Our experience in the area of health-related law, and particulary in pharmaceutical law, began in the 1960s and has developed in parallel with the evolution of Italian and European regulation of the sector.

We have specialist expertise in assisting Italian and international clients in both contentious and non-contentious matters relating to the pharmaceutical, cosmetics and medical devices sectors. We advise researchers and companies at the forefront of innovative treatment and clinical, genetic, advanced therapy and biotechnology research in human healthcare and the veterinary and food sectors, our focus being mainly on regulatory issues and related litigation.

We maintain close ties with the Italian regulatory bodies (Ministry of Health, AIFI), Farmindustria (Italy’s main pharmaceutical industry association) and other associations and bodies representing the sector.

Combining a high level of experience and professional competence with a practical and interactive approach and with the support of the expertise of other departments in the firm (employment, administrative, IP, data protection, antitrust, etc.), our team delivers top quality service to our clients on a daily basis, with particular focus on:

  • Manufacture of medicines and related regulatory-administrative profiles (e.g., environmental)
  • Authorization for placing medicines on the market (Italian and European procedures) and related regulatory issues (“orphan” medicinal products, generic products, biosimilar medicines, parallel imports)
  • Investigator-initiated and company-sponsored clinical trials and observational studies concerning medicines and medical devices; research projects in the advanced therapy sector
  • Bio-ethical profiles of treatments and research (assisting and sitting as members on Ethics committees)
  • Promotion of and scientific information concerning medicines (for both human and animal use) and medical devices for health workers and the public; related contracts (co-marketing, co-promotion, market research, conventions, sponsorship, etc.)
  • Continual medical education (CME) and relevant certification
  • Regulatory compliance and pharmacovigilance; contracts, monitoring of collaboration with patients’ associations, officials and administrations (grants, research grants, donations); organizational models according to Law no. 231/2001, anti-corruption plans;
  • Public procurement procedures in the pharmaceutical and healthcare sectors
  • Extraordinary transactions and joint ventures between businesses in the sector; organization of public-private partnerships and of associations between research bodies
  • Medical malpractice
  • Dispute resolution in all civil and administrative jurisdictions; consultancy in criminal investigations.
Articles

09.2017Pubblicità dei farmaci: Linee Guida del Ministero della Salute 6 febbraio 2017 e 5 luglio 2017

2013 - The EU Regulation on cosmetic products: main changes and critical remarks, in Lexology, 5 luglio 2013
2013 - Medical device clinical investigations: new requirements for investigation sites in Italy, in Lexology, 5 luglio 2013
2013 - Il nuovo regolamento comunitario sui cosmetici: principali novità ed osservazioni critiche, in Diritto 24 - Il Sole 24 ore, 5 luglio 2013
2013 - Cosmetici, tracciabilità fino a tre anni, in Economia Web, 5 luglio 2013