affordable, credible, efficient research vedic lifesciences – claim substantiation through human...
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AFFORDABLE, CREDIBLE, EFFICIENT RESEARCH
Vedic Lifesciences – Claim Substantiation through Human Clinical Studies
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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
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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
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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
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Vedic. Core Values
Commitment to Word and Work Empathize with Customer: Serve real needs Ethics – Honesty & Protection of human subjects Pro-activeness
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Vedic. Services
Regulatory
Dossier Preparation
& Consulting
PreclinicalFormula
tion and
Standardization
Toxicology
In vitro &
In vivo Animal studies
Clinical
Human Bioavailability Studies
Human Clinical Studies
Medical Writing
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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
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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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Vedic. Pre Clinical
Analytical method Development
25% Formulation Development
3%
Animal Pharmacol-
ogy19%
Toxicity Studies30%
Regulatory23%
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Vedic. Clinical
Trial Feasibility Project Management Site Selection Clinical Monitoring Investigational Product Management Audits Data Management Biostatistics Medical Writing
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Vedic. Certifications11
Audit Certification ISO 9001:2008
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Vedic Investigators' Meet, Mumbai: 2011A Human Growth Hormone Supplement
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Vedic Investigators' Meet, Mumbai: 2011A Joint Health Supplement
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Vedic. Therapeutic Expertise
Cardiac
Hea
lth
Dermato
logy
Prostr
ate H
ealth
Meta
bolic fu
nction
Gastro
enter
ology
Men
s' Hea
lth
Wom
ens'
Health
Imm
unity B
ooster
Sleep A
id
Respira
tory
Hea
lth
Lifesty
le Dise
ases
Join
t Hea
lth
Others
0
1
2
3
4
5
6
7
8
9
10
CompletedOngoing
Num
ber
of S
tudi
es
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Vedic. Global Reach
Canada; 6France; 1
Germany; 2
Hong Kong; 3
India; 19
Malaysia; 1
Netherlands; 3
USA; 9
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Vedic. Clinical Research Papers
Papers published on Joint Health
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Vedic. Clinical Research Papers
Paper published on Sexual Health
Paper published for Pain Management
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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
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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
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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.
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Vedic. Key people21
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. • 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.
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Vedic. Key people22
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.
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Vedic. Organogram23
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Vedic. Social Media24
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India 203, Morya Landmark 1, Off new Link Road,
Andheri West, Mumbai 400053
Tel.: +91 22 42172300 / +91 22 42025719
USA552, Shorebird Circle, Unit #1101, Redwood
Shores, CA. 94065
Tel.: (650) 855-4832
[email protected], www.vediclifesciences.com
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