AFFORDABLE, CREDIBLE, EFFICIENT RESEARCH
VEDIC LIFESCIENCES
Vedic. Introduction
 A decade of experience as full and functional service Research center
 Clinical Trials for label cl...
Vedic. Brand Promise
YOU CLAIM WE PROVE
To bring down the cost & time of R&D and become a strategic partner
of choice for ...
Vedic. Services
4
Product Development Services
Product Launch Services
Turn Ke y So lutio ns fo r Indian Marke t Entry
Vedic. Bone & Joint Health
 We have ready access to Advanced Efficacy Diagnostic
Tests: Digital X- Rays, DEXA, MRI (carti...
Vedic. Cardiac Health
 We support robust claims for reduction of Cholesterol,
LDL,VLDL, Lipoprotiens; increase in HDL lev...
Vedic. Weight Management
 At Vedic we can perform:
 Body Mass Index and Total Body Water using a Bioelectric
Impedance A...
Vedic. Regulatory Support
 Developing, writing, publishing and submission of regulatory files for
various global markets ...
Vedic. Regulatory Support
 Dietary supplement label claims compliant to FTC and other
guidelines
 Health claim under Art...
Vedic. Preclinical
 Pharmacological screening studies - in vitro and in vivo
 Toxicology
 Pharmacokinetics
 Analytical...
Vedic. Clinical
 Trial Feasibility
 Study Documents
 Site Selection
 Clinical Monitoring
 Project Initiation & Manage...
Vedic. Certifications
14
Audit Certification
Vedic Investigators' Meet, Mumbai: 2011
A Human Growth Hormone Supplement
15
Vedic. Therapeutic Expertise
16
Vedic. Global Reach
17
Vedic. Clinical Research Papers
 Papers published on Joint Health
18
Vedic. Clinical Research Papers
 Paper published on Sexual Health
 Paper published for Pain Management
19
CRO. Benefits
 Planne d, Structure d, Re g ulato ry co m pliant and acce pte d do cum e nts
 Hig h & Unbiase d Safe ty, ...
India. Benefits
 Study Start Up’s / initiations in 2months
 Shorter recruitment timelines and increased patient complian...
Vedic. Case Study - Reparagen
22
Vedic. Medical Advisory Panel
Arun Nanivadekar, MD is former Medical Director, Pfizer & Wyeth. He has been a member
of Sev...
Vedic. Key people
24
 Jayesh Chaudhary, as Founder, has been involved in product development and
international business s...
Vedic. Key people
25
Anil Yadav leads Quality Assurance at Vedic. He brings in over 7 years of
experience in the field of ...
Vedic. Social Media
26
India
203, Morya Landmark 1, Off new Link Road, Andheri West,
Mumbai 400053
Tel.: +91 22 42172300 / +91 22 42025719
USA
16...
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Vedic Lifesciences - the World's largest CRO for Clinical trials on Nutraceuticals

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Vedic Lifesciences is most likely the world's first and largest CRO for Clinical Trials on Nutraceuticals. We have completed 50 Human Studies and over 280 non-clinical studies on only Natural Products in the last 12 years. No other CRO globally has this kind of experience.

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Vedic Lifesciences - the World's largest CRO for Clinical trials on Nutraceuticals

  1. 1. AFFORDABLE, CREDIBLE, EFFICIENT RESEARCH VEDIC LIFESCIENCES
  2. 2. 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 2
  3. 3. 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 3
  4. 4. Vedic. Services 4
  5. 5. Product Development Services
  6. 6. Product Launch Services Turn Ke y So lutio ns fo r Indian Marke t Entry
  7. 7. 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 7
  8. 8. 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 8
  9. 9. 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) 9
  10. 10. 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
  11. 11. 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
  12. 12. 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
  13. 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 13
  14. 14. Vedic. Certifications 14 Audit Certification
  15. 15. Vedic Investigators' Meet, Mumbai: 2011 A Human Growth Hormone Supplement 15
  16. 16. Vedic. Therapeutic Expertise 16
  17. 17. Vedic. Global Reach 17
  18. 18. Vedic. Clinical Research Papers  Papers published on Joint Health 18
  19. 19. Vedic. Clinical Research Papers  Paper published on Sexual Health  Paper published for Pain Management 19
  20. 20. CRO. Benefits  Planne d, Structure d, Re g ulato ry co m pliant and acce pte d do cum e nts  Hig h & Unbiase d Safe ty, Ethics in Hum an Vo lunte e r se le ctio n and pro te ctio n  Re g ular m o nito ring and inspe ctio ns by traine d and q ualifie d staff to de te ct no n-co m pliance  Incre ase d data cre dibility and acce ptability  De dicate d and Traine d te am to e nsure be tte r co -o rdinatio n in m ulti ce nte r studie s  Pro duct use by se ve ral do cto rs fo llo wing sim ilar pro to co l le ading to m o re do cto r co nfide nce .  Incre ase d chance o f pro m o ting /m arke ting /sale s o f pro duct(s) in vario us o the r ne w g e o g raphie s o r m arke t se g m e nts  Incre ase d co m pliance to inte rnatio nalsyste m s and re g ulatio ns  Inte rnatio nally acce ptable to o ls fo r co lle ctio n o f data  Structure d & Planne d Analysis and Pre se ntatio n o f the data  Publicatio n o f data in inte rnatio nal pe e r re vie we d jo urnals
  21. 21. 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.  NOTTOFORGET  Lower R&D, Drug Discovery & Clinical Trial Cost  Increasing prevalence of diseases  Well trained and world class facilities  No language barrier
  22. 22. Vedic. Case Study - Reparagen 22
  23. 23. 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. 23
  24. 24. Vedic. Key people 24  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, MDheading 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, MDheading 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.
  25. 25. Vedic. Key people 25 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.
  26. 26. Vedic. Social Media 26
  27. 27. 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, USA Tel: 1(650)855-4832 bizdev@vediclifesciences.com, www.vediclifesciences.com 27

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