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.
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.
