William J. Lambert, PhD, is principal, Module 3 Pharmaceutical Consulting, Incline Village, NV.

William J. Lambert

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's Regulatory Sourcebook


eBook: Regulatory Sourcebook
October 2020
Pages: 26–28

When referring to this article, please cite it as W. Lambert, “Due Diligence Assessment of CMC Activities," 

Pharmaceutical Technology Regulatory Sourcebook

Articles

For planned acquisitions or licensing, a careful analysis of CMCl factors is vital to ensure no problem areas are overlooked. 