As a global organization with headquarters in both the United States and the United Kingdom, we bring a uniquely integrated perspective to regulatory and clinical strategy. Our expertise extends across the US, Europe (EU and UK), and Rest of World markets—allowing us to navigate the nuances of each region while aligning them into a cohesive global pathway. This breadth of knowledge enables our clients to move forward with clarity, confidence, and speed in an increasingly complex regulatory landscape.
United States
In the United States, we support clients in navigating complex regulatory pathways through deep expertise in FDA requirements for IVD and medical devices. Our team provides strategic guidance across pre-submission planning, clinical study execution, and post-market compliance, ensuring alignment with FDA expectations. We also help establish and maintain robust quality systems in accordance with 21 CFR Part 820 and evolving regulatory frameworks, enabling confident and compliant market entry.
Europe
Across Europe, including both the European Union and the United Kingdom, we guide clients through the evolving landscape of IVDR, MDR, and UKCA requirements. Our services span regulatory strategy, clinical performance and evaluation, and quality system alignment with ISO 13485 and regional expectations. We support seamless navigation of Notified Body and Approved Body processes, helping organizations maintain compliance while efficiently advancing toward market access in both EU and UK markets.
Rest of World
For Rest of World markets, we provide tailored regulatory, clinical, and quality compliance strategies that account for diverse and often rapidly changing requirements. From market-specific registrations to clinical data expectations and quality system adaptations, we help clients develop scalable approaches that support global expansion. Our experience across multiple international jurisdictions enables efficient entry into new markets while maintaining consistent compliance and operational excellence.