The Firm offers its Italian and international Clients exhaustive legal counsel in all legal matters stemming from activities in the healthcare and life sciences sectors. Our lawyers have leading expertise in this field and adopt an innovative, dynamic and multidisciplinary approach to help Clients achieve their objectives.
- The Firm a substantial expertise in the regulatory framework governing the sale and distribution of medical devices, prescription medicines, over-the-counter medications, cosmetics, as well advertising and online marketing of medicinal products and medical devices, meetings and conferences in pharmaceutical matters, organization models and ethical code pursuant to Legislative Decree no. 231/2001.
- The Firm has a wealth of experience dealing with all legal issues surrounding clinical trials, as well as research and development of medicinal products, including the drafting of clinical trial contracts, the management of issues which can arise during the trial (for example free supply of medicinal products, compassionate use, etc.); pharmacovigilance and processing of health data; processing of personal data of healthcare professionals or patients.
- The Firm has leading expertise in drafting contracts addressing issues typically encountered in the health care sector, such as joint ventures and technology transfer agreements, development agreements, IP rights acquisition and licensing agreements, as well as agreements for the production, supply, distribution and co-marketing of pharmaceutical products.
- The Firm has extensive expertise in enforcing pharmaceutical patents; management of regulatory, administrative and environmental issues; public procurement; compliance and best practices regarding the marketing authorization and advertising of medicinal products and medical devices; issues related to the price and reimbursement of medicinal products; market access and relationship with the competent authorities (including the Ministry of Health, AIFA – the Italian Medicines Agency, and EMA – the European Medicines Agency).