Auria Consulting Group provides comprehensive GMP audit preparation and remediation services tailored to pharmaceutical and life sciences organizations navigating inspections, regulatory scrutiny, or internal quality concerns. Whether preparing for a surveillance inspection, responding to agency findings, addressing operational gaps, or hosting a remote inspection, our seasoned team helps ensure compliance, rebuild regulatory trust, and strengthen long-term quality systems. We begin with a thorough assessment of processes, documentation, digital systems, and governance structures, identifying deficiencies, data integrity risks, and opportunities for enhancement. Beyond inspection preparedness, we collaborate with clients to build robust, sustainable systems that demonstrate continuous control, drive ongoing improvement, and establish confidence with global regulators.

Our audit preparation and remediation capabilities include, but are not limited to:

• Mock inspections, including remote and virtual audit simulation exercises

• Audit-ready documentation review, digital management, and development

• Strategic front-room and backroom coordination, including remote inspection logistics

• Expert coaching for SMEs, QA professionals, and senior leadership teams

• Comprehensive gap assessments and prioritized remediation planning tailored for both onsite and virtual audits

• Advanced root cause analysis and robust CAPA program development

• Design and execution of risk-based corrective action plans

• Expert response drafting and guidance for FDA 483s, Warning Letters, and international regulatory findings

• Data integrity assessments and remediation planning to ensure digital compliance

• Post-audit sustainability planning, digital compliance integration, and continuous improvement support

Let us help you move from inspection readiness to long-term regulatory resilience.