We assist clients in litigation and out-of-court cases concerning regulatory aspects of drugs
Marketing Authorizations with reference to their:
- issuance;
- maintaining;
- revision;
- protection.
Furthermore, we offer assistance and consulting services on pricing systems, on classification for the reimbursement of drugs by the National Health Service.
We address our services to national and international companies requiring assistance in the following issues:
- antitrust;
- best practices and compliance (also in relation to national and international ethical codes, GMPs, GDPs and GCPs);
- contracts drafting (licenses, MA transfers, manufacturing, toll manufacturing, distribution, storage, co-promotion and co-marketing);
- joint ventures, company transfers and share transfers as well as all the extraordinary operations in the relevant field of industry;
- participating in public tenders;
- privacy;
- advertising, competition and parallel imports issues;
- relationships with regulatory authorities (AIFA – Italian Drug Administration, Ministry of Health);
- clinical trials.