Quality Management and Assurance

PV quality systems you can trust and defend

You get structured, inspection-ready quality management for pharmacovigilance, so your SOPs, oversight, documentation, and controls stay aligned, up to date, and ready when regulators take a closer look.

Quality delivered by people who know how PV is inspected

You’re supported by pharmacovigilance quality experts who have built SOPs, maintained PSMFs, supported QPPVs, and guided organizations through inspections across multiple regions, so your quality system reflects real regulatory expectations, not theory.
CIOMSCIOMS
EMAEMA
FDAFDA
Health CanadaHealth Canada
ICHICH
MHRAMHRA
PMDAPMDA
WHOWHO

When quality slips, the risk lands on you

You’re expected to keep every part of your PV system aligned, SOPs, oversight, documentation, audits, and partners, even when things are outdated, inconsistent, or stretched thin. And when a small gap turns into a finding, you’re the one who carries the responsibility.

You’re expected to keep every part of your PV system aligned, SOPs, oversight, documentation, audits, and partners, even when things are outdated, inconsistent, or stretched thin. And when a small gap turns into a finding, you’re the one who carries the responsibility.

How we strengthen PV quality across your system

You get practical, inspection-ready quality support across every part of your PV system, so gaps are addressed early, oversight stays strong, and confidence replaces uncertainty.
SOP Development & Maintenance
SOP Development & Maintenance
You shouldn’t have to manage SOPs that are outdated or unclear. We help you build and maintain a clear, compliant set of procedures that reflect how your PV system really works. Your teams get practical guidance they can follow, and you get documentation you can defend in any inspection.
Pharmacovigilance System Master File (PSMF) Setup & Upkeep
Pharmacovigilance System Master File (PSMF) Setup & Upkeep
Your PSMF should give you confidence, not stress. We create and maintain a PSMF that accurately represents your PV system, stays up to date, and aligns with regulatory expectations. You always know it’s inspection-ready and truly reflects how your organization operates.
QPPV Office Services
QPPV Office Services
Whether you work with a QPPV or are the QPPV yourself, the expectations are high. We support you with structured oversight, timely updates, and clear documentation so nothing falls through the cracks. You stay fully informed, fully compliant, and never carry the burden alone.
PV Audits & Inspection Support
PV Audits & Inspection Support
Audits and inspections shouldn’t feel unpredictable. We help you understand where you stand, prepare the right evidence, and address gaps before they become findings. And when issues do arise, we guide you through corrective and preventive actions with clarity and confidence.
Quality Oversight Across All PV Activities
Quality Oversight Across All PV Activities
You shouldn’t have to monitor every detail yourself. We provide continuous oversight across partners, processes, data flows, and documentation to catch issues early and spot trends before they escalate. You gain visibility, control, and peace of mind across your entire PV system.
Build a PV Department That Fits Your Timeline
Stop managing the burden of building from scratch. Get more information on our fully integrated modules and discover exactly how we stabilize your safety operations.

FAQ

How do I know if this service is the right fit for my situation?
Every iVigee service is designed to meet you where you are. Whether you’re building a PV function, stabilizing operations, or preparing for more complex change, the right fit depends on your products, timelines, and current pressures. When you reach out, we focus on understanding your reality first, not pushing a predefined solution. From there, we’ll help you determine whether this service makes sense now, later, or not at all.
Can services be tailored, or are they delivered as fixed packages?
Will iVigee work alongside our internal team and existing vendors?
What happens after I request information about a service?
Still have questions?Can't find the answer you're looking for? Please chat to our friendly team.

Headline: Here’s Exactly What Working with Us Looks Like

You show us how your PV system works today
You walk us through your SOPs, documentation, partners, audits, and the areas where quality feels unclear, outdated, or vulnerable. We focus on understanding your real-world setup, not applying assumptions or templates.
We build a quality approach that fits your organization
You get a clear plan outlining what needs updating, what requires oversight, and what should be strengthened before an inspection. Responsibilities, timelines, and communication are defined upfront, so you know exactly what to expect.
You get ongoing quality support you can rely on
We maintain documentation, provide structured oversight, and surface issues early, so gaps don’t turn into findings. As your PV system evolves, we adjust with you, keeping quality aligned and defensible over time.
No fluff. No surprises. Just clarity and accountability.

Practical resources to help you make better PV decisions

Explore practical tools, insights, and resources designed to help you make confident PV decisions at your own pace.
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