA� � VOLTERRA Otologic� � Pharmaceutics,� Inc Merck

Delcath� � Systems,� Inc Oxford� � BioMedica� plc MSD

Demy-Colton� � Life� Science� Advisors Pathway� � Therapeutics,� Inc Neovacs� � SA

Dendreon� � Corporation Pepscan� � Therapeutics� NV Neusentis

DermTech Phage� � Pharmaceuticals,� Inc Novartis,� � AG

Dharma� � Biomedical,� LLC pharmaCline Novozymes

Diffusion� � Pharmaceuticals� LLC PharmacoFore,� � Inc Nycomed

DNA� 2.0 Phigenix,� � Inc. One� � Nucleus� Ltd

Drais� � Pharmaceuticals,� Inc Phrixus� � Pharmaceuticals,� Inc Pepscan� � Therapeutics� BV

DSX� � Therapeutics Plastid� � AS PEPTONIC� � Medical� AB

Dyax� � Corp. PLx� � Pharma,� Inc Pergamum� � AB

Dynavax� � Technologies� Corporation PolyMedix,� � Inc Phosphate� � Therapeutics� Limited

Edge� � Therapeutics Portola� � Pharmaceuticals,� Inc Prosidion,� � Ltd

Edimer� � Pharmaceuticals Precision� � Biosciences ProteoNic� � BV

EGEN,� � Inc Presidio� � Pharmaceuticals,� Inc Reverdia

Elan� � Pharmaceuticals,� Inc Pressure� � BioSciences� Inc Roche� � Applied� Science

Elevation� � Pharmaceuticals Profectus� � BioSciences,� Inc Royal� � Nedalco

EluSys� � Therapeutics,� Inc Profibrix,� � BV Sanofi

EntreMed,� � Inc Progenra,� � Inc Schering,� � AG

EnVivo� � Pharmaceuticals,� Inc Promedior,� � Inc Scottish� �Development� International

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1070� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

Envoy� � Therapeutics ProNAi� � Therapeutics,� Inc Selexis� � SA

EpiCept� � Corporation Protagonist� � Therapeutics,� Inc Solvay� � Pharmaceuticals� SA

Epizyme,� � Inc. Protox� � Therapeutics,� Inc SuppreMol,� � GmbH

EraGen� � Biosciences,� Inc PTC� � Therapeutics,� Inc Swissaustral� � Biotech� SA

Esperance� � Pharmaceuticals,� Inc Raptor� � Pharmaceutical� Corporation Technologiepark� � Heidelberg,�

GmbH

Euthymics� � Bioscience� Inc. Raven� � Biotechnologies,� Inc TechnoPhage,� � SA

Evercyte� � Gmbh Redwood� � Bioscience,� Inc Thrombotargets� � Europe� SL

ExSar� � Corporation Redx� � Pharma� Ltd UBIFrance

EyeGate� � Pharmaceuticals,� Inc Regeneron� � Pharmaceuticals,� Inc UCB� � Pharma� SA

Eyetech,� � Inc RegeneRx� � Biopharmaceuticals,� Inc uniQure� � BV

Ezose� � Sciences,� Inc ReGenX� � Biosciences,� LLC Venture� � Valuation

Falcon� � Genomics,� Inc. Regulus� � Therapeutics,� Inc Wiborg� � ApS

Fate� � Therapeutics,� Inc ReNeuron Xenetic� � Biosciences� Plc

FirstString� � Research,� Inc ResVerlogix� � Corporation ZF� � BIOTOX

FivePrime� � Therapeutics,� Inc Reviva� � Pharmaceuticals,� Inc. Fochon� � Pharma,� Inc

FluGen,� � Inc Revivicor,� � Inc Rexahn� � Pharmaceuticals,� Inc

Aceto� � Corporation Hi-Tech� Pharmaceuticals

ACIC Huahai� US� Inc.

Actavis� Inc. Impax� Laboratories

A.J.� Renner Ind-Swift� Laboratories,� Inc.

ALTA� SCIENCE Interchem� Corporation

All-Pak� Inc. Lachman� Consultants� Services,� Inc.

Amerigen� Pharmaceuticals� Inc. Mckesson� Corporation

Amneal Midlothian� Laboratories

Anapharm,� Inc. Momenta� Pharmaceuticals

Anchen� Pharmaceuticals,� Inc. New� chemic� Inc.

