A Qualified Person for Pharmacovigilance (QPPV) is essential for maintaining drug safety and meeting regulatory obligations. Melior Life Sciences (MLS) Pharmacovigilance QPPV Services provide the expertise and compliance you need to fulfill your pharmacovigilance responsibilities in the EU and beyond.
Dedicated QPPV Support: Appointing a qualified and experienced QPPV to oversee pharmacovigilance systems and ensure compliance with EU regulations.
24/7 Availability: Round-the-clock accessibility to handle urgent safety issues and regulatory inquiries.
Regulatory Liaison: Acting as the primary contact point for regulatory authorities such as EMA and national agencies.
Pharmacovigilance System Master File (PSMF) Management: Ensuring your PSMF is always up-to-date and audit-ready.
Signal Detection and Management Oversight: Monitoring and addressing safety signals effectively
Compliance Monitoring: Conducting audits and gap analyses to ensure your pharmacovigilance systems meet regulatory standards.
Regulatory Expertise: In-depth knowledge of EU pharmacovigilance requirements and global standards.
Proven Track Record: Successfully supporting pharmaceutical companies of all sizes in meeting their QPPV obligations.
Seamless Integration: Our QPPV works as an extension of your team, providing consistent support and guidance.
End-to-End Solutions: Seamless integration with your pharmacovigilance processes for streamlined operations.
Customisable Solutions: Flexible service models tailored to your specific needs, from interim QPPV support to full outsourcing.
Risk Mitigation: Proactive oversight to minimize compliance risks and ensure patient safety.
Ensure your compliance and drug safety obligations are met with confidence. Let our experienced QPPV professionals safeguard your pharmacovigilance system and regulatory standing.
Contact us today to learn how our QPPV services can enhance your pharmacovigilance processes.
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