AI-PoweredRegulatoryAffairsforEgypt
Streamline EDA workflows with intelligent document review, automated checklists, and approved templates
Still Managing Regulatory Affairs Manually?
Traditional approaches create bottlenecks, errors, and compliance risks
Missed Deadlines
Delayed approvals, penalties, and market entry setbacks
Document Chaos
Scattered files, version conflicts, and lost paperwork
Manual Review Errors
Human errors in checklist review lead to rework and rejections
How FDRAC Works
Four simple steps to transform your regulatory workflow
Upload
Upload your regulatory documents. AI extracts and validates data automatically.
Review
Smart checklists auto-verify requirements against EDA standards.
Generate
Pre-approved EDA templates auto-fill with your validated data.
Track
Real-time progress tracking with proactive expiry alerts.
Complete Regulatory Services
All the tools you need for EDA compliance in one platform
Dashboard
Unified view for all regulatory activities
Company Profile
Centralized company data
Licenses
Track & manage all licenses with expiry alerts
Manufacturers
Manufacturers document management
Products
Product registration services
Import Permits
Import permit approval workflow
Release Requests
Batch release & quality clearance
Customs Clearance
Customs documentation & clearance
Medical Release
Medical device release workflows
Labs & Conformity
Lab testing & conformity assessment
Storage
Manage company goods and supply orders
Sales
Sales authorization & distribution tracking
Vigilance
Post-market surveillance
Platform Services
All platform regulatory services
AI Assistant
24/7 AI support for regulatory queries
Powered by AI
Intelligent automation that reduces errors and accelerates approvals
AI Document Review
Intelligent extraction & validation from regulatory documents
Smart Checklists
Auto-generated checklists with real-time verification
Approved Templates
Pre-approved EDA templates with auto-fill capabilities
Expiry Alerts
Proactive alerts at 90, 60, and 30 days before expiry
Document Cloud
Centralized storage with access management
Multi-tenant Security
Role-based access: Manager, Account Manager
Flexible Pricing
Plans designed for every team size
Custom pricing based on your needs
Starter
For small consultancies
- Basic features
- Up to 3 companies
- Email support
- AI assistant
Professional
For growing teams
- All features
- Up to 10 companies
- Priority support
- AI assistant
Enterprise
For large organizations
- Unlimited companies
- Custom integrations
- Dedicated support
- SLA
Frequently Asked Questions
Ready to Transform Your Regulatory Workflow?
Join pharmaceutical and medical device companies streamlining their EDA compliance