Dr. Lopa Bakrania has 18 years of pharmaceutical process chemistry and CMC regulatory affairs experience. She is the Executive Director and Head of CMC Regulatory Affairs at Biohaven. Prior to ...

Students learn how to manage everything from pre-clinical IND-enabling studies to product licensure, and into post-approval life cycle management, post-approval change reporting categories, ...

Executing CMC strategies involves managing challenges to ensure compliance with evolving ... to meet regulatory trends and implement best practices in the manufacturing space. Navneet Kaur is a senior ...