Monograph Development: Why and When to Participate

March 15, 2020

J. Mark Wiggins is owner and compendial consultant with Global Pharmacopoeia Solutions LLC.

Joseph A. Albanese

Joseph A. Albanese, director of Analytical Strategy and Compliance at Janssen Research and Development, LLC

This article explores a proactive advocacy approach that a bio/pharmaceutical company may take through participation in the development of new and revised monographs in the various pharmacopoeias.