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Healthcare Regulation

Our specialist regulatory expertise is at the heart of our life sciences group, building a flexible, integrated team based locally in major markets to respond to our clients’ needs at any stage of the product life cycle.

Life Sciences companies are operating in a rapidly changing and increasingly demanding regulatory environment. Innovation, safety and value for money are major challenges. Well devised strategies add significant value. Breach of regulatory laws and codes attracts criminal and civil sanctions.

We have put specialist regulatory expertise at the heart of our Life Sciences group, building a flexible, integrated team based locally in major markets to respond to our clients’ needs at any stage of the product life cycle. Our European team is complemented by expert capability in the Middle East and China.

Our main focus areas:

  • R&D contracts
  • Clinical trials
  • Manufacturing agreements
  • Product classification
  • Market access and CE marking
  • Pricing and reimbursement
  • Supply chain and distribution
  • Advertising and promotional activities
  • IP/patents (life cycle strategies)
  • Data and regulatory exclusivity
  • Regulatory enforcement and
  • Sanctions/compliance (criminal)
  • Industry codes of conduct/self-regulation
  • Transparency – data and relationships with healthcare professionals
  • Administrative/public law
  • Public/private partnerships with healthcare institutions
  • Product recall and liability
  • Business development and partnerships

Our experience

Nano-physical healthcare products

Providing strategic advice to a global leader in nano-physical healthcare products in connection with the classification of its product in the UK (when classified differently in other European countries).

Pharmaceuticals

Representing a major pharmaceutical company within a criminal investigation launched on grounds including manslaughter, involuntary bodily harm, administration of toxic substances and misleading advertising.

Healthcare conglomerates

Advising a global healthcare conglomerate on clinical trials in 21 EU jurisdictions.

Key contacts

If you have any questions, contact a member of the Healthcare Regulation team for assistance:

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