Top-5 global pharma
Enterprise safety operations
Multi-region Argus Safety estates processing millions of ICSRs a year, with strict submission timelines to FDA, EMA, PMDA, and beyond.
Home / Clients
The companies that can’t afford safety-system downtime.
We partner with a small number of the world’s largest drug-safety operations. Client names are held in confidence — the work speaks through outcomes.
Who we work with
Trusted across the pharmacovigilance ecosystem.
CRO & BPO safety teams
Outsourced case processing
Providers running safety databases on behalf of multiple sponsors, where configuration and data segregation must be airtight.
Emerging biotech
Scaling from first approval
Companies standing up their first validated safety database and PV process ahead of a launch — and the inspections that follow.
Representative work
What partnership looks like in practice.
Anonymized engagements that reflect the kind of results our clients rely on us for.
Cloud migration for a top-5 pharma safety estate
Migrated a multi-region Argus Safety environment to a validated cloud platform with zero missed reporting timelines during cutover, and reduced infrastructure cost while improving performance.
Literature-to-safety integration for a global sponsor
Built a custom interface connecting a literature monitoring system to Argus, automating case creation and cutting manual data entry so triage teams could focus on medical assessment.
Inspection readiness for a first-launch biotech
Stood up a validated safety database with full 21 CFR Part 11 controls and traceable validation evidence, supporting a successful pre-approval inspection with no systems findings.
“What sets them apart is accountability. When we hand over a workstream, it comes back done, documented, and audit-ready. That’s rare.”— Director of Safety Systems, global pharmaceutical company
Ready to add a specialist to your safety-systems bench?
We take on a limited number of clients so every one gets senior attention. Let’s see if there’s a fit.
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