For planned acquisitions or licensing, a careful analysis of CMCl factors is vital to ensure no problem areas are overlooked.
Developing comprehensive chemistry, manufacturing, and controls programs are crucial to the success of a drug product. For planned acquisitions or licensing, a careful analysis of these critical factors is vital to ensure no problem areas are overlooked. Strategies for carrying out an effective due diligence exercise are described.
Pharmaceutical Technology eBook: Regulatory Sourcebook October 2020 Pages: 26–28
Citation
When referring to this article, please cite it as W. Lambert, “Due Diligence Assessment of CMC Activities," Pharmaceutical Technology Regulatory Sourcebook eBook (October 2020).
