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.