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Automated Regulatory Database Intelligence

PostMarket360 - Global Safety Surveillance

PostMarket360 Automated Regulatory Database Intelligence

Streamline post-market surveillance with automated extraction and analysis from global regulatory databases

PostMarket360 revolutionizes post-market surveillance by automatically extracting, analyzing, and monitoring adverse event data from global regulatory databases including FDA MAUDE, Health Canada MedEffect, Swiss Medic, EMA EudraVigilance, and 15+ other international regulatory sources.

Our AI-powered platform continuously monitors regulatory databases, extracts critical safety signals, performs trend analysis, and generates comprehensive reports to ensure complete visibility into your product's post-market safety profile across all major markets.

Multi-Database Monitoring

FDA MAUDE, Health Canada & more

Signal Detection

Automated trend analysis

Real-Time Alerts

Immediate notifications

Regulatory Reports

Automated compliance reporting

24/7

Monitoring

85%

Faster Detection

99%

Data Accuracy

Industry Challenges

Post-Market Surveillance Challenges We Solve

Multiple Database Monitoring

Manual monitoring of FDA MAUDE, Health Canada, Swiss Medic and other regulatory databases

Our Solution

Automated 24/7 monitoring across 15+ global regulatory databases with real-time data extraction

Delayed Signal Detection

Late identification of safety signals due to manual review processes

Our Solution

AI-powered signal detection with immediate alerts for emerging safety trends

Complex Reporting Requirements

Time-consuming manual compilation of regulatory reports across multiple jurisdictions

Our Solution

Automated report generation with jurisdiction-specific formatting and compliance requirements

Compliance & Security

Built-in Regulatory Compliance

Data Security

  • End-to-end encryption
  • Secure cloud storage
  • Access control
  • Audit trails

Regulatory Standards

  • HIPAA Compliance
  • GDPR Requirements
  • FDA 21 CFR Part 11
  • SOC 2 Type II

Validation & Controls

  • Automated validation
  • Quality controls
  • Error detection
  • Compliance monitoring
How We Do It

Implementation Process

1

Assessment

  • Requirements Analysis
  • Document Type Review
  • System Compatibility Check
2

Configuration

  • AI Model Training
  • System Integration
  • Workflow Setup
3

Testing

  • Accuracy Validation
  • Performance Testing
  • User Acceptance
4

Deployment

  • Go-Live
  • User Training
  • Ongoing Support