With more than 250 audits conducted worldwide, QULLA evaluates whether quality systems work in practice—not only whether procedures exist. Findings are translated into prioritized, executable improvements.
Audits and gap assessments focus on patient, product, data and execution risk. Remediation is right-sized to the operation and designed to withstand regulatory and client scrutiny.
Assignments can cover GMP, GDP, GCP interfaces, data integrity, computerized systems, manufacturing, quality control, supply partners and sponsor oversight.
Yes. Support can continue through root-cause analysis, CAPA design, governance, evidence review and inspection preparation.
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We work with organizations where the stakes are high and quality excellence is non-negotiable — from advisory to hands-on execution.
Whether entering Phase I or scaling toward later-stage development, we help build quality infrastructure that matches ambition without overbuilding for the current stage.
We help CDMOs sharpen their quality positioning, strengthen governance structures, and demonstrate the operational robustness that clients and regulators demand.