Customer Requirement
A large US-based pharmaceutical company with a broad global footprint, multiple manufacturing sites, and an extensive pharmaceutical portfolio needed reliable local pharmacovigilance (PV) compliance support across 11 international markets covering over 30 marketed products. The brands under its portfolio had significant visibility and consumer demand, making any PV non-compliance a high regulatory and reputational risk. To ensure seamless operations, the company’s Global Patient Safety team sought a partner capable of deploying qualified local QPPVs across 11 countries of Middle East and APAC.
Problem Statement
The client required swift and compliant setup of local PV infrastructure in regions with varying and evolving regulatory expectations. Key challenges included:
- Absence of local QPPVs in several target countries
- Imminent agency inspections demanding urgent compliance readiness
- Need to align and integrate local safety teams with the client’s global PV system
- Real-time reporting and escalation requirements
- Development of inspection-ready documentation and country-specific SOPs
Timeliness was critical, and the client expected an efficient, structured, and audit-ready mobilization plan.
Key Objective
To establish locally compliant QPPV presence across 11 markets within 30 days, build an inspection-ready pharmacovigilance framework integrated with the client’s global PV systems, and ensure uninterrupted product availability by achieving full compliance with local regulatory requirements.
DDReg Solutions & Processes Adopted
DDReg initiated a rapid, structured deployment strategy by leveraging its global PV network. The approach included:
- A country-specific implementation model led by local experts
- Engagement of qualified QPPVs across all 11 markets within 30 days
- Country-level PV requirement assessments and readiness evaluations
- Review and integration of critical PV processes including case handling, spontaneous reporting, signal detection, PSMF maintenance, aggregate reporting, and risk management planning
- Training all local PV resources on the client’s safety database, reporting timelines, and SOPs
- Establishing inspection-readiness documentation and customized local SOPs
- Addressing cultural and regulatory nuances specific to each country
- Final audit conducted by the client’s PV team validating DDReg’s QPPV setup and quality framework across all markets
Business Impact
DDReg successfully established QPPV and local safety contact coverage across all 11 countries within the agreed timelines. The client achieved full in-market pharmacovigilance compliance, ensuring their products remained available on shelves without interruption due to regulatory issues. This comprehensive compliance framework enabled the client to meet evolving country-specific PV requirements and built a sustainable framework for ongoing local PV compliance.
Key Learning
Rapid multi-country QPPV implementation is feasible through a structured, expert-led model backed by strong local networks. Inspection-readiness requires not only regulatory knowledge but also integration with global systems, training, and cultural adaptability. Strategic pharmacovigilance partnerships are key to sustaining global market access in high-risk regulatory environments.
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