Slide 1

Report
Preclinical, Safety and Quality
Standardization Studies for
Nutraceuticals
AFFORDABLE, CREDIBLE, EFFICIENT RESEARCH
Vedic. Introduction
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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 & Preclinical studies for label claim substantiation
Compliant data to meet regulatory requirements
Studies to check compliance with Dietary Supplement cGMP
ISO 9001:2008 certified
Vedic. Services
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Regulatory
Dossier
Preparation
&
Consulting
Preclinical
Formulation
and
Standardization
Toxicology
Clinical
In vitro
&
In vivo
Animal
studies
Human
Bioavailability
Studies
Human
Clinical
Studies
Medical
Writing
Vedic. Preclinical
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Pharmacological Screening studies - in vitro and in vivo
Toxicology and Safety studies
Bioavailability studies for active ingredients and finished
products
Analytical Development
Formulation Development
Completed 300+ studies (GLP and Non GLP)
Drug Interaction Studies
Vedic. Pre Clinical
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Regulatory
23%
Safety Testing
30%
Analytical method
Development
25%
Preclinical Claim
Substantiation
19%
Formulation
Development
3%
Vedic. Toxicology
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ACUTE
TOXICITY
SUB
ACUTE
TOXICITY
TERATOGENICITY
SAFETY
STUDIES
CARCINOGENICITY
CHRONIC
TOXICITY
MUTAGENICITY
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Vedic. Preclinical Claim substantiation
(Animal Pharmacology)
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Professionally drafted Protocols
Numerous In vitro and In vivo models available
Investigators with experience in specific fields
Well maintained animal houses
Close monitoring
Authentic data ensuring audit trail
Speedy data analysis, reporting, paper writing
Co-ordination of multi-site projects
Vedic. Analytical Method Development
& Validation
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Protocol Development as per International Standards
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Analytical Method Development.
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Measurement of Markers/Biomarkers for Research, Nutraceutical
Products Development, using HPLC or LC/MSMS
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Validation of methods to FDA ( FTC )/EMEA ( EFSA) guidelines in
accordance with GLP/GCP regulations
Vedic. Formulation Development
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STABILITY
FINISHED
FORMULATION
TECHNOLOGY
TRANSFER
PILOT BATCH
FORMULATION FEASIBILITY
COMPATIBILITY
ACTIVE INGREDIENT CHARACTERIZATION OR,
DIETARY SUPPLEMENT CHARACTERIZATION
PREFORMULATION
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Vedic. Partners
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Product Formulation Facility
Test Item Control Unit
Microbiology Laboratory
Vedic. Key people
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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.
Vedic. Key people
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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.
Dr. Vijay Gokarn has 7yrs of experience in herbal & pharmaceutical research industry. Proficient
in analytical method development & validation with proven expertise for standardization of single
& multiherb preparations & preclinical bioassays. A PhD degree in Analytical Chemistry on
Standardization of Botanicals from the University of Mumbai, he heads the Preclinical- Technical
Department as Asst. Project Manager- Technical. Dr. Gokarn supports the group in advanced
scientific standardization, validation & process development services in the field of
Phytomedicine, Nutraceuticals & Ayurvedic preparations.
Vedic. Social Media
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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
[email protected], www.vediclifesciences.com

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