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

“We appreciate the technical knowledge and skills the Bristows partners have when it comes to the patent.”

Chambers and Partners 2022

“They are all accomplished litigators with a particular strength in life sciences cases.”

Legal 500 2022

“The individuals live and breathe their subject matter, know the industry inside out and are supported by their excellent regulatory and competition colleagues, which helps them stand out in global pharma litigation.”

Legal 500 2022

“Probably the best UK-focused IP and TMT firm around.”

Legal 500 2022

“[The regulatory team] are committed to not only giving high quality advice but also supporting education and upskilling within the client team to support continuous learning and improvement.”

Legal 500 2022

Recent rankings and awards

Life Sciences and Healthcare - Tier 1

Life Sciences - Band 1

Life Sciences: Transactional - Band 2

Best Life Sciences Law Firm - Europe

Life Sciences - Band 4

Life Sciences - Band 4