Navin Rajesh

Background

About Navin Rajesh

Currently working at Vimta Labs Ltd as Senior Manager, Toxicology, Pre-clinical division. Served as Head, Toxicology & Animal House at the Drug Discovery Research division of Orchid Chemicals & Pharmaceuticals Ltd, Chennai since 2002. Served at Jai Research Foundation, Vapi, Gujarat from 1998 to 2002. A total of 25+ years of experience in basic and regulatory research front, having experience in the field of nonclinical research towards hazard and risk assessment for pharmaceuticals, vaccines, agrochemicals and biosimilars. A core investigative member for evaluating and presenting safety data to DBT/ICMR/DCGI/FDA/EMA/WHO committees for various therapeutic research programs and till date succeeded with a number of products into clinical trials and towards global market approvals. Notable achievement in leading the pre-clinical toxicology team who developed Enmetazobactam, a novel betalactamase inhibitor, which is currently being marketed in Hong Kong and is approved in Europe for marketing. A member of various research project committees has several publications to his credit. Well acquainted with OECD-GLP and compliance driven process. Experienced in conducting due diligence inspections representing multinational pharmaceutical companies and performed leading role in collaborative research programmes with other R&D setups. Experienced in developing pharmacology models and mechanism based toxicity experiments, chemical carcinogenesis, toxicokinetics and ADME liabilities and generating non-clinical dossiers. Was a primary contributor to the planning and construction of the Pre-clinical Facility at Orchid Chemicals & Pharmaceuticals Ltd, which eventually became the first Indian GLP accredited Pharmaceutical Laboratory in India. Experienced in establishing and supervising in-house breeding programs for rodents such as Wistar, SD, Lewis and Brown Norway rats as well as Swiss albino, Balb/c, C57/BL6, DBA/1, DB/DB, OB/OB, nude and SCID mice and non rodents such as Beagle dogs, rabbit etc, in compliance with and CPCSEA guidelines. Navin 7708001768, navinrajesh@gmail.com