Inspection-ready, by design.
PSMF, PV QMS, procedures, agreements, CAPA and change control, audits and inspection readiness — the documented backbone of a defensible PV system.
Expert-led. Controlled. Inspection-ready.
PV Quality & Compliance
7 service modules
What PV Quality & Compliance covers
Open a module to see the scope, what we deliver and the standards it is delivered against. Engage a single module or the whole area.
Engagement models to match your goals and resources.
Full-Service PV Outsourcing
End-to-end support across an agreed PV scope, under one accountable model.
Functional Services
Specialist support for selected PV activities, integrated with your own team.
Dedicated PV Teams
Experienced resources aligned to your operating model, procedures and systems.
Technology-Enabled Delivery
PV services supported through HAROM OnePV and the connected applications.
Every PV service, under one accountable partner.
Safety Operations
End-to-end ICSR handling, clinical safety, literature surveillance and submissions — run by experienced PV professionals with controlled, audited workflows.
Safety Science & Medical Writing
Aggregate reporting, signal and risk management, medical review, benefit-risk and regulatory safety writing — authored and reviewed by qualified PV scientists and physicians.
Next step
Let's scope PV Quality for you.
Tell us your products, markets and volumes — we will propose the modules and engagement model that fit.