QULLA helps sponsors and manufacturing partners design practical QP strategies for clinical and commercial supply, especially where products, testing or manufacturing originate outside the EU.
QULLA provides QP strategy, pre-assessment and release-readiness support. Legal batch certification or QP declaration is performed through the appropriately licensed MIA and its named QP.
Early QP input exposes documentation, audit, testing, importation and supply-chain gaps while they can still be resolved without delaying a trial.
QULLA supports the strategy and readiness work. Legal certification is performed by the QP named under the relevant manufacturing and import authorization.
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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.