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PIE Associates Consulting works with companies at every stage: from startups preparing for their first audit to established organizations managing multi-site quality programs. Our consultants bring hands-on experience across regulatory frameworks including FDA, ICH, GCP, GMP, GLP, and ISO standards. We work alongside your team to close gaps, build systems, and stay audit-ready, without disrupting operations. ​

 

WHAT WE DO:

• Quality Systems - SOP Development, QMS design, CAPA management

• Audit & Compliance - Inspection readiness, gap analysis, risk management

• Training & Support - GCP, GMP, GLP, GDP, GLCP training and in-house support​

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Click here to explore our services.

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We are also onboarding specialized consultants in cybersecurity, financial advisory, healthcare,

and insurance risk management - expanding our ability to serve your organization across disciplines.

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