Pharmacovigilance System Master File

Cox PharmaConsulting has experience and can offer flexible help with both the EU PSMF and UK PSMF

Help with setting up and transitioning to both an EU & UK PSMF, then support in PSMF maintenance. Cox PharmaConsulting can create the PSMF and can create processes to ensure each PSMF is maintained, current and compliant.

The Marketing Authorization Holder retains controlled access to the electronic PSMF enabled at the site of the main pharmacovigilance activities in Europe/UK and/or with the QPPV, to enable compliance with regulatory requirements.


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