ANDA� Inc. Novel� Laboratories,� Inc.

Apicore� LLC Novum� Phramceutical� Research

APP� Pharmaceuticals� Inc. Pharma� Medica� Research� Inc.

Ben� Venue� Laboratories� Inc. Qualitest� Pharmaceuticals

Biddle� Sawyer� Corporation Ren-Pharm� International

Bioniche� Pharma� Group� Limitied RTI� Health� Solution

Capsugel Sagent� Pharmaceuticals

Caraco Sandoz� Inc.

Cetero� Research Sovereign� Pharmaceuticals

■�미국제네릭협회 회원사 :� 60개사

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부록 6� �주요 전략적 협력사 현황 리스트 ❚ 1071

ChemWerth� Inc. Strides� Inc.

DAVA� Pharmaceuticals,� Inc. Synomics� Pharmaceutical� Services

Dr.Reddy's� Laboratories� Inc. Synthon� Pharmaceuticals

Eagle� Pharmaceuticals Taro� Pharmaceutical

ETHEX� Corporation Tedor� Pharma� Inc.

Fougera TevaPharmaceutical�

Gedeon� Richter TOLMAR,� Inc.

Great� Southern� Laboratories VersaPharm,� Inc.

Harris� Pharmaceutical Vijuk� Equipment

Hartmann� Pharmaceutical Vinchem� Inc.

Heritage� Pharmaceuticals Zydus� Pharmaceuticals

■�국내외 행사 및 학회 참가 리스트(2012� BIOKOREA,� 2011� ToxExpo)� :� 45개사

Analis� Belgium DIAsource� Immunoassays ProGenosis

Artialis DNAVision Straticell

B&C� Group DNAlytics Uteron� Pharma

Belgian� Volition D-Tek WOW� Technology

Bioptis EONIX Zentech

Cardio3 Eppendorf� Array� Technologies AstraZeneca,� � LP

CER� Groupe Eurogentec Bristol-Myers� Squibb� Company

Coris� Bioconcept IDS� Belgium Genentech,� Inc.

Diagam MDX� Health Pfizer�Glober� Research� and�Development

Diagenode Probiox SimuGen

ChoicePharma� � Korea Novotech� � AsiaKorea P-PRO� � Korea

CMIC� Korea Parexel� Korea PRA

Covance� Korea PharmaNet� � Korea Quintiles� � Korea

ICON� Korea A� Plus� Seoul� � (PPC) RPS

INC� Research� � Korea� (Kendle) PPD� Korea Theorem� � (Omnicare)

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1072� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

대구가톨릭대학교 GLP센터 안전성평가연구소

드림씨아이에스 에이디엠코리아

메드빌 엘에스케이글로벌파마서비스

바이오인프라 켐온

바이오톡스텍 퀸타일즈트랜스내셔널코리아

산업안전보건연구원 한국건설생활환경시험연구원

서울CRO 한국화학융합시험연구원

씨엔알 리서치 ICON� plc

【부록 7】� �국내 CRO�기업 조사 업체 리스트

■�2011�북미조사 회신 기업 리스트 :� 16개사

■�국내 행사 참가 및 한국보건산업진흥원 자체 보유 리스트 :� 14개사

글로벌헬스케어 세종씨알오

메디칼엑설런스 솔로몬메디칼리서치

사과나무임상연구소 아크로반

사이넥스 지디에프아이

서울의과학연구소 파마크로

서울의약연구소 한국의약연구소

서초바이오 메디팁

레퍼런스 바이오랩

Page 1076: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

1. 이 보고서는 한국보건산업진흥원의 2016년 자체사업제약산업 구조선진화

지원 및 해외 인허가 정보제공의 보고서입니다.

2. 이 보고서 내용을 대외적으로 발표할 때에는 반드시 한국보건산업진흥원에서

진행한제약산업 구조선진화 지원 및 해외 인허가 정보제공의 연구결과

임을 밝혀야 합니다.

Page 1077: 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북

중동·아프리카 지역 아웃소싱 기업 및전략적 협력사 디렉토리북

발행처 / 한국보건산업진흥원

발행인 / 이 영 찬

발행일 / 2016년 12월 31일

인쇄처 / 정우디앤피

전화 : 043-238-5331

KOREA HEALTH INDUSTRY

DEVELOPMENT INSTITUTE

www.khidi.or.kr