Drug development is a highly complex task that is a scientific, data-driven, multi-disciplinary, and detail-oriented activity. It requires diligent and proactive planning and management to overcome many significant obstacles in the path of success. In the pharmaceutical industry, CMC (Chemistry, Manufacturing, and Controls) is a critical function in the successful development and commercialization of new drugs. Applied to biopharma programmes, these principles become CMC project management, with its own regulatory and manufacturing constraints.
In the pharmaceutical industry as a whole and, especially, start-up biotech companies, the reliance on a virtual drug development model that involves global outsourcing of CMC activities has greatly increased. As a result, proper and proactive management of the drug-development project is extremely important to ensure the success of the project measured by timely completion within budget and meeting regulatory expectations of quality and compliance.
