GxP Consulting That Delivers Results
GxP Consulting That Delivers Results
From gap assessments to full QMS implementation, our consulting is led by senior auditors who have conducted 2000+ audits worldwide. We don’t just advise — we build compliance systems that hold up under inspection.
Our Consulting Services
- ICH GCP E6R3 Transition ConsultingGap assessment against E6R3 requirements. Transition roadmap and implementation plan. SOP review and update support. Team readiness assessment and targeted training. Mock inspections under the new standard.
- Quality Management System (QMS) Design & ImplementationQMS architecture and process mapping. SOP development and review. Risk management framework (ICH Q9). CAPA system design and optimization. Audit program development.
- Inspection ReadinessPre-inspection audits (FDA, EMA, MHRA, local authorities). Mock inspections with realistic scenarios. Back room support during live inspections. CAPA remediation and follow-up.
- Vendor OversightVendor/supplier qualification and audit programs. CRO, CMO, laboratory, and logistics provider oversight. Risk-based vendor management strategies.
- Enterprise AI & Digital ComplianceAI/ML validation strategy and lifecycle management. Automated compliance monitoring systems. Digital quality infrastructure and data integrity frameworks.
Why Companies Choose The QARP
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2,000+
Audits Completed Globally
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98%
Client Retention Rate
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25+
Countries Served
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