What we deliver
- ICSR case processing and expedited reporting
- SUSAR management and regulator notifications
- DSURs, PSURs and PBRERs
- Signal detection and benefit-risk evaluation
- Safety database setup and hosting (Argus, ARISg)
- Qualified Person for Pharmacovigilance (QPPV) services
Why it matters
- Patient safety is non-negotiable; PV must be airtight
- Avoid GVP and 21 CFR 312 compliance findings
- Scalable from first-in-human to post-marketing
