AFFORDABLE, CREDIBLE, EFFICIENT RESEARCH

VEDIC LIFESCIENCES

Vedic. Introduction

A decade of experience as full and functional service Research center Clinical Trials for label claim substantiation Research facilities in US and India Widest range of services for the Dietary Supplements,

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

ICH – GCP Compliant data to meet regulatory requirements Audited by International and Domestic Clients Complete product development support ISO 9001:2008 certified Headquarters in Mumbai, India with office in California, USA

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Vedic. Brand Promise

YOU CLAIM WE PROVE

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. Services

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Product Development Services

Product Launch ServicesTurn Key Solutions for Indian Market Entry

Vedic. Bone & Joint Health

We have ready access to Advanced Efficacy Diagnostic Tests: Digital X- Rays, DEXA, MRI (cartilage), Arthroscopy

We have in the past used International Efficacy Measurement viz VAS score, WOMAC, SF – 36, KOOS and other tests for physical function

We have more bone & joint health studies completed then any other Nutra CRO globally

We help ascertain product safety profile at Certified and Accredited facilities

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Vedic. Cardiac Health

We support robust claims for reduction of Cholesterol, LDL,VLDL, Lipoprotiens; increase in HDL levels, Controlling thickness of carotid artery intima and Media layers

We have facilities for the care of mobile and immobile volunteers

We have access to specialized digital Cath lab facility to perform Intravenous ultrasound

With the global market for heart health ingredients is projected to reach $15.2 billion by 2018 we help you get the right niche for your products to excel in the markets

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Vedic. Weight Management

At Vedic we can perform: Body Mass Index and Total Body Water using a

Bioelectric Impedance Analysis Instrument Total body composition – Dual-Energy X-ray

Absorptiometry (DEXA) Basal Metabolic Rate – Indirect calorimetry Metabolic

Monitor Diet management software's Appetite – Food frequency and appetite questionnaires

Obesity is a major driver for the widely prevalent metabolic syndrome and type-2 diabetes mellitus (T2DM)

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Vedic. Regulatory Support

Developing, writing, publishing and submission of regulatory files for various global markets such as:

- Regulatory Strategy input for a Food Supplement Development Plan- Vedic also supports IND, CTA, NDA, ANDA, marketing dossiers, etc for

drug submissions in any markets

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Vedic. Regulatory Support

Dietary supplement label claims compliant to FTC and other guidelines

Health claim under Article 13.5 or 14 of Regulation (EC) No 1924/2006

Substantiation of nutrition and health claims in several other countries

Natural Product Number (NPN) from Health Canada OTC/IND/NDA for a Botanical Drug Product GRAS Affirmations Medical Foods Clinical Trial Application to DCGI 505(b)(2) approvals from US FDA

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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. Clinical

Trial Feasibility Study Documents Site Selection Clinical Monitoring Project Initiation & Management Investigational Product Management Audits Data Management Biostatistics Medical Writing Clinical Research Papers

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Vedic. Certifications14

Audit Certification

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

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Vedic. Therapeutic Expertise16

Vedic. Global Reach17

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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CRO. Benefits

Planned, Structured, Regulatory compliant and accepted documents High & Unbiased Safety, Ethics in Human Volunteer selection and

protection Regular monitoring and inspections by trained and qualified staff to

detect non-compliance Increased data credibility and acceptability Dedicated and Trained team to ensure better co-ordination in multi

center studies Product use by several doctors following similar protocol leading to

more doctor confidence. Increased chance of promoting/marketing/sales of product(s) in

various other new geographies or market segments Increased compliance to international systems and regulations Internationally acceptable tools for collection of data Structured & Planned Analysis and Presentation of the data Publication of data in international peer reviewed journals

India. Benefits

Study Start Up’s / initiations in 2months Shorter recruitment timelines and increased patient compliance Faster Approval from Ethics Committee World class data processing infrastructure for data management and

biostatistics. Increasing adoption of Good Clinical Practice (GCP) Guidelines Products can be protected under TRIPS (Trade Related Intellectual

Property Rights) Large number of cGMP certified Contract Manufacturing Units

providing local support for product manufacturing services. NOT TO FORGET

Lower R&D, Drug Discovery & Clinical Trial Cost Increasing prevalence of diseases Well trained and world class facilities No language barrier

Vedic. Case Study - Reparagen22

Vedic. Medical Advisory Panel

Arun Nanivadekar, MD 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.

Shanta Banerjee, PhD 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.

Chungath Jolly, PhD 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 people24

Jayesh Chaudhary, as Founder, has been involved in product development and international business since 1994. He has over two decades of experience in nutraceutical regulatory affairs and claim substantiation for the EU, US and other markets. With a Major in Pharmacy and Microbial Engineering from University of Minnesota, Jayesh was responsible for the Biocatalyst and Natural Products technical support Boehringer Mannheim GmbH in the early ‘90s, before he founded Vedic Lifesciences. Jayesh’s key interest remains innovations in research methodologies to suit the current market conditions and challenges being faced by industry.

Jayesh Chaudhary, as Founder, has been involved in product development and international business since 1994. He has over two decades of experience in nutraceutical regulatory affairs and claim substantiation for the EU, US and other markets. With a Major in Pharmacy and Microbial Engineering from University of Minnesota, Jayesh was responsible for the Biocatalyst and Natural Products technical support Boehringer Mannheim GmbH in the early ‘90s, before he founded Vedic Lifesciences. Jayesh’s key interest remains innovations in research methodologies to suit the current market conditions and challenges being faced by industry.

Navneet Sonawane, MD heading Clinical Research, has 13 years of experience in clinical practice including 7 years in nutraceutical clinical research, which include areas such as medical writing, regulatory affairs, project management & quality assurance. Navneet has successfully managed Human studies for a large number of health conditions. At Vedic, she has developed a strong network of GCP trained clinical investigators and research sites and has been appreciated by clients around the globe. Navneet is experienced in efficiently managing nutraceutical research projects ensuring strict timelines and regulatory compliance.

Navneet Sonawane, MD heading Clinical Research, has 13 years of experience in clinical practice including 7 years in nutraceutical clinical research, which include areas such as medical writing, regulatory affairs, project management & quality assurance. Navneet has successfully managed Human studies for a large number of health conditions. At Vedic, she has developed a strong network of GCP trained clinical investigators and research sites and has been appreciated by clients around the globe. Navneet is experienced in efficiently managing nutraceutical research projects ensuring strict timelines and regulatory compliance.

Vedic. Key people25

Anil Yadav leads Quality Assurance at Vedic. He brings in over 7 years of experience in the field of Quality assurance with experience in writing and implementation of standard operating procedures, documentation, qualification audits and training. His focus at Vedic on system development and training activities has helped in constant up gradation of the team’s expertise and capabilities. Anil, a Biochemistry and Microbiology major, has successfully led the Vedic teams for several ISO 9001:2008 and ICH-GCP sponsor audits.

Anil Yadav leads Quality Assurance at Vedic. He brings in over 7 years of experience in the field of Quality assurance with experience in writing and implementation of standard operating procedures, documentation, qualification audits and training. His focus at Vedic on system development and training activities has helped in constant up gradation of the team’s expertise and capabilities. Anil, a Biochemistry and Microbiology major, has successfully led the Vedic teams for several ISO 9001:2008 and ICH-GCP sponsor audits.

Vedic. Social Media26

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

West, Mumbai 400053

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

USA16 Barcelona Circle, Redwood Shores, CA 94065, USA

Tel: 1(650)855-4832

bizdev@vediclifesciences.com, www.vediclifesciences.com

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