Regulatory dossier writing

We understand that a consistent and compliant regulatory dossier is mandatory to obtain timely clinical trial approval or smooth marketing authorisation (MA). However, the way 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)
  • eCTD or NEES compilation and reformatting
  • Readability testing and writing of patient leaflet
  • Translations

Our regulatory dossier submission services include:

  • All European procedures
  • Follow-up and monitoring of registration up to receipt of the MA (incl. national finalisations to each individual EU country if needed)

We also offer post-marketing dossier maintenance, including:

  • MA maintenance and transfer
  • Minor and major variations
  • Renewal of MA
  • Periodic Safety Update Report (PSUR) compilation
  • Full life cycle management of MA
  • Compliance to XEVMPD and ISO IDMP