CMC, or Chemistry, Manufacturing, and Controls, plays an important role in the new drug development process by ensuring that a drug can be consistently produced with the required quality, safety, strength, purity, and stability. During the phases of pharmaceutical development, CMC activities cover areas such as drug substance development, formulation, manufacturing processes, analytical methods, specifications, packaging, and stability testing. In the early stages of the drug discovery and development process, CMC helps researchers understand the physical and chemical properties of a drug candidate and develop a suitable formulation and manufacturing approach. As the candidate moves into preclinical and clinical development, CMC work becomes more detailed to support reliable production of material for clinical studies. Analytical testing is also used to monitor impurities, identity, potency, purity, and other quality attributes. As development progresses, the manufacturing process is refined and supported with appropriate controls and documentation for regulatory submissions. Therefore, CMC is a key part of the overall drug development process in clinical research, helping ensure that the drug being tested and eventually supplied to patients is consistently manufactured and meets established quality requirements.