Regulatory Dossier Writing and Management Services

Experienced Technical Writers Providing Compliant Documentation

Regulatory writing is not only an essential part of the product development and the approval process, but it is also a skill that must be continuously refined as you gain regulatory knowledge and experience. With product approval on the line, RA dossier preparation should never be left in the hands of inexperience.

ProPharma Group’s expert consulting teams have experience writing within all five modules of the Common Technical Document (CTD). Our Chemistry, Manufacturing and Controls (CMC) experts, as well our Quality and Clinical experts, are involved in a broad spectrum of technical writing activities, such as:

  • Regulatory variations
  • Investigational Medicinal Product Dossier (IMPD)
  • Investigational New Drug (IND) applications
  • Investigator’s Brochure (IB)
  • Responses to regulatory authorities concerning pre-clinical and clinical technical documentation (e.g. IND/NDA, CMC, etc.)

We will advise and support the development and outline of your drug and device strategy, provide specific project management, select and interact with your CMO, and author your CMC, preclinical, clinical or technical documentation needed for regulatory submissions.  We also have a dedicated publishing team that provides high quality electronic submissions in all accepted formats (e.g. eCTD, NeeS) to the authorities. Our publishing services cover all regions worldwide and supplements our dossier writing with seamless submission to the Competent Authorities.

We perform both due diligence and GAP Analysis of existing dossiers, as well as compile new full applications and supplement existing applications with sections and modules, including summaries and overviews for:
  • Pharmaceutical medicinal products
  • Biologics and biotech products
  • Hybrids
  • Generics
  • Biosimilars
  • Orphan drugs (including Orphan Drug Designation applications and annual updates)