Safety operations, run to the standard your label demands.

K3 pharmacovigilance covers the operational core of drug safety: individual case intake and processing, quality narratives, expedited submissions, and the aggregate reports that anchor your regulatory calendar. Our safety specialists work to documented conventions, with QC built into every case, not bolted on after.

We integrate cleanly with your safety database and your medical review — as a full outsourced function or as surge capacity when volumes spike.

What we deliver

• ICSR case processing — intake, triage, data entry, quality review, submission
• Case narratives — clear, consistent, medically reviewed
• Aggregate reports — DSUR, PSUR/PBRER, PADER on your regulatory calendar
• SAE reconciliation — with clinical data management, on a fixed cadence
• Signal detection support — data preparation and first-line analysis
• Audit & inspection support — documentation that answers before it's asked

How we engage

FSP — a standing safety & evidence function with governance, SLAs, and capacity planning. Project-based — this scope, one accountable lead, priced to the outcome. Resourcing — senior specialists embedded in your team, compliance-current from day one.

Works with