Mamta Gautam-Basak

Mamta currently serves as a senior technical advisor for US Pharmacopeia's Promoting the Quality of Medicines program, a USAID-funded initiative that helps low- and middle-income countries improve the systems that ensure the quality of and increase the supply of priority medicines. In this role, she provides technical oversight and direction to all global implementation activities related to regional and country regulatory systems.

Prior to USP, Mamta spent 20+ years with the Food and Drug Administration (FDA) working in various scientific and regulatory roles primarily within the Center for Drug Evaluation and Research (CDER). She was consistently recognized for her ability to bring technical insight to regulatory, policy, quality, and compliance challenges for global pharmaceutical manufacturers specifically focused on product development and regulatory submission processes for INDs and NDAs. She is able to provide CMC guidance for pre-IND, EOP2, pre-NDA, market approval, and post-approval life cycle management of drug products and advise how to make the operation process of drug development more intelligent and cost-effective while navigating regulatory requirements.

Mamta earned her PhD in analytical chemistry from the Indian Institute of Technology-Delhi and her MSc and BSc in chemistry from the University of Delhi. She also earned a post-graduate diploma in chemistry and chemical engineering from the Tokyo Insitute of Technology where she was one of two people selected from India and one of fourteen worldwide selected to participate in a UNESCO-sponsored fellowship with Japan's Ministry of Health.