From Strategy to Submission, All in One Place
DossiAIr handles everything: planning your regulatory strategy, generating compliant content, validating against agency rules, and packaging for submission. No more juggling tools or manual handoffs.
How DossiAIr Works
A complete workflow that takes you from initial planning to submission-ready package
Plan Your Strategy
Before you commit to structure
Upload your source documents and let AI analyze them. Get a complete picture of what you have, what you're missing, and what risks you face—before creating any submission structure.
Strategy Analysis
ReadyBuild Your Submission
AI generates compliant content
Create your eCTD structure with one click, then let AI generate section content using your source documents and 3,400+ regulatory prompts. Each section is tailored to your target agency's specific requirements.
Validate Everything
200+ rules, zero surprises
Real-time validation checks your submission against 200+ regulatory rules. Catch issues before they become rejection letters—from ICH structure requirements to agency-specific formatting rules.
Compliance Status
Submit with Confidence
Ready for any gateway
Generate validated eCTD packages ready for submission. Supports both eCTD v3.2.2 and v4.0 formats, with complete XML backbone, hyperlinked PDFs, and agency-specific formatting.
Six Functional Modules, One Unified Platform
DossiAIr provides specialized modules for every aspect of regulatory work—all connected and working together.
Products
Product Master DataComplete Product-Country-Submission (PCS) hierarchy with IDMP compliance, renewal tracking, and 45+ data fields per product.
Documents
Intelligent Document ManagementAI-powered classification of 131 document types with multi-modal extraction of text, tables, and figures.
Strategy
Submission PlanningAI-powered gap analysis, risk assessment, and timeline planning with SME review workflows across 6 expert roles.
Submissions
eCTD Generation15+ submission types with 280+ eCTD sections, AI content generation using 3,400+ prompts, and gateway integration.
IR Responses
Agency Question HandlingAI question parsing, response generation, precedent matching, and 5-step strategy wizard for complex IRs.
Intelligence
Regulatory TrackingCentralized guideline management, alert system, and cross-agency comparison tools across 27 agencies.
Just Ask. AI Does the Rest.
A context-aware AI assistant that knows your submission, your documents, and regulatory requirements. Not sure how to use a feature? Just ask—your AI assistant guides you through any functionality.
Assistant Mode
Page-focused helpCompletes tasks within the current page. Ask questions, generate content, run validations, or get help with any feature—all without leaving where you are.
Personal Attendant Mode
End-to-end automationCompletes your workflow end-to-end by navigating to different pages on its own. Handles multi-step processes autonomously, and teaches you features along the way.
Memory That Gets Smarter
DossiAIr remembers context, learns from experience, and continuously improves to serve you better.
Conversation Memory
Remembers your current session context. Reference earlier messages and maintain continuity throughout your work.
Activity Memory
Tracks what you've done across sessions. AI knows your recent submissions, documents, and completed tasks.
Organization Memory
Learns your company's preferences, terminology, and compliance patterns. Shared across your entire team.
Reflection Memory
AI analyzes its own performance to improve. Learns from corrections and gets better with every interaction.
How Memory Helps You
Stop explaining the same context over and over. AI remembers your products, preferences, and past work.
Organization memory ensures every team member gets the same high-quality, standardized outputs.
Reflection memory means AI learns from mistakes and corrections—it literally gets smarter the more you use it.
One Platform, 27 Agencies
Create once, submit everywhere. Each agency has specific requirements—DossiAIr knows them all.
Major Regulatory Agencies
Plus Extended Coverage
Works with Your Systems
Connect to your existing document management systems. No manual uploads needed.
Veeva Vault
Sync documents and metadata automatically
DocuBridge
Import and export eCTD packages seamlessly
Custom Systems
Connect any system via Model Context Protocol (MCP)
Enterprise Ready
Built for pharmaceutical companies and CROs with strict security and compliance requirements.
Data Security
- ✓SOC 2 Type II
- ✓End-to-end encryption
- ✓Private cloud deployment
Compliance
- ✓21 CFR Part 11
- ✓Complete audit trails
- ✓Electronic signatures
Multi-Tenant
- ✓Product isolation
- ✓Client separation
- ✓Zero cross-contamination
Access Control
- ✓Role-based permissions
- ✓SSO integration
- ✓Team management
See the Complete Platform in Action
Schedule a personalized demo to see how DossiAIr can transform your regulatory workflow