Transcript
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
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
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)
i
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
ii
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
iii
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
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)
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
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)
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
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
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 �
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
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, %)
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
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
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
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
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
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...
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
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
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
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
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
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
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
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
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)
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 ○ ○
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 ○ ○
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 ○ ○
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)
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 ○ ○
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 ○ ○
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 ○ ○
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)
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
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)
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
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
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
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
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
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
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
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
부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 69
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
70� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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 biocenter@acdima.com
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.
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 info@activa-cro.com
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.�
72� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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 sfli@alliancepharmaco.com
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.
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)
74� ❚ 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% 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.
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
76� ❚ 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� 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
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 Jonathan.calderwood@almacgroup.com
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.
78� ❚ 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 ○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
○ ○ ○ ○
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
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.� �
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
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.�
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 SooHo.Park@amriglobal.com
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.
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
○ ○
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
86� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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
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�
88� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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
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
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 prakash.k@anthembio.com
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.
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
○
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
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�
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
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
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 Nick.Johnson@aptuit.com
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.
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
○ ○ ○ ○
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
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
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.� �
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
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.�
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 info@pru.com.jo
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.
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 alan.white@arriello.com
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.
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
○ ○ ○ ○
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
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.
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
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.
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 fabrice.trovero@artimmune.com
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.�
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
○
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
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$� to� establish� efficacy�
of� a� candidate� drug.� No� delay� for� delivery� of� information� regarding� protocols,�
planning�availability…studies�are�planned�with� the� sponsor,�with�expected�deliverables�
.� Expriments� conducted� by� well� trained� technicians� and� managed� by� expert�
researchers,� authors� of� recognized� publications� in� the� field.�
Current� Status� of
Accredited�
Certification
ISO� 9001
114� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
11. ASREGTEC, ASUNTOS REGULATORIOS TECNICOS
1.� Corporate� General� Information
Corporate� Name ASREGTEC,� ASUNTOS� REGULATORIOS� TÉCNICOS
Corporate� Ownership Private� Company
Head� Office� Address QUITO
Facilities� City� &� Country QUITO,� ECUADOR
Web-site� Address www.asuntosregulatoriosec.com
No.� of� Employees Two� /� Deisy� Criollo� and� Monica� Toasa
Financial� Status
Sales� Revenue� in� 2015
(US� K$)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 deisy_criollo@hotmail.com,� noemi.c@asuntosregulatoriosec.com
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.
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
116� ❚ 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-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
○
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.
118� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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.
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
120� ❚ 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� 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.
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 Sales1@hollyally.com
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!
122� ❚ 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
○
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
124� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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
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
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 Kristina.berggren@bioinvent.se
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.�
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
128� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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
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�
130� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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
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.�
132� ❚ 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% 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
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 nullepart@gmail.com
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.
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
○ ○ ○
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.
136� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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
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.
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 mdenis@biomedcode.com�
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.
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
○
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.
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
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 bb@biostata.com
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.
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
○ ○ ○
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.
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
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 jlee@brockcapital.com
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)
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
〇
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.
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 jsnyder@cato.com
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.
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
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
152� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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 -
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.
154� ❚ 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
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 Kazuko.aoyagi@celerion.com
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.
156� ❚ 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○
(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
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
158� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
•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.
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.
160� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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
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
162� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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.
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 askcharlesriver@crl.com
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.
164� ❚ 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 ○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
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
166� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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.
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 ycpark@croen.co.kr
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 hjsung@croen.co.kr
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.
168� ❚ 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
○ ○
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.
170� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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
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.
172� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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 vijay@clearsynth.com
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� info@clearsynth.com
24. CLEARSYNTH LABS LTD
1.� Corporate� General� Information
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
174� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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
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○
176� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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
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
178� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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
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.
180� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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
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
182� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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 bd@clinserv.net
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
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 Erin.King@clinstar.com
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
184� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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.
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
〇
186� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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
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.
188� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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.
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.
190� ❚ 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
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
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
192� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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 info@co-research.com
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
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
E-maileunhee.lee@covance.com� :� Eunhee� Lee/Early� Development� Services
jongho.ahn@covance.com� :� Jongho� Ahn� /� Clinical� Development� Services
30. Covance Inc.
1.� Corporate� General� Information
194� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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.
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
○ ○
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
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.
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.
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.
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 jcarabello@cpronline.com
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.�
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
○ ○
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
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 info@croturk.com
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
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 CunninghamAsso@aol.com
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.
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)
206� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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
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.
208� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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.
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.
210� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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 d.bemporad@cyprotex.com
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
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.
212� ❚ 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
○ ○
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
214� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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.
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.
216� ❚ 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,� 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
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 Dean.Erhardt@d2rx.com
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.� �
218� ❚ 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
○ ○
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
220� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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
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.
222� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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 Bill.p@dragonbio-consultants.com
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.
부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 223
2.� Corporate� Service� &�Business� Area
Corporate�
Main�
Service� Area
Contract� Research
&� Development
Contract
Manufacturing
Contract� Sales� &
MarketingConsulting
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 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
224� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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
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.
226� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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
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 bd.asia@ecronacunova.com
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
228� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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.
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
○ ○
230� ❚ 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% 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.� � �
부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 231
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
232� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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.�
부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 233
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
234� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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.�
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.
236� ❚ 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
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�
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 contactus@elezabypharmacy.com
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
238� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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 pdeplma@ebsi.com
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
부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 239
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
○ ○ ○
240� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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.
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
242� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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.
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
244� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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
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.
246� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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.
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
○ ○
248� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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
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 info@endopoint.co.il
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
250� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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 uni8311@gdfi.co.kr
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
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
○ ○ ○
252� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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.
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.�
254� ❚ 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
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� �
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 infomexico@esternmedical.com
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.
256� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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.
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.
258� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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 bd.excel@excel-cro.com
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.
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 dyoon@exponent.com
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
260� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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.
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
〇
Phase� IIIFinishedProduct
BusinessDevelopment
〇
Phase� IVSales� &Marketing
〇
Corporate�Product� Area
New� DrugBiologics
HerbalMedicine
BiosimilarsNCE NME
〇 〇 〇 〇 〇Generics APIs Devices Others
〇 〇
262� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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.
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.
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
〇
Phase� IIIBusiness
Development〇
FinishedProduct
Phase� IVSales� &Marketing
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 info@farmacro.com
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
266� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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 info@farzaninstitute.com
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
부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 267
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 info@garphi.com
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.
268� ❚ 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
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
〇
RegulatoryAffairs
〇
Phase� III 〇FinishedProduct
〇Business
Development〇
Phase� IV 〇 Sales� &Marketing
〇
Corporate�Product� Area
New� DrugBiologics
HerbalMedicine
BiosimilarsNCE NME
〇 〇 〇 〇 〇Generics APIs Devices Others
〇 〇 〇 NDDS,�
Neutraceuticals,� OTCs
부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 269
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.
270� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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
부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 271
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
〇
RegulatoryAffairs
〇
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
272� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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 giant@giantcro.com
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.
부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 273
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 steve@globalengage.co.uk
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.
274� ❚ 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
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 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.
부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 275
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.
276� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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
info@bohongmedicine.com,
lilian.lo@bohongmedicine.com,�
melody.wang@bohongmedicine.com
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.
부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 277
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 lcyj@gzboji.com;� boji588@163.com
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.
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 piyush.chahar@gvkbio.com� /� piyushchahar@gmail.com
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,�
278� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
55. GVK BIOSCIENCES PVT. LTD.
1.� Corporate� General� Information
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
280� ❚ 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
○
* can take it up, if the NCE is discovered in India. For others we can assist through our partners.
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.
282� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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
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.
284� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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).�
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 ssong@harlan.com
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
286� ❚ 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� IIClinical� TestSample
FinishedProducts
RegulatoryAffairs
○
Phase� IIIFinishedProduct
BusinessDevelopment
Phase� IVSales� &Marketing
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.
288� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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
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.
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 Jinna.kim@hcment.com
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
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
〇
RegulatoryAffairs
〇
Phase� IIIFinishedProduct
BusinessDevelopment
〇
Phase� IVSales� &Marketing
〇
Corporate�Product� Area
New� DrugBiologics
HerbalMedicine
BiosimilarsNCE NME
〇 〇 〇 〇 〇Generics APIs Devices Others
〇 〇
292� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
3.� Corporate� Business�Overview
In-house� Facilities
Research� &Development
Preclinical ClinicalCustom
ManufacturingCustom� Sales
〇
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
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
〇
Phase� III
FinishedProduct
BusinessDevelopment
〇
Phase� IVSales� &Marketing
〇
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 sales@u-chem.co.kr,� info@u-chem.co.kr
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
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.
296� ❚ 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
〇
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
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.�
298� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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.
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.
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.�
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
302� ❚ 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
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
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 purui888@163.com
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
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 mailserver@iesung.co.kr,� mrjang@iesung.co.kr
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
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
306� ❚ 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○
(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)
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
308� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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.
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)
310� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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
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.
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 Jaewook.lee@iconplc.com
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.
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
○ ○
314� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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
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
316� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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
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�
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
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 business.development@icri.mx
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.
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.
부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 321
2.� Corporate� Service� &�Business� Area
Corporate�Main�
Service� Area
Contract� Research&� Development
ContractManufacturing
Contract� Sales� &Marketing
Consulting
〇
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
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.
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 Markus.thor@inovacia.se
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.
324� ❚ 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� IIClinical� TestSample
FinishedProducts
RegulatoryAffairs
Phase� IIIFinishedProduct
BusinessDevelopment
Phase� IVSales� &Marketing
Corporate�Product� Area
New� DrugBiologics
HerbalMedicine
BiosimilarsNCE NME
○
Generics APIs Devices Others
부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 325
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.
326� ❚ 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
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
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 iprc@iprc.com.jo
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
328� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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.
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.�
330� ❚ 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� II ◯Clinical� TestSample
FinishedProducts
RegulatoryAffairs
◯
Phase� IIIFinishedProduct
BusinessDevelopment
◯
Phase� IVSales� &Marketing
◯
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 caixi@joinn-lab.com� or� contact@joinnlaboratories.com
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.
332� ❚ 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� IIClinical� TestSample
FinishedProducts
RegulatoryAffairs
○
Phase� IIIFinishedProduct
BusinessDevelopment
Phase� IVSales� &Marketing
Corporate�Product� Area
New� DrugBiologics
HerbalMedicine
BiosimilarsNCE NME
○ ○
Generics APIs Devices Others
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.
334� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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
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.
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 contact@kcrcro.com
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.
336� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
69. KCR, SA
1.� Corporate� General� Information
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
338� ❚ 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
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
〇
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
부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 339
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
〇
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.
340� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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.
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
342� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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 oal@keosys.com
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
부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 343
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.
344� ❚ 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� 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
○ ○
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
346� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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.
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
348� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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.
부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 349
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.
350� ❚ 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
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
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 fabrice.trovero@key-obs.com
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.
352� ❚ 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 ○R&D� Strategy&� ManagementPre-clinical
Test� SamplePhase� I Clinical� Trials
Phase� II Clinical� TestSample
FinishedProducts
RegulatoryAffairs
Phase� IIIBusiness
DevelopmentFinishedProduct
Phase� IVSales� &Marketing
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
354� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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
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 Kees.bol@kinesis-pharma.com.sg
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.
356� ❚ 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� IIIFinishedProduct
BusinessDevelopment
○
Phase� IV ○Sales� &Marketing
Corporate�Product� Area
New� DrugBiologics
HerbalMedicine
BiosimilarsNCE NME
○ ○ ○ ○ ○
Generics APIs Devices Others
○ ○
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.
358� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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
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 chrisyun@kinexum.com
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
360� ❚ 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
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
○ ○ ○
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.
362� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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
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 info@klinar-cro.com�
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
364� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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.
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 poteiza@silanes.com.mx
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
366� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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.
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
○ ○
368� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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.
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
370� ❚ 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
We� currently� have� no� clients� in� Asia
No.� of� Asian� Clientsin� recent� 3� years
We� currently� have� no� clients� in� Asia
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 lalclinica@lalclinica.com.br�
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.
372� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
78. LBBM
1.� Corporate� General� Information
Corporate� Name LBBM
Facilities� City� &� Country Argentina
Web-site� Address www.lbbmresearch.com
Contact(Korean�Business)
E-mail info@lbbmresearch.com�
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.�
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 try3177@hotmail.com
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.).
374� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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 peter@marinbio.com
Company� History
17� years� old.� � CRO� (Contract� Research� Organization),� bioanalytical� services,� no� proprietary� programs.
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
○ ○ ○
376� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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
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
378� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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 jmcmenamin@mcguirewoods.com
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
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.
380� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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.
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 info@medismart.com.tr
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
382� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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 n.allen@medpace.com
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
부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 383
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.
384� ❚ 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
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
〇
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
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
386� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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
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
〇
Phase� III 〇 BusinessDevelopment
FinishedProduct
Phase� IV 〇 Sales� &Marketing
388� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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 info@meneresearch.com
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
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 china@midas-pharma.com�
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.
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
○ ○
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.
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 info@monitorcro.com
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
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 mcohen@myoderm.com
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.
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
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.
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.
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 info@nagyresearch.com
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
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 contact@novatrials.com
E-mail info@nagyresearch.com
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
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 info@novagenix.com
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
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 Juhn.Jeong@novotech-cro.com
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
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.
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
○ ○
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
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.
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
406� ❚ 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
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
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 Priya.p@ocimumbio.com� &� Geethanjali.t@mapmygenome.in
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
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
○
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
410� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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.� �
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
412� ❚ 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
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
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.
414� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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 info@oncall-llc.com
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.
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
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 info@optimum-cro.com
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
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 info@optimumclintrial.com
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
418� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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 aaronburke@pacificbiolabs.com
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.�
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
○ ○
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
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 asiabiz@PAREXEL.com
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
422� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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.
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○
424� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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.
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.
426� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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.
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
428� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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).
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◌
430� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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 parthi@reverseinformatics.com
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
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
○
432� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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.
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.
434� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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
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.
436� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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
◯
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.
438� ❚ 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
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
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 info@perfection-cro.com
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
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 rfalleti@pharma-trade.it
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.
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
〇
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
〇
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
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 mwkim1621@gmail.com
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.
부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 445
2.� Corporate� Service� &�Business� Area
Corporate� Main�
Service� Area
Contract� Research
&� Development
Contract
Manufacturing
Contract� Sales� &
MarketingConsulting
〇
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
〇
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
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 jjoh@synex.co.kr
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.
448� ❚ 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 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
〇
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
450� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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
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.
452� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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 emingerlance@prahs.com
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
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
○ ○ ○ ○
454� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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
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
456� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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.
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
458� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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.
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○
460� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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
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 NYLee@pharmanet.com
106. PharmaNet/i3Inc.
1.� Corporate� General� Information
462� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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.
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
○ ○
464� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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
부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 465
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.
466� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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
부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 467
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
468� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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 pharmaseed@pharmaseedltd.com
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
부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 469
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 howardkim@plsbio.com
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.
470� ❚ 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
Represent� many�
producers
부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 471
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.
472� ❚ 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� 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.
부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 473
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 insook.cho@ppdi.com
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 Michael.Clay@ppdi.com
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.
474� ❚ 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
○ ○ ○ ○
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○
476� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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.
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
478� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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
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 info@q-trials.com
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
480� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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 info@quadro-cro.com
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
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 Misook.hyun@quintiles.com
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
482� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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.
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
○ ○
484� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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.
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.
486� ❚ 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
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.�
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 contact@r2scro.com
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
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 bd@ray-cro.com
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
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 rob.chaney@reachbio.com
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
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
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.
492� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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.
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.
494� ❚ 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,� 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
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.� �
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 bloliuboschitz@rd-latam.com
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
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.
498� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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 alton.yu@ricerca.com
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).
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
○
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.
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
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
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 info@scidreco.com
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
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 postmaster@shcares.com.cn
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
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 yluo@shanghaigenomics.com
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
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.
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 XiaoFeng.Yu@loudon-research.com
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
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.
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 SUDESH.KUMAR@SHIVAANALYTICALS.COM
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
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
○
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
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
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 louisliu@shjnj.com� /� corinaliu@shjnj.com
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.
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
○ ○ ○
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
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.
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 michaelzheng@sinolite.net
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
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
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.
520� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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
〇
RegulatoryAffairs
〇
Phase� IIIFinishedProduct
BusinessDevelopment
〇
Phase� IVSales� &Marketing
〇
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 coordinacion@solucionesgxp.com
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.
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
○ ○ ○ ○
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
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.
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 NSHAH@SRKSTRATEGIES.COM
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
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)
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
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.
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.
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 michael.sigmund@cro-sss.de
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
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
○ ○
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
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
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.
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
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
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 sales@u-chem.co.kr,� info@u-chem.co.kr
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
538� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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
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
○ ○
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.
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
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
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 mdegan@symbiosis.com.ar
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.
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
○ ○ ○
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.
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○
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 sivaram.venkat@syngeneintl.com
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.
548� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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.
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
○ ○ ○ ○
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.
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
552� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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.
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.
554� ❚ 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
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
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.
556� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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 wpearlson@targethealth.com
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).
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
○ ○ ○
558� ❚ 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
○
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.
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.
560� ❚ 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� 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
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 info@tca.co.il
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
562� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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 shay.g@TechnoSTAT.co.il
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
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 doug.valverde@ttrials.com
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.�
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
○ ○
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.
566� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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
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 Nitin.Jain@theoremclinical.com
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
568� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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
부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 569
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
○ ○ ○ ○
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
부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 571
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:
572� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
•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.� �
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
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.
574� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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
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.
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 jenny.zhang@tigermed.net,� bd@tigermed.net
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
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.
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 info@triumpharma.com
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
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 dae.rhee@truvenhealth.com
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.
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
○
582� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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.
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○
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
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 SREENIVAS@VIMTA.COM
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
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
586� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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.
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
부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 589
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-
590� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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
부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 591
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.
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
부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 593
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 drkkim@wcct.com
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).
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
부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 595
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
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 info@xceneresearch.com
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
부록 1� �글로벌 아웃소싱 그룹 디렉토리 ❚ 597
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 info@zeincro.com
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
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 sales@apichem.cn,� zwchem@163.com
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.
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
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
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
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 ○ ○
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 ○ ○
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 ○ ○
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
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 gson@ginapath.com
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
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 yhchoi@accessbio.net
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.
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 agio@agio-pharma.com�
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
610� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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.
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 info@akrikhin.ru
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
612� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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,�
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.
614� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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.
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 info@alkorbio.ru
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.
616� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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 sangk@amgen.com
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.
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.
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 gson@ginapath.com
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.
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� $)� per� year.
Mission,� Vision� and� Values
To� offer� the� best� affordable,� quality� and� certified� drug� variety,� in� benefit� of� human� kind,� than� allows�
company� growth,� a� better� way� of� life� to� our� employees� and� great� benefit� to� Mexican� society.
To�grow�up� to�occupy� the�35�position� in� the�Mexican�pharmaceutical�market� for�2020,� to�achieve� leadership�
in� generics� market� share� and� become� an� internationalsupplier� source.
Values�are� fundamental� to�support� a�wealthy� company,� they�guide�our�professional�performance,� to�believe�
and� promote� them� is� part� of� us:� Competition,� commitment,� congruity,� integrity,� service� and� teamwork.
620� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
Corporate� Name Apsen
Corporate� Ownership Renato� Spallicci
Head� Office� Address Rua� La� Paz,� 37,67� CEP� 04755-020� São� Paulo/SPFacilities� City� &� Country Brazil
Web-site� Address www.apsen.com.br
No.� of� Employees 885� (2014)
Financial� Status
Sales� Revenue� in� 2014 Capital(US� K$) 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
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
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 marcom@arterium.ua
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.
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.
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 Yoonjoo.cho@astrazeneca.com
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.
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.
626� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
2006년 01월 01일부터 2012년 12월 10일까지 출원된 AstraZeneca사의 특허의 키워드 분포는 붉은 점으로
나타난다.
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 choi@avidrp.com
Contact
(Korean� Business)
Name Robert� Morrsion,� PhD
Address 3711� Market� Street,� Philadelphia,� PA� 19104
Telephone 215-298-9813
E-mail Morrison@avidrp.com
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
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.
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 azt@aztfarma.ru
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.
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 bhfz@bhfz.com.ua
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.
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.
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.
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 epinilla@bestpharma.cl
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.
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 Sales1@hollyally.com
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
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 biocad@biocad.ru
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
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.
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 Kristina.berggren@bioinvent.se
2.� Description� of� Collaboration�Opportunities
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
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.
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.
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 post@biola.kz
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
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 bdixon@biorelix.com
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.
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 crodriguez@biocano.cl
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
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.
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 info@biosintez.com
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”.
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 comercial@blisfarma.com.br
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
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.
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 younok.dumortiershin@bms.com
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
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.
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 gson@ginapath.com
2.� Description� of� Collaboration�Opportunities
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.
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 pwoo@celgene.com
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.
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.
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.
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 mail@npfkem.ru
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.�
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 csh@cshpharm.com
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
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 sudhakarbangera.cdsa@thsti.res.in�
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.
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 swsong@cmic.co.kr
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.
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.
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 tech@diapr.kiev.ua
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
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.�
�
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.�
�
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.
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 mdegan@eurofarma.com.ar
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.
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 acorte@ebime.com.mx
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�
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 ashlesha.gaunder@ecronacunova.com
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
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
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.
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 ekolab-sekretar@mail.ru
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
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.
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 huibers_paul_h@lilly.com
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
672� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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.
부록 2� �전략적 협력사 디렉토리 ❚ 673
2006년 01월 01일부터 2012년 12월 10일까지 출원된 Eli� Lilly� &� Co사의 특허의 키워드 분포는 붉은 점으로
나타난다.
674� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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 info@farmak.ua
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
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.
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.
부록 2� �전략적 협력사 디렉토리 ❚ 677
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 sales@farmproekt.ru
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
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 info@ferain.ru
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
부록 2� �전략적 협력사 디렉토리 ❚ 679
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.
680� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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.
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 sfleites@ferrerargentina.com
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
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.�
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.
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 bdint@gccpl.com;� gcs@gccpl.com�
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.�
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 prim@galenopharm.ru
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
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.
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.
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 Jskob777@gmail.com
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
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 inform@geropharm.ru�
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
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.�
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 direcciontecnica@gramonbago.com.uy
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.
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 Ki-lyong.b.bae@GSK.com
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.
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.�
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
info@bohongmedicine.com
lilian.lo@bohongmedicine.com
melody.wang@bohongmedicine.com
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
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 piyush.chahar@gvkbio.com� /� piyushchahar@gmail.com
2.� Description� of� Collaboration�Opportunities
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.
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 opil@lundbeck.com�
2.� Description� of� Collaboration�Opportunities
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�
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.
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.
부록 2� �전략적 협력사 디렉토리 ❚ 703
2006년 01월 01일부터 2012년 12월 10일까지 출원된 H.� Lundbeck�A/S사의 특허의 키워드 분포는 붉은 점으
로 나타난다.
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 spark86@its.jnj.com
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
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.�
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.
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 info@jurabek.uz
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
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�
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.� �
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.
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.
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 info@krka.biz
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
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
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�
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.
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 secretary@vitamin.com.ua
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
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
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.
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 dosa@laboratoriodosa.com
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.
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 info-lazar@lazar.com.ar�
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
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.
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 info@elea.com
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.
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 dptmed@acfarma.com�
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.
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 info@bago.com.ar
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.�
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 directorio@laboratoriosbernabo.com
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.
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 info@lab-fabra.com.ar
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."�
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 laboratoriosima@datamarkets.com.ar
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.�
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 contacto@liomont.com.mx
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.
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 info@phoenix.com.ar
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.
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 cmonteleone@poen.net.ar
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
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
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 o.pechaeva@lekhim.ua�
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
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.
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 fwanckel@saval.cl
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
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 info@megawecare.com
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
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
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
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.
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.
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 youngjoo.kim@merckgroup.com
2.� Description� of� Collaboration�Opportunities
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.
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.
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
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.
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 mez@endopharm.ru
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
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.
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 fab@mosfarma.ru
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
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).
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 DON_HYUN@MERCK.COM
2.� Description� of� Collaboration�Opportunities
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
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.�
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 info@medservice.kz
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
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.
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 paullai@nalpharma.com
2.� Description� of� Collaboration�Opportunities
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
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 jitohi@namiki-s.co.jp
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.
