Healthcare and Life Sciences
The phenomenon of innovation and the diversity that characterises it present countless opportunities and challenges for healthcare systems and players in the health and life sciences sector. Access to innovation, quality and safety, sustainability, equity, public/private coordination, without neglecting the imperative of respect for the bioethical standards consolidated in our civilisational values, have had the impact of strengthening and increasing the complexity of regulation in the health sector.
We provide legal advice to entities operating in the healthcare sector, offering a specialised service in the regulatory environment of the areas of medicines, medical devices, healthcare providers, cosmetics and technological projects with healthcare applications. Our advice includes, in particular:
- Support to pharmaceutical companies, with a special focus in regulatory areas and in the implementation and negotiation of partnerships for the marketing of medicinal products;
- Legal advice on matters related to health technologies assessment, including in relation to reimbursement and prior assessment agreements.
- Support for pharmaceutical companies, with a special focus on regulatory areas and issues related to pricing and reimbursement;
- Marketing and advertising of medicines and health products;
- Preparation and negotiation of contractual models used in the marketing and promotion of medicines;
- Advice on compliance issues, including the management and control of all types of interactions between pharmaceutical industry entities, healthcare professionals or healthcare organisations;
- Regulatory framework for food supplements;
- Preparation of defences in administrative offence proceedings and monitoring of proceedings;
- Matters related to clinical research;
- Advising healthcare providers;
- Regulatory framework for genetic testing;
- Support for manufacturers and distributors of medical devices;
- Specific biotechnology-based projects and start-ups
- Due diligence, restructuring operations and mergers and acquisitions in the healthcare sector.
