ARC Regulatory

Diagnostic compliance sits at the core of what ARC Regulatory does. Operating as a specialist CRO and regulatory consultancy, the company supports pharmaceutical, diagnostics and laboratory clients navigating the intersection of IVD development, companion diagnostics and clinical research. Headquartered in the United Kingdom, ARC Regulatory positions itself explicitly as a partner for Dx compliance in translational research.

The company's service model spans four interconnected pillars. Its regulatory team guides clients through the global regulatory landscape for IVD and CDx development, covering strategy, submissions and ongoing compliance. Clinical services provide IVD and CDx-focused monitoring with a global reach, supporting clinical performance studies from initiation through study close-out. A quality practice delivers QMS auditing, risk management and QMS implementation, while ARC Research Laboratories offers IVD development and validation services using advanced technologies.

CRO and Sponsor Delegation for IVD Studies

As a full-service CRO, ARC Regulatory guides sponsors through every phase of IVD and CDx clinical development. The company also offers IVD Clinical Study Sponsor Delegation, enabling clients to outsource the initiation and management of IVD studies to ARC's team. This model is particularly relevant to pharma sponsors supporting translational biomarkers in early clinical development, where the company provides proprietary risk-based monitoring of central testing laboratories across the full development life cycle.

For diagnostics companies, ARC Regulatory supplies R&D compliance support and full-service CRO capabilities for clinical performance studies, meeting pharmaceutical sponsor expectations. Laboratory clients benefit from analytical testing capabilities, rounding out a broad but IVD-specific service offering.

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