End-to-end quality oversight, GCP compliance assessments, protocol and process review, and risk-based quality support across all phases of clinical development.

Cross-functional operational oversight, monitoring strategy refinement, issue escalation pathways, governance frameworks, quality-by-design implementation, vendor oversight, and lifecycle support to ensure compliant study execution.

Preparation, QC, and structuring of regulatory submissions including CTN/CTA, IND components, eCTD-aligned documentation, and global authority correspondence.

Lean, scalable Quality Management Systems, SOP frameworks, eQMS implementation, controlled document migration support, vendor qualification frameworks and vendor audit support.

Mock inspections, team readiness sessions, storyboarding, audit response development including root cause analysis and CAPA identification, and on-site/off-site inspection support (FDA, EMA, MHRA, Health Canada,TGA.

Customized, lean, risk-based quality system setup for early-stage companies, governance frameworks, training programs, and scalable processes that support growth and future inspections.