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
Save 15+ hours per week
That's 780 hours per year = 19 weeks of 40-hour 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 in 30-60 seconds with RAG technology. Auto-cites your uploaded source documents. 3,400+ regulatory prompts for FDA, EMA, PMDA, NMPA.
131 document types auto-classified (95% accuracy). Multi-modal extraction for tables/charts. 50+ ICH guidelines integrated. 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 7 global agencies. Know your submission quality score 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, and NMPA.
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 what advances your career.
Use those saved 15 hours/week to study new regulations, attend webinars, or pursue advanced certifications (RAC, PMP, etc.).
Spend time on regulatory strategy, agency interactions, and critical thinking— the high-value work that gets you promoted.
Handle 2-3x more submissions without working longer hours. Become the go-to person on your team for complex projects.
Finish your work during work hours. No more nights and weekends. Spend time with family, hobbies, and rest.
Invest in tools that invest in your career
Real feedback from regulatory affairs professionals using DossiAIr daily.
"I used to spend 8 hours just formatting and QC-checking Module 2. Now it takes 2 hours and I'm confident there are no errors. Life-changing."
Sarah Chen, RAC
Senior RA Specialist, Biotech Startup
"Finally, a tool built by someone who understands regulatory work. The AI suggestions are actually useful, not generic. Saves me hours every day."
Michael Rodriguez
RA Manager, Mid-Size Pharma
"I haven't worked a weekend in 6 months. That alone is worth the subscription. Plus I got promoted because I could handle 3x more projects."
Dr. Emily Watson
Director Regulatory Affairs, Global CRO
Plans designed for regulatory professionals, consultants, and small teams.
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