Insights
Guidance, analysis, and commentary from our practice, focused on the regulatory questions that matter most to the organisations we work with.
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