Regulatory compliance advisory for life sciences
Clarity for complex regulation across the EU, UK and US: regulatory strategy, pharmacovigilance, audits and inspections, and product compliance.
Get in touchSectors
We advise organisations across a range of regulated industries. Where complex regulatory obligations exist, we bring the expertise to manage them.
Practices
Each practice area is staffed by senior advisers with direct experience of the relevant rules, regulators, and regulatory decisions.
Data Privacy and Cyber Security
Data protection and information security for organisations handling personal, health, and AI data. GDPR and privacy by design, DPIAs and international transfers, breach response, and cyber security governance, including risk assessment, controls, and incident readiness.
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Data Protection Officer Services
Outsourced and fractional Data Protection Officer services under the UK GDPR and EU GDPR, from mandatory appointment and data protection impact assessments through breach notification, international transfers, and supervisory-authority liaison, with a dedicated specialism in clinical trials.
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Audits and Inspections
Independent regulatory audit programmes, mock inspections, gap assessments, and CAPA support, across sponsor, supplier, and manufacturing audits in the EU, UK, and US.
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Postmarketing Surveillance
A compliant, audit-ready pharmacovigilance system across the EU, UK, and US, from PV system design and QPPV support through case and aggregate reporting, signal management, and health-authority inspections.
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Clinical Trials
GCP compliance and inspection readiness across the trial lifecycle, from protocol design through close-out, aligned to ICH E6(R3) and E8(R1), with direct health-authority experience.
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Life Cycle Management
Regulatory lifecycle management across the EU, UK and US: authorisation strategy, regulatory IP rights, variations and renewals, market access, and interactions with EMA, MHRA and FDA across the full product lifecycle.
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We publish practical analysis of regulatory change, prepared by the advisers who work on it.
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To learn more about our practices, please contact us to arrange a discussion.