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For planned acquisitions or licensing, careful analysis of CMC factors ensures 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
eBook: Regulatory Sourcebook
When referring to this article, please cite it as W. Lambert, “Due Diligence Assessment of CMC Activities," BioPharm International Regulatory Sourcebook eBook (October 2020).