Case Study – QPPV and LSO Services

A mid-sized US pharmaceutical company was preparing its first submission and launch in Europe. While the organisation had an established pharmacovigilance system in the United States, it had no PV infrastructure in place across the EU, UK or Switzerland.

To support its expansion, the company needed to establish a compliant European PV framework, including QPPV, QPPV Office and Local Safety Officer coverage, along with local literature monitoring, ICSR and regulatory oversight processes and inspection-ready documentation. The challenge was not only to meet regional regulatory requirements ahead of approval, but also to build a sustainable system capable of supporting ongoing compliance across multiple territories after launch.

End-to-end QPPV & LSO/LPPV Support

• Established the EU, UK and Swiss PV framework
• Established and managed the QPPV Office and local PV network
• Implemented local literature monitoring across EEA countries, UK and Switzerland
• Supported regulatory authority interactions and safety-related enquiries
• Provided the global team guidance on core safety data management and post-authorisation safety activities
• Strengthened global PV procedures and implemented local working instructions to ensure inspection readiness

The Result

• Successful EU submission supported by a compliant global and local PV system
• Local PV infrastructure in EEA, UK and Switzerland operational at the time of approval
• Clear roles, responsabilities and oversight documented across all stakeholders
• Successful support through audits and inspections at EMA and country level
• Strong collaboration leading to an ongoing strategic partnership

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