Our team of lawyers has solid expertise in medical and pharmaceutical law. Our interventions mainly cover:
- Consultancy in healthcare and pharmaceutical regulation, including compliance with ANMDMR rules;
- Support for obtaining or amending the necessary authorizations, as well as in authorization procedures for medical products and devices;
- Advice on medical matters: co-payment, malpractice, clinical trials, insurance, patient relations;
- Drafting and reviewing commercial contracts (distribution, services, etc.) and internal documentation (working procedures, compliance policies);
- Assistance in the application of legal requirements concerning labelling, declarations of conformity and instructions for use of medical devices and equipment;
- Support in contractual negotiations (with distributors, service providers, partners, financiers), as well as for the conclusion of collaboration agreements, leasing, acquisitions or outsourcing;
- Legal representation before administrative authorities (ANMDMR, DSP, etc.) and courts, in commercial disputes and malpractice cases;
- Assistance in inspections and controls carried out by health or competition authorities.
