Authorization dossiers, SmPC & PL, clinical and non-clinical reports
Science and regulation, on one platform
An experienced team follows your product through the safety and market-access stages as well. A decision made at authorization stays defensible in the reimbursement dossier.
- 01.2.1
Authorization and approval dossiers
Dossier preparation in CTD format, submission management and follow-up of authority correspondence
- 01.2.2
SmPC & PL preparation, clinical / non-clinical reports
Preparation and revision of the Summary of Product Characteristics and Package Leaflet in line with current guidelines