Claim substantiation for Cosmeceuticals / Personal Care Products through Human Clinical testing

AFFORDABLE, CREDIBLE, EFFICIENT RESEARCH

Claim Substantiation for

Cosmeceuticals through Clinical Testing

Vedic. Introduction

A decade of experience as full and functional service CRO Widest range of services for the Nutraceuticals, Dietary Supplements,

Botanical Drug Products, Medical Foods, Natural Health Products, Cosmetics & Personal Care Products

Clinical trials for label claim substantiation Compliant data to meet regulatory requirements Efficient study design for testing cosmetic products Cosmetic efficacy studies Quality check of developed product Delivery of safe and effective products to the customers. ISO 9001:2008 certified Headquarters in Mumbai, india with office in California, USA

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Vedic. Services3

Vedic. Benefits

Experienced team of medical experts with experience in studies for Acne, Melasma, Weight Loss, Hair removals, etc

Claim Substantiations possible - “Clinically Proven” tags at affordable costs

Protocols made in accordance with ICH-GCP Unmatched Quality, Effective Costs and Reduced Timelines End to end service provider for all your products Quality Research for better market acceptance

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Vedic. Capabilities

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SKIN HAIR OTHERS

Lightening/Fairness

Anti-ageing

Acne/oil control

Blemishes/Marks

Softness/Elasticity

Body odour

Excessive sweating

Cleaning

/Conditioning

Growth stimulation

Growth retardation

Dandruff Control

Styling / Colouring

Repair

Oral Hygiene

Eye care

Weight Loss and

Management

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Vedic. Site Capabilities

Access to Right Set of Volunteers Comprehensive and Independent Facility Specialized in Cosmetics, Cosmeceutical and Dermatological Safety and

Efficacy studies Offer services to National and International sponsors for Safety as well as

Efficacy Testing Fulfill client’s expectations with Reliable, Consistent and Efficient

performance

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Vedic. Invitro Tests

Invitro screening of herbal extracts for cosmeceutical applications Skin irritation Phototoxicity E.g: Invitro SPF testing: Estimation of protection from UVB (short wave

UV light) and UVA (long wavelength UV light) Instrument Used: Optometrics LLC, SPF- 290S Assist in product development stage

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Vedic. Safety Studies – Standards & Methods

Standards followed: ASTM BIS

Primary Irritation Patch Test: To ascertain the safety in terms of irritation potential of the cosmetic

products against a positive control on the healthy human subjects

Repeat Insult Patch Test: The objective of this test is to determine the irritation and/or sensitization

potential of the test material(s) after repeated application under occlusive, semi- occlusive or open patches to the skin of human subjects

The above are based on Client requests and preferences

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Vedic. Clinical Studies Expertise

Clinical studies compliant to ICH –GCP Experienced medical writing team Dedicated project management team ICH-GCP trained and qualified clinical research monitors Independent ethics committee approvals Evaluations for clinical studies based on:

Expert dermatologist assessment Instrument assessment Self assessment carried out by the volunteers

Comprehensive data management and statistical analysis Final report writing

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Vedic. Investigators

Rich experience in managing Dermatology and Venereology patients

Dynamic, energetic and result oriented professionals Ability to deliver quality data within specified timelines

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Vedic. Instrumental Capabilities

Instrument Measures Evaluates efficacy of

Visiometer® Wrinkle Depth Anti Ageing Products

Cutometer® Skin Elasticity Anti Ageing Products

Tewameter® Skin Softness Moisturizers

Chromameter® Skin color according to pigmentation Fairness creams, tanning products

Mexameter® Skin melanin content / erythema Fairness creams, tanning products, anti-marks creams

Sebumeter® Skin Oiliness Anti-acne products

Corneometer® Skin Moisture Moisturizers

Visioscan® Skin Surface Texture Moisturizers

Skin Ph® pH-level on the skin surface Soaps, Face Wash

Studies the skin surface directly with Special UV-A light

Shows the skin structure and level of dryness

Evaluates desquamation and sebum production

SKIN LIGHTENINGVisiometer®Manufacturer: Courage + Khazaka electronic GmbH

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Elasticity / Anti – ageing Cutometer ®Manufacturer: Courage + Khazaka electronic GmbH

Measures precise skin elasticity

The chart shows elasticity as a function of age

00.10.20.30.40.50.60.70.80.91

0 10 20 30 40 50 60 70 80

Cu

tom

eter

Rea

din

g

Age

Elasticity

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Skin SoftnessTewameter ®Manufacturer: Courage + Khazaka electronic GmbH

Measures trans epidermal water loss

Evaluates efficiency of the skin water barrier

0.0

1.0

2.0

3.0

4.0

5.0

6.0

0 4 8 12 16 20 24

TE

WL

(g

/m2

/h)

No. of hrs

Moisture-Locking Ability

Lotion Cream Control

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Skin FairnessChromameter ®Manufacturer: Konica Minolta

Measures the skin color according toL* Lightness

a* Redness

b* yellowness

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Skin Fairness Mexameter ® Manufacturer: Courage + Khazaka electronic GmbH

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Measure the two components, mainly responsible for the colour of the skin:

Melanin and Hemoglobin (erythema)

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Skin oilinessSebumeter®Manufacturer: Courage + Khazaka electronic GmbH

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Allows determination of even slightest changes in the skin surface sebum content

Measures oiliness in acne prone skin

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Skin softnessCorneometer ®Manufacturer: Courage + Khazaka electronic GmbH

Measures skin moisture levels

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Skin drynessVisioscan®Manufacturer: Courage + Khazaka electronic GmbH

Measures the level of dryness of the skin

Measures desquamation on skin and scalp

Evaluates sebum production

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Skin pHSkin-pH-Meter® Manufacturer: Courage + Khazaka electronic GmbH

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Evaluates the quality of the Hydrolipidic film on the skin

especially in developing soaps, cleanser or detergents

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Vedic. Key people21

Jayesh Chaudhary is Founder & Managing Director of Vedic Lifesciences. He has been involved in product development and international business since 1994. He is thorough with regulatory affairs, research and marketing for nutraceutical and phyto-pharmaceutical actives and formulations for the EU and US markets. Trained in Pharmacy and Microbial Engineering from University of Minnesota, Jayesh was responsible for the Biocatalyst and Natural Products technical support and national sales at Boehringer Mannheim India in the early ‘90s.

