The CMC Submission Team

The eCTD submission team works most effectively with the contributions of functionally-managed sub-teams (CMC, Nonclinical, Clinical, Labeling, and Regulatory Affairs/Publishing) and the dotted-line reporting to upper management through the Project Management Team.

In order to promote efficiency and effectiveness in the planning, preparation, and review of CMC submission documents, the CMC submission team should include active and responsible representatives, as follows:

• Authors: Subject matter experts and technical leads, assigned to each CMC section
• CMC Reviewers, i.e. key decision makers
• Representative(s) from the Contract Manufacturing Organization (CMO) who provides source documentation, some authoring of CMC sections, and review
• Regional partners (Europe, Japan, etc) to address regional differences
• Publishing/Regulatory Operations
• Regulatory Affairs, responsible for regulatory strategy and review

In addition, word-processing and editing assistance can be given to authors who need it through the functional areas (ideally) or by the publishing group.

It is recommended that the CMC sub-team meet on a regular basis, meeting weekly in the months preceding the submission.

CTD Quality Consulting would be happy to provide a complimentary call to discuss your current process and determine possible training needs that would improve your efficiencies in drug development.

- Dr. Michelle Herrera Foster, Ph.D., CTD Quality Consulting, 978-356-0872