Vedic Lifesciences has completed 65 Human Studies and over 300 non-clinical studies on only Natural Products in the last 16 years.

1. AFFORDABLE, CREDIBLE, EFFICIENT RESEARCH
VEDIC LIFESCIENCES

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
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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
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4. Vedic. Services
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5. Product Development Services

6. Product Launch Services
Turn Ke y So lutio ns fo r Indian Marke t Entry

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
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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
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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)
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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
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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
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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)
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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
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14. Vedic. Certifications
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Audit Certification

15. Vedic Investigators' Meet, Mumbai: 2011
A Human Growth Hormone Supplement
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16. Vedic. Therapeutic Expertise
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17. Vedic. Global Reach
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18. Vedic. Clinical Research Papers
 Papers published on Joint Health
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19. Vedic. Clinical Research Papers
 Paper published on Sexual Health
 Paper published for Pain Management
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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. 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. Vedic. Case Study - Reparagen
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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.
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24. Vedic. Key people
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 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. Vedic. Key people
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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. Vedic. Social Media
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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
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