The consolidated experience and knowledge gained in the pharmaceutical sector and related sectors (such as veterinary, food supplements, cosmetics, medical devices, medical applications, etc.) and a pragmatic approach allow us to support in-house legal and regulatory teams in dealing with complex issues also from a technical and technological-scientific point of view, supported by a proven and selected network of technical and scientific experts.
We provide support and advice on a national and international level in judicial and extra-judicial activities and in the development of strategies for product development and protection, from clinical trials to production, marketing, communication, and scientific information.
More specifically, we assist companies in complying with the regulations governing the manufacture and sale of pharmaceutical and biotechnology products and support the company’s regulatory team in dealing with legal aspects entailed by relations with the regulatory authorities, the preparation of registration dossiers, the marketing authorizations, the negotiations related to price, reimbursement, and market access strategy.
We assist our clients in the negotiation and drafting of confidentiality agreements, of agreements related to research and development, co-development, supply of active ingredients, transfer and exploitation of proprietary technologies, licensing and acquisition of intellectual property rights, joint ventures, research and development agreements, clinical trial and clinical research agreements, partnership agreements and all types of commercial agreements in the sector of biotechnology.
We protect trademarks, know-how and patented specialties in the healthcare & life sciences sector, including in the context of patent litigation, intellectual property in general and competition and offer assistance in arbitration proceedings and advertising self-regulatory bodies.
We follow operations in the structuring and management of extraordinary Merges and Acquisitions transactions and related to the transfer of business units, production facilities or corporate holdings.