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.
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 partnerships@nektar.com
2.� Description� of� Collaboration�Opportunities
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
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.
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.
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 nb13@menovopharm.com
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.�
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.� � �
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 sangwook.kim@novartis.com,� dongjun.park@novartis.com� �
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
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.
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.
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 info@petrovax.ru
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
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 Ki-Yean.Hong@pfizer.com
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
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.
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.
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 pharmasoft@pharmasoft.ru
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.
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 adelarosa@pharmasset.com
2.� Description� of� Collaboration�Opportunities
Collaboration�
Opportunities� for�
In-Licensing
anti-RNA� virus� compounds
Collaboration�
Opportunities� for�
Out-Licensing
anti-RNA� virus� compounds
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.
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 info@pharmasyntez.com
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.�
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.�
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.
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
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.
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
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.
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 marcos.valadares@pluricellbiotech.com.br
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.
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
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�
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.
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
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.
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 ymoon@ptcbio.com,� mconn@ptcbio.com
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.�
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.
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 Partnering1@pharma.com
2.�Additional�Business�Propositions�for�Collaboration�to�Korean�Pharmaceutical�Companies
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
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.
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
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 t.kwon@rccorp.us
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.� �
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 naminkang@gmail.com
2.� Description� of� Collaboration�Opportunities
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
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 scorning@roemmers.com.ar�
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
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.
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 SungJoo.Lee@sanofi.com� /� Min.Ryoo@sanofi.com� �
2.� Description� of� Collaboration�Opportunities
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�
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.
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.
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.
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 Fiala@serendex.com
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.
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
E-mailfrederic.fouilloux@kr.netgrs.com� /
Jean-luc.picker@kr.netgrs.com�
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)
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.
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.
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 Phoenix.he@tenrypharm.com
2.� Description� of� Collaboration�Opportunities
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 Louisliu@shjnj.com
2.� Description� of� Collaboration�Opportunities
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.
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.�
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
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 ggomez@silanes.com.mx
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
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.
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 michaelzheng@sinolite.net
2.� Description� of� Collaboration�Opportunities
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 centr@kurgansintez.ru
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.
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 sjayasena@somagenics.com
2.� Description� of� Collaboration�Opportunities
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.
820� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
Corporate� Name STADA� CIS
Web-site� Address http://stada.ru
Contact E-mail med@stada.ru
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
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
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�
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.
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 gerardo.sanchez@stendhalpharma.com
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
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.
826� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
Corporate� Name TATCHEPHARMPREPARATY
Head� Office� Address http://www.tatpharm.ru/
Contact E-mail galiev@tatpharm.ru
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
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.�
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.
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�
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”.
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 SOHANG_CHATTERJEE@THERAMYT.COM
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.
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 informacion@tuteur.com.ar
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.
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.
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.
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 Alex.oh@valeant.com
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
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 alan.shaw@vaxinnate.com
2.� Description� of� Collaboration�Opportunities
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.� � � �
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 ir@veropharm.ru
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
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.
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.�
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.
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 genencia@vesaliuspharma.cl
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
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.
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 Talia.Nikolao@wcct.com
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.
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 uf@uf.ua
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
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.�
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.
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 sales@excelpharma.com
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.
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 sales@apichem.cn,� zwchem@163.com
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.
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 sac@zodiac.com.br�
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.
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 edmondcho@zuelligpharma.com
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.
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 sbyt@zvezda.kharkov.org
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
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.
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
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
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 info@afrabchem.com
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
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.
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 info@africamedec.com
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
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 admin@mojildrug.com
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
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 hoffice@alphamoun.com
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
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 info@atcopharma.com�
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
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 info@bcnplc.com
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
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.�
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 info@ke.betashelys.com
Company� Description� &� Organization
[vision� &� mission]
To�deliver�value� to�all� our� stakeholders�as�a� responsible�corporate�Citizen� that�provides�quality,� affordable�
medicines� &� products� globally.
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 bplplant@biopharmabd.com
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
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.
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 cadila@swiftkenya.com
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
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 ctdrugs@yahoo.com
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
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 info@chemiron.org
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
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 cloriti@gmail.com
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
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 info@cosmos-pharm.com
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
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 info@danadamsgh.com
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
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 info@dawalimited.com
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
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
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 elys@africaonline.co.ke
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
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 info@emzorpharma.com
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
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.
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 info@entranceindustries.com
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
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 info@ernestchemists.com
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
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 info@escortspharma.com
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
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 info@evansmedicalplc.com
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
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
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 info@geminipharmltd.com
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
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 info@haltons.co.ke
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
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 info@harleysltd.com
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
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.
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 sales@impactchemicals.co.ke
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
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.
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 info@inradcorp.org
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
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.�
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 info@kpi.co.ug
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
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
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 info@kspico.com
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
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 info@kaalug.com
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
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 info@laballied.com
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
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 lords@swiftkenya.com
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
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 mgpharm@vodafone.com.gh
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
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 admin@mdchemicals.com
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
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 maxpharmackenya@yahoo.com
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
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 sales@medipharm.co.ug
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
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 Fiona.migadde@mtk.co.ug
E-mail Fiona.migadde@mtk.co.ug
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
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 info@nerospharma.com
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
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 orange@orangegroups.com
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
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 info@osschemie.co.ke�
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
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 frontdesk@ciplaqcil.co.ug
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
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 info@pharmaken.net
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
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 info@radiancepharma.co.ke
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
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 reals@realsgroup.com
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
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 info@regalpharmaceuticals.com
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
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 info@rene.co.ug
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
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 info@skylightchemicals.co.ke
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
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 squarekenya@gmail.com
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
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.
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 info@surgilinksltd.com
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
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 info@ucl.co.ke
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
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 vacserateam@vacsera.com
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
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 info@vortexpharm.com
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
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 info@zenufa.com
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
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
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 kmh81@cu.ac.kr
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
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
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 medvill@unitel.co.kr
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
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
○ ○ ○ ○ ○ ○ ○
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
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 bsbae@bioinfrakorea.co.kr
Ⅱ.�수탁시험,�분석 서비스 현황
1. 서비스 영역
영역 전임상 임상1상 임상2상 임상3상 PV PMSData
Management통계분석 인허가대행 컨설팅
해당
여부O O O
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
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 043-210-7778thjung@biotoxtech.co
m
Ⅱ.�수탁시험,�분석 서비스 현황
1. 서비스 영역
영역 전임상 임상1상 임상2상 임상3상 PV PMSData
Management통계분석 인허가대행 컨설팅
해당
여부○
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
험
-� 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
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 psytool@hanmail.net
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
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 wkkuk@hamail.net
Ⅱ.�수탁시험,�분석 서비스 현황
1. 서비스 영역
영역 전임상 임상1상 임상2상 임상3상 PV PMSData
Management통계분석 인허가대행 컨설팅
해당
여부○
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
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 shkim@ktr.or.kr�
Ⅱ.�수탁시험,�분석 서비스 현황
1. 서비스 영역
영역 전임상 임상1상 임상2상 임상3상 PV PMSData
Management통계분석 인허가대행 컨설팅
해당
여부○
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
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
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 jelim@admkorea.co.kr
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
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.�
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
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
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.
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
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
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 ihyang@cnrres.co.kr
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
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.
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
○ ○
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
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.
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
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”
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
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 redux0078@chemon.co.kr
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
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.
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
○
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
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
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 In-jung.hwang@dreamcis.com
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
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
○ ○ ○ ○
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
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
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
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.
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 gson@ginapath.com
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
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
○ ○ ○ ○
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
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�
jaewook.lee@iconplc.c
om
Ⅱ.�수탁시험,�분석 서비스 현황
1. 서비스 영역
영역 전임상 임상1상 임상2상 임상3상 PV PMSData
Management통계분석 인허가대행 컨설팅
해당
여부○ ○ ○ ○ ○ ○ ○
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.
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 dycho@kitox.re.kr
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
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)
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
○
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
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
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
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 lee.yongbum@lskglobal.com
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
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.
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
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
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.
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.
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.
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)
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
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 yoo.juah@novotech-cro.com
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.
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
○
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
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.
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
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
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 urcro@PharmaCRO.co.kr�
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.
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
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
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:� urcro@PharmaCRO.co.kr
Providing
Realtime
Service� Delivery
Tel:� +82-31-707-1139~40
e-mail:� urcro@PharmaCRO.co.kr
Realtime
Feed-back
Tel:� +82-31-707-1139~40
e-mail:� urcro@PharmaCRO.co.kr
4.� Corporate� Competitiveness
No.� of� Regulatory�
Inspections
Classification FDA(US) EMA(EU) PMDA(Japan) Others
Pre-Clinical� Area
Clinical� Area ○ ○
Manufacturing� Area
Others
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
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 Misook.hyun@quintiles.com
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
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
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
○ ○
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
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.
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
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.
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.
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 rosaoh@biolabs.com
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
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.
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
○ ○ ○ ○
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
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)
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.
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 shyoon@scas-btt.com
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.
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
○
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
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.
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
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.
