Delivering clarity for complex regulation.
Trusted advisors to businesses operating in regulated industries worldwide.
- Europe & UK
- North America
- Asia Pacific
- Regulatory Strategy
- Audits & Inspections
- Data Protection & Privacy
- Artificial Intelligence
- Product Safety & Compliance
Sectors
We advise organisations across a range of regulated industries. Where complex regulatory obligations exist, we bring the expertise to manage them.
Practices
Focused practice areas, each staffed by senior advisers with direct experience in the rules, the regulators, and the decisions that matter.
Life Cycle Management
Authorisation strategy, IP regulatory rights, market access, and interactions with the relevant regulatory authorities, including EMA, MHRA, and FDA, across the full product lifecycle.
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Clinical Trials & GCP
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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Pharmacovigilance & Drug Safety
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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GMP & QMS
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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Audits & 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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Data Protection & Privacy
GDPR compliance for organisations handling personal, health, and AI data, including privacy by design, DPIAs, international transfer mechanisms, breach response, and data governance.
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Practical perspectives on regulatory change, written by the people advising on it.
Connect with us now
If you are interested in learning more about our practices, our team is ready to speak today.