Regulatory affairs
- Complete registration of medicinal products and services in particular registration procedures
- MRP/RMS or CMS and Decentralised procedure (DCP), National procedure
- Comparison and harmonisation of SmPC for MRP/DCP
- Reformatting the NtA to CTD and conversion to eCTD
- Contact person for Pharmacovigilance
- Overview (Quality, Non Clinical, Clinical) for Module II
- Electronic Submission Outsourcing
- Coordination of DCP slots