Developing In Vitro Diagnostic (IVD) devices requires careful navigation across complex and varied regulatory landscapes. The constantly evolving U.S. FDA and IVDR (EU) regulations creates a challenge to secure market approval and maintaining compliance requires more than just filling out forms—it demands specialized expertise.
Our regulatory services are designed to meet this critical market need by transforming compliance from a hurdle into a streamlined strategic advantage. We provide the dedicated guidance and operational support to get the job done well.
Partner with us to reduce risk, accelerate your time-to-market, and ensure your life-changing diagnostic technology reaches the patients who need it most.
Tara Jones
Principal Regulatory & Clinical Consultant
“Success in bringing innovations to market starts with assembling the right team. A robust regulatory and clinical strategy serves as your core foundation, charting a clear, well planned course from initial concept to market launch.”
U.S. Regulatory and Clinical Strategy
✓ Analytical and clinical protocol development
✓ PreSTAR for pre-submissions and 513(g) requests
✓ Breakthrough device designation
✓ eSTAR 510(k), de novo, and PMA FDA submissions
✓ USA representative and registration services
✓ Strategic FDA correspondence
Global Registrations
✓ Strategy, gap analysis, and QMS assessment
✓ IVDR
✓ UKCA
✓ Health Canada
Core Solutions
WE ARE SPECIALISTS
CLINICAL SERVICES
REGULATORY SERVICES
With you from strategy through submission.
QUALITY SERVICES
Quality system planning, audit support and remediation.