Case Study: CMC Authoring for a Global Healthcare Company
Background – Client Needs:
A global healthcare company was in need of an end to end support for setting up a CMC Gap Analysis, Authoring and Publishing team for CMC related projects with a focus on the LATAM region.
The Client Faced the Following Challenges:
- Reviewing and reporting gaps in the CMC dossier according to the relevant regulatory requirements
- Authoring the CMC documentation
Project Initiation & Key Objectives:
The client chose to leverage Celegence’s team of domain experts for strategic regulatory consulting and management and subject matter expertise to provide continuous support for the CMC Gap Analysis, Authoring and Publishing activities.
Celegence Solution & Approach:
The Celegence team performed the following activities as part of this engagement:
CMC Authoring Project Achievements
Celegence has been successfully supporting this client in executing regulatory operations projects related to their regulatory writing, publishing, and submissions to the various health authorities.
CMC Authoring Success
Celegence provides the pharmaceutical industry with consulting services that are tailored to the evolving operational and strategic needs of manufacturers in areas such as RIMS data management, publishing, and medical writing. Get in touch today to discuss your regulatory needs by reaching out to email@example.com.