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
GDPR, privacy by design, and cyber security governance for personal, health, and AI data.
Learn more
Data Protection Officer
Outsourced and fractional DPO services under the UK and EU GDPR, with a specialism in clinical trials.
Learn more
Audits and Inspections
Independent audits, mock inspections, gap assessments, and CAPA support across the EU, UK, and US.
Learn more
Postmarketing Surveillance
Audit-ready pharmacovigilance across the EU, UK, and US, from PV system design to QPPV and inspections.
Learn more
Clinical Trials
GCP compliance and inspection readiness across the trial lifecycle, aligned to ICH E6(R3) and E8(R1).
Learn more
Life Cycle Management
Authorisation strategy, variations, and market access across the full product lifecycle.
Learn more
Quality Management
Quality management systems and manufacturing compliance, including data integrity and GxP.
Learn more
Artificial Intelligence
EU AI Act readiness, risk classification, and governance for AI in medical and health contexts.
Learn more
Regulatory Due Diligence
Regulatory risk assessment for M&A and private equity across the EU, UK, and US.
Learn more
Devices, IVD, Combination Products & Digital Health / AI
Regulatory support under EU MDR and IVDR, including combination products and digital health.
Learn more
Food, Cosmetics & Environment
Food law, cosmetics, novel foods, and chemicals and environmental compliance.
Learn more
Product Safety, Recalls, Liability & Compliance
Product safety, recall planning, post-market risk, and engagement with regulators.
Learn more
Risk Management & Business Continuity
Enterprise and quality risk management, business continuity, and crisis response.
Learn moreSpecialists in this sector
Working in life sciences?
Tell us about your product, programme, or compliance question and we will come back to you promptly.