IVD Regulatory Consulting Services

Navigating the regulatory pathway for in vitro diagnostics (IVDs) and companion diagnostics (CDx) is increasingly complex, with evolving global requirements and heightened expectations from agencies. Effective IVD regulatory consulting provides sponsors with the expertise, strategy, and execution support necessary to accelerate development, reduce risk, and achieve timely market access.

Precision for Medicine’s IVD Regulatory Consulting services span the full product lifecycle—from early strategy and agency interactions through analytical and clinical study design, global submissions, and postmarket compliance. With deep experience across FDA, EMA, MHRA, NMPA, PMDA, and IVDR-designated Notified Bodies, our team ensures programs are aligned with the right regulatory pathway. This expertise not only streamlines approvals but also enhances product quality, patient safety, and commercialization readiness. Sponsors benefit from comprehensive guidance on regulatory strategy, risk assessments, labeling, quality system compliance, and postmarket surveillance. Discover how, by integrating regulatory insight with scientific and operational expertise, IVD regulatory consulting transforms challenges into competitive advantages and can enable your company to bring high-quality diagnostics to market more efficiently.