Regulatory Consulting Services

Human Medicinal Products

Regulatory consultancy in the entire lifecycle management of a medicinal product starting to the submission of a marketing authorizations until the implementation of the required changes in order to take account of technical and scientific progresses:

  • Medicinal product registration: applying for EU marketing authorisation (National, MR and DC Procedures) and Extra-EU marketing authorisation, and relative management throughout the authorization process;
  • Drug life-cycle management: Setting up and submission of the type IA, IB, II, Line Extension variations, AIC transfer practices and Renewals;
  • Due diligence and gap analysis of Module 3;
  • NTA file conversion for the registration in Nees or eCTD format;
  • Preparation of SmPC (summary of product characteristics) package leaflets and labels according to the current guidelines;
  • Preparation of Bridging Report for package leaflets;
  • Preparation of dossiers in digital format to support applications for reimbursement and pricing for the negotiation of equivalent/biosimilar medicines;
  • Certificate of Pharmaceutical Product (CPP) application;
  • Assessment of regulatory compliance of medical and scientific information materials;
  • Ministry of Health procedure management related to narcotic drugs and psychotropic substances authorizations.