Ramnarayan Randad

Biography

Ramnarayan Randad is a Quality Assurance Leader and Master Review Chemist in the office of Life Cycle API, ONDP. In addition to the CMC reviews, he has served on number of working group such as Risk-Based Review, Complex Drug Substance, Question based Review (QbR), Quality by Design based QbR revision, the Office of Generic drugs Education and Training committee, DMF Completeness assessment team, Center for Science and advancement, and US Pharmacopeia monograph development committees. He has frequently represented Agency on CMC issues and regulatory science in public speaking engagements. He is an author of “FDA Drug Review and Regulation” to the “Burger’s Medicinal Chemistry, Drug Discovery and Development”. Prior to joining FDA, he worked in private sector for 15 years as a Research Chemist, Principal Investigator, Group Leader, and Director of Chemistry. He has authored more than 25 scientific papers in the peer reviewed journals and has >10 US patents to his credit. His work has led to the design and development of a drug lead. He received PhD from National Chemical Laboatory, Poona University, India in 1985. Soon after, he came to US as a Postdoctoral Associate of Prof. Herbert C Brown, Nobel Laureate, Purdue University Ramnarayan Randad is a Quality Assurance Leader and Master Review Chemist in the office of Life Cycle API, ONDP. In addition to the CMC reviews, he has served on number of working group such as Risk-Based Review, Complex Drug Substance, Question based Review (QbR), Quality by Design based QbR revision, the Office of Generic drugs Education and Training committee, DMF Completeness assessment team, Center for Science and advancement, and US Pharmacopeia monograph development committees. He has frequently represented Agency on CMC issues and regulatory science in public speaking engagements. He is an author of “FDA Drug Review and Regulation” to the “Burger’s Medicinal Chemistry, Drug Discovery and Development”. Prior to joining FDA, he worked in private sector for 15 years as a Research Chemist, Principal Investigator, Group Leader, and Director of Chemistry. He has authored more than 25 scientific papers in the peer reviewed journals and has >10 US patents to his credit. His work has led to the design and development of a drug lead. He received PhD from National Chemical Laboatory, Poona University, India in 1985. Soon after, he came to US as a Postdoctoral Associate of Prof. Herbert C Brown, Nobel Laureate, Purdue University

Research Interest

Structural Biology in Drug Discovery Immunology Generic Drugs Cancer Biology