The healthcare and life sciences sector is evolving rapidly, driven by technological and scientific advancement, therapeutic innovation, increasing use of data, and integration between public and private operators. In this context, managing regulatory complexity has become a competitive factor. Authorizations, contracts, testing, and risk management require coordination between specialized skills. We assist operators in the National Health Service, accredited providers, private healthcare groups, and companies in the healthcare sector (pharmaceuticals, medical devices, healthcare services and technologies) both in their day-to-day activities and their extraordinary operations.
WHAT WE DO
- Regulatory affairs and compliance (MDR/IVDR, market surveillance, Italian Leg. Decree 231/2001, data protection)
- Public contracts and specialized contract development: tenders, framework agreements, outsourcing, supply and services
- Data and digital health: GDPR, telemedicine, cybersecurity
- R&D and collaborations: research contracts, licensing, technology transfer
- Acquisitions, restructurings, joint ventures
- Disputes and crisis management: inspections, litigation, regulatory/commercial disputes