Presentation on theme: "Affordable, Credible, Efficient Research"— Presentation transcript:
1 Affordable, Credible, Efficient Research Preclinical, Safety and Quality Standardization Studies for NutraceuticalsAffordable, Credible, Efficient Research
2 Vedic. IntroductionA decade of experience as full and functional service CROWidest range of services for the Dietary Supplements, Nutraceuticals, Botanical Drug Products, Medical Foods, Natural Health Products, Cosmetics & Personal Care ProductsClinical & Preclinical studies for label claim substantiationCompliant data to meet regulatory requirementsStudies to check compliance with Dietary Supplement cGMPISO 9001:2008 certified
4 Vedic. PreclinicalPharmacological Screening studies - in vitro and in vivoToxicology and Safety studiesBioavailability studies for active ingredients and finished productsAnalytical DevelopmentFormulation DevelopmentCompleted 300+ studies (GLP and Non GLP)Drug Interaction Studies
7 Vedic. Preclinical Claim substantiation (Animal Pharmacology) Professionally drafted ProtocolsNumerous In vitro and In vivo models availableInvestigators with experience in specific fieldsWell maintained animal housesClose monitoringAuthentic data ensuring audit trailSpeedy data analysis, reporting, paper writingCo-ordination of multi-site projects
8 Vedic. Analytical Method Development & Validation Protocol Development as per International StandardsAnalytical Method Development.Measurement of Markers/Biomarkers for Research, Nutraceutical Products Development, using HPLC or LC/MSMSValidation of methods to FDA/EMEA (EFSA ?)guidelines in accordance with GLP/GCP regulations
10 Vedic. Partners Product Formulation Facility Test Item Control Unit Microbiology Laboratory
11 Vedic. Key peopleJayesh Chaudhary is Founder & Managing Director of Vedic Lifesciences. He has been involved in product development and international business since 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.
12 Vedic. Key peopleKunal Bhatt has 8 years of experience within the pharmaceutical industry, having ledseveral Global Phase I - IV drug studies in various capacities and diverse therapeutic areaslike Neurology, Psychiatry (Adult and Pediatric), Oncology, Diabetes, Urology and Cardiology.Masters in Pharmacology and Biotech from Sheffield Hallem University, UK, Kunal has workedin areas of Global Project Management, Clinical Operations and Regulatory. As a GlobalBusiness Development Manager his good business planning acumen and interpersonal relationshelp 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.