We provide dossier preparation and follow-up services in line with TİTCK requirements for human medicinal products, from the marketing authorisation application through to all post-authorisation activities.
- Review of marketing authorisation application dossiers against TİTCK requirements
- Preparation and/or translation of marketing authorisation dossiers in CTD/eCTD format
- Follow-up of the preliminary review and authorisation procedures until the marketing authorisation is granted
- Technical support in completing information and documents requested by the authorisation committees
- Preparation of variation and renewal applications
- Preparation of marketing authorisation transfer applications
- Preparation and revision of the SmPC and PIL
- Preparation, conduct and reporting of PIL readability (user) testing
- Preparation of Module 2.4 and 2.5 overviews
- Preparation of analytical documentation
- Liaison with licensors and active substance manufacturers; obtaining CEP, DMF and GMP documents
- Preparation of documentation for on-site GMP and risk-based inspections
- Handling and follow-up of correspondence with the Ministry of Health
- Customs exemption, control certificate and import notification applications