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 Thme173@naver.com
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)
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
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
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 mjchoi@seoulcro.co.kr
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).�
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
○
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
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)
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�
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
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
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 Yeonyeu.goo@startechscience.com
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
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
○ ○ ○ ○
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
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○
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
■�중국,�인도,�동남아 지역 아웃소싱 기업 :� 843개사
부록 5� �주요 아웃소싱 그룹 현황 리스트 ❚ 1029
Taiwan�Bio� � Industry�OrganizationZhejiang� Xianju� Junye
Pharmaceuticalmedicalchem� manuf
biotechcorp Beijing� Lianben� � Pharm-Chemicals meggle� group
J.B.� PHARMACY� � GROUP� SDN�
BHDZhuhai� Rundu� Pharmaceutical ningbo� menovo� pharmaceutical
AIN� MEDICARE� � SDN� BHDShanghai� Polymer
Pharmaceutical&Excipientnanchang� baiyun� pharmaceutical
CANAAN� ALPHA� � SDN� BHDSichuan� Province� Yuxin
Pharmaceuticalnanhai� beisha� pharmaceutical
DOLPHIN� � HEALTHCARE� SDN�
BHD
Cheng� Du� HRTD� technologies� of� �
Biotechnologynanjing� labmediate
GAMAT� EMAS� SDN� � BHD Fan� Zhi� Biotech nanjing� balance� trade� holdings
HOVID� BERHAD Accendatech nanjing� daze� trade
XORIX� SDN� BHD Nantong� Huafeng� Chemical nanjing� golden� chemical
BIO-SCIENCE� � MARKETING� SDN
BHDChedom� Pharma nanjing� guochen� chemicals
BIOVALENCE� SDN� � BHDChangzhou� Watson� Fine�
Chemicalnanjing� harmony� pharmtech
EMPIRE� � CARRIAGE� SDN� BHDShanghai� Pansopharm �
Technologyhanjing� hipower� international
IDAMAN� PHARMA
MANUFACTURING� SDN� BHDChemindustry nanjing� suru� chemical
IDAMAN� PHARMA� � SDN� BHDChongqing� Kangle� �
Pharmaceuticalnantong� acetic� acid� chemical
IIUM� TRADING� � SDN� BHD Suzhou� Stone� Lake� Pharma� Tech nantong� jinghua� pharmaceutical
MALAYSIAN� � VACCINES Hengshi� Group nantong� menthol� factory
NOVA� � LABORATORIES� SDN� BHD Cheng� Feng ncm� hersbit� chemical
PHARM-D� SDN� � BHD Wuxi� Fortune� Pharmaceutical newchem� spa
PHARMANIAGA
MANUFACTURING� BERHADIn� Sung� Trading nexchem� pharmaceutical
PRIME� � PHARMACEUTICAL� SDN
BHD
Taizhou� Waigaoqiao� Liantong
Pharmaceutical
ningbo� double� sun� �
pharmaceutical
RANGE� PHARMA� � SDN� BHD Shenyang� Tonglian� Medicines ningbo� team� pharmaceutical
SANTIS� PHARMA� � SDN� BHD Tianxin� Pharmaceutical ningbo� yuanfa� bioengineering
Y.S.P.� � INDUSTRIES� (M)� SDN�BHD Quobang� Pharmachem ningbo� zhenhai� haide� biochem
YENHER� � AGRO-PRODUCTS� SDN�
BHD
Minsheng� Group� Shaoxing� �
Pharmaceuticalnortheast� pharmaceutical� group
CCM� � PHARMACEUTICALS� SDN�
BHDZHP panjin� huacheng� pharmaceutical
ACE� ADVERTRADE� � SDN� BHDShandong� Liaocheng� Ehua� �
Medicine
pharmaceutical� co.,� ltd.�Shenzhen�
youpuhui
1030� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
AVERROES� PHARMACEUTICALS�
SDN� BHDValiant� Fine� Chemicals pharmaceutical� expresss� of� china
DYNAMIC� � PHARMASHOPPE� &�
HEALTHCARE� SDN� BHDZhejiang� Hisoar� Pharmaceutical PHEXCOM
EURO� � CHEMO-PHARMA� SDN�
BHDECHEM� Pharmaceutical
southwest� synthetic� �
pharmaceutical
NASMIR� HARD� � GELATIN
CAPSULES� SDN� BHDHubei� Hongyuan� Pharmaceutical qidong� ruifeng� chemical
PROFOUND� � KESTREL�
LABORATORIES� SDN� BHD
Guangzhou� Baiyunshan� Chemical� �
Pharmaceutical� Factoryqilu� pharmaceutical
CAMBRIDGE� � HERBAL� SDN� BHDChina� Sinopharm� International� �
Corporationqingdao� mingyue� seaweed� group
Transmedic� Pte� � Ltd Huahengshengwu qingdao� dingkang� silica� gel
Antah� � Healthcare� Group Tianjin� Minxiang� � Pharmaceuticalqingdao� hailang� silica� gel� � drier�
factory
Summit� Company Guangzhou� Endless� Biotech qingdao� haiyang� chemical
zuellig� pharma Boai� Nky� Pharmaceuticalsqingdao� huanghai
bio-pharmaceutical
DKSH Sinolite� Industrial qingdao� jinfeng� pharmaceutical
LF� AsiaShijiazhuang� Jirong� �
Pharmaceutical
qingdao� kangyexin� medicinal� �
silincagel� desiccant
Hoang� Vu� � Trading Shanghai� Syncores� Technologiesqingdao� kangyuan� �
pharmaceutical
Nanogen� � Biopharma� Co� Ltd Zhejiang� Tianyu� Pharmaceutical qingdao� makall� group
Jebsen&JessenChemicalsVietnamC
oLtd�Fujie qingdao� puke� parting� materials
STADA-VNJointVentureCo.,Ltd� Lang� Bo� Medicine qufu� gongly� chemical� industry
GlomedPharmaceuticalCo.,Inc� Hangzhou� Doeasypharma qufu� sheng� ren� pharmaceutical
VINAPHARM Anyang�Hongqiao�Trade�Co.,� � Ltd. qufu� tianli� medical� � supplements
Mekophar acesys� pharmatech quzhou� aokai� chemical
Alcare� � Pharmaceuticals� Pte� Ltd amino� life� biotech reyoung� pharmaceutical
Veredus� � Laboratories angle� yeast rivocean� group
KINGSTON� � MEDICAL Anhui� Benma�Pioneer� Technologyrudong� county� lianfeng� � chemical
industry
Global� Trade� � Linkages� Private
Limitedanhui� dexinjia� Bio&pharm
run� shaanxi� days� biological
technology
Ecron� acunova anhui� jinbang�medicine� � chemical sdart� international
AMRI� Global� � smartsourcing anhui� langxi� lianke� industrialshaanxi� haixinqinghua
pharmaceutical� And� chemical
C-CAMP anhui� sanxing� resin� technology shaanxi� hanjiang� � pharmaceutical
부록 5� �주요 아웃소싱 그룹 현황 리스트 ❚ 1031
Clinical� � Development� Services
Agency
anhui� shanhe� pharmaceutical
excipients
shaanxi� huaqi� medical� �
technology
GVK� BIO anqui� Lu'an� pharmaceutical shaanxi� sciphar� hi-tech� � industry
DR.� REDDY'S apeloa� tospo� pharmaceuticals shaanxi� xiyue� pharmaceutical
VEENA� TAMTA� � BHATIA ashland� specialty� ingredientsshandong� binzhou� zhiyuan
bio-technology
Ministry�of� � Science�&�Technology�
Government� of� Indiabaoji� jinsen� pharmaceutical shandong� boyuan� pharmaceutical
ABLE baoji� oasier� bio-techshandong� fangxing� technology� �
evelopment
CALYX� � Chemicals� &�
Pharmaceuticals
beijing� aoboxing� biotech� �
company
shandong� guangrao� lifeng� �
biotechnology
Pharmexcil beijing� unicotton� biotech shandong� head
SUVEN� Life� � Sciencesbeijing� fengli� jingqiu� � commerce�
and� trade
shandong� jincheng� �
pharmaceutical�
&� chemical
NANDU� � Chemicalsbeijing� hope� international� �
pharmaceutical� tech&dev
shandong� jiulong� hisince� �
pharmaceutical
supreempharma beijing� J&R� times� � technologyshandong� lukang� pharmaceutical� �
group
Aaranya� � BioSciencesbeijing� kcode� pharmaceutical� �
R&D
shandong� lukang� record� �
pharmaceutical
Arjuna� Natural� � Extracts� Limitedbeijing� shuangxuan� microbe� �
culture� medium� products� factoryshandong� luoxin� pharmacy� stock
Biotechnology� � Industry� Research�
Assistance� Council
beijing� sun-novo� � pharmaceutical�
reseachshandong� luwei� pharmaceutical
Criyagen� Agri� � &� Biotech� Private�
Limited
beijing� taiyang� pharmaceutical� �
industry
shandong� renhetang� �
pharmaceutical
Translation� � Health� Science� And�
Technology� Institutebeijing� yingmao� pharmaceutical
shandong� rongyuan� �
pharmaceutical
ENSEVAL
beijing� zhongliantianhong� �
chemical�
information� center
shandong� ruiying� pionner� �
pharmaceutical
dnr� � Distributionbengbu� bbca� tushan� �
pharmaceutical
shandong� shuanghua� �
pharmaceutical
AAM bidlink� E-Biz� tech shandong� tianli� pharmaceutical
PENTA� VALENT binzhou� holly� pharmaceutical
shandong� weifang� �
pharmaceutical�
factory
PT.� PARIT� � PADANG� GLOBAL biocompounds� pharmaceutical shandong� xiangrui� medicines
Kalbe bys� chem-pharm shandong� xinyi� pharmaceutical
Sanbe cangzhou� senary� chemical� � S.&T. shandong� yangcheng� biotech
1032� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
Dexachangshu� yikang� chemical� �
industry
shandong� yinfeida� �
pharmaceutical
Soho� Groupchangshu� huagang� �
pharmaceuticals
shandong� zhongke� taidou� �
chemical
PT� Tempo� Scan� � Pacific� Tbkchangshu� fushilai� medicine� � &�
chemical
shandong� zouping� huiyuan� �
chemical� factory
Beijing� Pharma� � And� Biotech�
Center
changzhou� bihai� environmental� �
protection� technology
shanghai� acebright� �
pharmaceutical� group
Changshu� New� � Venture changzhou� carbochemshanghai� colorcon� coating
technology� limited
Hunan� Dongting� � Pharmaceuticalchangzhou� hubin� medicine� raw� �
materials
shanghai� fenghong� �
pharmaceutical� excipient� and�
technology
Shenzhen� Boda� � Biopharmchangzhou� jiaerke� �
pharmaceutical� group
shanghai� haodeng� organic� �
chemical
CHARIOTEERchangzhou� kaiyi� chlorine� &� � alkali�
chemicalshanghai� honest� chem
CHANGZHOU� � SUNLIGHT�
PHARMACEUTICAL
changzhou� kangpu� �
pharmaceuticalshanghai� jinban� pharmaceutical
JIANGSU� ALPHA� �
PHARMACEUTICALchangzhou�new�area� jili� � chemical shanghai� jinhe� bio-technology
Shaxingchangzhou� pharmaceutical� �
factoryshanghai� jinjinle� industries
Hangzhou� � utanpharma� biologychangzhou� ruiming� �
pharmaceuticalshanghai� jinshan� � pharmaceutical
Shanghai� �Record�Pharmaceuticals changzhou� sinly� pharmchemshanghai� modern� hasen
pharmaceutical
AlputonInc�changzhou� tianhua� �
pharmaceuticalshanghai� nanxiang� reagent
OmnicareClinicalResearch�changzhou� yabang� �
pharmaceutical
shanghai� nuocheng� �
pharmaceutical
GlobalMedicalConsultingServices(
Shanghai)Co.Ltd.�changzhou� yonghe� fine� chemical shanghai� pharmaceutical� � holding
MedkeyMed-TechDevelopmentCo
Ltd�chaoyang� guangda� chemicals shanghai� puyi� chemical
ProswellMedicalCorporation� chemfuture� pharma� tech shanghai� qiao� chemical� science
BeijingMedpaceMedicalScience&T
echnologyLtd�
chengdu� huayi� medicinal� �
accessary� material
shanghai� qingping� �
pharmaceutical
ExcellenceFutureInternationalCons
ultingCoLtd�chengdu� lier� pharmaceutical
shanghai� shenmei� �
pharmaceutical� technology
H&JMedinforConsultantsLtd�chengdu� longquan� high-tech� �
natural� pharmaceuticalshanghai� shyndec� �pharmaceutical
부록 5� �주요 아웃소싱 그룹 현황 리스트 ❚ 1033
RUNDO-CRONOVA chengdu� shengnuo� biopharm shanghai� twisun� bio-pharm
ShanghaiLoudonMarketingConsul
tantCoLtd�
chengdu� xindu� kuixing� bio-chem� �
factoryshanghai� wintide� biotechnology
EPSChinaCoLtd�chifeng� yingfa� pharmaceutical� � & �
chemicalshanghai� xiechem� lmp
MacroStatChinaClinicalResearchC
oLtd�
china� resources� zizhu� �
pharmaceuticalshanghai� yongyi� biotechnology
BeijingJoinnPharmaceuticalCenter� chongqing� chunrui� pharm-chem shantou� baokang� pharmaceutical
BeijingBionovoMedicineDevelopm
entCoLtd�chongqing� ensky� chemical
shanxi� jixiang� biological� �
engineering
CHINDOCPharmaServices�chongqing� quanxinxiangsheng
bio-pharmaceuticalshanxi� kangxin� pharmaceutical
BeijingMedSeptMedicalConsulting
CoLtd�
chongqing� shenghuaxi
pharmaceuticalshanxi� yunpeng� pharmaceutical
BeijingCRO,Inc.� dalian� toyounger� chemical shenyang� syndy� pharmaceutical
VivoDevelopmentLtd�dandong� yichuang� �
pharmaceutical
shenyang� yi'an� medical� �
supplements
