AMTF Avvocati assists pharmaceutical and biotechnology companies, technology startups, manufacturers of medical equipment and devices, public and private hospitals, clinics, and other suppliers in the medical, diagnostic, and pharmaceutical sectors in contractual and compliance matters as well as in litigation.

Among other things, we handle all stages of product marketing, both to public and private customers (from the simplest to the most complex RIS/PACS systems). We provide timely advice on regulatory, contractual, and compliance issues, ensuring reliable solutions in a constantly evolving regulatory environment.

Main services

  • Consultancy on authorization and marketing authorization procedures
  • Consultancy on distance selling advertising for effective communication, including through influencers, including the authorization process for promotional messages with the Ministry of Health.
  • Support in participating in tenders for hospital supplies, to SN entities, and in the execution of contracts
  • Assistance in joint ventures and extraordinary transactions in the medical and pharmaceutical sectors
  • Drafting and negotiation of distribution and supply agreements, co-promotion, fostering, distribution, agency, production license
  • Intellectual property protection, with a particular focus on patent protection and trade secrets, as well as trademark portfolio management
  • Management of administrative and civil litigation
  • Consulting on regulatory and legal compliance
  • Consultancy on biological, chemical, originator, biosimilar, and generic drugs, including in tender procedures and relations with entities in the supply chain
  • Assistance in activities related to drug distribution, such as subsidized distribution, direct distribution, and DPC
  • Ordinary and precautionary litigation before ordinary judicial authorities, national and EU administrative litigation (Regional Administrative Court, Council of State, Court of Justice of the European Communities)
  • Consultancy on new technologies applied to the sector and regulatory issues related to the processing of patients' personal data (AI, IOMT, telemedicine and remote diagnostics, health apps)

Approach

Our team offers a multidisciplinary service, attentive to technological innovations and the specific needs of the sector. Our extensive experience, interest in understanding the technical specifications of individual products, and ability to anticipate critical issues enable us to offer effective solutions, building a relationship of trust with each customer.

Experience and method

We supported a medical device company in obtaining authorizations and participating in a public tender, ensuring regulatory compliance and the commercial success of the operation.