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QPPV Obligations, Covered with Confidence

QPPV services carry real legal accountability, the UK and EU QPPV roles sit on your shoulders, and getting the appointment or a transition wrong creates compliance risk you cannot afford. This practice is led by Dr. Natalia Kalousova Kocankova, SVP and Head of PV Operations, with over 20 years of hands-on QPPV experience across pharma, biotech, and rare diseases, providing qualified, experienced coverage backed by a team built to keep your PV system running without interruption.

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Natalia brings real-world experience from:

QPPV SERVICES

QPPVs who have done this before,
many times over.

Our QPPV practice is built on genuine experience, not theoretical knowledge. Every QPPV we provide has held the role across pharma, biotech, and rare diseases, and knows what EU and UK competent authorities expect. From initial appointment through inspections and regulatory inquiries, we keep you covered.

QPPV Appointment and Regulatory Accountability

The QPPV is your primary pharmacovigilance contact with competent authorities and carries full legal responsibility for your PV system. This practice appoints your QPPV ahead of your first Marketing Authorization Application, oversees safety governance, escalation pathways, and PV activities, and supports interactions with competent authorities during inspections and regulatory inquiries.

QPPV Continuity and Transition Support

QPPV transitions create compliance risk if they are not managed carefully. We provide structured support through every transition, including the replacement of an existing QPPV, maintaining oversight continuity so your PV system stays uninterrupted regardless of organizational or personnel changes.

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