Monograph Development: How to Participate; How to Harmonize

J. Mark Wiggins

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

Joseph A. Albanese

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

This article details the more operational aspects of monograph submissions, answering the question of how to participate.