Affordable, Credible, Efficient Research

1. Affordable, Credible, Efficient Research Vedic Lifesciences - Clinical Trials for Nutraceuticals

2. 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 • ICH – GCP Compliant data to meet regulatory requirements • Audited by International and Domestic Clients • Headquarters in Mumbai, India with office in California, USA

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.

4. Vedic. Services

5. Vedic. Global Reach

6. Vedic. Bioavailability Studies Bioavailability is measurement of the rate and extent to which a therapeutic product/ingredient reaches systemic circulation • Conducted on healthy volunteers • Checks availability of the active ingredient in biological samples

7. Vedic. Bioavailability Studies…contd • Access to USFDA, EMEA, MHRA, DCGI, ENVISA audited facilities • Adherence to country specific guidelines • Well equipped/comprehensive and independent infrastructure • Qualified and experienced staff • Apt designs for achieving client’s study objectives

8. Vedic. Study Feasibility • Visits to the Investigator site to assess and evaluate the capabilities of the site and site staff to conduct a clinical study • Sites assessed in terms of • Infrastructure • Patient pool • Investigator and site staff qualifications & experience • Other protocol related requirements • A timely, detailed report of the same sent to the sponsor

9. Vedic. Study Feasibility…contd • Detailed doctors database • Direct contact with the key investigators and trial sites • Experience over diverse therapeutic areas • Efficient site identification and selection process • Well designed Site Selection Questionnaires

10. Vedic. Doctors’ Database

11. Vedic. Project Management • Project Manager with strong communication and problem solving skills • Serving as one point contact for the client • Experienced, trained, dedicated and proactive team • Robust Project Management Plan • Adherence to quality, budget and timelines • Timely and effective communication with clients • Periodic and detailed project reports • Close Monitoring of ‘Project milestones/deliverables’

12. Vedic. Therapeutic Expertise

13. Vedic. Clinical Monitoring As per ICH-GCP E6.5.18 monitoring should be carried out by the sponsor or sponsor representatives for each clinical trial to ensure; • Rights and well being of the patients involved in the study, • Reported trial data is accurate, complete and verifiable through source documents and • Conduct of trial as per the protocol / regulatory requirements • Visits start immediately after the first patient is recruited and are done on a monthly basis or as per the client/protocol requirement • Clients updated via monitoring visit reports and follow up letters

14. Vedic. Clinical Monitoring • ICH – GCP driven Study Monitoring • Highly trained and experienced monitoring team • Frequent team meetings for query resolution • Adherence to Standard Operating Procedures, protocol and regulatory requirements • Good Investigator Relationship Management • Transparent and accurate pass through cost

15. Vedic. Test Product Management According to ICH E6.5.12,13,14, Investigational Product (test product/ placebo) under study in the clinical trial requires adequate approvals/ permissions, handling and management throughout the study duration This involves the following: • Import/Export of the IP • Manufacturing, Packaging and Labeling • Randomization and Blinding • Shipment of the IP to the sites • IP accountability at sites • Collection of the unused IP from the sites • Destruction of the IP

16. Vedic. Test Product Management • Quick custom clearance of import shipment • Management of shipments to sites • Storage of Investigational Product as per label specifications • Cold Chain management for IP shipments • Software generated randomization code • Inventory management and accountability • Efficient coordination with local and international couriers

17. Vedic. Site Capabilities • ICH-GCP trained and Experienced Staff • Faster Ethics Committee Approvals • Experience of diverse therapeutic areas • Access to accredited central labs and state of the art local labs • Patient protection • Faster Recruitment Rate • Good Retention Rate

18. Vedic. Data Management • Creation of a database as per the study requirements • Double data entry to ensure data accuracy • Data Clarification Forms for query resolution • Data discrepancy check • Data base lock

19. Vedic. Data Management • Easy to understand and user friendly databases • Accurate and credible data • Quick turn around time for query resolution • Minimum time to database lock following last patient out

20. 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 people • 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.

21. Vedic. Key people • 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.

22. Vedic. Project Managers • 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. • 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.

23. Vedic. Social Media

24. 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 bizdev@vediclifesciences.com,www.vediclifesciences.com