Pre-Assessment & Mock Audit

Pre-Assessment & Mock Audit

Identify Compliance Gaps Early and Strengthen Inspection Readiness Before Regulators Arrive

AGON supports pharmaceutical facilities in preparing for regulatory inspections through structured pre-assessments and mock audits. Our experts evaluate existing systems, processes, and documentation against GMP and international regulatory expectations to determine true readiness. By simulating real audit conditions, we uncover compliance gaps, operational risks, and systemic weaknesses, and provide clear corrective and preventive pathways to ensure your facility enters inspections with confidence and control.

What We Deliver

Review of existing systems, processes, and documentation against GMP and regulatory requirements
Mock audits simulating regulatory inspections to evaluate compliance readiness
Identification of gaps, risks, and improvement opportunities in quality, production, and engineering systems
Actionable recommendations and corrective/preventive action (CAPA) plans

Deliverables

Pre-assessment reports highlighting compliance gaps
Mock audit reports with findings and recommendations
CAPA plans addressing identified risks to ensure regulatory readiness

Categories

We understand the importance of approaching each work integrally and believe in the power of simple.

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