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