FDA regulated industries lose billions each year to quality and compliance problems

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It's 2024. Maybe a checklist shouldn't be the first tool you reach for.

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~5% of regulations account for half of all citations. Is your organization focusing on the right ones?

Minimize regulatory risk by focusing on the most value added areas

Many organizations take an approach to managing regulatory risk that assumes most outcomes are equally likely or have equal risk. But that's simply not the case. Our platform helps you focus your resources in a dynamic regulatory landscape.

Not sure how a regulation applies?Check what the FDA thinks

Search citations by CFR and look up how they are interpreted in inspector comments and warning letters.

We get it. The regulations are written by lawyers for lawyers, and yet it's generally scientists and engineers tasked with day to day compliance. That's why we made things like inspector comments and warning letters specific to regulations in your sector available for review.