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

 

Get In Touch

Insights Hub

Sharing insights, questioning norms, asking the right questions - we'll never lose sight of what you're striving for. Our insight and expertise will help you bring the most innovative therapies within reach of patients around the world.
Placeholder Image
28.06.23
Steve

Cell & Gene Therapy: Maximizing Commercialization Potential

How to Navigate the Less Obvious Barriers to Brining Advanced & Highly Targeted Treatments to

Start a conversation today

If you’re developing something truly ground-breaking, Biopharma Excellence is the nearest resource you’ll find to someone who’s been there before.

Socials: