Human medicines
Our unit dedicated to regulatory activities for human medicinal products is made of qualified professionals with wide expertise in this sector. The services offered in this area ensure full assistance over the whole life cycle of the drug.
The main services offered are:
- Feasibility studies and regulatory intelligence
- Consultancy on dossiers and authorisation procedures for human medicines
- Consultancy on product information and readability testing of human medicines
- Consultancy on price dossiers and reimbursement
- Drug traceability, antifraud stickers and serialisation
- Free Sale Certificates and Certificates of Pharmaceutical Product
- Consultancy on manufacturing sites and audits
- Promotion and scientific information
- Pharmacovigilance
- Clinical Trials
- ASMF Submission to EDQM in order to obtain CEP
