Before launching the EAP (once granted by the authorities)
Before launching an ATUc in France, Pharma Blue sets up a dedicated team (cellule ATU) and tools for the management of the ATUc.
Provided services include but are not limited to:
- Prepare technical agreements (TAs) between the ATU holder, Pharma Blue, the manufacturer as well as the distributor (or any other third parties) to clarify roles and responsibilities including SDEA for pharmacovigilance.
- Project management
- Initial review and approval of artworks and packaging components
- Setting up a dedicated team within Pharma Blue for the management of the ATO
- Setting up a database for the management of the ATU