Anna Wawrzyniak

Anna Wawrzyniak is a senior scientific and regulatory advisor in the Life Sciences team. As a non-lawyer with a Ph.D. in biomedical sciences, Anna provides detailed scientific and regulatory advice to the firm’s pharmaceutical, food and feed clients. She draws on her technical and regulatory expertise to help clients in strategic planning and in navigating regulatory proceedings, especially in areas where a deep understanding of the underlying science is important. In particular, she advises pharmaceutical clients on regulatory issues relating to product classification, biologics, advanced therapies, orphans, paediatrics, market and data exclusivities.

Anna has deep expertise in the following areas:

• The development and approval of medicinal products;
• Strategies for obtaining and maintaining regulatory exclusivities, including orphan market exclusivities, regulatory data exclusivities (new active substance status) and paediatric incentives;
• Support to high stake litigation on regulatory aspects;
• PRIME, accelerated approvals, conditional and exceptional marketing authorisations;
• Advanced therapies, biologic and substances of human origin;
• Borderline classification;
• Regulatory due diligence;
• Novel foods and food supplements; and
• Feed.