Partnering with Your CDMO for CMC Preparation


Collaborative partnering between Contract Development and Manufacturing Organizations (CDMO) and the drug product submission applicants (Applicant) is becoming increasingly important with the emphasis on product design by regulatory agencies. The CDMO can provide the appropriate resources to build the scientific knowledge base for the product and the depth of science‐based information for the drug design and development that are required in the CMC sections of the application.

Partnering with a CDMO offers several benefits, including:

  1. CDMOs can provide the essential scientific, manufacturing and quality control module preparation and review services
  2. CDMOs can provide the scientific basis for the Pharmaceutical Development Report
  3. CDMOs have the unique product and process knowledge
  4. CDMOs are most knowledgeable about their components equipment and processes

Finding the right CDMO relies on each CDMOs knowledge, experience with report preparation and the level of support they can provide the applicant. With the right partner, leveraging the product knowledge base of the CDMO for the preparation of the CMC sections can significantly improve the quality of the submission.