Project Description

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:

  • Regulatory planning and execution for different projects related to the CMC variations, renewals, and line extensions
  • Regulatory writing and formatting of Module 3 as well as other documentation related to the submission
  • Implemented the BPaaS (Business-Process-as-a-Service) model of IT tools and processes to execute projects
  • Backfilling the business resource needs to support ongoing projects and regulatory affairs activities

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.

  • Celegence’s in-depth knowledge of regulatory business processes helped to set up the delivery team for this client quickly, and were able to meet all project timelines for variations and renewals.
  • In this project, the BPaaS delivery model was leveraged wherein Celegence takes the responsibility of setting up the IT tool. This, along with the maintenance, vendor management, Publishing and Submission processes, and document archiving related to the dossiers was all handled by the Celegence team.

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 info@celegence.com.

Get in touch today to discuss your regulatory needs by reaching out to info@celegence.com or contact us online. Find out more information on Celegence’s medical writing service.

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