IndoUSrare is proud to host an upcoming webinar on “Chemistry, Manufacturing, and Controls (CMC) in Drug Development.” Our expert speaker, Partha S. Mukherjee, Ph.D., Head of CMC Analytical Development at Amicus Therapeutics Inc., will share his invaluable expertise.
Join Harsha Rajasimha, Ph.D., Founder & Executive Chair of IndoUSrare, as he guides this in-depth discussion on the latest trends and advancements in drug development.
Webinar Abstract:
Chemistry, Manufacturing, and Controls (CMC) ensures product safety and quality by defining manufacturing practices and product specifications. Starting after a lead compound is identified, CMC continues through all stages of drug development to approval and covers post-approval changes. CMC standards maintain consistency in identity, safety, quality, stability, purity, and potency between clinical trial products and commercial batches.