Pharmacovigilance (PV) isn’t only a compliance exercise–it demonstrates ongoing commitment to patient safety, and can be a powerful tool for approval of a biopharmaceutical. We’ll help you find the optimum approach which combines quality and reliability with efficiency.

 

Seeking external support with PV delivery has become common practice due to soaring workloads. As regulators demand more data to understand safety signals, internal teams find themselves increasingly stretched. We can help in a number of flexible and customizable ways – with solutions ranging from flexible staffing/short-term tactical support to long-term strategic partnership.

 

A rounded approach to PV that delivers on all points

 

We can provide PV support in any or all of the following areas:

  • ICSR management – including collection, evaluation, processing, distribution & reporting
  • Safety database hosting and support
  • Literature monitoring
  • Pharmacoepidemiology
  • Signal management
  • Risk management
  • Periodic safety reports
  • Pharmacovigilance system and compliance
  • EU-QPPV / local QPPV
  • Quality system, audit and inspection support
  • Safety data exchange agreements

 

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11.10.21
Christian Schneider

Biopharma’s Big Inflection Point: There’s never been a better time to innovate with next-generation medicine

by Christian K. Schneider, MD

In all of the years I have been tracking and helping to drive...

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