Pharmacovigilance System Set-Up

Developing a pharmacovigilance system and its quality system can tie up capacities and become a challenge. At Insuvia we aim to help pharmaceutical companies overcome this faster, easier, and cost-effectively. We work around the deadlines, no matter how tight. We make sure that you have the PSMF, EudraVigilance, and QPPV details for your Marketing Authorization Application on time.

Our pharmacovigilance processes are specifically adapted to the needs of small and mid-sized pharmaceutical companies. We provide them with a cost-effective full-service safety department as an outsourced solution. We can establish a compliant Pharmacovigilance System, create and maintain the Pharmacovigilance System Master File, provide a full QPPV Office or any part of it, and help you fulfil all pharmacovigilance obligations in the EU & UK, CIS, or MENA.

Services Offered:

Set-Up of Pharmacovigilance System Master File (PSMF)

Appointment of the  EU Qualified Person for Pharmacovigilance  (EU QPPV)

Applicants’ registration in the EudraVigilance system

Implementation of a pharmacovigilance processes, SOPs and quality system aspects

Set-up and validation of a Safety Database

Risk Management Plan development

Consultations on Pharmacovigilance System implementation

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Pharmacovigilanec systems and PSMFs implemented
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Years of EU-QPPV experience
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The time we need to get all documents ready for your MA Application

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Jul 21, 2021

Integration of Client-Vendor Pharmacovigilance Systems

Pharmacovigilance (PV) activities are fundamental to both patient safety and regulatory compliance,…

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Oct 18, 2021

QPPV Outsourcing in EU/EEA and its benefits for MAH

To place its medicines on the market in the European Union (EU)…

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Feb 25, 2022

Requirements for Nomination of a PV Contact Person

Under the requirements for the EU pharmacovigilance system, the Marketing Authorization Holders…