CMC regulatory affairs refers to the technical and regulatory aspects of drug development and production, which includes the chemical composition of the drug substance, its manufacturing process, and the controls in place to ensure its quality and consistency. CMC stands for Chemistry, Manufacturing, and Controls. CMC regulatory compliance is a process of governance that ensures CMC practices are carried out in agreement with regulatory agencies requirements and expectations. The CMC section of a regulatory submission typically includes information about the drug substance and drug product, such as their physicochemical properties, methods of manufacture, specifications, stability data, and analytical methods used to test the product. The CMC information is critical for regulatory authorities to assess the safety, efficacy, and quality of a drug and to determine whether it meets the requirements for approval and marketing authorization. CMC regulatory affairs and compliance is seen as a process of governance which ensures CMC practices are carried out in agreement with regulatory agencies requirements and expectations. CMC regulatory strategy is applied throughout the product lifecycle and is pivotal in ensuring that drugs and treatments being manufactured are safe, effective, and of high quality for patients.