Due Diligence Assessment of CMC Activities

October 16, 2020

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

Pharmaceutical Technology, Pharmaceutical Technology-10-15-2020, Volume 2020 eBook, Issue 3

Pages: 26–28

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.

Read this article in Pharmaceutical Technology's Regulatory Sourcebook October 2020 eBook.

Article Details

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).