Healthcare and Pharmaceutical
For many years, the healthcare sector has been a key focus of the firm’s practice. The team dedicated to the healthcare and pharmaceutical sector is led by a partner with more than 25 years of experience in the support to the pharmaceutical industry. Our lawyers have a deep knowledge about the national and international regulation applicable to this highly regulated sector and are familiar with its specific problems.
From the main practice area of support to the pharmaceutical industry, the team has in the last few years expanded its activity to the advice and support to the medical devices, cosmetics and advanced therapy medicinal products (cellular, genetic or tissue therapy) sectors.
Lawyers
Main areas of advice:
- Advertising of medicines and medical devices
- Clinical trials
- Protection of formulae and other inventions (know-how and patents)
- Pharmacovigilance
- Mergers and acquisitions (M&A) in the pharmaceutical industry
- License, agency, supply, distribution, joint-venture and co-promotion agreements, related with medicines, medical devices and cosmetics
- Commercial agreements with wholesalers and other market players
- Permits for pharmacies
- Authorizations for advanced therapy medicinal products (cellular, genetic or tissue therapy)
- Labelling and information leaflet of medicines and medical devices
- Contacts with regulatory authorities, in particular with Infarmed