Regulatory Writing

The MMS regulatory writing team specializes in the preparation of CTD components of regulatory submissions. We have drafted Module 2-5 documents for more than 50 regulatory submissions over the last five year period and continue to support many of our clients with repeat submission activities. In addition, we have strong experience with many regional Module 1 regulatory documents.

Our areas of expertise include:

  • Strategic positioning of data and messages for the various regulatory agencies receiving the Common Technical Document (CTD)
  • Expertise and understanding of the division-specific requirements to aid and speed the review of the CTD
  • Distinction for Japan, Canada, Europe and ROW countries for various strategic elements of the CTD including but not limited to exposure, adverse events and laboratory parameters
  • Effective and clear positioning of Clinical Overview document that sets your CTD apart from others
  • Expertise in special safety topics for various indications and specialized discussion and referencing of these topics as appropriate within the CTD
  • Proprietary processes for effective 505(b)(2) submissions
  • Effective positioning of the Risk Management plan within the context of the CTD
  • Easy adaptation to future applications (sNDAs, MAAs and other regional applications)

Document Deliverables

  • ISS, ISE, Modules 2-5 documents for CTD
  • Product Monographs and Core Data Sheets (CDS)
  • Summary of Product Characteristics (SmPCs)
  • Briefing documents for agency meetings (Click here to register and request our documents in the public domain)
  • Expertise in special safety topics for various indications and specialized discussion and referencing of these topics as
  • Risk Management Plans (RMPs)
  • Investigator Brochures
  • Orphan Drug Applications
  • Fast Track Requests
  • Pediatric Study Plans

Regulatory Submission Support Based on Strong Science and Strength of Process. We Do Data Best!

Contact Us Today!