Submission and liaison

Dossier submission is a critical step in the approval process. Ensuring regulators have the required information in the correct format at the right time is key to the process. It is also vital feedback from regulators is communicated to product development teams.

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 meet the requirements of 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