Applied GMP.
Real-World Compliance.
About
PRAXIS GMP Consulting Group provides hands-on GMP auditing, quality systems assessments, and operational excellence support for pharmaceutical and biotech manufacturers—delivering practical, inspection-ready solutions grounded in real manufacturing experience.
Our Services
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Independent on-site GMP audits aligned with ISO 9001 / 13485, delivering empirical findings and inspection-ready remediation plans.
Our experts routinely audit against 21 CFR Part 210, 211, 600, 820, USP Monographs/General Chapters, ICH, and other applicable governing bodies.
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Practical, inspection-ready CAPA and nonconformance support focused on true root cause analysis and effective corrective actions.
We help organizations through approaches that emphasize scientific rationale, system-level corrections, and outcomes that are defensible to regulatory bodies.
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ICH Q9-aligned risk management assessments that strengthen compliance, decision-making, and operational focus on patient risk.
We focus on practical application of risk management principles and integration into day-to-day GMP operations that withstand regulatory scrutiny and inspection challenge.
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GMP-aligned operational excellence support using practical CI tools such as DMAIC, Kaizen/Gemba, and daily management systems.
We work with manufacturing and quality teams to identify performance gaps, reduce variability, and embed practical improvement practices that are sustainable and inspection ready
Our Expertise
PRAXIS GMP Consulting Group has supported a wide range of regulated organizations including:
503B compounding pharmacies
Sterile pharmaceutical manufacturers
Medical device manufacturers
Biotechnology firms
Cosmetics manufacturers of OTCs
Our experience is established in deep understanding of end-to-end product manufacturing from process validation and control, CAPA systems and defect management, and ongoing quality assurance and remediation.
Across all environments, our focus has remained consistent: applying sound GMP principles, risk-based thinking, and operational disciple to support patient safety, product quality, and regulatory compliance.
Contact Us
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