Our team handles legal regulatory technically challenging and complex multi-jurisdictional matters and provide assistance in relation to: General Regulatory Advice and relationships with the authorities in Italy and EU Consultancy and Market Researches Insurance Authorization of new companies Insurance Legal design of innovative products Insurance Reorganization of intermediary networks Life Sciences R&D  and  Manufacturing Life Sciences Early access programs, Marketing authorization and entry to market procedures Life Sciences Price & Reimbursement and payback governance Life Sciences Advertising and Promotion Life Sciences Recall, withdrawal and shortage procedures Life Sciences Patients Support Programs, Patients Associations and Scientific Associations relationships Our track record includes:
  • Assisting on various market access strategies from a regulatory and compliance perspective (i.e.: institutional and local events, advisory boards, relationships with patients’ associations, sponsorships and awarnes projects and campaigns, telemedicine projects
  • Assisting various pharmaceutical companies in P&R and payback procedures, settlement agreements with AIFA and related judicial claims
  • Legal design of innovative insurance products, including the first class III life insurance product linked to hedge funds ever market in Italy