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AFFORDABLE, CREDIBLE, EFFICIENT RESEARCH Vedic Lifesciences – Claim Substantiation through Human Clinical Studies.

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Presentation on theme: "AFFORDABLE, CREDIBLE, EFFICIENT RESEARCH Vedic Lifesciences – Claim Substantiation through Human Clinical Studies."— Presentation transcript:

1 AFFORDABLE, CREDIBLE, EFFICIENT RESEARCH Vedic Lifesciences – Claim Substantiation through Human Clinical Studies

2 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 2

3 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 3

4 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 4

5 Vedic. Core Values  Commitment to Word and Work  Empathize with Customer: Serve real needs  Ethics – Honesty & Protection of human subjects  Pro-activeness 5

6 Vedic. Services Regulatory Dossier Preparation & Consulting Preclinical Formulation and Standardization Toxicology In vitro & In vivo Animal studies Clinical Human Bioavailability Studies Human Clinical Studies Medical Writing 6

7 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 7

8 Vedic. Preclinical  Pharmacological screening studies - in vitro and in vivo  Toxicology  Pharmacokinetics  Analytical Development  Formulation Development  Completed over 275 studies (GLP and non-GLP) 8

9 Vedic. Pre Clinical 9

10 Vedic. Clinical  Trial Feasibility  Project Management  Site Selection  Clinical Monitoring  Investigational Product Management  Audits  Data Management  Biostatistics  Medical Writing 10

11 Vedic. Certifications 11 Audit Certification ISO 9001:2008

12 Vedic Investigators' Meet, Mumbai: 2011 A Human Growth Hormone Supplement 12

13 Vedic Investigators' Meet, Mumbai: 2011 A Joint Health Supplement 13

14 Vedic. Therapeutic Expertise 14

15 Vedic. Global Reach 15

16 Vedic. Clinical Research Papers  Papers published on Joint Health 16

17 Vedic. Clinical Research Papers  Paper published on Sexual Health  Paper published for Pain Management 17

18 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 18

19 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 19

20 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. 20

21 Vedic. Key people 21 Jayesh Chaudhary is Founder & Managing Director of Vedic Lifesciences. He has been involved in product development and international business since 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.

22 Vedic. Key people 22 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.

23 Vedic. Organogram 23

24 Vedic. Social Media 24

25 India 203, Morya Landmark 1, Off new Link Road, Andheri West, Mumbai Tel.: / USA 552, Shorebird Circle, Unit #1101, Redwood Shores, CA Tel.: (650)


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