Generate Complete NDA & BLA Submissions in Days
AI-powered platform that automates FDA NDA, BLA, ANDA, and EMA MAA generation. Built on 5-layer intelligence architecture with 3,400+ regulatory prompts for complete eCTD workflow automation.
5 Intelligence Layers
Each layer builds on the previous one, creating a comprehensive AI-powered regulatory automation system
Layer 1: Content Intelligence
Smart Document Classification & Routing
Automatically classify, extract, and route documents with 95% accuracy using multi-modal AI
- 131 document types with automatic classification
- 122 ICH section mappings for precise routing
- Multi-modal PDF extraction (text, tables, figures)
- Quality scoring and semantic tagging
- 80% reduction in document search time
Layer 2: Structural Intelligence
Tables, Charts & Figures Extraction
Extract and reuse structural elements from existing documents with AI-powered element library
- 217+ registered tables, charts, and figures
- One-click table insertion from library
- AI-suggested relevant tables by section
- Change detection and auto-propagation
- 25 hours saved per submission
Layer 3: eCTD Compliance Intelligence
Compliance-Driven Generation
Generate agency-specific content with 3,400+ regulatory prompts for FDA, EMA, PMDA, NMPA (China), MHRA, TGA
- 3,400+ agency-specific regulatory prompts
- 50+ ICH guidelines in knowledge base
- 7 global agencies (FDA, EMA, HC, PMDA, MHRA, TGA, NMPA)
- Compliance scoring (0-100 per section)
- Up to 99.7% faster regulatory updates
Layer 4: Cross-Reference Intelligence
Automated Linking & Validation
Automatically detect, create, and validate cross-references across your entire submission
- Automatic syntactic and semantic link detection
- Multi-format hyperlinks (Markdown, PDF, eCTD XML)
- Link validation and auto-update on changes
- Zero broken links guarantee
- 25+ hours saved per submission on linking
Layer 5: Validation & Maintenance
Continuous Compliance Monitoring
Real-time validation against 200+ regulatory rules with automated change tracking
- 200+ validation rules (ICH, FDA, EMA)
- Change impact analysis with dependency graphs
- 21 CFR Part 11 compliance (electronic signatures)
- Complete audit trails for regulatory inspection
- Real-time compliance scoring
Compliance Status
Core Platform Features
100+ features designed specifically for pharmaceutical regulatory submissions
AI Document Generation
Generate regulatory content in 30-60 seconds using context-aware AI and agency-specific prompts
- ✓Up to 99% faster than manual writing
- ✓Target 95%+ compliance scores
- ✓Multi-agency support
Conversational AI Chat
Ask questions about your submission in natural language. Get instant answers about status, compliance, and issues
- ✓<3 second response time
- ✓Full submission context
- ✓Proactive insights
Multi-Modal PDF Extraction
Extract tables, charts, and figures from input files
- ✓Text + images extraction
- ✓Table structure preservation
- ✓Auto-categorization
Element Library
Centralized library of all tables, charts, and figures with smart search and reuse capabilities
- ✓217+ elements
- ✓AI-suggested insertion
- ✓Version tracking
Global Dossier Management
Create once, submit everywhere. Manage submissions to 7 global agencies from single source
- ✓FDA, EMA, HC, PMDA, MHRA, TGA, NMPA
- ✓Auto-format conversion
- ✓Regional modules
eCTD Package Generation
Generate validated eCTD v3.2.2 and v4.0 packages with XML validation and PDF assembly
- ✓ICH M2/M4 compliant
- ✓XML validation
- ✓Hyperlinked PDFs
Projected Business Impact
Potential value delivered through AI-powered automation
Potential Time Savings
2-3 weeks → 2-3 days
Projected Annual Savings
Through automation
Target Compliance
ICH guideline adherence
From Assistive AI to Agentic AI
Our roadmap: evolving from intelligent assistance to fully autonomous regulatory operations
Today: Assistive AI
Human-in-the-loop AI that amplifies regulatory team capabilities
- →Generates draft content for review
- →Suggests cross-references for validation
- →Identifies compliance issues
- →30% human involvement for decisions
Upcoming: Agentic AI with MCP
Fully autonomous agents handling end-to-end submission creation and maintenance
- ✦MCP server to seamlessly fetch source documents to avoid manual uploads
- ✦Auto-gathers supporting materials
- ✦Validates and self-corrects compliance
- ✦Manages complete lifecycle autonomously
- ✦5% human involvement (review only)
Product Roadmap
Autonomous Document Assembly
Autonomous Compliance Validation
Autonomous Lifecycle Management
Strategic Regulatory Intelligence
See All 5 Layers in Action
Schedule a personalized demo to see how DossiAIr transforms your regulatory workflow