Quality Assurance & GxP Compliance
We build and repair the quality systems regulators inspect — from QMS design and supplier quality to remediation under consent decree — so your audits stay boring and your product keeps shipping.
When quality slips, everything stops. Our quality directors and auditors have run GxP quality systems and led remediation on both sides of an FDA 483. We harden your QMS, close CAPAs that actually hold, prepare you for inspection, and stand up the supplier-quality and data-integrity controls that keep findings from recurring.
100%
Audit readiness maintained
483 / WL
Remediation experience
ALCOA+
Data-integrity controls
How we help
Audit readiness, remediation, and quality systems that hold up under inspection.
Quality Management Systems
QMS design, harmonization, and optimization across GxP operations.
Audit & Inspection Readiness
Internal, supplier, and mock-FDA audits that keep you inspection-ready.
Remediation & CAPA
483, Warning Letter, and consent-decree remediation with CAPA that holds up.
Supplier & Vendor Quality
Supplier qualification, audits, and quality agreements across the supply chain.
Data Integrity
ALCOA+ assessments, controls, and remediation across systems and processes.
GxP Training & Culture
Role-based GxP training and quality-culture programs that stick.
A clear path, start to finish.
Diagnose
Gap assessment against GxP and your quality standards.
Remediate
Prioritized CAPA and quality-system remediation with owners.
Embed
Senior practitioners operate the system alongside your team.
Sustain
Controls and documentation that keep audits uneventful.
The people behind the work.
Vetted, screened, and matched to your exact needs — on a contract, interim, or permanent basis.
Held to the highest bar.
We work to the standards your regulators, auditors, and customers expect.
Industries this practice serves
Let’s talk about quality assurance & gxp compliance.
Tell us what you’re working on and we’ll show you how this practice can help.