Accelerate Your
Regulatory Submissions
from Months to Days
Enterprise-grade AI platform that automates NDA, BLA, ANDA, and MAA generation for pharmaceutical and biotech companies. Streamline your FDA, EMA, PMDA, and NMPA submissions with intelligent automation and built-in regulatory compliance.
How It Works
From raw documents to submission-ready eCTD in four intelligent steps
Upload Documents
Drop your source documents - stability studies, clinical reports, manufacturing data, and more
- PDF, Word, Excel support
- Batch upload capability
- Auto-classification
AI Generates Content
Multi-modal AI extracts tables, figures, and text. Agency-specific prompts draft compliant sections
- Multi-modal extraction
- 3,400+ regulatory prompts
- Smart cross-linking
Review & Refine
Expert-in-the-loop editing with real-time compliance checks and suggested improvements
- Rich text editor
- Compliance scoring
- Version control
Export eCTD
Download validated, submission-ready eCTD package with XML backbone and all hyperlinks
- eCTD 4.0 compliant
- Validated XML
- Ready for ESG upload
Traditional Regulatory Processes
Manual workflows create bottlenecks that slow time-to-market
Manual Processes
per submission
Compliance Risks
error rate
Agency Variations
formats & rules
Update Management
change tracking
5 Layers of AI Intelligence
Our proprietary AI architecture automates every step from document upload to submission-ready eCTD
Content Intelligence
Auto-classify documents, extract tables & figures with 95% accuracy using multi-modal AI
AI document classification
Multi-modal PDF extraction
Quality scoring & validation
Structural Intelligence
Build compliant eCTD structure automatically with intuitive drag-and-drop editing
eCTD tree builder
Drag-and-drop interface
Pre-built template library
eCTD Compliance Intelligence
Agency-specific customization for FDA, EMA, PMDA, NMPA with real-time compliance
Multi-agency support
ICH guideline integration
Real-time compliance checks
Cross-Reference Intelligence
Automatically link related sections and validate all references across documents
Semantic link detection
Auto-linking engine
Reference validation
Validation & Maintenance
Real-time compliance checks with comprehensive change tracking and audit trails
Live validation
Change detection
Complete audit trails
Everything You Need
One platform for complete regulatory automation
Complete eCTD Submissions
Generate NDA, BLA, ANDA, and MAA submissions with AI-powered content for all 5 modules
Supplements & Amendments
Create FDA supplements (CBE, PAS) and EMA variations (Type IA/IB/II) while maintaining compliance
Information Request Responses
Draft AI-powered responses to FDA, EMA, and PMDA queries with full document traceability
Agency-Specific Intelligence
3,400+ regulatory prompts ensure FDA, EMA, PMDA, and NMPA compliance out of the box
Real-Time Compliance Validation
Automated checking against ICH guidelines and 200+ agency-specific rules
Intelligent Document Processing
Auto-extract tables, classify documents, and maintain cross-references automatically
What You Can Generate
From initial submissions to post-approval changes - handle your entire regulatory lifecycle
Initial Submissions
- •FDA: NDA, BLA, ANDA, 505(b)(2)
- •EMA: Marketing Authorization Application (MAA)
- •PMDA: J-NDA (Japanese NDA)
- •NMPA: Chinese NDA
- •Health Canada: New Drug Submission (NDS)
Supplements & Variants
- •FDA: CBE-30, CBE-0, PAS, Annual Reports
- •EMA: Type IA, Type IB, Type II Variations
- •PMDA: Partial Change Applications
- •All Agencies: Labeling updates, manufacturing changes
Agency Communications
- •Information Request (IR) responses
- •Complete Response Letter (CRL) responses
- •Deficiency letter responses
- •Pre-submission meeting documents
- •EMA Day 120/180 query responses
Regulatory Intelligence That Never Sleeps
Continuous monitoring keeps your 3,400+ prompts current and your submissions ahead of guideline changes
Track Guideline Updates
Monitor ICH, FDA, EMA, PMDA, NMPA, and 3 more agencies for new guidelines, Q&As, and technical specifications.
Example: FDA publishes new gene therapy CMC guidance → DossiAIr alerts you and updates affected prompts within hours
Analyze Compliance Trends
Learn from approval patterns and deficiency trends across agencies to avoid common pitfalls.
Example: Trend detected: FDA issuing 40% more stability deficiencies → Your Section 3.2.P.8 flagged for review
Ready to Transform
Your Workflow?
Start automating your regulatory submissions today