Gap Analysis

Gap Analysis

Assess. Improve. Comply with Confidence.

Agon ME conducts comprehensive Gap Analysis assessments to identify areas of non-compliance and develop a clear, actionable plan to achieve full regulatory alignment. Our detailed evaluations cover every aspect of facility, process, and documentation, ensuring adherence to authority requirements including USFDA, EU, JFDA, SFDA, and GCC regulations.

What We Deliver

Pre-Assessment & Mock Audits

Facility and documentation review before official inspections
Simulation of regulatory audits to assess system readiness
Identification of compliance gaps and critical risk areas

Detailed Gap Analysis Report

Thorough assessment of technical and quality systems
Prioritized corrective and preventive action plan (CAPA)
Recommendations for process enhancement and compliance improvement

Implementation & Follow-Up

Support in executing CAPA and system upgrades
Verification of corrective action effectiveness
Continuous monitoring to sustain regulatory compliance

Ensure your facility meets every standard — confidently and consistently.

Categories

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

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