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Affordable, Credible, Efficient Research

Affordable, Credible, Efficient Research. Vedic Lifesciences. Vedic. Introduction. A decade of experience as full and functional service Research center

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Affordable, Credible, Efficient Research

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  1. Affordable, Credible, Efficient Research Vedic Lifesciences

  2. Vedic. Introduction • A decade of experience as full and functional service Research center • 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 • ISO 9001:2008 certified • Headquarters in Mumbai, India with office in California, USA

  3. Vedic. Brand Promise YOU CLAIM WE PROVE Vision To bring down the cost & time of R&D and become a strategic partner of choice for Nutraceutical, Cosmeceutical and Traditional Medicine companies.

  4. Vedic. Difference • Expert team for developing global label claims • Wide therapeutic knowledge and expertise • Esteemed panel of Medical Advisors • Experienced Medical Writers • Flexible payment terms and conditions • Shared risks • Core strengths:ICH-GCP compliant systems and globally accepted data • GCP trained investigators in several health conditions that India has to offer • Unique models for data capture • Papers published in peer reviewed journals

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

  6. Vedic. Services

  7. Product Development Services

  8. Product Launch ServicesTurn Key Solutions for Indian Market Entry

  9. 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

  10. 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

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

  12. Vedic. Pre Clinical

  13. 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

  14. Vedic. Certifications Audit Certification

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

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

  17. Vedic. Therapeutic Expertise

  18. Vedic. Global Reach

  19. Vedic. Clinical Research Papers (latest papers to be added) • Papers published on Joint Health

  20. Vedic. Clinical Research Papers • Paper published on Sexual Health • Paper published for Pain Management

  21. 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

  22. 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

  23. Vedic. Case Study - Reparagen

  24. 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.

  25. Vedic. Key people • 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. Dr. Navneet Sonawane 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.

  26. Vedic. Key people • Kunal Bhatt heads Business Development and has also led several Global Phase II - IV drug studies, in various capacities and diverse therapeutic areas. A Masters in Pharmacology and Biotechnology from Sheffield Hallam University, UK, Kunal has worked in areas of global project management and clinical operations. Kunal has been instrumental in creating a network of collaborators and business partners for our global expansion and has helped manage a large number of research studies.. • 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 upgradation 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.

  27. Vedic. Organogram

  28. Vedic. Social Media

  29. India 203, Morya Landmark 1, Off new Link Road, Andheri West, Mumbai 400053 Tel.: +91 22 42172300 / +91 22 42025719 USA 16 Barcelona Circle, Redwood Shores, CA 94065, USATel: 1(650)855-4832 bizdev@vediclifesciences.com,www.vediclifesciences.com

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