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Preclinical, Safety and Quality Standardization Studies for Nutraceuticals AFFORDABLE, CREDIBLE, EFFICIENT RESEARCH Vedic. Introduction 2 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 3 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 4 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 5 Regulatory 23% Safety Testing 30% Analytical method Development 25% Preclinical Claim Substantiation 19% Formulation Development 3% Vedic. Toxicology 6 ACUTE TOXICITY SUB ACUTE TOXICITY TERATOGENICITY SAFETY STUDIES CARCINOGENICITY CHRONIC TOXICITY MUTAGENICITY 6 Vedic. Preclinical Claim substantiation (Animal Pharmacology) 7 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 8 Protocol Development as per International Standards Analytical Method Development. Measurement of Markers/Biomarkers for Research, Nutraceutical Products Development, using HPLC or LC/MSMS Validation of methods to FDA ( FTC )/EMEA ( EFSA) guidelines in accordance with GLP/GCP regulations Vedic. Formulation Development 9 STABILITY FINISHED FORMULATION TECHNOLOGY TRANSFER PILOT BATCH FORMULATION FEASIBILITY COMPATIBILITY ACTIVE INGREDIENT CHARACTERIZATION OR, DIETARY SUPPLEMENT CHARACTERIZATION PREFORMULATION 9 Vedic. Partners 10 Product Formulation Facility Test Item Control Unit Microbiology Laboratory Vedic. Key people 11 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 12 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 13 14 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