QPPV Representation and Oversight
Qualified QPPV support with continuous oversight of your EAEU pharmacovigilance system and regulatory obligations.
EAEU QPPV Services
Dedicated Qualified Person for Pharmacovigilance (QPPV) services across the Eurasian Economic Union (EAEU), supporting Marketing Authorisation Holders (MAHs) in maintaining a compliant, effective and inspection-ready pharmacovigilance system.
Our model combines regional regulatory expertise with centralised PV oversight, supporting seamless integration between EAEU requirements and your global pharmacovigilance system.
Bpharma’s EAEU QPPV sits between your global PV system and the EAEU regulatory environment, connecting the two and providing regional oversight, governance and compliance support.
Country-specific feasibility and service availability are confirmed for each project. Regulatory obligations and authority decisions remain with the applicable responsible parties.
Regional oversight · Governance · Compliance
In detail
What we take care of
PSMF Development & Maintenance
Development, review and ongoing maintenance of the Pharmacovigilance System Master File (PSMF), helping keep it accurate, current and aligned with the operational PV system.
Benefit‑Risk & Safety Oversight
Continuous oversight of product safety profiles, emerging safety information, signals and potential changes to the benefit-risk balance.
RMP & Risk‑Minimisation Oversight
Support for Risk Management Plans (RMPs) and oversight of applicable additional risk-minimisation measures.
Case Management Oversight
Oversight of safety-data collection, case processing, follow-up, exchange, reconciliation and regulatory reporting.
Audit & Inspection Readiness
Continuous compliance oversight, inspection preparation, audit support, corrective and preventive action (CAPA) follow-up and documentation readiness.
