Life Sciences and Healthcare

Our firm specialises in assisting companies in the sector, providing each client with help in devising strategies to develop and protect products throughout their life cycle, from clinical trials to marketing, to support in defining the best market access strategy. Our clients include national and international manufacturers of pharmaceuticals, biotechnological products, cosmetics, medical devices and applications, food supplements and veterinary drugs, which we assist in the following areas:

• management of legal aspects related to relations with the EMA and the Italian Medicines Agency, including procedures for obtaining marketing authorisations and price negotiation and reimbursement procedures;
• assistance in compliance with regulations on the manufacture and sale of pharmaceutical products, biotechnological products and medical devices;
• assistance in civil and administrative litigation in product liability cases, appeals against public tenders, and pharmaceutical expenditure measures;
• assistance with the regulatory aspects of advertising and scientific information of the company;
• drafting and negotiation of contracts for the transfer and exploitation of proprietary technologies and for the formation and sharing of registration and marketing authorisation dossiers;
• drafting and negotiation of agreements on confidentiality, supply of active ingredients, research and development;
• protection of our clients’ trademarks and patented specialties, including in the context of patent litigation;
• consultancy in extraordinary M&A operations and relating to the transfer of company branches or corporate shareholdings with specific reference to business, due diligence and regulatory aspects of the life sciences sector.