System setup.
Designing and standing up a quality system framework from zero (greenfield) or from broken state. Triple-domain coverage in one engagement: bioanalytical, bioequivalence, clinical trials.
The fit.
Organisations building a quality system from scratch — CRO operations leads, combination-product founders, post-incident rebuilds.
What this delivers.
Architectural framework, governance substrate, cross-domain SOP scaffolding, implementation roadmap.
Where the edge is.
PQIOS architectural framework. Governance-substrate thinking. Triple-domain coverage in one engagement — most consultancies operate single-domain. Where domain edges blur (BA-BE handoffs, CT-device combination products), the cross-domain integrator role is rare.
The shape of the work.
Every engagement is scoped per situation. The shape — focused diagnostic, structured implementation, ongoing partnership — emerges from the discovery conversation rather than a fixed package. Some engagements are short and intense; some are months-long structural builds; some are recurring quality oversight. We talk first, then scope.
Discovery.
Conversation to understand current state, target regulatory regime, organisational scale.
Scoping.
Phased proposal with deliverables aligned to regulatory inflections.
Build.
Architectural framework, governance substrate, SOP scaffolding aligned to operational reality.
Handover.
Documentation, training, post-handover support window for the first inspection cycle.