Pharmacovigilance & QPPV

Pharmacovigilance & QPPV

Turnkey PV systems
(clinical → post-marketing) including case processing, signal management,PSUR/PBRER, RMPs, audits/inspection readiness, and PSMF governance.

EU / UK QPPV & LPPV Provision
  • We provide named QPPV and deputy support with 24/7/365 availability, ensuring continuous compliance and safety oversight.
  • Our network includes local PV coverage where required, built to meet all UK/EU legal obligations for Marketing Authorisation Holders (MAHs).
  • We also manage PSMF establishment and maintenance, ensuring robust documentation and inspection readiness.
PV for devices/IVDs

Dedicated PV solutions for medical devices and IVDs, including:

  • PMS / PMCF (MDR) and PMPF (IVDR) programs

  • SSCP / SSP documentation

  • Vigilance case handling and FSCA support

Book a free call

Let’s talk! Book a free 30-minute call with a senior team member to explore how we can support your goals.