ARC Regulatory
Private Company
Funding information not available
Overview
ARC Regulatory is a specialized services partner for pharmaceutical, biotech, and diagnostic companies navigating the intricate regulatory and clinical development pathways for IVDs and companion diagnostics. The company offers a full suite of solutions including regulatory strategy, clinical monitoring (CRO services), quality systems, laboratory validation, and proprietary SaaS digital tools like the ARC360® platform. With over 14 years of industry experience, a focus on translational biomarker research, and a recent expansion into Asia and new laboratory facilities, ARC positions itself as a critical enabler for the precision medicine ecosystem, aiming to reduce time-to-market for novel diagnostics and corresponding therapies.
Technology Platform
ARC360® SaaS platform, including a Regulatory Navigator for IVD/CDx trial requirements, a Laboratory Toolkit for IVDR Article 5(5) compliance, and Online Training modules.
Opportunities
Risk Factors
Competitive Landscape
ARC competes in a niche segment against the specialized regulatory arms of large global CROs (e.g., IQVIA, Parexel, PPD) and other boutique regulatory consultancies focused on diagnostics. Its differentiation lies in its deep, exclusive focus on IVD/CDx within clinical trials, its Sponsor Delegation service, and its proprietary ARC360® software tools.