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

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.

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What others say

“They provide a great service. They have a really business-friendly style of drafting and they’re very good at drafting in a way that laypeople can understand. They always have an eye on commerciality and know instinctively which issues are important.”

Chambers and Partners 2019

“The ‘excellent’ and ‘client-focused’ Bristows LLP has a strong reputation in patent litigation, but also works on matters involving transactions, regulations and competition.”

Legal 500 2019/18

“A leading destination for advice with regard to digital health and medtech, and associated data privacy issues.”

Chambers and Partners 2019

Recent rankings and awards

Life Sciences – Band 1
Chambers and Partners UK 2019

Life Sciences: Transactional - Band 2
Chambers and Partners UK 2019

Pharmaceuticals and Biotechnology - Top tier
Legal 500 2019

Life Sciences - Band 3
Chambers and Partners Europe 2019