Our services

Global and Local Regulatory Affairs

Global Regulatory Affairs Support

Your Local Regulatory Affairs and Pharmacovigilance Office

Pre-launch activities:

  • Pricing & Reimbursement applications
  • General Proxy activities to AIFA
  • Request for the SIS code
  • AIFA Front End (registration and management)
  • Support for the preparation of the packaging material according to the approved texts
  • Optical stickers
  • Traceability requirements
  • Unifarm database (for bilingualism requirement fulfillment in the Italian province of Bolzano)
  • Farmastampati database (for stocks/selling out)
  • Appointment of the responsible person for Scientific Service
  • Notification of the launch date to the Italian Agency/other concerned official databases
  • Registration in the National Pharmacovigilance Network (“RNF”)
  • Support for compassionate use /early access programs (Law 648/96, AIFA 5% fund, Decree 8 May 2003 and Decree 11 February 1997)

Post-launch activities: