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.
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, NDS and other regional applications)
- 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)
Regulatory Operations & Supporting Technologies
MMS provides high quality and region specific regulatory submission support using validated document management and eCTD systems. Throughout the submission authoring and compilation process, we proactively use our established systems to streamline activities, incorporate efficiencies, and work on multiple applications types in parallel to meet regulatory submission strategies.
MMS utilizes a SharePoint-based document management system to manage, organize and connect regulatory documents in a compliant, efficient and easy to use way. This document management system provides support for the whole document lifecycle from the inception and authoring, up to the submission and archiving of regulatory documents.
MMS uses Lorenz Docubridge to build, view, validate and publish compliant submissions based on CTD, eCTD, NeeS, IMPD, CTA, NeeS, DMF, ASMF and other submission structure requirements. The Docubridge system used by MMS meets requirements for eCTD and non-eCTD submissions, whether electronic or paper. An integrated validation function also ensures compliance of the submission to ICH and regional specifications.