Focus on Risk-Based Quality We help adjust your SOPs, monitoring plans, and vendor oversight models so they reflect these risk-based expectations—without overloading your team.
Updated Compliance Requirements Our experts map your current practices to the new regulatory expectations—ensuring your operations are both compliant and audit-ready.
Operational Efficiency & Data Quality We help you simplify workflows, reduce duplication, and build systems that improve both performance and compliance.
Scope of Work
Step-by-step structure of the consulting engagement
Virtual kick-off meeting to confirm objectives and timelines
Collection and organization of SOPs, policies, training records, and other quality documents
Review of documentation hierarchy and governance structure
High-level review of selected SOPs and workflows
Comparison of current practices with ICH GCP E6(R3) requirements
Identification of short-term and high-risk compliance gaps
Assessment of data integrity, sponsor oversight, vendor management, and quality systems
Mapping findings to R3 standards with risk and impact analysis
Initial recommendations for SOP updates, training, and process adjustments
Preparation of a preliminary Gap Assessment Report
Consolidated Gap Assessment Report
Strategic Transition Roadmap with prioritized steps and timelines
Virtual debrief session to review findings and discuss implementation approach
Follow-up Q&A session
Advisory input during SOP revision, training, or internal alignment