QULLA supports biotech sponsors and CDMOs at the interface where quality, CMC, manufacturing and business priorities must work together. We make accountability visible and execution risk manageable.
Support spans partner selection, due diligence, audits, quality agreements, technology transfer governance, performance oversight and issue escalation across international CDMO networks.
It is evidence that the sponsor understands critical outsourced activities, makes risk-based decisions, follows performance and retains accountability without duplicating the CDMO's complete quality system.
Yes. QULLA supports on-site assessments and audits internationally, with ongoing strategy, governance and follow-up delivered efficiently from Switzerland.
Explore all QULLA services · Read the Purple Papers · About Richard van Ewijk
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.