MedWisdom LifeScience specializes in navigating the complex regulatory landscape in Italy, a pivotal market for global medicinal products and medical device manufacturers. With Italy’s mixed public-private healthcare system, stringent regulations overseen by the Ministry of Health demand meticulous attention from foreign manufacturers.

While drug regulations fall under the purview of Agenzia Italiana del Farmaco (AIFA), medical devices adhere to the directives set forth by the European Union’s competent authorities. MedWisdom LifeScience offers expert Regulatory Affairs guidance, assisting foreign manufacturers in deciphering Italian regulations and devising strategic approaches for compliant market authorizations. Our services include streamlined submission procedures and comprehensive Regulatory support tailored to meet the specific needs of entering and maintaining compliance in the Italian market.

Medwisdom Lifescience offerings

• Strategic Regulatory Service
• Regulatory Affairs & Regulatory Intelligence
• CE Marking Process Support
• EU CTD dossiers, including preparation of NeeS and eCTD dossiers
• Lifecycle management of medicinal products
• Pharmacovigilance System
• National and European registration and maintenance procedures (MRP and Centralized)