Stop wrestling with Word docs and Excel trackers. Generate regulatory documents in 30-60 seconds with 5-layer AI intelligence. Ask questions about your submission in natural language. Automate the tedious parts.
Your AI Regulatory Assistant
See how DossiAIr eliminates the tedious tasks that consume your day.
9:00 AM - Hunt for Documents
Search through 5 email threads, 3 SharePoint folders, and 2 USB drives to find the latest stability report.
11:00 AM - Copy-Paste Marathon
Manually extract tables from 15 study reports into Word. Hope you don't introduce errors.
2:00 PM - Version Control Hell
Is it "Module2_v3_final_FINAL_approved_v2.docx"? Spend 45 minutes reconciling versions.
4:00 PM - Manual QC
Check 200+ cross-references by hand. Find 12 broken links. Manually fix each one.
6:00 PM - eCTD Packaging
Fight with Lorenz Docubridge for 2 hours. XML validation errors make no sense.
Result: 9 hours, exhausted, stressed
9:00 AM - Upload & Extract
Upload stability report. AI extracts tables, figures, and text automatically. 3 minutes.
9:15 AM - AI-Assisted Writing
AI suggests relevant tables and content. One-click insert. Focus on analysis, not formatting.
10:00 AM - Automated Version Control
Every change tracked. One source of truth. Revert to any version instantly.
11:00 AM - AI QC Check
AI validates all cross-references, checks ICH compliance, flags issues. 5 minutes.
11:30 AM - One-Click eCTD
Click "Generate eCTD". Perfect XML, validated package ready. Submit to FDA ESG.
Result: 2.5 hours, confident, on time
Significant Time Savings
Automate repetitive tasks and focus on high-value regulatory work
Built with input from 100+ regulatory professionals. Every feature solves a real pain point.
Ask questions in plain English: "What sections are missing for Module 3?" "Are there compliance issues?" Get answers in under 3 seconds with full submission context and proactive insights.
Generate complete regulatory sections with RAG technology. Auto-cites your uploaded source documents. 3,400+ regulatory prompts for FDA, EMA, PMDA, NMPA, and 27 agencies.
131 document types auto-classified. Multi-modal extraction for tables/charts. 390+ AI tools with deep situational awareness. Automatic compliance checking and gap detection.
AI detects and creates hyperlinks automatically. Validates all 200+ links in seconds. Layer 4 intelligence ensures 100% link accuracy with semantic and syntactic detection.
Real-time compliance checks with 200+ validation rules. Agency-specific requirements for 27 global agencies. Know your submission quality before you submit.
SHA256-based change detection. Automatic impact analysis: "Table X updated → Used in 3 sections." Track who changed what and when with full audit trails (21 CFR Part 11 compliant).
Our founders have 20+ years combined experience in regulatory affairs. We've prepared INDs, NDAs, MAAs, and supplements for FDA, EMA, PMDA, NMPA, and 20+ other agencies worldwide.
We built DossiAIr because we were tired of:
❌ Spending 80% of our time on copy-paste and formatting instead of regulatory strategy
❌ Fighting with outdated tools that weren't built for modern regulatory work
❌ Manual QC processes that still missed errors despite taking hours
❌ Working nights and weekends because there wasn't enough time during the day
We built the tool we wish we'd had. Now you can use it too.
When you automate the tedious tasks, you have time for strategic regulatory work.
Spend time on regulatory strategy, agency interactions, and critical thinking— the high-value work that matters most.
With automated validation and compliance checking, focus on content quality rather than manual formatting and QC.
Handle more submissions by automating repetitive tasks, without sacrificing quality or working longer hours.
Automate the tedious tasks that keep you working nights and weekends. Focus on what matters.
Comprehensive regulatory automation built for enterprise needs.
Full support for NDA, BLA, ANDA, MAA, supplements, variations, annual reports, and IR responses across all major agencies.
Direct submission to FDA ESG, EMA CESP, Health Canada, PMDA, TGA, Swissmedic, and more with validated eCTD packages.
Complete audit trails, electronic signatures, and access controls meeting FDA requirements for electronic records.
Plans designed for regulatory professionals, consultants, and small teams.
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Join 500+ regulatory professionals who've reclaimed their time and accelerated their careers.
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