Six connected disciplines — led by quality, risk, and statistics — that keep complex products compliant, defensible, and audit-ready. Engage one, or the whole arc.
A quality system that fits how your team actually works — lean enough to run, rigorous enough to pass an FDA inspection or MDSAP audit without a scramble.
Risk management that's woven into design and clinical evidence — not a document assembled at the end. Traceable, current, and ready to defend.
The statistical backbone your quality and risk decisions rest on — sound study design, the right sample size, and analysis you can defend to an auditor or a reviewer.
A defensible design and development file and usability evidence that reflect how your product is actually used — two areas that draw the most scrutiny on combination products.
Drug-device and biologic-device products have to satisfy quality requirements for both constituents at once. We build one integrated system under 21 CFR Part 4 — not two that contradict each other.
We're not your regulatory lead — we make your submissions stronger. We supply the quality, risk, and statistical evidence they depend on and support your RA team through review.
Whether you need a one-time strategy or an embedded regulatory partner, we scale to fit.
A focused engagement to find the gaps — a quality and risk assessment with a prioritized, documented roadmap you can act on.
End-to-end ownership of a deliverable — a QMS build, a risk file, a statistical analysis, a human-factors program — with clear scope, milestones, and accountability.
Fractional quality, risk, and data leadership — we join your team on a retained basis to steer strategy and execution together.
Independent assessments for investors, acquirers, and boards — a fast, honest read on quality, risk, and compliance readiness.
Bring us the problem, not the solution. A 30-minute call is usually enough to point you at the right first step.
No obligation · Direct with a principal consultant