Regulatory Affairs




  • 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 authorization

    Regulatory support for interventional and observational clinical trials performed in Italy