Pharmaceutical regulatory law

Our experience and understanding of the pharmaceutical sector is well-established and widely recognised, not least because of our trail-blazing track record in the field, and the unmatched scientific acumen of our lawyers in areas such as medicine, molecular biology and pharmacology.

The pharmaceutical industry is one of the world’s most heavily regulated sectors, and we have particular expertise on all facets of European medicine and regulatory law. Several of our lawyers have worked in-house at international pharmaceutical companies.

Whether as part of patent life cycle management or to challenge the market entry of competitors, we understand the importance of developing an integrated strategy which takes the regulatory landscape into account. We are able to advise on an array of issues such as regulatory data and data exclusivity; market authorisation; alternative routes to product approval; and Supplementary Protection Certificates, an area where our experience is a standout in the industry.