Life Sciences

Health Care and Pharmaceutical department assists domestic and international clients in the pharmaceutical, biotechnological, medical device, cosmetic and nutraceuticals areas, in contentious/non contentious matters and regulatory activities operating with a multidisciplinary approach (administrative, IP, labor, EU/antitrust, privacy).

Specific expertise in: ● participation in public tenders ● regulatory issues (marketing authorizations, pricing/reimbursement, packaging/labeling, import, compassionate use, orphan drugs, generics/biosimilars, pharmacovigilance, placing of devices/cosmetics on the market, import/manufacturing, permissible claims, borderline products) ● compliance issues (GMP, GCP, privacy, corrupt practices, safety, CME seminars, environmental issues for plants and labs, internal audits) ● marketing, advertising, promotion ● drafting/review of corporate resolutions, commercial contracts (licence, distribution, agency, supply), advice/due diligence in M&A ● product liability and medical malpractice ● infringement and counterfeiting ● litigation before IP/civil/administrative courts ● clinical trials on medicines and devices (for sponsor companies, cooperative groups, institutions): assistance in administrative procedures/privacy issues, ● research/trial contracts, biobanking, contacts with authorities (EMA, MoH, AIFA, ECs) ● advanced therapy products/applied genetics ● advise (expert witness) in criminal inquiries