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.