Gap Analysis & Inspection Readiness

At GLORAMP, we help organizations proactively identify compliance gaps, mitigate regulatory risks, and achieve full inspection readiness across GxP functions. Our structured, evidence-based approach ensures your systems, processes, and documentation align with global health authority expectations.

Comprehensive GxP Gap Assessments

We deliver in-depth GxP gap analyses across critical regulatory and quality domains — ensuring alignment with MHRA, EMA, and EudraLex GMP expectations.

Our assessments cover:

Pharmacovigilance (PV): PSMF, SDEAs, signal management, and reporting systems
Good Manufacturing Practice (GMP): Annex-specific compliance reviews and documentation
Good Distribution Practice (GDP): WDA licensing, transport, and supply chain oversight
Regulatory Affairs (RA): CTA and MAA dossier structure, eCTD operations, and submission readiness
Medical Devices & IVDs: MDR/IVDR technical file evaluation and conformity documentation

Each assessment is benchmarked against current regulatory baselines, resulting in clear, risk-based remediation plans with defined priorities, timelines, and actionable recommendations.

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