Ensuring Drug Safety. Empowering Patient Trust.
Pharmacovigilance isn’t just about regulatory compliance — it’s about saving lives. Our PV services monitor and manage drug safety across the clinical and commercial lifecycle.
Why This Service Matters
In a global regulatory landscape, safety reporting ensures patient protection and builds credibility with agencies. Timely, compliant PV is critical.
Our Key Capabilities
End-to-end clinical trial management you can trust
📋 Clinical Trial Safety Monitoring
- SAE processing and expedited reporting
- Narrative writing and SUSAR submissions
- DSUR and sponsor safety letters
🏢 Post-Marketing PV
- ICSR management
- Signal detection and benefit-risk analysis
- Periodic Safety Update Reports (PSUR/PBRER)
🧠 Regulatory & Audit Support
- Compliance with FDA, EMA, CDSCO, ICH E2E
- Local QPPV coordination
- Audit support and CAPA implementation
🩺 Therapeutic Area Expertise
- Oncology
- CNS & Psychiatry
- Infectious Diseases
- Cardiometabolic Disorders
- Rare & Orphan Diseases