EN PL

Post-authorisation

After medicinal drug product approval we can support the maintenance and Life Cycle Management of your products, including:

  • Strategy planning for single/grouped variation submissions,
  • Preparation of dossier for variation procedures in CTD/eCTD/NeeS format,
  • Preparation of Expert reports for variations – Quality Overall Summary, Preclinical and Clinical Overview, Preclinical and Clinical Summary,
  • Preparation of documentation for the purpose of renewals or withdrawals,
  • Variation procedures monitoring in national and European procedures,
  • Annual fees monitoring,
  • Communication with Competent Authorities,
  • MAH transfer proceeding,
  • Sunset clause exemption submissions/managing,
  • Ongoing tracking of changes in legislation, including active participation in the public consultation concerning the new version of the legislative acts, guidelines and procedures.