ClindaMedicineStudy� datong� tongxing� antibiotic shenzhen�salubris� �pharmaceutical
ShanghaiCaresBiotechCoLtd� dingkang� pharmaceuticalshijiazhuang� baiqi� chemical� �
industry
GleneaglesCRC(China)PteLtd�donggang� hongda�
pharmaceutical
shijiazhuang� concorde� �
pharmaceutical
TigermedConsultingCoLtd� dongming� huiren� bio-product shijiazhuang� haili� � pharmaceutical
BeijingZhongweibicheng
dongming� shengyuan� �
bio-chemical�
technology
shijiazhuang� haosheng� chemical
BeijingDMSPharmaLtd�dongtai� baoshun� �
orgarisms-manufactures
shijiazhuang� hengrun� science� � &�
technology
ShanghaiSLGCoLtd� dongtai� xinyuan� chemical shijiazhuang� lixin� � pharmaceutical
ShanghaiPharmaEngineCoLtd� dongying� heyi� chemicalshijiazhuang� polee� �
pharmaceutical
ShanghaiNewsummitBiopharmaC
oLtd�dongying� huakang� chem
shijiazhuang� wuyue� �
pharmaceutical� factory
ShanghaiGenomics,Inc.�yuchengshi� haihe� biological� �
agentsshijiazhuang� yongyuan� chemical
CCBRBeijingCenter� enantio� tech� corporation shouguang� nuomeng� chemical
InCROMChina� farmasino� pharmaceuticalssichuan� guanghan� sanxingdui� �
natural-chemical
Accelovance(China)CorpLtd� fujian� fukang� pharmaceuticalsichuan� hongmao� �
pharmaceuticals
Shanghai� � Medicilon� Inc. fushun� shunte� chemical sichuan� jiexiang� herb� material
1034� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
Convance� Inc.� � Beijing futaste� pharmaceutical sichuan� jinshan� pharmaceutical
GiantMed-PharmaServices,Inc.� guan� enkang� chemicalsichuan� long� march� �
pharmaceutical
GuangzhouBojiClinicalResearchCe
nter�guangdong� bohong� medicine
sichuan� neijiang� huixin�
pharmaceutical
BeijingKendleWitsMedicalConsulti
ngCoLtd�guangdong� dilikang� medicine sichuan� xicheng� pharmaceutical
ExcelPharmaStudiesInc�guangdong� leawell� �
pharmaceutical
sichuansheng�shifangshi� �huakang�
medicine� raw� material� factory
VenturepharmCROServiceGroup�guangdong� tongde� �
pharmaceutical
sichuan� zhonghong� natural� �
pharmaceutical
QuintilesMedicalDevelopment(Sha
nghai)CoLtd�
guangxi� changzhou� natural� �
pharmaceuticalsinopharm
BioDuroBeijingCoLtd� guangzhou� bairui� medicinesinopharm� weiqida� �
pharmaceutical
Xi'anNewDrugEvaluationandRese
archCenter�guangzhou� standard� pharma
sinopharm� zhijun� suzhou� �
pharmaceutical
ChangzhouWujinYabangPharmac
eut
icalChemicalCoLtd�
guanguangzhou� hanfang� �
pharmaceuticalstarlake� bioscience
AutekBio(Beijing),Inc.� guilin� pharmaceutical strand� bioscience
SinoGenoMaxCoLtd� haimen� bestfine� chemical success� int'l� logistics
ShanghaiGenePharmaCoLtd�hanhangzhou� liren� �
pharmaceuticalsung� wun� pharmacopia
FrontageLaboratories(Shanghai)C
oLtd�hanzhong� trg� biotechnology sunny� group� sel� biochem
BiotechPharmaceuticalCoLtd� harbin� aolin� pharmaceutical sunresin� new� materials
BeijingC&NInternationalSci-techC
oLtd�harbin� pharmaceutical� group sunrise� group� corporation
Ascenta(Shanghai)R&DCenter�hebei� changshan� biochemical� �
pharmaceuticalsuzhou� ausun� chemical
BeijingUnion-Genius hebei� huachen� pharmaceutical suzhou�bec�biological� � technology
CrownBioscience(Beijing)Inc.� hebei� huaxu� chemical suzhou� dawnrays� pharmaceutical
ShanghaiPharma-proServiceCoLtd� hebei� huaxu� pharmaceutical suzhou� homesun� pharmaceutical
ShanghaiIgConTherapeuticsInc� hebei� jianmin� starch� glucose suzhou� huihe� pharmaceutical
WuXiAppTecCoLtd(WuXiPharmaT
echCoLtd)�hebei� jiheng� pharmaceutical lianyungang� ningkang� chemical
FrontierBiosciencesCoLtd� hebei� jingye� chemicalsuzhou� kaiyuan� minsheng� sci� � & �
tech
NationalChengduCenterforSafetyE
valuationofDrugs�
hebei� shengxue� dacheng
pharmaceuticalsuzhou� lanxite� biotechnology
부록 5� �주요 아웃소싱 그룹 현황 리스트 ❚ 1035
VitalBridge(China),Inc.�hebei� veyong� animal� �
pharmaceuticalsuzhou� lixin� pharmaceutical
AbMaxBiotechnologyCoLtd� hebei� xiecheng� biotechnologysuzhou� no.5� pharmaceutical� �
factory
ShanghaiTenGenBiomedicalCoLtd� hebei� xingang� pharmaceuticalsuzhou� qichuang� business� �
consulting
ShanghaiAmbrosiaPharmaceutical
sCoLtd�
hebei� xingtai� metallurgy� �
magnesiumsuzhou� synthetic� chemical
BasileaPharmaceuticaChinaLtd�hebei� yinuo� animal� husbanory� �
science� and� technologysuzhou� tailida� technology
SundiaMediTechCoLtd� hebei� yuxing� bio-engineering suzhou� tianlu� � bio-pharmaceutical
ShenzhenChipsceenBiosciencesLtd� hebei� zhaozhou� limin� glucose suzhou� tianma� pharma� group
HDBiosciencesCoLtd� hebei� tianxu� natural� pigment suzhou� wellfair� chemicals
Vector� Gene� � Technology� Co� Ltd henan� huashang� pharmaceutical suzhou� wugan� pharmaceutical
HuaxipharmCoLtd� henan� huifeng� pharmaceutical suzhou� xingye� chemical
ShanghaiChemPartnerCoLtd� henan� jiushi� pharmaceutical taicang� puyuan� pharmaceutical
Zensun(Shanghai)Sci&TechCoLtd� henan� lihua� pharmaceutical taicang� xintal� alcohol
ShanghaiLeadDiscoveryPharmaceu
ticalCoLtd�henan� purui� pharmaceutical taishan� xinning� pharmaceutical
ShanghaiChemExplorerCoLtd� henan� sunny� industrytaixing� yangzi� pharmaceutical� �
industry
SinocroInc.� henan� topfond� pharmaceutical taizhou� bolon� pharmachem
Chemizon,Inc.�henan� xinxiang� huaxing� �
pharmaceutical� factorytaizhou� highsun� pharmaceutical
AsymchemLaboratories(Tianjin)Co
Ltd�
henan� xinyi� medicine� group� � fine�
chemical� industrytaizhou�xingming� �pharmaceutical
ShanghaiSINCHPharmaceuticalsTe
ch.CoLtd�henan� yuchen� fine� chemical taizhou� xinyou� pharmaceutical
ShanghaiUnitedPharmatechCoLtd�henan�zhenghong�pharmaceutical� �
adjuvanttaizhou� yojoy� pharmaceutical
NanjingChemzamPharmtechCoLtd�hengshui� changhao� �
biotechnologythe� united� laboratories� � limited
2Y-Chem,Ltd.� yunnan� pharmaceutical� industrytianjin�bokelin�medical� �packaging�
technology
ShanghaiLeadChemCoLtd�huakang� pharmaceutical� science� �
and� technologytianjin� J&K� limited
PharmaronBeijingCoLtd� huanggang� luban� pharmaceutical tianjin� jingye� fine� chemicals
HezeRuiyingPharmaceuticalGroup
CoLtd�
huanggang� saikang� �
pharmaceutical
tianjin� jinhuitaiya� chemical� �
industry
JiangsuHengruiMedicineCoLtd� huanggang� wellman� biosciences tianjin� kingyork� group
TianjinTaslyGroupCoLtd� huanghua� jinhua� additives tianjin� pacific� pharmaceutical
1036� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
ZhejiangHuahaiPharmaceuticalCo
Ltd�
huangshan� tianmu� menthol� �
pharmaceuticaltianjin� zhongjin� � pharmaceutical
ShandongXinhuaPharmaceuticalC
oLtd�MFCI tianjin� zhongrui� � pharmaceutical
GosunPharmaceuticalCoLtd� huazhong� pharmaceutical tipr� pharmaceutical
ZhejiangHisunPharmaceuticalCoLtd�hubei� danjiangkou� kaitai� �
hormonetitan� pharmaceutical
GL� Biochem� � (Shanghai)� Ltd hubei� fangtong� pharmaceuticaltonghua� maoxiang� �
pharmaceutical
HangzhouBIODOORBiotechnology
CoLtd�
hubei� lansun� biochemistry� �
pharmaceuticaltpsh� technology
BeijingKawinTechnologyShare-Hol
dingCoLtd�
hubei� provincial� bafeng� �
pharmaceuticals&chemicals� sharevitalpharms� company� limited
ShanghaiSynTheAllPharmaceutical
sCoLtd�hubei� qianjiang� siwei� amino� � acid shenzhen� voosong� technology
SirioPharmaCoLtd�hubei� shenyun� biotechnology� �
developmentweifang� shengtai� medicine
ShenzhenWatsinGenetechLtd� hubei� teyer� pharmaceutical weihai� disu� pharmaceutical
PharmaVantageChinaLtd.� hubei� yitai� pharmaceutical weilian� fine� chemical
UnisonoFieldmarketing(Shanghai)
CoLtd�
hubei� zhongmu� anda� �
pharmaceuticalwenzhou� opal� chemical� industry
EastwinBiotechnologyCoLtd� huinan� jiameng� pharmaceuticalwenzhou� xiaolun� coating� �
technology
SiberHegnerChina�huixian� dongpu� synthetic� �
intermediate
wuhan� sinocon� new� chemical� �
materials
Genetimes� � Technology� Inc hunan� dibo� tragacanta wujiang� bolin� industry
BeijingSolarbioScience&Technolog
yCoLtd�hunan� Er-kang� pharmaceutical
wujiang� yongxiang� alcohol� �
manufacturing
JingmeiBiotechCoLtd� hunan� kerey� biotechnology wuxi� jinghai� amino� acid
ShanghaiCarewayMedi-pharmTec
hnologyCoLtd�hunan� warrant� pharmaceutical xi'an� honson� biotechnology
QuintilesMedicalDevelopment(Sha
nghai)CoLtdhunan� zhongqi� pharmaceutical xiangyang� yuchang� fine� � chemical
BeijingMed-PharmCoLtd� IMCD� china xianju� pure� pharmaceutical
Zuellig&Woo(Zhuhai)MedicineCoL
td�improve� medical� technology xinxiang� kexin� chemical
PharmaLinkChina� inner� mongolia� lantai� � industrialxinxiang� xinhui� yaoye� youxian� �
gongsi
NovaMedPharmaceuticals(Shangh
ai)CoLtd�jiangsu� SMK� pharmaceutical
xinxiangshi� chaoyang� chemical� �
materials
부록 5� �주요 아웃소싱 그룹 현황 리스트 ❚ 1037
KPMG� Advisory� � (China)� Limited Ji'an� hairui� natural� plantxinyaqiang� silicone� chemistry� �
jiangsu
JP� � International� Group jiangsu� nhwa� pharmaceuticalxiuzheng� pharmaceutical� group� �
liuhe� pharmaceutical
ZSAssociates� jiangsu� qinfen� pharmaceuticalxuancheng� baicao� �
pharmaceutical
ShanghaiRundoBiotechJapanCoLt
d�
jiangsu� chemical� information� �
centerxuchang� rida� bio-technology
TheSmithersGroup-ChinaOffice� jiangsu� chengyi� pharmaceutical xuzhou� hengkai� ginkgo� products
AccessPeopleCoLtd�jiangsu� chiatal� fengchai� �
pharmaceuticalxuzhou� noon� agro-chemie
BeijingOrientbitTechnologyLtd�jiangsu� dafeng� city� tiansheng� �
pharmaceuticalyabang� chemical
BeijingCHNMEDConsultingCoLtd� jiangsu� dawning� pharmaceutical yabao� pharmaceutical� group
SinomonitorInternational�jiangsu� grand� xinyi� �
pharmaceuticalyancheng� kale� new� matericals
LanGeZhiYang(Wuxi)SalesConsulti
ngCoLtd�
jiangsu� hengsheng� �
pharmaceuticalyancheng� kangqiang� farm
BeijingCenturyMedicalBridgeCoLt
d�jiangsu� hi-stone� � pharmaceutical yancheng� shengda� chemical
SINOTRUSTInternationalInformatio
n&Consulting(Beijing)CoLtd�jiangsu� huachang� chemical yangzhou� pharmaceutical
IPSOS(China)MarketingResearch&
ConsultingCoLtd�jiangsu� huaxu� pharmaceutical yangzhou� tianhe� pharmaceutical
Gallup(China)Research,Ltd� jiangsu� jiangshan� � pharmaceutical yangzhou�winsome�aba�pharmacy
VisionInvestment(InvestInVision)� jiangsu� jiujiujiu� technology yantai� dongcheng� biochemicals
AndazGlobalSolutions� jiangsu� jubang� pharmaceutical yantai� luyin� pharmaceutical
RAXMedicalRegistrationCenter� jiangsu� kangheng� chemicalyanzhou� shengbao� �
pharmaceutical
BeijingCannyConsultingInc.� jiangsu� renhang� pharmaceutical yichang� tianren� pharmaceutical
BeijingPharmaandBiotechCenter�jiangsu� senxuan� pharmaceutical� �
&� chemicalyicheng� goto� pharmaceutical
DexinglongMedicineManagement
ConsultingCoLtd�jiangsu� shenhua� pharmaceutical
yingcheng� wuhan� organic� �
material
BizProInternational� jiangsu� swellxin� bio-pharm.yixing� city� xingyu� medicine� �
chemicals
BlueBellScientificTechnologyConsu
lting(Shanghai)CoLtd�jiangsu� tiansheng� �pharmaceutical yixing� jiangshan� bio-tech
SynovateBusinessConsulting� jiangsu� yizhenghe� � biotechnology yonghe� chemical
BiologicsConsultingGroup,Inc.� jiangsu� yongda� pharmaceuticalyueyang� one� hundred� �
pharmaceutical
1038� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
OnpressInternational� ziangxi� aifeimu� pharma
yueyang� xinzhang's� �
pharmaceutical�
industry
WiCONInternationalGroup� jiangxi� chibang� pharmaceuticalyuhuan� huanglong� zibuye� �
guanjiangchang
Yangtze� River� � Pharmaceutical�
Group� Co.,� Ltd.
