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 (including Rx to OTC switch),
- 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,
- MA Transfer,
- Ongoing tracking of changes in legislation, including active participation in the public consultation concerning the new version of the legislative acts, guidelines and procedures,
- Medical informarion.