Dr. Mamta Gautam-Basak

Senior Technical Advisor, US Pharmacopeia

Industry/Field

FDA, Pharma

Bio

After 20+ years with FDA as a regulatory scientist, drug application reviewer, and CMC team lead, Mamta is excited to help the next generation of CMU entrepreneurs understand the complexities of drug development regulation so that they can build proactive strategies into their growth plans as early and efficiently as possible. I am fluent in all aspects of the regulatory process in drug development and have seen what happens when companies miss critical requirements and details.