jiangxi� dexing� parchn� sodium� �
isovitamin� cyunan� forever� bright� � cyclodextrin
North� China� � Pharmaceutical�
Group� Co.,� Ltd.jiangxi� fushine� pharmaceutical yunnan� linyuan� spice
Lupin� � Chemicals� (thailand)�
Co.,ltd.
jiangxi� ganliang� � pharmaceutical�
materialyunnan� sansheng� pharmaceutical
Thai� Meiji� � Pharmaceuticaljiangxi� hongyuan� � pharmaceutical�
materialyuwei� biological� pereparation
Rhodia jiangxi� huitong� pharmaceuticalzhejiang� apeloa� kangyu
pharmaceutical
Bio� Lab� � Co.,Ltd. jiangxi�gold� lotus� � pharmaceuticalzhejiang� apeloa� medical� �
technology
Pure� Chem� � Co.,Ltd.jiangxi� kangshengtang� �
pharmaceuticalzhejiang� chemsyn� pharm
Osotspajiangxi� new� ganjiang� �
pharmaceutical
zhejiang� dongcheng� �
pharmaceutical
M� &� H� � Manufacturing jiangxi� renqi� pharmaceutical zhejiang�east-aisa� �pharmaceutical
Thai� Nakorn� � Patana jiangxi� rongxing� � pharmaceutical zhejiang� excel� pharmaceutical
Natrapharm� � Inc. jiangxi� shengdian� S&T zhejiang� hisun� pharmaceutical
United� � Laboratories jiangxi� shenli� pharm&chem zhejiang� hutu� pharmchem
Pascual� � Laboratories jiangxi� synergy� pharmaceuticalzhejiang� huzhou� zhanwang� �
pharmaceutical
hkki jiangxi� uniqmol� pharmaceutical zhejiang� kente� chemical
ikatanapotekerindonesiajiangyin� yuecheng� jiangnan� � fine�
chemical
zhejiang� kinglyuan� �
pharmaceutical
SYMBIOSISjiaxing� junkang� �
commerce&industrialzhejiang� langhua� � pharmaceutical
XINYI� � CHEMICALS jiayi� pharmaceutical zhejiang� limin� chemical
Anhui� Heryi� � Chemicals jilin� changqing� ginseng zhejiang� lujian� capsule
SAVANT� PHARM jiangcheng� oil� chemical zhejiang� shaxing� pharm� &� � chem
Chongqing� � everything�
pharmaceuticaljilin� jiufeng� biotechnology zhejiang� shenghua� biok� biology
Sichuanjinshanzhiyaoco.ltdjinan� chenghui� shuangda� �
chemicalzhejiang�shengshi� �bio-technology
Waigaoqiao� � Liantong jinan� huimeng� biotech zhejiang� sixian� pharmaceutical
부록 5� �주요 아웃소싱 그룹 현황 리스트 ❚ 1039
sacren� snowjinan� jinda� pharmaceutical� �
chemistry
zhejiang� tiantai� fuda� medical� �
chemistry
Zhejiang� � Tiantai� Pharm jinan� kehui� pharmaceutical zhejiang� xianfeng� technology
Kaifeng� � Pharmaceutical jinan� mingxin� pharmaceuticalzhejiang� xianju� xianle� �
pharmaceutical
Zhejiang� Supor� � Pharmaceuticals jinan� new� coordinate� S&T zhejiang� yatai� pharmaceutical
Huangpu� � Chemical ji'nan� orgachem� pharmaceuticalzhejiang� yongning� �
pharmaceutical
Guangzhou� � Winsun�
Pharmaceuticaljinan� taifei� science� &� � technology zhejiang� yongtai� technology
Changzhou� Kony� � Pharmaceuticaljingdezhen� kaimenzi� medicinal� �
chemistry
zhejiang� changming� �
pharmaceutical
Dolder� � Shanghai jingzhou� hongda� biotechnologyzhengzhou� fuyuan� chemical� �
industry
b2starjining� liujia� pharmaceutical� �
adjurant� limited� company
zhengzhou� ruikang� �
pharmaceutical
Hongjiu� � Biotechjintan� qianyao� pharmaceutical� �
raw� material� factoryzhenjiang� dera� medical
Guilin� Xingda� � Pharmaceuticaljintan� sanfang� pharmaceutical� �
material
zhenjiang� gaopeng� �
pharmaceutical
Guang� Dong� Bo� � Hong�Medicine jinzhou� jiutai� pharmaceuticalzhenjiang� kangfu� biological� �
engineering
China� Union� � Chempharma jizhou� city� huayang� chemical zhiwe� chemical� technology
Fuchi� � Pharmaceutical jqc� pharmaceutical
zhushan� county� tianxin� medical� �
& �
chemical� industry
Indian� Drug� � Manufacturers'�
Associationjubilant� organosys
zibo� qianhui� biological� �
technology
1040� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
2cureX� Somedic� � AB�
APL� StratoSphere� Pharma� AB�
APL� (Apotek� Produktion� &� Laboratorier� AB)� Taconic�
ArrayDiagnostica� TAG� Copenhagen� A/S�
Bang� &� Olufsen� Medicom� A/S� tebu-bio� ApS�
BioAdvice� A/S� TFS� Trial� Form� Support� International� AB�
Biomodics� Theorem� Clinical� Research�
BioMonitor� ApS� Truly� Translational� Sweden� AB�
Bioneer� A/S� Umetrics� AB�
Bioperm� AB� Unilabs� a.s.�
BioPorto� Diagnostics� A/S� Unizymes� Laboratories� A/S�
Biotech-IgG� AB� UpFront� Chromatography� A/S�
Caslo� Laboratory� ApS� Vipergen�
CCBR-Synarc� Visiopharm�
Chemotechnique� Diagnostics� AB� Xellia� Pharmaceuticals� ApS�
ChemPartner� Europe� Zelmic� AB�
Chempilots� a/s� Alumni� AB�
CiToxLAB� Scantox� A/S� AssuransSelector� AB�
CMC� Biologics� Awapatent� A/S�
Commitum� AB� BRANN� AB�
Croel� AB� Budde� Schou� A/S�
Cyncron� A/S� Capish�
Dako� Denmark� A/S� Chas.� Hude� A/S�
DanTrials� ApS� Colloidal� Resource� AB�
Dupont� Chemoswed� Conlega�
Ecron� Acunova� A/S� Connector� Medical� AB�
Encorium� Denmark� ApS� Copenhagen� Bio� Science� Park,� COBIS�
Euro-Diagnostica� AB� Cross� Technology� Solutions� AB�
Eurofins� Denmark� A/S� DGM� A/S�
Exiqon� A/S� Elomatic� Engineering� AB�
Fermenco� ApS� Fagerström� Industrikonsult� AB�
Galenica� AB� Firm� Factory� Network�
Genovis� AB� Force� Technology�
Glycom� A/S� Groth� &� Co� i� Malmö� HB�
HB� Medical� ApS� Guardian� IP� Consulting� I/S�
Hylae� Clinical� Research� AB� Holme� Patent� A/S�
Imagnia� AB� Høiberg� A/S�
■�메디콘밸리(북유럽)�입주기업(2012�업데이트)� :� 161개사
부록 5� �주요 아웃소싱 그룹 현황 리스트 ❚ 1041
Immunodiagnostic� Systems� Nordic� a/s� (IDS� Nordic� a/s)� ICE� A/S�
ImmunoSigns� A/S� Innovationsbron� AB�
Innovagen� AB� Inspicos� A/S�
Intomics� A/S� JOIN� Business� &� Technology� AB�
Jubile� Kinase� APS� KIPA� -� Krahbichler� Intellectual� Property� Advisors� AB�
Kem-En-Tec� Diagnostics� A/S� L&K� biosciences� Aps�
KJ� Ross-Petersen� ApS� Larix� A/S�
KLIFO� A/S� Larsen� &� Birkeholm� A/S�
LifeAssays� AB� Lund� Science� AB�
Ludesi� MDBC� A/S�
Medical� Prognosis� Institute� A/S� Medico-Chemical� Lab.� ApS.�
Mekos� Laboratories� ApS� MediTeam� Consulting� Aps�
Metina� AB� Mizarra� Business� Management�
Microlytic� ApS� NIRAS� A/S�
Mycometer� NNE� Pharmaplan� A/S�
Nanosep� � AB� NNIT� A/S�
NEUROTECH� A/S� Norconsult� Danmark� A/S�
Newpharmaresearch� AB� Nordic� Patent� Analyzer� AB�
Niels� Clauson-� Kaas� A/S� Nordic� Patent� Service� A/S�
Nordic� Bioscience� A/S� Nordic� Service� Group�
NORMA� A/S� Patentgruppen�
Novozymes� Biopharma� Sweden� AB� PharmAdvice� ApS�
Nuevolution� A/S� Plougmann� &� Vingtoft�
Parexel� Denmark� A/S� Pluzek� Consult�
Particle� Analytical� Aps� Pre-Clinical� Services� ApS�
PerCell� Biolytica� AB� QP� Support� AB�
Phase� Holographic� Imaging� QTRACE� AB�
Phase� One� Unit� Semcon� Caran� AB�
pK� Chemicals� A/S� Setterwalls� Advokatbyrå AB�Polypeptide� Laboratories� (Sweden)� AB� Söderlind� &� Co� AB�
PolyPeptide� Laboratories� A/S� Sterigenics� Denmark� A/S�
PPD� Ström� &� Gulliksson� AB�
Prolight� Diagnostics� AB� Tarpoon� Bioscience� AB�
Pronova� BioPharma� Danmark� A/S� Teknopol� AB�
Protista� International� AB� The� IPR� Company�
QPharma� AB� Validation� and� Inspection� Europe� AB�
Quantibact� A/S� Wiborg� ApS�
Quintiles� AB� Xendo� Pharma� Services� A/S�
Ramidus� AB� Xplico� A/S�
1042� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
Rechon� Life� Science� Zacco� Denmark� A/S�
Rosco� Diagnostica� A/S� ZBM� Patents�
ScanBi� Diagnostics� AB� Zealand� Care� A/S�
Schafer-N� Zelo�
Smerud� Medical� Research� ApS�
ADDS INFORMA
ALTIZEM MEDIDATA
ATLANSTAT PAREXEL� INTERNATIONAL
AUXESIA PHIDEA� MARVIN
AXONAL PIERREL� RESEARCH
BIOFORTIS PPD� Italy
BIOSTATEM PREMIER� RESEARCH� GROUP
CARDINAL� SYSTEMS QUINTILES
CDL� PHARMA ARCOMED
CEMKA-EVAL CEPHA
CEMO� S.A. CHILTERN� INTERNATIONAL
CENTRE� CAP CLINTEC� INTERNATIONAL
CLINACT COVANCE
CLININFO EASTHORN� CLINICAL� SERVICES� IN� CEE
CLINTEC ECRON
CREAPHARM FGK� CLINICAL� RESEARCH
DCI� (Développement� Clinique� � International) ICON� CLINICAL� RESEARCH
EURAXI� PHARMA MEDPACE
4CLINICS� (ALL� FOR� IT) PHARMAKL
FORENAP PHARMNET
FOVEA PHARMTEST
HARRISON� CLINICAL� RESEARCH PPD
i3 PRA� INTERNATIONAL
ICON� CLINICAL� RESEARCH� SARL PRAGUE� CLINICAL� SERVICES
ICTA PREMIER� RESEARCH
IRIS� PHARMA QUINTILES
ITEC� Services ABL
KAPPA� SANTE ASSIGN
KEYRUS� BIOPHARMA AUTHOR!
