SafePhV is an innovative cloud-based software designed to manage adverse events and ensure compliance with global pharmacovigilance regulations. It streamlines pharmacovigilance processes, increasing efficiency, speeding up time-to-market, and reducing costs. The platform is fully configurable and adaptable to unique pharmacovigilance requirements and existing IT ecosystems. Developed by Topia Life Sciences, SafePhV leverages AI-driven analytics for proactive drug safety management and global monitoring, featuring an integrated, user-friendly PV database that ensures compliance and efficient data handling.
- AI/ML & NLP
- Automated Case Intake
- Case Processing
- WHO DD/MedDRA Medical Coding
- Dynamic Auto Labelling
- Monitoring & Notifications
- Auto Narratives & Medical Review
- Regulatory Reports & e-Submission
- Interactive Reports & Dashboard
- ICSR & PSR E2B R2 & R3
- Signal Detection
- Regulatory Compliance 21 CFR Part 11, ANNEX 11, GDPR, GXP. GAMP5