Regulatory

Our regulatory practice serves the most heavily regulated industries globally - we work with clients including leading pharmaceutical and biotechnology companies and major producers of medical devices, chemical products, food and cosmetics.

Combining legal and technical expertise, our lawyers are uniquely equipped to navigate the complex national and EU legal framework and advise on all regulatory aspects of the life cycle management and commercialisation of blockbuster products. Our regulatory team also has experience in representing pharmaceutical companies before national and European courts (CFI and ECJ) as well as before regulatory authorities (including the EU Commission, EMA, MHRA, NICE and DOH).

Life cycle management: We advise leading international companies on the full range of strategic issues arising during the life cycle of a pharmaceutical product, from development to commercialisation. This broad spectrum includes advising on anything from the marketing authorisation of a product to the legal implications of parallel trade. In advising on life cycle management issues, our focus is typically on maximising IP regulatory protection.

Litigation: Our lawyers have expertise in representing leading pharmaceutical companies before the national and the European Courts and before regulatory authorities including the Commission, EMA, MHRA, NICE and DOH. Our network of established relationships with leading technology law firms in Europe and the US enables us to deliver a seamless service in the co-ordination of multi-jurisdictional litigation and legal advice.

Clinical trials: We advise on the interpretation of the legislation applicable to clinical trials. The regulatory team has expertise in drafting and negotiating clinical trial agreements, and provides regular advice to pharmaceutical companies in relation to product liability issues arising out of the conduct of clinical trials, including negotiating settlement agreements.

Product liability: We regularly advise pharmaceutical companies in relation to product liability issues arising out of the conduct of clinical trials and on the interpretation and scope of the product liability directive (including negotiating settlement agreements). Our team also advises on issues in relation to the recall of defective healthcare products from the market, either on the initiative of the client or at the request of the regulatory authorities. 

Regulatory due diligence: We have developed extensive experience in conducting regulatory due diligence exercises in the context of the acquisition of pharmaceutical and biotechnology companies.

Advertising: Our team advises pharmaceutical companies on the national and EU legislative framework, the applicable codes of practice and guidelines and potential defamation claims arising out of promotional material.