Stay Ahead of Regulators. Never Behind on Submissions.
Zabrizon's AI regulatory operations platform automates submission preparation, monitors GxP compliance gaps, manages CAPA workflows, and delivers real-time regulatory intelligence — so your teams can focus on strategy, not paperwork.
Regulatory Compliance AI Capabilities
AI-powered compliance and submission management across the entire product lifecycle.
eCTD Submission Automation
AI-assisted assembly, validation, and submission of electronic Common Technical Documents — reducing manual compilation effort and submission errors.
- Automated eCTD dossier assembly from source documents
- Validation against FDA, EMA, and ICH eCTD specifications
- Gap analysis against submission requirements before filing
- Submission tracking and health authority correspondence management
GxP Compliance Monitoring & CAPA
Continuous monitoring of GMP, GCP, and GLP compliance obligations with AI-powered deviation detection and automated CAPA workflow management.
- Real-time GxP compliance gap identification across systems
- Automated CAPA initiation, assignment, and tracking
- Root cause analysis assistance with AI-suggested corrective actions
- Trend analysis across CAPA types and repeat deviations
Regulatory Intelligence & Label Management
AI monitoring of global regulatory agency communications — guidance updates, labelling changes, and enforcement actions — with impact assessment for your portfolio.
- Daily monitoring of FDA, EMA, PMDA, and TGA regulatory feeds
- Automated impact assessment against your product portfolio
- Labelling change management and version control
- Competitive intelligence on approval timelines and precedents
Validation Lifecycle Management
Computer system validation (CSV) documentation and management — from IQ/OQ/PQ through periodic review — supporting 21 CFR Part 11 and Annex 11 compliance.
- Automated validation documentation templates and traceability
- Risk-based validation planning and execution
- Periodic review scheduling and documentation
- Audit trail management and access control review
Regulatory Frameworks Supported
Comprehensive coverage across global regulatory requirements for pharmaceutical and medical device companies.
Ready to Build a Proactive Regulatory Compliance Programme?
See how Zabrizon's AI reduces submission preparation time and keeps your organisation audit-ready at all times.
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