Innovation and its diversity are challenging and present a wide number of opportunities to health systems and its agents. Questions such as access to innovation, quality and safety, sustainability, equity, and bioethics respect have had an impact on the reinforcement of the health sector regulation, as well as on its complexity.

To assist the entities developing their activity on the health sector, pbbr’s dedicated team provides legal advice on a variety of matters, including regulatory, compliance, commercialisation and publicity of medicines, medical devices and health products, as well as on matters involving clinical rehearsing and pricing of medicines.

pbbr’s legal assistance includes pharmaceutical and biotechnology companies, and other players in the health sector such as medical devices distributors, health care providers, veterinarian and cosmetic products distributors, start-ups and non-profit organisations linked to medical research, including assistance to:

• Pharmaceutical companies especially on regulation matters, pricing and co-pricing
• Commercialisation and publicity of pharmaceutical and healthcare products and on the legal framework of food supplements
• Tissue and cells banks
• Specific technological based projects and start-ups
• Medical devices manufacturers and distributors
• Matters related to clinical rehearsals and regulatory framework of genetic tests
• Support on infrastructure Project Finance operations within public/private partnerships (PPP) on the health sector
• Due diligence, mergers, acquisitions and restructuring operations on the health sector