ARC Regulatory

Regulatory navigation for IVD and companion diagnostics sits at the core of what ARC Regulatory does. The firm operates as a specialist contract research organisation serving pharmaceutical, diagnostics and laboratory clients that require expert guidance through the clinical and compliance demands of in vitro diagnostic and CDx development.

The service portfolio spans four principal disciplines. On the regulatory side, the team supports clients in navigating global frameworks applicable to IVD and CDx programmes. Clinical monitoring is delivered with a global presence, with a particular focus on IVD and CDx study designs. Quality services cover QMS auditing, risk management and QMS implementation, while ARC Research Laboratories provides IVD development and validation using advanced technologies.

The CRO offering guides sponsors from strategy through to study close-out across every phase of IVD and CDx clinical development. A dedicated IVD Clinical Study Sponsor Delegation service allows clients to initiate and manage IVD studies through a single trusted partner. The firm's proprietary ARC360 platform is positioned to accelerate clinical performance studies, supporting monitoring of central testing laboratories across the full clinical development life-cycle.

Sector coverage reflects the firm's cross-disciplinary positioning. Pharmaceutical clients benefit from support in translational biomarker programmes and early clinical trial authorisations, including risk-based monitoring of central testing laboratories. Diagnostics companies receive R&D compliance support and full-service CRO capability for clinical performance studies. Laboratory clients access analytical testing capabilities aligned to their regulatory obligations.

Further information is available at arc-regulatory.co.uk.