Manage Your Trials with Seamless Data
Our Pharmacovigilance and Postmarket Surveillance services can integrate with our other service offerings within the Veranex clinical data services for a complete view into your study's data.
Global Regulatory Expertise
Real-Time Safety Surveillance
Advanced Safety Intelligence
Seamless Integration Partnership
Establishing FDA-Compliant Pharmacovigilance System for Generic Drug Manufacturer
Situation
A generic pharmaceutical company needed a robust pharmacovigilance (PV) system to meet FDA post-marketing safety requirements and maintain product credibility. The challenge was to design an integrated, compliant framework for adverse event (AE) monitoring, data processing, and reporting across multiple departments.Successes
-
Full FDA compliance achieved with zero penalties
-
Streamlined reporting enabled faster, more accurate FDA submissions
-
Proactive safety monitoring established for early signal detection and risk assessment
-
Operational efficiency improved through technology integration
-
Enhanced patient safety and strengthened product reputation
Services by Veranex
-
Regulatory assessment and tailored FDA compliance strategy
-
System design and implementation for AE collection, assessment, and reporting
-
PV team training on regulations and safety database use
-
Comprehensive PV management including real-time case processing, signal detection, and trend analysis
Medical Writing
Medical Writing
Our medical writing experts transform complex clinical data into compelling regulatory narratives that accelerate approvals and eliminate costly revision cycles.
Clinical Data Management
Clinical Data Management
Our Clinical Data Management transforms complex trial data into regulatory-ready datasets, providing the compliant foundation that drives successful drug approvals.
Biostatistics and Statistical Programming
Biostatistics and Statistical Programming
Our Biostatistics and Statistical Programming transforms complex clinical data into compelling evidence that drives regulatory approvals and patient access.
Combination Product
