Global Regulatory & Compliance Advisory
Specialist advice for organisations navigating regulatory complexity, rooted in life sciences with practices in data protection, privacy, and AI that extend across sectors and jurisdictions.
Photo: Rowen Smith / Unsplash
Who we serve
Our work is grounded in life sciences, with advisory practices that travel across sectors wherever regulatory obligations arise.
Focused practice areas, each staffed by senior advisers with direct experience in the rules, the regulators, and the decisions that matter.
Jack Anstey / UnsplashAuthorisation 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 / UnsplashGCP 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 / UnsplashSafety 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 / UnsplashQuality 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 / UnsplashIndependent 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 / UnsplashGDPR compliance for organisations handling clinical, health, and AI data, including privacy by design, DPIAs, international transfer mechanisms, breach response, and data governance.
Learn morePractical perspectives on regulatory change, written by the people advising on it.
Markus Winkler / UnsplashThree regulators, one safety obligation. Where EU GVP, UK MHRA, and US FDA postmarketing requirements align, and where they diverge, and how to stay audit-ready in all three.
By Scott McCulloch
Conny Schneider / UnsplashClinical research runs on sensitive personal data. Five priorities for handling it lawfully under the EU and UK GDPR, without slowing the science.
By Scott McCulloch
Anders Jildén / UnsplashUnder MDR and IVDR, technical documentation is a living file. How to keep clinical evidence, post-market surveillance, and risk management coherent and inspection-ready.
By Scott McCulloch
Let’s talk
Whether you’re early in development or facing an immediate compliance question, we’re straightforward to reach and quick to respond.
