QPPV Services
DDReg’s specialized pharmacovigilance services identify, efficiently manage and communicate the signals of potential adverse events. We combine expert analysis with advanced methodologies for effective safety signal detection and proactive management in pharmacovigilance.
DISCOVER MOREOur Comprehensive Approach to Pharmacovigilance and QPPV Services
A Qualified Person for Pharmacovigilance (QPPV) plays a critical role in managing and enhancing the safety profile of medicinal products. Acting as the primary contact for regulatory authorities, a QPPV ensures that the benefit–risk data is managed effectively while implementing quality audits, signal management, and comprehensive training programs.
Global regulatory agencies mandate the appointment of a QPPV, with each region establishing its own requirements regarding qualifications and residency. Our approach integrates strategic oversight with detailed evaluations of pharmacovigilance processes to ensure that marketing authorization holders maintain compliant and efficient systems.
Global QPPV Support & Regulatory Compliance
DDReg supports organizations worldwide with an extensive network of seasoned experts who deliver local person for pharmacovigilance solutions. Our team ensures that every pharmacovigilance document and process aligns with legal and regulatory standards. We offer services that cover quality audits, signal detection, and the seamless integration of safety compliance measures.
Whether you require guidance on amendments to your quality management systems or need assistance with regulatory notifications, our services are designed to keep your pharmacovigilance system robust and adaptive. We blend expertise in both traditional and innovative approaches to provide a well-rounded, efficient solution.
Our QPPV and LPPV Expertise
- Development of the Pharmacovigilance System Master File (PSMF)
- Review of SDEA agreements and contracts with commercial partners
- Registration for Eudravigilance as QPPV/Deputy QPPV
- Notification to competent authorities regarding QPPV & PSMF changes
- Amendment to Quality Management Systems (QMS) for pharmacovigilance and development of PV SOPs
- Retainer services for QPPV and Deputy roles
- Monthly reconciliation and communication reports with compliance metrics
- Signal detection with medical review prior to quarterly meetings
- Conducting Signal Surveillance Meetings and generating frequency tabulations
- Oversight of the Pharmacovigilance Quality Management System