Healthcare, Life Sciences & Chemicals

Our London office at Holborn Gate, 330 High Holborn, London, WC1V 7QH, acts for multinational and UK-based clients across healthcare, life sciences and chemicals. We advise on regulatory compliance, commercial arrangements, transactions and disputes specific to England & Wales, helping clients manage product lifecycles, clinical development and manufacturing, and environmental and safety obligations.

Overview

The sector combines highly regulated pharmaceutical, medical device and biotech activity with chemical manufacturing and distribution. Legal advice typically spans regulatory authorisation and post‑market obligations, intellectual property and technology transfer, commercial contracting, corporate transactions and crisis management (recalls, safety incidents and enforcement). Post‑Brexit changes and evolving UK regulatory regimes (including UK REACH and a bespoke medicines and devices framework) require targeted local expertise.

Key legal considerations

Regulatory approvals and lifecycle management – classification, MHRA submissions, clinical trial authorisations and ongoing pharmacovigilance or vigilance obligations.
Data protection and patient data – compliance with UK GDPR and Data Protection Act requirements, DPIAs for research and clinical trials, and secure data sharing with CROs and partners.
Product liability and safety – labelling, instructions for use, liability exposure, product recalls and incident reporting.
Environmental and health & safety – chemical registration and control under UK REACH, COSHH obligations, permits and reporting to the Environment Agency and HSE.
Competition, procurement and pricing – NHS procurement rules, CMA merger control, and interactions with reimbursement and HTA bodies such as NICE.

Commercial, transactional and dispute work

Typical matters include licensing and supply agreements, manufacturing and CMO arrangements, collaborations, M&A due diligence for regulated assets, outsourcing to CROs/CMOs, and managing cross‑border supply chains. We also advise on export controls, sanctions compliance and contractual protections for quality, indemnities and regulatory change. Disputes commonly involve regulatory enforcement, product liability claims and contractual performance issues.

Practical checklist for operators in England & Wales

Confirm product classification (medicine, device, chemical) and applicable UK regulatory pathway.
Secure necessary authorisations (MHRA approvals, clinical trial authorisation, environmental permits) before market entry.
Conduct DPIAs and establish lawful bases for processing patient and research data.
Put robust supplier and quality agreements in place with clear allocation of regulatory responsibilities.
Review insurance, recall procedures and incident response plans; document pharmacovigilance/vigilance systems.
Check UK REACH registration and downstream obligations for chemical substances and ensure H&S compliance.

Jurisdiction and sources

General information only; not legal advice and not a substitute for advice on a particular matter.