Cláudia Mendes Pinto

Cláudia assists clients throughout their products’ life-cycle, from early development stages to certification/authorisation, and post-market issues. This includes product qualification and classification, determination of regulatory pathways, authorisation and conduct of clinical studies (medicinal products, medical devices and IVDs), CE marking of medical devices and IVDs, GxP matters, interactions with regulatory authorities and notified bodies, pricing and reimbursement and post-market activities (e.g., marketing and promotion, interactions with healthcare professionals, pharmacovigilance and device vigilance). Being a Portuguese-qualified lawyer, Cláudia advises on the Portuguese and EU regulatory frameworks.

Some focus areas include companion diagnostics and the conduct of combined trials, borderline and combination products, economic operators and supply chain matters, advanced therapy medicinal products, and the human blood, tissues and cells legislation.

Cláudia also frequently assists life sciences clients with a variety of agreements, such as clinical studies, supply, manufacturing, services and distribution agreements. She also has experience in internal investigations, regulatory due diligence for mergers and acquisitions, coordination of multijurisdictional projects, as well as litigation in state and arbitral courts.