Our regulatory practice advises clients across the sector including pharmaceuticals and biotechnology, cell and gene therapies, veterinary medicine, medical devices, in vitro-diagnostics and digital health. Our team has a variety of backgrounds, within the fields of bioscience, genetics and neuroscience.

As most of our lawyers have spent some time in-house, we understand the priorities faced by our clients in the day-to-day running of their business and navigating the national and EU framework.

We advise leading international companies on the full range of strategic issues arising during the life cycle of a product, from its development to its commercialisation. This encompasses advising, amongst other things, on clinical trials, marketing authorisations, CE Marking, recalls, the legal implications of parallel trade and market access.

“Regulatory IP” rights are a vital issue for our clients and we help clients analyse their products in development together with the IP regulatory rights available under the regulatory legal framework (such as regulatory data protection, orphan exclusivities, SPC and paediatric rewards).

We have a deep understanding of the challenges that medical device and IVD companies face in light of the MDR (and IVDR) revolution.

Our team represents clients before the national and European courts as well as before the competent authorities, including the European Commission, the European and UK medicines authorities (EMA and MHRA), Notified Bodies, the National Institute for Health and Care Excellence (NICE), the Department of Health, NHS England, the HFEA and the HTA.

We have a particular specialisation in more challenging issues such as cell and gene therapies, synthetic biology, genomics, borderline products and the use of AI.

Our team has conducted regulatory due diligence on behalf of clients acquiring or investing in businesses across the sector. We draw upon a deep sector knowledge to identify legal and regulatory risks as well as assessing them, whilst maintaining a commercial focus to resolve these potential issues.

Key contact

Alex Denoon

Contact

Publications

Biotech Review of the Year

Read here

Experience

Our client is trialling its approved medicine in two novel indications which will significantly expand the market. We analysed the “regulatory IP” opportunities for the expanded markets, which involved considerations of regulatory data protection, biosimilars and SPCs. We worked with our competition team to finalise the advice.

For some years, we have helped our client navigate multiple regulatory hurdles to develop an innovative system to deliver medicines directly into the brain. The therapy poses multiple challenges for regulators, but promises to revolutionise conditions ranging from Parkinson’s to glioma.

Latest articles

What others say

“Bristows is a very good firm, particularly in coordinating multi-jurisdictional litigation. They have a good network of colleagues across Europe.”

Chambers and Partners Europe 2024

“They are really great, client-centric, and very knowledgeable about the industry. The Bristows team comes up with pragmatic solutions, and adds a personal touch to advice. They have a solid team across the board. I do not see them as just there to make a profit. They are efficient and true partners.”

Chambers and Partners Europe 2024

“They are very strong in the life sciences area with deep understanding of the regulations and requirements. They deliver as promised, are friendly to work with and communicate clearly and openly.”

Chambers and Partners 2024

“One of the UK’s leading life sciences practices. Across the firm, there is tremendous strength in depth. Great understanding of the market through acting for a wide range of clients.”

Legal 500 2024

“A ‘truly exceptional’ [Life sciences] practice which assists clients with the full gamut of commercial, regulatory and IP-related issues.”

Legal 500 2024

Recent rankings and awards

Life Sciences (Europe wide) - Band 4

Life Sciences (Europe wide) - Band 4

Life Sciences: Transactional - Band 2

Life Sciences: IP/Patent Litigation - Band 1

Life Sciences and Healthcare - Tier 1

Life Sciences: Transactional - Band 2