Get Answers, See Progress
We provide 30+ years of experience winning countless regulatory decisions and market access for in-vitro diagnostics makers and supporting clinical studies. We've helped clients pass hundreds of quality audits and held over 10,000 trainings sessions for end-users to help bring testing sites live quickly and safely.
Regulatory Affairs/CRO Services
Quality Systems Compliance
Point-of-Care Analyzer Training
We help companies at every stage,
from startups to established global IVD makers.
We gather market insights on your product concepts, build out your quality system, and develop a tailored regulatory strategy for your diagnostic, accelerating the path to achieving your first approval.
We help with ISO and QMS requirements, audit prep, and eliminate costly guess work as you expand your approved product portfolio, while also expediting your commercial implementation efforts.
We free up your team to focus on their best work by taking lead on projects, handling end-user training, and bringing in our global network of experts to help you drive to the finish line ahead of time.