Chemistry, Manufacturing, and Controls (CMC) plays a pivotal role in the development, licensing, manufacturing, and ongoing marketing of pharmaceutical products. CMC professionals help ensure that pharmaceutical products are consistently effective, safe and high quality for
To conduct clinical investigations and market pharmaceutical products, pharmaceutical companies are legally required to obtain and maintain regulatory approvals. Regulatory Affairs is a discipline and strategic function within the overall organizational structure of a pharmaceutical company that directly interacts with government regulatory agencies concerning regulatory approvals. The Food and Drug Administration (FDA), European Medicines Agency (EMA), Japanese Pharmaceuticals and Medical Devices Agency (PMDA), for example, are government regulatory agencies typically involved in the approval process. Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs
(RA) is a specific area within RA that has the ultimate responsibility for providing CMC regulatory leadership and strategy required to achieve regulatory approvals. As a strategic function, CMC RA collaborates closely with multiple scientific, technical, quality, and commercial areas within a company or with external contract manufacturing organizations (CMOs). To help companies effectively and efficiently achieve regulatory approvals, CMC Regulatory Affairs provides knowledge, understanding, interpretation and utilization of regulatory guidances and regulations, as well as industry and government agency best practices and trends.