Ramesh SUBRAMANI

Toxicology, Pharmacology, and Regulatory Affairs

Dr. Ramesh Subramani is a veterinarian, certified Regulatory Professional, and a certified Toxicologist and Pharmacologist with two decades of experience in the pharmaceutical industry, GLP, and non-clinical CRO projects. He is an expert in regulatory strategies and safety assessments for small molecule New Chemical Entities (NCEs) and reformulated (505b2) drugs. He has a proven track record in rapidly transitioning early-phase drugs into clinical development (IND) and subsequent approval (NDA). He has led non-clinical safety programs for several novel and reformulated drugs and has been responsible for over 100 IND/NDA submissions, including oral solids, injectables, topical preparations, and ophthalmic drugs.

He provides strategic and tactical leadership on toxicology issues impacting drug development programs. He possesses extensive experience in toxicological risk assessment of chemicals/drugs, environmental risk assessments, evaluation of extractables and leachables, computational toxicology assessments, qualification of organic and inorganic impurities/excipients, nitrosamines, and the establishment of limits for genotoxic/carcinogenic compounds.

Currently, he serves as President of Regulatory and Non-Clinical Consultancy, advising start-ups on non-clinical development and regulatory strategies. Previously, he held positions as Senior Toxicologist (SME) at pharmaceutical companies and CROs, including Advinus Therapeutics Ltd., Vivo Biotech, Dr. Reddy’s Laboratories, and Eurofins Scientific.