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Local QPPV Done Right, Country by Country

Local QPPV requirements differ in every market, and getting them wrong creates compliance risk you can't see until an inspection finds it. Veronika Machalova leads our local QPPV network, with hands-on experience across Europe, Asia, Africa, the Americas, and Australia, making sure every country you operate in is covered accurately by people who know what regulators expect on the ground.

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Quality systems built to satisfy the world's most demanding regulators.

LOCAL QPPV

A local QPPV in every country
you sell in

Local QPPV only works when responsibilities are clear, activities are consistent, and national requirements are understood on the ground. Veronika and her team ensure every country you operate in is covered by the right experts, with the right knowledge, at all times.

Responsible Person at Country Level and Deputy

We provide qualified Responsible Persons at country level, supported by trained deputies, acting as a single point of contact across all covered countries. Our local experts serve as your official interface with authorities, ensuring national safety requirements are met accurately, consistently, and on time.

Case Intake and Follow-Up

We support local case intake and follow-up activities in line with country-specific requirements. Our experts ensure adverse events are captured correctly, relevant information is obtained efficiently, and cases are managed in accordance with local expectations.

Local Inspection and Audit Readiness

We support local inspection and audit preparedness by ensuring documentation, processes, and local PV systems meet authority expectations. Our experts understand how regulators assess compliance and help you respond confidently before, during, and after inspections.

Compliance at Country Level

We support compliance with national Pharmacovigilance (PV) legislation, guidance, and authority expectations in each country where you operate. Our local experts translate regulatory requirements into practical actions and help you maintain a compliant, inspection-ready local PV system.

Supporting Process of aRMMs

We support the implementation and maintenance of Additional Risk Minimisation Measures (aRMMs) in line with national authority requirements. Our local experts ensure aRMM activities are practical, documented appropriately, and ready for inspection.

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