Medicines Regulatory

Our team is committed to providing strategic guidance and robust support, helping you overcome regulatory hurdles and achieve your goals. We advise clients on all aspects of regulatory and compliance requirements, including:’

• Navigation of Pharmaceutical Regulations: Guiding clients through complex regulatory frameworks. Ensuring clients adhere to national and international regulatory standards.
• Strategic Guidance: Providing expert advice on regulatory strategies to facilitate market access. Helping clients navigate the regulatory landscape to achieve business objectives.
• Advising on UK and EU Litigation: Providing robust legal support and representation of clients navigating pharmaceutical regulations in regulatory disputes. Acting for clients in litigation before the High Court of England & Wales as well as EU national courts and the General Court and Court of Justice in relation to enforcing and challenging regulatory exclusivities.
• Compliance Support: Assisting in meeting all necessary legal and regulatory requirements for pharmaceutical products.
• Risk Management: Identifying and mitigating potential regulatory risks.
• Documentation and Submissions: Preparing and reviewing regulatory documents and submissions to competent authorities.
• Regulatory Updates: Keeping clients informed about changes in the regulatory landscape and their implications. Ensuring clients remain compliant with evolving regulatory requirements.