A vital reference book for professionals in the industry as well as sponsors of human clinical trials and clinical research organizations, Regulatory Compliance for Biologics and Drugs features: examples of forms on how to write specific process deviations (that the FDA find acceptable), how to implement an effective document change control system, and an effective strategy on investigating a sterility test failure. The book covers specific topics related to regulatory compliance with relevant background information in a clear, concise, and authoritative manner. Situations that are complex and highly interpretive are explained using real experiences. Features also include sections on how virtual companies can deal with contract manufacturing and testing.