MAPI AVERION
■�유럽 CRO협회 회원사 리스트 :� 267개사
부록 5� �주요 아웃소싱 그룹 현황 리스트 ❚ 1043
MEDI� AXE BIOCLINICA
MEDIBRIDGE CENTRAL� LAB� LOGISTICS� (CLL)
MEDPASS� International CENTRE� FOR� HUMAN� DRUG� RESEARCH� (CHDR)
MISSION� TEC CTCM�MAASTRICHT
MONITORING� FORCE� SERVICES CLINICAL� TRIAL� SERVICE� (CTS)
OMNICARE� Clinical� Research� SARL CLINTEC� INTERNATIONAL
OPTIMED� SA CURATRIAL� SMO� &� RESEARCH
OROXCELL DIAGRAM
POPSI� CUBE DINOX
PPD� France� SNC EB� FLEVORESEARCH
QUANTA� MEDICAL IAC
QUINTILES ICON� CLINICAL� RESEARCH
RCTs INC� RESEARCH� NETHERLANDS
RD� CLINIQUE JULIUS� CLINICAL� RESEARCH
RPS� Research� France KENDLE� INTERNATIONAL
STATITEC KINESIS� HOLDING
THERADIS� PHARMA LAP� &� P� CONSULTANTS
UMANIS MEDIAL
AD� HOC� CLINICAL MEDIRENT
AEPODIAμ MEDISERV
B&C� GROUP OCS� BIOMETRIC� SUPPORT
B&D� LIFE� SCIENCES OMNICARE� CLINICAL� RESEARCH
BIOMEDICAL� SYSTEMS PAREXEL� NEDERLAND
CLINBAY PHARMACOKINETIC� CONSULTANCY� SERVICES
CLINITUDE PHARMANET
COMPLY� SERVICES PPD
CROPHA PRA� INTERNATIONAL
EONIX PSR� GROUP
EPMC� PHARMA QPS� NETHERLANDS
4� CLINICS QUINTILES
HARRSON RESEARCH� DRIVE
IDDI STICARES� INTERACT
KASA� CONSULT TRIAL� FORM� SUPPORT
KEYRUS VENN� LIFE� SCIENCES
LAMBDA� PLUS VRN
MEDPOLE WCN
OMNICARE 3D� HEALTH� RESEARCH
PPD ADKNOMA� Health� Research
QUITILES APICES� SOLUCIONES
1044� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
RESEARCH� LINK BIOCLEVER� 2005
RPS� BELGIUM CHILTERN� INTERNATIONALSpain
SYMFO CLINTEC� INTERNATIONAL
EUROCLINTRIALS COVANCE� CAPS
LCA CROME� SOURCE
ARLENDA CTI
PHARMAVIZE DYNAMIC� SOLUTIONS
AMACE HARRISON� CLINICAL� RESEARCH� IBERICA
ALTIS ICON
ATLAS INC� RESEARCH
CRM LEON� RESEARCH
ENCORIUM MEDITRIAL� SL
ETHIC� MEDICAL� ARAŞTIRMA NUVISAN� CDS� SPAIN
FARMA� TEAM ONMEDIC� NETWORKS
KLINAR PAREXEL� INTERNATIONAL
CRO-KUANTUM PHARM-OLAM� INTERNATIONAL
TOLGA� MENE� CRO PHARMANET/I3
MONITOR� MEDIKAL� ARAŞTIRMA PHARMACEUTICAL� PRODUCT� DEVELOPMENT� SPAIN
NOVAGENIX PHIDEA
OMEGA PIVOTAL
OPTIMUM PRA� INTERNATIONAL
PPD PREMIER� RESEARCH� GROUP
QUADRO� CRO QUANTUM� EXPERIMENTAL
QUINTILES QUINTILES
SIGMA RESEARCH� PHARMACEUTICAL� SERVICES
ZEINCRO SERMES� PLANIFICACION
ACCOVION� GmbH TRIAL� FORM� SUPPORT
ALLIED� CLINICAL� MANAGEMENT ANALYTICALSERVICESINTERNATIONAL�
ANALYZE� &� REALIZE� AG APTIVSOLUTIONS�
APTIV� SOLUTIONS� GMBH BALANCEDCLINICALRESEARCHLTD�
BIOSKIN� GmbH CAMPBELLCHARLESASSOCIATES2000LTD�
CENTRIAL� GMBH CANARYLTD�
CLINIT� AG CAPRICORNLABORATORYEQUIPMENTLTD�
CLINREX� GMBH CHARLESKENDALLBIOLOGISTICS�
CONRESO� GMBH CITYSPRINTHEALTHCARE�
CROLLL� GMBH CLINIRXRESEARCHUKLTD�
CROMSOURCE� GMBH CRYO-STORELTD�
ECRON� ACUNOVA� GMBH DIANTHUSMEDICALLTD�
FGK� CLINICAL� RESEARCH DORA�WIRTH� (LANGUAGES)� LTD
부록 5� �주요 아웃소싱 그룹 현황 리스트 ❚ 1045
FOCUS� CLINICAL� DRUG� DEVELOPMENT� GMBH FIVE� HATS� INTERNATIONAL� LTD
HARRISON� CLINICAL� RESEARCH� DEUTSCHLAND HEALTHPROTECTIONAGENCY�
HEALTH� RESEARCH� SERVICES ICONDEVELOPMENTSOLUTIONSLTD�
INC� RESEARCH� GMBH LAB21LTD�
INTERLAB�CENTRAL�LAB�SERVICES-WORLDWIDE� �GMBH LEVYASSOCIATESLTD�
LFK-LABORATORIUM� FUER MCINTOSHSCIENTIFICADVICESERVICESLTD�
KLINISCHE� FORSCHUNG� GMBH MEDICAL�EQUIPMENT�SUPPLIES�&� �MANAGEMENT�LTD
MDT� MEDICAL� DEVICE� TESTING MEDICINES� EVALUATION� UNIT
MEDICOMP� GMBH MEDICAL� RESEARCH� NETWORK
MEDICRO� GMBH MILLER� INSURANCE� SERVICES
MEDPACE� MEDICAL� CONSULTING� GMBH MSOURCEMEDICALDEVELOPMENTLTD�
NUVISAN� GMBH NOVALANGUAGESERVICES�
PAREXEL� INTERNATIONAL NUMERUSLIMITED�
PHARMALOG� INSTITUT� FÜR� KLINISCHE� FORSCHUNG�
GMBH
PHARMACEUTICALDEVELOPMENTSERVICESLTD�
PHARM-OLAM�DEUTSCHLAND� INTERNATIONAL�GMBH PIRAMALHEALTHCARE�
PROINNOVERA� GMBH PRIMEVIGILANCELTD�
QUINTILES� GMBH QUAYPHARMACEUTICALSLTD�
RPS� RESEARCH� GERMANY RICHMONDPHARMACOLOGY�
SCIDERM� GMBH SATELLITE(NICHECROSERVICES)�
SIRO� CLINPHARM� GERMANY SEAHORSESCIENTIFICSERVICESLTD�
THEOREM� CLINICAL� RESEARCH SYNEQUANONLTD�
WINICKER� NORIMED� GMBH TRANSCRIPPARTNERSLLP�
CHILTERN� INTERNATIONAL THE� CLINICAL� TRIAL� COMPANY
DIMENSIONE� RICERCA THELONDONCLINIC�
ICON WOODLEY� EQUIP� COMPANY
INC� RESEARCH
Actavis Helm
Alkaloid Hospira
AlfredE.Tiefenbacher JadranGalenskiLaboratorij
ApotexEurope Medochemie
ArrowGenerics Mylan
CombinoPharm NobelPharmaceuticals
ConsilientHealthLtd RanbaxyEurope
EGISPharmaceuticals Sandoz
■�유럽 제네릭의약품협회 회원사 리스트 :� 24개사
1046� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
Farmoz SopharmaAD
FreseniusKabi Stada
GedeonRichter TEVAEurope
GoldshieldGroupplc Zentiva
Acon� � Laboratories,� Inc Russo� � Partners,� LLC Finnish� � Bioindustries
Alkermes,� � Inc Schwegman,� � Lundberg,� Woessner BIOCAT
Amakem� � NV Sequitur,� � Inc Genopole
ARVYS� � Proteins,� Inc Spherix,� � Inc Geron� � Bio-Med,� Ltd
BaroFold,� � Inc StrathKirn,� � Inc Gist-brocades� � International� BV
Ben� � Venue� Laboratories,� Inc The� � Context� Network Grifols� � International� SA
Bio-Quant,� � Inc TTC,� LLC Healthcapital� � SA
BioAtla UniQuest� � Pty� Limited IDA� � Ireland
Biovista,� � Inc. Ventria� � Bioscience ImmunoGenes� � AG
C2N� � Diagnostics,� LLC Viking� � Healthcare� Solutions,� Inc InDex� � Pharmaceuticals� AB
CBL� � Biopharma� LLC Allinky� � Biopharma INSERM-TRANSFERT
Celsense,� � Inc Alnylam� � Pharmaceuticals� Europe,�AG Integrated� � Biologix� Gmbh
■�덴마크 대사관 협조 리스트 :� 31개사
53Peoplesprl� ProgenosisSA�
AdvancedTechnologyCorporationS.A.� QualityAssistanceSA�
AepodiaS.A.� SGSLaboSimon�
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
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
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
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
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
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
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
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
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
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
CALYX� � Chemicals� &�
Pharmaceuticals
hubei� provincial� bafeng� �
pharmaceuticals&chemicals� share
wuxi� jinghai� amino� acid
Pharmexcil hubei� qianjiang� siwei� amino� � acid xi'an� honson� biotechnology
SUVEN� Life� � Sciences hubei� shenyun� biotechnology� �
development
xiangyang� yuchang� fine� � chemical
NANDU� � Chemicals hubei� teyer� pharmaceutical xianju� pure� pharmaceutical
supreempharma hubei� yitai� pharmaceutical xinxiang� kexin� chemical
Aaranya� � BioSciences hubei� zhongmu� anda� �
pharmaceutical
xinxiang� xinhui� yaoye� youxian� �
gongsi
Arjuna� Natural� � Extracts� Limited huinan� jiameng� pharmaceutical xinxiangshi� chaoyang� chemical� �
materials
Biotechnology� � Industry� Research�
Assistance� Council
huixian� dongpu� synthetic� �
intermediate
xinyaqiang� silicone� chemistry� �
jiangsu
Criyagen� Agri� � &� Biotech� Private�
Limited
hunan� dibo� tragacanta xiuzheng� pharmaceutical� group� �
liuhe� pharmaceutical
Translation� � Health� Science� And�
Technology� Institute
hunan� Er-kang� pharmaceutical xuancheng� baicao� pharmaceutical
ENSEVAL hunan� kerey� biotechnology xuchang� rida� bio-technology
dnr� � Distribution hunan� warrant� pharmaceutical xuzhou� hengkai� ginkgo� products
AAM hunan� zhongqi� pharmaceutical xuzhou� noon� agro-chemie
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
1056� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
CHANGZHOU� � SUNLIGHT�
PHARMACEUTICAL
jiangsu� grand� xinyi� � pharmaceutical yicheng� goto� pharmaceutical
JIANGSU� ALPHA� �
PHARMACEUTICAL
jiangsu� hengsheng� � pharmaceutical yingcheng�wuhan� organic� �material
Shaxing jiangsu� hi-stone� � pharmaceutical yixing� city� xingyu� medicine� �
chemicals
Hangzhou� � utanpharma� biology jiangsu� huachang� chemical yixing� jiangshan� bio-tech
Shanghai� � Record� Pharmaceuticals jiangsu� huaxu� pharmaceutical yonghe� chemical
상해의약(그룹)유한회사 jiangsu� jiangshan� � pharmaceutical yueyang� one� hundred� �
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
서안양림제약유한회사 ziangxi� aifeimu� pharma zhejiang� east-aisa� � pharmaceutical
상해뢰윤상약업유한회사 jiangxi� chibang� pharmaceutical zhejiang� excel� pharmaceutical
천진중신약업그룹주식유한회사 jiangxi� dexing� parchn� sodium� �
isovitamin� c
zhejiang� hisun� pharmaceutical
상해신선봉약업유한회사 jiangxi� fushine� pharmaceutical zhejiang� hutu� pharmchem
절강해정그룹유한회사 jiangxi� ganliang� � pharmaceutical�
material
zhejiang� huzhou� zhanwang� �
pharmaceutical
리주의약그룹주식유한회사 jiangxi� hongyuan� � pharmaceutical�
material
zhejiang� kente� chemical
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
zhejiang� lujian� capsule
하북성고영기업그룹회사 jiangxi� renqi� pharmaceutical zhejiang� shaxing� pharm� &� � chem
이군제약유한책임회사 jiangxi� rongxing� � pharmaceutical zhejiang� shenghua� biok� biology
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
d�
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
tingCoLtd�
jinan� jinda� pharmaceutical� �
chemistry
zhenjiang�gaopeng� � pharmaceutical
H&JMedinforConsultantsLtd� jinan� kehui� pharmaceutical zhenjiang� kangfu� biological� �
engineering
RUNDO-CRONOVAInternationalPhar
maceuticalsResearch&Development
CoLtd�
jinan� mingxin� pharmaceutical zhiwe� chemical� technology
ShanghaiLoudonMarketingConsulta
ntCoLtd�
jinan� new� coordinate� S&T zhushan� county� tianxin� medical� � &�
chemical� industry
EPSChinaCoLtd� ji'nan� orgachem� pharmaceutical zibo� qianhui� biological� � technology
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.
