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- 360-degree support to companies already operating – or wishing to start operating – in the Italian market for all activities needed to satisfy local requirements:
- SIS code
- Access to AIFA Front End system
- Appointment of the representative/distributor in Italy
- Appointment of a proxy at Health Authorities
- Scientific Service
- Regional obligations
- Regulatory revision of the Italian SPC, labelling, PIL and artwork
- Updating of national databases following SPC/PIL variations
- Management of texts for compliance with the bilingualism project (Farmarete) and with Farmastampati
- Management of “bollino” orders
- Traceability: expert support for resolution of issues; hands-on management of daily data transmission to the MoH database
Regulatory activities required for maintenance of marketing authorizationRegulatory support for interventional and observational clinical trials performed in Italy
