Taly Dvorkis

I am a Director in Fieldfisher’s Regulatory department, specialising in healthcare and life sciences. I advise on pharmaceutical, medical device, digital health, novel foods, nicotine/vape, and consumer businesses on UK regulatory requirements, including product compliance, advertising, enforcement and ongoing compliance.

I have extensive experience supporting clients in regulator‑facing and contentious regulatory matters, including engagement with the MHRA, GPhC, CQC and ASA. My work often involves advising on regulatory risk in commercially sensitive and time‑critical situations.

I bring valuable in‑house experience, having previously worked at electronic cigarette company JUUL Labs, whom I continue to advise. This experience informs my practical, commercial approach when advising businesses operating in highly regulated and scrutinised markets.

I act for a wide range of clients, from early‑stage life sciences and digital health companies to established multinational healthcare and consumer health businesses. I regularly work on UK‑led matters with EU and international elements, collaborating closely with colleagues across Fieldfisher’s global offices.

I am a regular speaker at industry events and contribute to healthcare and life sciences publications. I am dual‑qualified in New York and England & Wales and hold a degree in physics from MIT.

I am the Vice Chair of the Legal Issues and Compliance Committee of the ABHI.

Representative matters include:

• Advising a multinational healthcare manufacturer on contentious regulatory issues before UK health regulators, including product compliance, advertising and enforcement risk.
• Acting for medical device manufacturers on UK regulatory developments under the UK Medical Devices Regulations (UK MDR), including transition planning and compliance with the CE/UKCA marking regime.
• Advising digital health and life sciences companies on artificial intelligence as a medical device (AIaMD) and software as a medical device (SaMD), including regulatory classification, compliance and UK market access considerations.
• Working with device manufacturers on post-market surveillance and compliance reporting. 
• Supporting a major consumer health business on UK regulatory compliance, including the application of medicines, medical devices and consumer protection legislation.
• Advising product manufacturers on compliance with ABHI code and anti-bribery laws in HCP interactions.    
• Advising an international health and wellness company on botanical and health claims, including compliance with UK advertising rules and substantiation requirements.
• Acting for a UK digital dermatology and skincare business on regulatory compliance, including the application of medicines and online pharmacy rules.
• Providing ongoing regulatory advice to a global diabetes medical device company on UK market compliance.
• Advising a number of online clinics and pharmacy groups on healthcare regulation, including digital health models, prescribing and consumer law.
• Acting for early‑stage biotech companies, including an mRNA biotech start‑up, on UK regulatory strategy and market entry.