Restoring Inspection Readiness and Building a Long-Term Pharmacovigilance Partnership
A mid-sized biotechnology company operating in the EU faced critical pharmacovigilance (PV) compliance findings following an inspection by the European Medicines Agency and Medicines and Healthcare products Regulatory Agency. With a follow-up inspection approaching and dissatisfaction with its existing QPPV provider, the company needed rapid support to stabilize its PV system and restore inspection readiness.
ProPharma appointed a senior EU Qualified Person for Pharmacovigilance (QPPV) and quickly integrated into the client’s quality management system to strengthen oversight and compliance.
As the partnership developed, support expanded to include EU and UK QPPV and deputy roles, Local Persons Responsible for Pharmacovigilance across most EU countries, literature screening, and regulatory intelligence for Risk Management Plans and additional risk minimization measures in more than 50 countries.
The result was two successful PV inspections, strong audit outcomes, improved access to historical safety data, and a long-term, multi-year pharmacovigilance partnership.
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