Quality Systems & Compliance
Build a phase-appropriate QMS from the ground up, or fix the one you have, sized so a small team can maintain it.
Quality systems built for growing companies
Hands-on QMS, GMP and supplier quality consulting, and fractional Head of Quality support, for pharmaceutical, biotechnology, medical device, combination product, 503B and cosmetic companies, especially early-stage and virtual teams without an in-house quality department.
I help you build a quality system that fits how your company actually operates, audit the partners you rely on, and get ready for FDA inspection. Then I hand it off to a team that can run it.
20+years of quality experience
6quality systems built or remediated
20–25audits a year across 8 countries
10+FDA, state & ISO inspections supported
Practical quality support, delivered directly
I work directly with your team to build practical quality systems, address compliance risks and keep development and manufacturing moving.
Supplier Quality & CMC Oversight
Qualify and audit CDMOs, labs and suppliers worldwide, and oversee GMP manufacturing for clinical and commercial supply.
FDA Inspection Readiness
Assess readiness, prepare teams and records, run mock inspections and support response and remediation.
Fractional Head of Quality
Serve as your interim or fractional Head of Quality, advising leadership on quality strategy, risk management and inspection readiness.
Tell me what you’re working on
Project-based, fractional and interim engagements, sized to your stage and your team.
Let's Talk