With a mixed public-private healthcare system, Italy attracts medicinal products or device manufacturers from across the globe. At the same time, the requirement for controlled drug / device releases in the market necessitates foreign manufacturers to be more vigilant on the regulations imposed by the Ministry of Health. While Agenzia Italiana del Farmaco, AIFA - the Italian Medicines Agency - is responsible for drug regulations, medical devices are regulated by European Union’s competent authorities.

Freyr, as a global regulatory partner, assists foreign manufacturers in interpreting the Italian regulations and advises them on Regulatory strategies to be implemented for the region for compliant market authorizations. With streamlined and quicker submission procedures, Freyr provides Regulatory support and consulting services in Italy for:

  • Medical Devices
  • Drugs
  • Biotech
  • OTC
  • Cosmetics

Freyr Offerings

  • Strategic Regulatory Consulting
  • Regulatory Affairs & Regulatory intelligence
  • End to end support for CE Marking Process
  • Redaction of EU CTD dossiers, including preparation of NeeS and eCTD dossiers
  • Lifecycle management of medicinal products: updates, variations and renewals
  • IDMP
  • Pharmacovigilance
  • National and European registration and maintenance procedures (MRP and Centralized)
  • In-country representation

Freyr Advantages

  • Strategic and well-versed local regulatory knowledgebase - with Italian Ministry of Health
  • Expert Regulatory team with proven global RA expertise
  • Proactive and Collaborative approach
  • Quick turnarounds and faster time-to-market
  • Keeping abreast with region-specific legislation and Regulatory guidelines