Regulatory Dossier Writing

We understand that a consistent and compliant regulatory dossier is the key to obtaining timely clinical trial approval and smooth marketing authorisation (MA). However, the path to approval may be burdensome. That’s where our dossier development team comes in, helping you to accelerate the drug approval process.

For more than 20 years we have focused on Chemistry, Manufacturing & Control (CMC) subjects, hence we can offer you in-depth knowledge, insight and unparalleled experience.

Our regulatory dossier writing and formatting services include:

  • Focus on module 3 and 2.3-2.7 quality sections for IMPD, IND and full MA or NDA
  • Expertise to adapt level of detail according to all development phases (phase 1-4)
  • Ability to cover all territories (US FDA, EMA, Canada, Japan Brazil, Row)
  • Electronic common technical document (eCTD) compilation and reformatting
  • Readability testing and writing of patient leaflets
  • Translations