Ramesh SUBRAMANI

Toxicology, Pharmacology and Regulatory

Dr. Ramesh Subramani is a Veterinarian, board-certified Regulatory Professional and board-certified Toxicologist & Pharmacologist with two decades of pharmaceutical industry, GLP and non-clinical CRO experience. He is an expert in regulatory strategy and safety assessment of small molecules of new molecular entities (NCE) and reformulated (505b2) drugs. He has a track record of rapidly moving early-stage drugs into clinical development (IND) and eventual NDA. He has managed non-clinical safety programs for several new and reformulated drugs and was responsible for over 100 IND/NDA, including oral solids, injectables, topicals and ophthalmic drugs.

He provides strategic and tactical leadership on toxicology issues affecting drug development programs. He has extensively worked on toxicological risk assessment of chemicals/drugs, environmental risk assessment, evaluation of extractables and leachables, computational toxicology evaluations, qualification of organic and inorganic impurities/excipients, nitrosamines and setting limits for genotoxic/carcinogenic compounds.

He is currently president of Regulatory and Non-Clinical Consultancy and provides advice to start-ups on non-clinical development and regulatory strategy. He previously held Senior Toxicologist (SME) positions with pharmaceutical companies and CROs including Advinus Therapeutics Ltd., Vivo Biotech, Dr. Reddy’s Laboratories and Eurofins Scientific.