Who We Are
PRAXIS GMP Consulting Group is an independent consulting firm specializing in GMP auditing, quality systems, risk management, and operational excellence for small- to mid-sized regulated manufacturing environments.
We have worked directly with pharma, biotech, medical device, CDMO/CMO, and OTC organizations to deliver practical, inspection-ready solutions grounded in real-world manufacturing expertise.
We partner closely with quality and operations teams to assess compliance, resolve systemic issues, and strengthen inspection readiness through clear actionable guidance.
Our approach emphasizes clarity, accountability, and execution—helping teams translate regulatory expectations into sustainable day-to-day practice.
Our Experience
PRAXIS GMP Consulting Group was founded from direct hands-on experience in the OTC and pharmaceutical manufacturing industries.
From OTC creams and aerosols to sterile parenteral drug products, our team has proven experience from direct responsibilities hosting FDA PAI, GMP, and For-Cause inspections and site remediations. We bring regulator-tested perspective to quality system design, remediation, and sustainment.
Our experiences come from deep understanding of end-to-end product manufacturing from process validation and control, CAPA systems and defect management, and continuous quality assurance and remediation.
PRAXIS GMP Consulting Group has supported a wide range of regulated organizations including:
503B compounding pharmacies
Pharmaceutical manufacturers performing aseptic processing of sterile injectables
Medical device manufacturers of surgical robotics
Biotechnology firms working in gene editing technologies
Cosmetics manufacturers of OTCs
Across these 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.