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European Union/UK Product Life Cycle Regulation

Working with colleagues in the US and China or separately on discrete EU matters, the members of our London- and Brussels-based team provide advice on all aspects of EU and UK regulatory law and procedures for companies in the pharmaceuticals (human and veterinary), biotechnology, medical devices, and food sectors. We have many decades of experience in advising the suppliers of both prescription-only and over-the-counter products and have developed special experience in the field of novel technology products such as gene-based, cell-based and tissue-engineered products. We also have substantial experience in relation to borderline products and mainstream cosmetic, food supplement and biocide products. We provide contentious and noncontentious advice side-by-side and have represented clients in many administrative law proceedings against regulatory agencies before both UK national courts and the European Court of Justice.

  • Reach in Multijurisdictional Matters: We have long maintained a network of preferred specialists in other jurisdictions within and outside the EU that we collaborate with when matters raise local law issues as well as overarching aspects of EU law.

  • Depth of Knowledge: In addition to including former senior regulators and counsel to regulatory authorities, our team includes a significant number of lawyers who are also qualified in medicine, toxicology, pharmacy, or other scientific disciplines.

  • Navigating Coverage and Reimbursement Challenges: Our EU and UK teams also routinely manage efforts to ensure optimal payment for biomedical products under the complex national payment systems.

Providing timely updates and commentary on legal and regulatory developments to the European life sciences community and beyond.
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Recognition

  • Chambers UK
    Life Sciences: Product Liability – UK-wide: Band 1 (2024)
    Life Sciences: Regulatory – UK-wide: Band 1 (2024)
  • The Legal 500 UK
    Industry Focus: Life Sciences & Healthcare (2023)
  • Chambers Global
    Life Sciences (Europe-wide) (2023)
  • Chambers Europe
    Life Sciences (Europe-wide) (2023)
  • BTI Client Service All-Star

    Ian Dodds-Smith was recognized as a BTI Client Service All-Star for 2011, one of a handful of regulatory lawyers selected to this list. According to BTI, this exclusive honor conveys commitment to client service excellence. The All-Star lawyers are determined by unprompted candid feedback from nearly 300 Corporate Counsel at large and Fortune 1000 organizations. BTI asks Corporate Counsel to delineate the attorneys delivering the best client service.