AFFORDABLE, CREDIBLE, EFFICIENT RESEARCH

Vedic Lifesciences – Claim Substantiation through Human Clinical Studies

Vedic. Introduction

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

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

Clinical Trials for label claim substantiation ICH – GCP Compliant data to meet regulatory requirements Audited by International and Domestic Clients Complete product development support Headquarters in Mumbai, India with office in California, USA

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Vedic. Brand Promise

We offer an opportunity to substantiate your product claims in a scientific and credible environment. Conforming to USA, EU and other Global Regulations, our expertise and resources help you deliver on your promise to enable people to live healthier lives.

To bring down the cost & time of R&D and become a strategic partner of choice for Nutraceutical, Cosmeceutical and Traditional

Medicine companies.

Vision

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Vedic. Difference

Expert team for developing global regulatory strategies Wide therapeutic knowledge and expertise Esteemed panel of Medical Advisors Experienced Medical Writers Flexible payment terms and conditions Shared risks Core strengths: Our people and ICH-GCP compliant systems GCP trained investigators in several disease indications that India

has to offer Unique models for data capture Papers published in peer reviewed journals

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Vedic. Core Values

Commitment to Word and Work Empathize with Customer: Serve real needs Ethics – Honesty & Protection of human subjects Pro-activeness

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Vedic. Services

Regulatory

Dossier Preparation

& Consulting

PreclinicalFormula

tion and

Standardization

Toxicology

In vitro &

In vivo Animal studies

Clinical

Human Bioavailability Studies

Human Clinical Studies

Medical Writing

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Vedic. Regulatory

Regulatory Strategy input for a Food Supplement Development Plan. Developing, writing, publishing and submission of regulatory files for

global regulatory authorities such as: Federal Trade Commission (FTC) – USA Food and Drug Administration (FDA) – USA European Food Safety Authority (EFSA) – Europe Natural Health Products Directorate (NHPD) – Canada Therapeutic Goods Administration (TGA) – Australia Food Standard Australia New Zealand National Pharmaceutical Control Bureau – Malaysia

Vedic also supports IND, CTA, NDA, ANDA, marketing dossiers, etc for drug submissions in any markets

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Vedic. Preclinical

Pharmacological screening studies - in vitro and in vivo Toxicology Pharmacokinetics Analytical Development Formulation Development Completed over 275 studies (GLP and non-GLP)

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Vedic. Pre Clinical

Analytical method Development

25% Formulation Development

3%

Animal Pharmacol-

ogy19%

Toxicity Studies30%

Regulatory23%

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Vedic. Clinical

Trial Feasibility Project Management Site Selection Clinical Monitoring Investigational Product Management Audits Data Management Biostatistics Medical Writing

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Vedic. Certifications11

Audit Certification ISO 9001:2008

Vedic Investigators' Meet, Mumbai: 2011A Human Growth Hormone Supplement

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Vedic Investigators' Meet, Mumbai: 2011A Joint Health Supplement

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Vedic. Therapeutic Expertise

Cardiac

Hea

lth

Dermato

logy

Prostr

ate H

ealth

Meta

bolic fu

nction

Gastro

enter

ology

Men

s' Hea

lth

Wom

ens'

Health

Imm

unity B

ooster

Sleep A

id

Respira

tory

Hea

lth

Lifesty

le Dise

ases

Join

t Hea

lth

Others

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2

3

4

5

6

7

8

9

10

CompletedOngoing

Num

ber

of S

tudi

es

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Vedic. Global Reach

Canada; 6France; 1

Germany; 2

Hong Kong; 3

India; 19

Malaysia; 1

Netherlands; 3

USA; 9

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Vedic. Clinical Research Papers

Papers published on Joint Health

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Vedic. Clinical Research Papers

Paper published on Sexual Health

Paper published for Pain Management

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Vedic. Initiatives

NUTRACEUTICAL RESEARCH ASSISTANCE PROGRAM No obligation quote with suitable study design Consulting for in house project management

ACElerator Generation of own data Faster mobilization of product into the market Strong marketing tool to increase sales and credibility of the product

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Vedic. Case Study - Reparagen

Background

• North American client

• Proprietary joint health supplement

• Claims substantiation through human clinical studies.

Challenge

• Stringent timelines

• Budget constraints

• Publication in a peer – reviewed journal

Solution• Robust Study

Designs under guidance of experienced Medical Advisory Board

• Faster Ethics Committee Approvals

• DSR® for faster recruitment

• Dedicated Project Management Team

• ICH-GCP compliant data

Impact

• Own science v/s borrowed sciences

• Publication in high impact peer reviewed journal

• Increased Brand credibility

• Increase in sales

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Vedic. Medical Advisory Panel

Dr. Arun Nanivadekar is former Medical Director, Pfizer & Wyeth. He has been a member of Several Ethics Committees and editorial advisory boards. He has been honored with the Lifetime Achievement award by Indian Society of Clinical Research in 2008, for his contributions to the field of clinical research. Dr. Nanivadekar at Vedic provides strategic regulatory inputs for innovative study design.

Dr. Shanta Banerjee is Managing Director of Phytomed Service and Plantachem GbR, Germany. She has received her PhD degree in Pharmaceutical chemistry and worked as postdoctoral Scientist in renowned research laboratories across Europe and America. She has co authored a number of publications on active constituents of medicinal plants. Dr. Shanta Banerjee plays a key role in the areas of clinical study design and botanical product development.

Dr. Chungath Jolly completed his PhD and M.Sc. in Pharmacognosy and Phytochemistry. He has served in the positions of Research Advisor, Technical Advisor and Director at prestigious and meritorious organizations. Dr. Jolly adds tremendous value to the projects in the areas of Pharmacognosy and Phytochemistry for all the herbal formulations.

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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. • 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.

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.

Vedic. Organogram23

Vedic. Social Media24

India 203, Morya Landmark 1, Off new Link Road,

Andheri West, Mumbai 400053

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

USA552, Shorebird Circle, Unit #1101, Redwood

Shores, CA. 94065

Tel.: (650) 855-4832

bizdev@vediclifesciences.com, www.vediclifesciences.com

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