We thrive on our innovative and tailored approach to consultancy. To ensure that our legal advice meets these high standards at all times, and is focused on the client’s actual needs, the team is organised, under a single coordination umbrella, into four macro-sections:
- Pharma: in this sector, we advise on the supply chain of the traditional pharma industry throughout the “life” of medicines (including generics, biologics and biosimilars). We have specialist experience in public and private clinical research activities, which also covers areas such as rare diseases, advanced and gene therapies. This section also covers contexts close to pharmaceuticals, such as nutraceuticals, all ordinary legal and regulatory aspects, corporate and contractual assistance, relations with the Italian Medicines Agency (AIFA) and other competent authorities, acquisition transactions, public procurement and litigation before the Administrative and Ordinary Courts.
- Medical devices: including new technologies and virtual instruments, apps and telemedicine systems – we provide regulatory assistance (licenses, permits, CE marking and national and European authorisation procedures), commercial and operational assistance (contracts, evaluation of services and promotional activities, compliance procedures and internal protocols, privacy, import/export) and administrative assistance (tenders for public contracts), as well as litigation.
- Biotech: we boast extensive experience in start-ups, venture capital and listings on regulated markets, as well as in the protection of intellectual property, M&A transactions and industrial and technological joint ventures between players of different nationalities.
- Clinics/hospitals: we have considerable knowledge and expertise in assisting leading Italian and international operators in the healthcare sector, both as owners and/or managers of RSAs and clinics, including those operating under contract with the Italian National Health System and across several regions.