Jayesh Chaudhary is Founder & Managing Director of Vedic Lifesciences. He has been involved in product development and international business since 1994. He is thorough with regulatory affairs, research and marketing for nutraceutical and phyto-pharmaceutical actives and formulations for the EU and US markets. Trained in Pharmacy and Microbial Engineering from University of Minnesota, Jayesh was responsible for the Biocatalyst and Natural Products technical support and national sales at Boehringer Mannheim India in the early ‘90s. • Dr. Navneet Sonawane is heading the Clinical Research

Department. She has 12 years of experience in the field of Medical Science & Clinical Research, which include areas such as Medical Writing, Regulatory Affairs, Project Management & QA. She has successfully headed Global Clinical Studies across various therapeutic segments. During her tenure at Vedic, she has developed a strong network of GCP trained clinical investigators around India and has been appreciated by Sponsors around globe. She places a high premium for meeting time line while ensuring delivering of quality.

• Dr. Navneet Sonawane is heading the Clinical Research Department. She has 12 years of experience in the field of Medical Science & Clinical Research, which include areas such as Medical Writing, Regulatory Affairs, Project Management & QA. She has successfully headed Global Clinical Studies across various therapeutic segments. During her tenure at Vedic, she has developed a strong network of GCP trained clinical investigators around India and has been appreciated by Sponsors around globe. She places a high premium for meeting time line while ensuring delivering of quality.

Vedic. Key people22

Kunal Bhatt has 8 years of experience within the pharmaceutical industry, having led

several Global Phase I - IV drug studies in various capacities and diverse therapeutic areas

like Neurology, Psychiatry (Adult and Pediatric), Oncology, Diabetes, Urology and Cardiology.

Masters in Pharmacology and Biotech from Sheffield Hallem University, UK, Kunal has worked

in areas of Global Project Management, Clinical Operations and Regulatory. As a Global

Business Development Manager his good business planning acumen and interpersonal relations

help in crafting Business & Marketing Plans.

Kunal Bhatt has 8 years of experience within the pharmaceutical industry, having led

several Global Phase I - IV drug studies in various capacities and diverse therapeutic areas

like Neurology, Psychiatry (Adult and Pediatric), Oncology, Diabetes, Urology and Cardiology.

Masters in Pharmacology and Biotech from Sheffield Hallem University, UK, Kunal has worked

in areas of Global Project Management, Clinical Operations and Regulatory. As a Global

Business Development Manager his good business planning acumen and interpersonal relations

help in crafting Business & Marketing Plans.

ANIL YADAV leads VL’s QA department. After completing his graduation in

Microbiology he obtained a Master degree in Biochemistry from the Mumbai University.

He brings in over 7 years of experience in the field of Quality Assurance with actual

hands on experience in Product development, Documentation and Training.. His focus at VL on System development and Training activities has helped in constant up-gradation of

our expertise and abilities.

ANIL YADAV leads VL’s QA department. After completing his graduation in

Microbiology he obtained a Master degree in Biochemistry from the Mumbai University.

He brings in over 7 years of experience in the field of Quality Assurance with actual

hands on experience in Product development, Documentation and Training.. His focus at VL on System development and Training activities has helped in constant up-gradation of

our expertise and abilities.

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Vedic. Key people

Seema Damakale has got a total work experience of 7 years in Pharma and Research industry. She has played various roles during her tenure, right from Sales and Marketing to Quality Assurance and now, Project Management. With her exuberance and dedication towards project work and her quest for meeting timelines, she has been an excellent role model. Seema is a Science Graduate and has completed her Post Graduate Diploma in Clinical Research and Diploma in Business Management.

Seema Damakale has got a total work experience of 7 years in Pharma and Research industry. She has played various roles during her tenure, right from Sales and Marketing to Quality Assurance and now, Project Management. With her exuberance and dedication towards project work and her quest for meeting timelines, she has been an excellent role model. Seema is a Science Graduate and has completed her Post Graduate Diploma in Clinical Research and Diploma in Business Management.

Sakshi Pawar is involved in handling Feasibility and Project Management of trials at Vedic and has over 11 years of professional experience in Clinical Research. During this period she has actively participated in sponsor/regulatory audits, including those conducted by USFDA, MHRA, EMEA and DCGI. . Sakshi has completed her Diploma in Clinical Research and General Nursing and Midwifery. She has worked for BA-BE studies.

Sakshi Pawar is involved in handling Feasibility and Project Management of trials at Vedic and has over 11 years of professional experience in Clinical Research. During this period she has actively participated in sponsor/regulatory audits, including those conducted by USFDA, MHRA, EMEA and DCGI. . Sakshi has completed her Diploma in Clinical Research and General Nursing and Midwifery. She has worked for BA-BE studies.

India

203, Morya Landmark 1, Off new Link Road, Andheri West, Mumbai 400053

Tel.: +91 22 42172300 / +91 22 42025719

USA

552, Shorebird Circle, Unit #1101, Redwood Shores, CA. 94065

Tel.: (650) 855-4832

[email protected], www.vediclifesciences.com

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