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.