MAINTENANCE
The management of marketing authorisation documentation and regulatory compliance are becoming an increasingly important part of regulatory activities. We provide advice and support with the implementation of all measures associated with general concepts, including the assumption of all work, or certain aspects of them in case of capacity issues.
- Classification, processing and submission of national and European variations
- Annual Reports
- Processing, compilation and submission of line extensions
- Processing, compilation and submission of national and European renewal applications
- Submission of PSURs (PSUR repository, eSubmission Gateway)
- Sunset clause notifications (SSC notifications)
- Review of the validity of product information texts
- Review of conformity with manufacturing documents (regulatory compliance)
- Development of strategies for responding to deficiency letters