Be Inspection-Ready for ICH E6(R3)
ICH E6(R3) raises the bar for risk-based quality management, Vendor oversight, and modern quality systems. For most organizations, meeting that standard requires an assessment of where current SOPs, policies, and processes fall short—and a clear plan to close those gaps.
Our Approach
A structured assessment from GxP experts
Our team of senior Quality and GxP SMEs reviews your existing SOPs, policies, work instructions, and quality management systems against E6(R3) requirements across all relevant functional areas. Every gap is documented, prioritized by risk, and paired with a concrete recommendation so your team has an actionable path forward.
The engagement is scoped to your organization’s needs, whether that means a focused review for a lean biotech team or a broader cross-functional assessment. Where relevant, we can also support SOP updates, rewrites, or team interviews to evaluate how processes are being implemented in practice.
THE CHALLENGE
Most organizations don’t know where they stand
ICH E6(R3) introduces meaningful changes to how Sponsors are expected to manage quality systems and Vendor oversight. Acting without a structured assessment of existing documentation creates regulatory, operational, and reputational risk.
What you receive
Deliverables
Gap List
Every identified compliance gap, organized by functional area and mapped to the specific E6(R3) requirement it fails to meet.
Risk & Compliance Commentary
SME analysis on the regulatory significance of each finding, including the context teams need to understand urgency and prioritize remediation.
Suggested Revisions
Concrete recommendations on how each document should be revised, created, or retired.
Cross-Document Dependencies
Where a gap in one document affects related SOPs or policies, we flag those interdependencies to ensure recommendations account for the full document ecosystem.
WHY DILIGENT
Deep GxP expertise, applied directly to your processes
Each assessment team includes a strategic SME with 35+ years of GxP compliance experience alongside senior technical SMEs who execute hands-on document review across E6(R3) domains.
Inspection Readiness
A clear, documented compliance position across all relevant functional areas.
A Remediation Roadmap
Every gap comes with a specific recommendation. Quality and functional teams have an actionable path forward the day the report is delivered.
Risk Reduction
Gaps are prioritized by regulatory and operational exposure, so remediation effort is focused where it matters most.
Cross-Functional Alignment
Structured read-outs by functional area give Quality, Clinical Ops, Regulatory, PV, and other teams a shared understanding of their E6(R3) obligations.
A Stronger Trial Foundation
R3-aligned processes reduce operational variability and build a foundation of compliance
Understand your ICH E6(R3) compliance position.
Schedule a consultation to discuss an assessment for your organization.