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
- Gap 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.
- Pre-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.
- AI/ML validation strategy and lifecycle management. Automated compliance monitoring systems. Digital quality infrastructure and data integrity frameworks.
Scale Your Training with Enterprise AI
Upload your SOPs and get AI-powered compliance training, SOP Q&A, regulatory monitoring, and more — purpose-built for pharma, biotech, and CROs.
Explore Enterprise AI →