1058� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
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� �
pharmaceutical
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�
BeijingKendleWitsMedicalConsultin
gCoLtd�
liaoyang� oxirano� material Hebei� Chengxin� Co.,� Ltd
ExcelPharmaStudiesInc� liaoyuan� city� baikang� �
pharmaceutical
BROTHER� ENTERPRISES� HOLDING� �
CO.,� LTD.
VenturepharmCROServiceGroup� liaoyuan�silver�eagle� �pharmaceutical YANGZHOU� PHARMACEUTICAL�
CO.,� � LTD
QuintilesMedicalDevelopment(Shan
ghai)CoLtd�
lifecome� biochemistry Ningbo� Green-Health� �
Pharmceutical� Co.,Ltd.
BioDuroBeijingCoLtd� linshu� huasheng� chemical SHANDONG�FENGYUAN�CHEMICAL� �
CO.,� LTD.
Xi'anNewDrugEvaluationandResearc
hCenter�
livzon� pharmaceutical� group Chengdu� CSHPHARM� Co.,Ltd.
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�
BeijingC&NInternationalSci-techCoLt
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
CrownBioscience(Beijing)Inc.� nanhai� beisha� pharmaceutical Zibo� Wanchang� Science� &� �
Technology� Co.,Ltd.
ShanghaiPharma-proServiceCoLtd� nanjing� labmediate BEIJING� NORDHUNS� CHEMICAL� �
TECHNOLOGY� CO.,LTD
ShanghaiIgConTherapeuticsInc� nanjing� balance� trade� holdings Jiangsu� Hansyn� Pharmaceutical� �
Co.,Ltd
WuXiAppTecCoLtd(WuXiPharmaTec
hCoLtd)�
nanjing� daze� trade SICHUAN�ZHONGBANG�TECHNICAL� �
DEVELOPING
FrontierBiosciencesCoLtd� nanjing� golden� chemical Lianyungang� Shenghe� �
Biotechnology� Co.,Ltd
NationalChengduCenterforSafetyEv
aluationofDrugs�
nanjing� guochen� chemicals Jiangsu� Baosheng� Longcheng� �
Pharmaceutical� Co.,� Ltd
VitalBridge(China),Inc.� nanjing� harmony� pharmtech Jizhou� Huaheng� Biological� �
Technology� Co.,Ltd
AbMaxBiotechnologyCoLtd� hanjing� hipower� international Anhui� Bayi� Chemical� Industry� �
Co.,Ltd
ShanghaiTenGenBiomedicalCoLtd� nanjing� suru� chemical SYMBIOSIS
ShanghaiAmbrosiaPharmaceuticalsC
oLtd�
nantong� acetic� acid� chemical XINYI� CHEMICALS
BasileaPharmaceuticaChinaLtd� nantong� jinghua� pharmaceutical Anhui� Heryi� Chemicals
SundiaMediTechCoLtd� nantong� menthol� factory SAVANT� PHARM
ShenzhenChipsceenBiosciencesLtd� ncm� hersbit� chemical Chongqing� everything� �
pharmaceutical
HDBiosciencesCoLtd� newchem� spa Sichuanjinshanzhiyaoco.ltd
Vector� Gene� � Technology� Co� Ltd nexchem� pharmaceutical Waigaoqiao� Liantong
HuaxipharmCoLtd� ningbo� double� sun� � pharmaceutical sacren� snow
1060� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
ShanghaiChemPartnerCoLtd� ningbo� team� pharmaceutical Zhejiang� Tiantai� Pharm
Zensun(Shanghai)Sci&TechCoLtd� ningbo� yuanfa� bioengineering Kaifeng� Pharmaceutical
ShanghaiLeadDiscoveryPharmaceuti
calCoLtd�
ningbo� zhenhai� haide� biochem Zhejiang� Supor� Pharmaceuticals
ShanghaiChemExplorerCoLtd� northeast� pharmaceutical� group Huangpu� Chemical
SinocroInc.� panjin� huacheng� pharmaceutical Guangzhou�Winsun� �Pharmaceutical
Chemizon,Inc.� pharmaceutical� co.,� ltd.� Shenzhen� �
youpuhui
Changzhou� Kony� Pharmaceutical
AsymchemLaboratories(Tianjin)CoLt
d�
pharmaceutical� expresss� of� china Dolder� Shanghai
ShanghaiSINCHPharmaceuticalsTech
.CoLtd�
PHEXCOM b2star
ShanghaiUnitedPharmatechCoLtd� southwest�synthetic� �pharmaceutical Hongjiu� Biotech
NanjingChemzamPharmtechCoLtd� qidong� ruifeng� chemical Guilin� Xingda� Pharmaceutical
2Y-Chem,Ltd.� qilu� pharmaceutical Guang� Dong� Bo� Hong� Medicine
ShanghaiLeadChemCoLtd� qingdao� mingyue� seaweed� group China� Union� Chempharma
PharmaronBeijingCoLtd� qingdao� dingkang� silica� gel Fuchi� Pharmaceutical
Yangtze� River� � Pharmaceutical�
Group� Co.,� Ltd.
qingdao� hailang� silica� gel� � drier�
factory
Indian� Drug� Manufacturers'� �
Association
North�China� �Pharmaceutical�Group�
Co.,� Ltd.
qingdao� haiyang� chemical Enaltec� Labs
Lupin� � Chemicals� (thailand)� Co.,ltd. qingdao� huanghai� �
bio-pharmaceutical
SHJNJ� Modern� Pharmaceutical
Thai� Meiji� � Pharmaceutical qingdao� jinfeng� pharmaceutical Anyang� Jiuzhou� Pharmaceutical
Rhodia qingdao�kangyexin�medicinal� � silinca�
gel� desiccant
Zhejiang� Kangle� Pharmaceutical
Bio� Lab� � Co.,Ltd. qingdao� kangyuan� � pharmaceutical Beijing� Oriental� Friendship� �
Advertising
Pure� Chem� � Co.,Ltd. qingdao� makall� group Ruibang� Laboratories
Osotspa qingdao� puke� parting� materials Ningxia� Tairui� Pharmaceutical
M� &� H� � Manufacturing qufu� gongly� chemical� industry Ningxia� Kingvit� Pharmaceutical
Thai� Nakorn� � Patana qufu� sheng� ren� pharmaceutical Jubangpharm
Natrapharm� � Inc. qufu� tianli� medical� � supplements Beijing� Lunarsun� � Pharmaceutical
United� � Laboratories quzhou� aokai� chemical Zhejiang� Warrant� � Pharmaceutical
Pascual� � Laboratories reyoung� pharmaceutical Tosun� Pharmaceutical
www.hkki.org rivocean� group Yantai� Justaware� � Pharmaceutical
www.ikatanapotekerindonesia.net rudong� county� lianfeng� � chemical�
industry
Zhejiang� Jinhua� Conba� � Bio-Pharm
www.sapi.org.sg run� shaanxi� days� biological� �
technology
aasenbo
www.phama.org.my sdart� international Fuan� Pharmaceutical
부록 6� �주요 전략적 협력사 현황 리스트 ❚ 1061
www.mps.org.my/ shaanxi� haixinqinghua� �
pharmaceutical� And� chemical
Sichuan� Intercontinental� �
Pharmaceutical
http://www.phap.org.ph/ shaanxi� hanjiang� � pharmaceutical Yangzhou� Liberty� � Pharmaceutical
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
acesys� � pharmatech shaanxi� xiyue� pharmaceutical Lanxite
amino� life� � biotech shandong� binzhou� zhiyuan� �
bio-technology
Chongqing� carelife� � Pharmaceutical
angle� yeast shandong� boyuan� pharmaceutical Hebei� Lianao� Pharmaceutical
Anhui� Benma� � Pioneer� Technology shandong� fangxing� technology� �
development
Sichuan� Xieli� Pharmaceutical
anhui� dexinjia� � Bio&pharm shandong� guangrao� lifeng� �
biotechnology
Hunan� Jiudian� Pharmaceutical
anhui� jinbang� � medicine� chemical shandong� head Zhejiang� Xianju� Junye� �
Pharmaceutical
anhui� langxi� � lianke� industrial shandong� jincheng� � pharmaceutical�
&� chemical
Beijing� Lianben� � Pharm-Chemicals
anhui� sanxing� � resin� technology shandong� jiulong� hisince� �
pharmaceutical
Zhuhai� Rundu� Pharmaceutical
anhui� shanhe� � pharmaceutical�
excipients
shandong� lukang� pharmaceutical� �
group
Shanghai� Polymer� �
Pharmaceutical&Excipient
anqui� Lu'an� � pharmaceutical shandong� lukang� record� �
pharmaceutical
Sichuan� Province� Yuxin� �
Pharmaceutical
apeloa� tospo� � pharmaceuticals shandong� luoxin� pharmacy� stock Cheng� Du� HRTD� technologies� of� �
Biotechnology
ashland� � specialty� ingredients shandong� luwei� pharmaceutical Fan� Zhi� Biotech
baoji� jinsen� � pharmaceutical shandong� renhetang� �
pharmaceutical
Accendatech
baoji� oasier� � bio-tech shandong�rongyuan� �pharmaceutical Nantong� Huafeng� Chemical
beijing� � aoboxing� biotech� company shandong� ruiying� pionner� �
pharmaceutical
Chedom� Pharma
beijing� � unicotton� biotech shandong� shuanghua� �
pharmaceutical
Changzhou� Watson� Fine� Chemical
beijing�fengli� � jingqiu�commerce�and�
trade
shandong� tianli� pharmaceutical Shanghai� Pansopharm� Technology
beijing� hope� � international�
pharmaceutical� tech&dev
shandong� weifang� � pharmaceutical�
factory
Chemindustry
beijing� � J&R� times� technology shandong� xiangrui� medicines Chongqing� Kangle� � Pharmaceutical
beijing� kcode� � pharmaceutical� R&D shandong� xinyi� pharmaceutical Suzhou� Stone� Lake� Pharma� Tech
beijing� �shuangxuan�microbe�culture�
medium� products� factory
shandong� yangcheng� biotech Hengshi� Group
1062� ❚ 중동·아프리카 지역 아웃소싱 기업 및 전략적 협력사 디렉토리북
beijing� sun-novo� � pharmaceutical�
reseach
shandong� yinfeida� � pharmaceutical Cheng� Feng
beijing� taiyang� pharmaceutical� �
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
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
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
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
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
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
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
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
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
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)
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
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.
top related