Regulatory Submissions Are Painful
Manual processes, endless formatting, compliance anxiety, and months of work for each submission.
Four Steps to Submission Ready
From raw documents to validated eCTD package
Plan
Upload your documents. AI analyzes gaps, assesses risks, and predicts likely agency queries.
Build
AI drafts compliant sections using 3,400+ regulatory prompts tailored to your target agency.
Validate
Automatic compliance checks against 200+ rules. Fix issues before they become rejections.
Submit
Download validated eCTD package with XML backbone, hyperlinks, and checksums. Ready for gateway.
Just Ask. AI Does the Rest.
Chat with your submissions using text or voice. Choose the mode that fits your needs. 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, build on previous questions, and maintain continuity throughout your work.
Activity Memory
Tracks what you've done across sessions. AI knows your recent submissions, documents you've worked on, and tasks you've completed.
Organization Memory
Learns your company's preferences, terminology, formatting standards, and compliance patterns. Shared across your entire team.
Reflection Memory
AI analyzes its own performance to improve. Learns from corrections, adapts to your feedback, 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.
Why DossiAIr?
Not just another document tool—purpose-built for regulatory submissions
3,400+ Regulatory Prompts
Pre-built prompts for every eCTD section, tailored to each agency's specific requirements. Not generic AI.
27 Global Agencies
FDA, EMA, PMDA, NMPA, Health Canada, TGA, SAHPRA, MHRA, CDSCO, COFEPRIS, and more.
AI That Learns
Agent memory learns your organization's preferences, terminology, and compliance patterns over time.
System Integration
Connect to Veeva Vault, DocuBridge, and other systems. Sync documents automatically.
21 CFR Part 11 Compliant
Complete audit trails, electronic signatures, and tamper-proof change tracking.
Enterprise Ready
Multi-tenant isolation for CROs, role-based access, SSO support, and dedicated security.
What You Can Create
Initial Submissions
- • NDA, BLA, ANDA (FDA)
- • MAA (EMA)
- • J-NDA (PMDA)
- • New Drug Submissions (Health Canada)
- • All eCTD Module 1-5 content
Supplements & Variations
- • CBE-30, CBE-0, PAS (FDA)
- • Type IA, IB, II Variations (EMA)
- • Manufacturing changes
- • Labeling updates
- • Annual reports
Agency Responses
- • Information Request (IR) responses
- • Complete Response Letters
- • Deficiency responses
- • Day 120/180 queries (EMA)
- • Pre-submission documents
Ready to Transform Your Regulatory Workflow?
See how DossiAIr can help you generate compliant submissions faster.