Organization and Responsibilities of the Chemistry, Manufacturing, and Controls Function within Regulatory Affairs: A Survey of 17 Companies

Abstract

To facilitate management of the technical and regulatory Chemistry Manufacturing and Controls (CMC) issues within core dossiers, companies have turned to a range of organizational structures and procedures to manage the input most effectively. The objectives of this survey were to identify how companies have organized to provide regulatory strategy for the CMC sections of dossiers and to assess how, on a global basis, CMC documentation is created and reviewed. Seventeen of the top 30 United States- and European-based pharmaceutical companies participated in the survey.