From EAP application preparation until granted by ANSM
Pharma Blue provides advice and support for filing the ATUc application to ANSM and can be designated as “Exploitant” in the ATU application.
Provided services include but are not limited to:
- Prepare the ATU application including the protocol for therapeutic use (PUT), application form, SPC, leaflet & label in French.
- Provide ad-hoc advice or respond to specific questions, including strategy and/or positioning of the ATUc programme.