Our professionals' team advises pharmaceutical and biotechnology companies, healthcare technology start-ups, medical device and equipment manufacturers, public and private hospitals, clinics and other healthcare service providers on administrative, regulatory, commercial and corporate matters, contracting and compliance, both in and out of court.
The department works closely with financial advisors, auditing firms and external consultants enrolled in the lists and registers kept by public authorities, enabling rapid intervention and qualified networking, with constant updates on the latest regulations.
The team's activities include, among others, advice on:
joint ventures and extraordinary transactions involving pharmaceutical companies
project financing in the hospital sector
inclusion in the national health system, accreditation of health care establishments and medical centres, home care, indirect care, rates and reimbursements
AICs (marketing authorisations for drugs)
OTCs (over-the-counter or self-medication drugs)
• advertising and distance selling of medicines and medical devices
assignment of receivables and securitisation arising from the supply of medicines
pharmaceutical conventions and conferences, organisational models and sector-specific codes of ethics
medical staff (remuneration of doctors in conflict of interest, authorisations, etc.) and nurses
state aid and unfair competition, abuse of economic dependence, misleading advertising, advertising self-regulation and unfair commercial practices
ordinary and precautionary litigation before ordinary judicial authorities, national and EU administrative litigation (Regional Administrative Court (TAR), Council of State, Court of Justice of the European Communities)
clinical and management trials, pharmacovigilance and health data processing
antitrust compliance
patent and trademark protection;
typical sector agreements (co-promotion, fostering, distribution, agency, production licensing, etc.)
new technologies applied to the pharmaceutical and medical sector (digital health) and regulatory issues related to the processing of personal data of patients and HCPs: AI, IoMT, telemedicine and remote diagnostics, health apps, digital therapies, wearable devices, P4 Medicine
