Practices
Where we advise
Each practice area is handled by advisers with direct, working knowledge of the relevant regulations, authorities, and operational realities.
Jack Anstey / UnsplashLife Cycle Management
Authorisation strategy, IP regulatory rights, market access, and interactions with EMA, MHRA, and FDA across the full product lifecycle.
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Girl with red hat / UnsplashClinical Trials & GCP
GCP compliance and inspection readiness across the trial lifecycle, from protocol design through close-out, with direct health-authority experience.
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National Cancer Institute / UnsplashPharmacovigilance & Drug Safety
Safety system design and ongoing PV support, covering QPPV roles, signal management, ICSR and aggregate reporting, RMPs, and audit readiness across the EU, UK, and US.
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Glsun Mall / UnsplashGMP & QMS
Quality and manufacturing compliance for clinical and commercial supply, including data integrity, import/export requirements, and GxP considerations for AI and emerging technologies.
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Zulfugar Karimov / UnsplashAudits & Inspections
Independent GxP 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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Scott Rodgerson / UnsplashData Protection & Privacy
GDPR compliance for organisations handling clinical, health, and AI data, including privacy by design, DPIAs, international transfer mechanisms, breach response, and data governance.
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Igor Omilaev / UnsplashArtificial Intelligence
Regulatory strategy for AI in regulated environments, covering EU AI Act readiness, risk classification, technical documentation, and governance for AI used in medical, clinical, and health contexts.
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MJ Duford / UnsplashRegulatory Due Diligence
Regulatory risk assessment for M&A and private equity transactions, covering product and portfolio liability across the EU, UK, and US.
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Piron Guillaume / UnsplashDevices, IVD, Combination Products & Digital Health / AI
End-to-end regulatory support under EU MDR and IVDR, covering combination products, companion diagnostics, Notified Body strategy, and AI compliance for digital health products.
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Bozhin Karaivanov / UnsplashFood, Cosmetics & Environment
Regulatory advice across food law, cosmetics regulation, novel foods authorisation, and chemicals and environmental compliance.
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CHUTTERSNAP / UnsplashProduct Safety, Recalls, Liability & Compliance
Structured support for product safety issues, covering risk assessment, recall planning, post-market risk management, and engagement with regulatory authorities.
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