Pharmacovigilance & Drug Safety
Comprehensive safety monitoring throughout your product lifecycle with expert EU QPPV and regulatory compliance support
Our Pharmacovigilance Services
Adverse Event Case Processing
Comprehensive case intake, processing, and reporting with 24/7 support for serious adverse events
- Case receipt and triage (15-day/7-day timelines)
- Medical review and causality assessment
- Regulatory reporting (ICSR submission)
- Follow-up and case reconciliation
Signal Detection & Management
Proactive identification and evaluation of emerging safety signals using statistical and clinical methods
- Automated signal detection algorithms
- Clinical review and validation
- Signal assessment and prioritization
- Risk characterization and communication
Periodic Safety Reports
Expert preparation of PSURs, PBRERs, and DSURs with comprehensive benefit-risk assessments
- PSUR/PBRER preparation and submission
- Development Safety Update Reports (DSUR)
- Cumulative safety data analysis
- Benefit-risk evaluation
Risk Management Plans
Development and maintenance of comprehensive RMPs aligned with EU GVP requirements
- RMP development and updates
- Risk minimization measures design
- Effectiveness monitoring
- Post-authorization safety studies
EU QPPV Services
Qualified Person for Pharmacovigilance services with full EU regulatory expertise
- EU QPPV designation and responsibilities
- Pharmacovigilance system oversight
- Regulatory interaction and liaison
- GVP compliance monitoring
Safety Database Management
Complete safety database setup, maintenance, and regulatory compliance
- Database validation and maintenance
- Data migration and integration
- User training and support
- Regulatory audit preparation
EU Pharmacovigilance Regulatory Framework
Our services are fully aligned with the European regulatory landscape, ensuring complete compliance with all applicable guidelines and requirements.
Compliant
Our PV Process Excellence
Case Receipt
24/7 intake through multiple channels with automated acknowledgment
Triage & Assessment
Immediate classification and timeline determination
Medical Review
Expert clinical evaluation and causality assessment
Regulatory Reporting
Timely submission to authorities and database entry
Quality Control
Comprehensive review and continuous monitoring
Advanced PV Technology
Safety Database Platforms
ARISg, Oracle Argus, Veeva Vault Safety
Signal Detection Tools
Empirica Signal, EVDAS, Statistical algorithms
Regulatory Gateways
EudraVigilance, FDA FAERS, ICH E2B(R3)
Document Management
Validated eCTD systems and GxP platforms
Ensure Product Safety Excellence
Partner with our EU QPPV experts for comprehensive pharmacovigilance solutions