Automated Regulatory Database Intelligence You Can Trust
Streamline post-market surveillance with automated extraction and analysis from global regulatory databases. Continuous monitoring meets automated compliance.
15+
Global Databases
24/7
Real-Time Monitoring
85%
Faster Detection
99%
Data Accuracy
Watch PostMarket360 In Action
See how our AI engine powers efficient, global post-market surveillance.
Centralized Access
Monitor FDA, Health Canada, and more from one hub.
Rapid Signal Detection
Identify emerging safety trends instantly with AI.
Total Compliance
Automated, consistent, and error-free reporting.
Intelligent AI, At your fingertips
Transform Market Data Into Value
Streamline your post-market surveillance operations with our advanced intelligence platform.
Multi-Database Monitoring
Automatically extract and monitor adverse event data from global regulatory sources.
- FDA MAUDE & Health Canada
- EMA EudraVigilance
- 15+ International sources
AI Signal Detection
Continuously analyze extracted data to identify and extract critical safety signals.
- Automated trend analysis
- Emerging safety events
- Early warning indicators
Regulatory Reporting
Generate comprehensive compliance reports tailored for varying jurisdictions.
- Real-time automated alerts
- Jurisdiction-specific formats
- Audit-ready documentation
Built-in Regulatory Compliance
Enterprise-grade security and global regulatory compliance for pharmaceutical safety surveillance.
FDA Security
Full compliance with FDA FAERS requirements and 21 CFR Part 11 regulations.
- FAERS integration
- 21 CFR Part 11 compliant
- Audit trail management
Regulatory Vigilance
EudraVigilance and EMA compliance with automated data submission capabilities.
- EudraVigilance connectivity
- PSUR/PBRER generation
- GVP Module compliance
WHO & Global
Integration with WHO VigiBase and compliance across 247 countries.
- VigiBase access
- ICH E2B(R3) format
- Multi-country reporting
Data Security & Privacy
Enterprise Security
Bank-level encryption and security protocols for all safety data.
- AES-256 encryption
- SOC 2 Type II certified
- ISO 27001 compliant
Compliance Controls
Comprehensive audit trails and access controls for regulatory inspections.
- Complete audit logs
- Role-based access
- GDPR compliant
Implementation Process
A streamlined 4-phase approach to deploying global post-market surveillance.
1
PHASE 1
Assess
Comprehensive assessment of your product portfolio and regulatory requirements.
- Product portfolio mapping
- Regulatory requirements analysis
- Current workflow evaluation
2
PHASE 2
Configure
System setup and integration with your regulatory database sources.
- Database connectivity setup
- Alert rules configuration
- Report templates customization
3
PHASE 3
Train
Comprehensive training for your pharmacovigilance and regulatory teams.
- System administration training
- End-user workshops
- Best practices documentation
4
PHASE 4
Deploy
Full production launch with ongoing support and optimization.
- Production go-live
- 24/7 support activation
- Performance monitoring
Ongoing Support
Dedicated Support
24/7 expert support team with guaranteed response times for critical safety issues.
Regular Updates
Continuous platform enhancements and regulatory database updates at no extra cost.
Performance Reviews
Quarterly business reviews with analytics insights and optimization recommendations.
Post-Market Surveillance Challenges We Solve
1
Multi-Source Monitoring
Consolidate data from fragmented global regulatory sources.
2
Signal Detection
Identify emerging safety signals before they become critical.
3
Compliance Reporting
Automate time-consuming PSUR and PBRER report generation.
Why PM360 Matters
Global Complexity
Managing post-market surveillance across 195 countries with varying regulations is overwhelming. PM360 unifies it all.
Resource Intensive
Manual monitoring requires dedicated teams working around the clock. PM360 automates 85% of routine tasks.
Regulatory Risk
Missing deadlines or signals can result in severe penalties. PM360 ensures 100% compliance with proactive alerts.
Ready to Transform Post-Market Surveillance?
Join leading life sciences organizations using PostMarket360 to automate tracking and reduce regulatory risks.