QPPV Office & PSMF Management

Our QPPV office consists of PV experts covering all major territories. We have the European Union (EU/EEA QPPV), the United Kingdom (UK QPPV), the Eurasian Economic Union (EAEU-QPPV). We also have the local QPPVs (or contact persons for PV, national PV responsible persons, or local safety officers) to fulfil the PV obligations on the country level.

All of our QPPVs have the appropriate background, significant expertise, continuous training. More importantly – our QPPVs have the right attitude, prudence, and excellent communication skills to lead PV systems effectively.

Our QPPV office and global PV infrastructure exist within the same PV organization. We create a unique opportunity for a seamlessly integrated and unified global PV system and effective oversight by the QPPV.

Services Offered:

European Union (EU) Qualified Person for Pharmacovigilance (EU/EEA QPPV) and Deputy

United Kingdom QPPV (UK QPPV) and the UK national contact persons for PV

Eurasian Economic Union QPPV (EAEU-QPPV) and Deputy

Medical Advisory and Safety Physician teams

Pharmacovigilance System Master File (PSMF) and and regional PV System Sub-Files (PSSF)

Years of EU-QPPV experience
QPPV projects include innovative, biological, or Advanced Therapy Medicinal products (ATMPs)
Available to you 24/7, 365 days a year

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Oct 18, 2021

QPPV Outsourcing in EU/EEA and its benefits for MAH

To place its medicines on the market in the European Union (EU)…

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Feb 25, 2022

Requirements for Nomination of a PV Contact Person

Under the requirements for the EU pharmacovigilance system, the Marketing Authorization Holders…

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Dec 16, 2020

BREXIT – Key Changes in the UK Pharmacovigilance System

The United Kingdom (UK) has left the European Union (EU), and the…