Sector
Life Sciences
Full-lifecycle regulatory support for pharmaceutical, biotech, medical device, IVD, and digital health organisations, from first-in-human studies through post-market obligations, across the EU, UK, US, and Asia Pacific.
Practices in Life Sciences
The specialist disciplines we bring to life sciences clients.
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
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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Quality Management
Quality management systems and manufacturing compliance for regulated products, including data integrity, import/export requirements, and quality considerations for AI and emerging technologies.
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Artificial 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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Regulatory 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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Devices, 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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Food, Cosmetics & Environment
Regulatory advice across food law, cosmetics regulation, novel foods authorisation, and chemicals and environmental compliance.
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Product 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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Risk Management & Business Continuity
Risk and resilience built on recognised standards: enterprise and quality risk management, business continuity, and crisis response, so audits, disruption, and the unexpected find you prepared.
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