top of page
Chemistry, Manufacturing, and Controls (CMC)
Regulatory activities related to ensuring that the product is manufactured according to approved specifications.
Implications
A critical aspect of pharmaceutical development that ensures a drug�s chemistry, manufacturing processes, and quality controls are consistent and meet regulatory standards, often essential for drug approval and commercialization.
Example
Example: A pharmaceutical company focuses on Chemistry, Manufacturing, and Controls (CMC) to ensure that its new drug formulation meets all quality and regulatory standards before submitting for FDA approval.
Related Terms
Different from clinical trials, which test the safety and efficacy of a drug, CMC ensures that the drug is produced consistently and meets all necessary quality standards for commercialization.
Get INSTANT comprehensive market research of any industry
Chat with AII Consultant Now!
bottom of page