Raquel Ballesteros

Raquel holds top positions in leading international legal rankings in Life Sciences & Healthcare (Tier 1 in Chambers & Partners 2020–2023; Life Sciences and Biotechnology “Lawyer of the Year” 2020 in Best Lawyers) and serves as an Expert Advisor to the European Commission on a range of digital health and telemedicine projects.

Raquel helps clients navigate the increasingly complex regulatory framework applicable to innovative health-related products and services (personalised medicines and advanced therapies, new vaccines, orphan drugs, genetically modified organisms (GMOs), medical devices and software, cosmetics, food and food safety products such as biocides and pesticides, etc.).

In particular, she helps accelerate market access for these products and services by managing the legal issues and challenges across their lifecycle (clinical trials, public R&D funding, marketing authorisations, compassionate use, product compliance, GMP (Good Manufacturing Practice), pricing and reimbursement, advertising, public procurement, marketing and anti-bribery compliance, privacy and data protection, distribution, traceability, pharmacovigilance, etc.).

She is also a strong litigator in her practice areas, with a particular focus on regulatory and compliance disputes, public procurement litigation and product liability. She also acts in arbitration proceedings and is regularly appointed as an arbitrator in cases before Spain’s leading national arbitral tribunals.

Raquel is a regular lecturer at Universidad Carlos III de Madrid, teaching European Pharmaceutical Law and Digital Health Law.