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Regulatory Affairs

LEF is a provider of Regulatory Affairs services to both National and European pharmaceutical industry companies. Regulatory compliance growing complexity requires growing focused and skilled resources. Our commitment is to proactively ensure the quality, efficacy and safety of your products.

The integration of Regulatory Affairs services in the organization allows a greater efficiency towards problem solving solutions, shortening time to peak-sales.

Services: ​Human Medicines and Veterinary Medicines
  • Consultancy in RA
  • Pre-MA activities:   
    • ​Preparation of MA (M1-M5);
    • Submission and follow-up of National, Mutual Recognition and Decentralised Procedures.
  • Post-MA activities:
    • MA Variations;
    • MA Renewal;
    • Price and Reimbursement;
  • Pharmacovigilance activities.

Other services
  • Quality Expert Reports;
  • Non-Clinical Expert Reports;
  • Clinical Expert Reports;
  • Readability testing / Bridging Report.

Health Products
  • Technical documentation;
  • Notification for the placing on the market;
  • Management post-market activities.