Every dose monitored. Every signal answered.
A 24×7 safety unit that captures, evaluates, and reports adverse events across 34 markets — protecting patients long after approval.
"Safety is not a department. It is a discipline that every batch, every prescription, and every patient interaction is measured against."
Four pillars of our safety system.
Every intake channel unified into one safety database.
Medical review, causality, seriousness, expectedness.
Expedited & periodic reporting to 34 health authorities.
Signal detection, RMPs, label updates, communication.
Six ways to reach our safety desk.
Patients, caregivers, and healthcare professionals — anyone can report. All reports are confidential and reviewed within 24 hours.
From intake to expedited report.
The clock we run against.
| Case Type | Regulatory Clock | Internal SLA | Status |
|---|---|---|---|
| Serious, unexpected (SUSAR) | 7 calendar days | 5 days | On track |
| Serious, expected | 15 calendar days | 10 days | On track |
| Non-serious | 90 days (periodic) | 30 days | On track |
| Fatal / life-threatening | 7 days (initial), 8 days follow-up | 24 hours | Critical |
| Special situations (pregnancy, misuse) | 15 calendar days | 10 days | On track |
Statistical vigilance, not just paperwork.
We run quantitative signal detection (PRR, ROR) across our case database every month, plus qualitative literature and label review.
- PRR & ROR disproportionality analysis
- Quarterly signal validation committee
- Literature screening (Embase, PubMed) — weekly
- Trigger for RMP updates & label changes
Meet our QPPV.
18 years in drug safety across South Asia and MENA. Certified by ISoP, former reviewer at DGDA drug safety cell. Available on-call, globally, for regulator inspections and urgent safety decisions.
Every risk has a plan.
Standard labeling, package leaflets, and pharmacovigilance activities.
HCP educational materials, patient alert cards, controlled distribution.
Registries, PASS studies, restricted-access programs.
The reports we author every cycle.
Local safety representation, worldwide.
Weekly scans, global databases.
Embase, PubMed/Medline, and local scientific journals — screened weekly for adverse event mentions relevant to our portfolio.
Every employee is a safety officer.
Annual awareness — how to recognize & report an AE.
Detailed training — CIOMS form, timelines, follow-up.
GVP modules, MedDRA coding, signal methodology.
Independently verified.
What patients & HCPs ask us.
A reaction to report? A safety question? We're on the line — 24×7.
Reporting takes 3 minutes and helps every future patient. Your report is confidential and reviewed by a physician on our team.