Only the regulator runs the audit. We've been on every other side of it.
ParaQualis started from a simple observation: the people responsible for quality and regulatory compliance spend most of their time fighting their own tools, not doing the work that actually protects patients and products.
Our starting belief
Quality and compliance should enable value, not constrain innovation. A regulatory review that takes weeks and produces a checklist nobody trusts isn't protecting anyone. It's just overhead. Giving that time back is the whole point.
How we work
Software for a regulated environment has to be trustworthy before it is clever. We build from experience of what actually gets scrutinized in an inspection, and what holds up once it is.
Team
Craig Wylie
Founder, ParaQualis
Craig has supported organizations through every side of a regulatory audit that isn't the regulator's own: the preparation beforehand, the audit itself, and the remediation after: consent decrees, warning letters, and full quality system transformations among them. That's not theory. It's what ParaQualis is built from: knowing exactly what gets scrutinized, what actually holds up under it, and what a team needs in place before the inspector walks in and after they leave.
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Want to hear more?
If you work in quality or regulatory and want to hear what we're building, get in touch.
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