Accelerate Your
First Submission
Complete your first IND submission in 3 months with 5-layer AI intelligence, 131 document types, and RAG-powered content generation.
✓ 30-day free trial • ✓ No credit card required • ✓ Cancel anytime
The Biotech Challenge
Biotech startups face unique hurdles when preparing their first regulatory submissions
Limited Resources
Small teams with tight budgets can't afford expensive enterprise software or large regulatory consulting fees
First-Time Submissions
Many biotech teams are going through the IND/NDA process for the first time and need expert guidance
Time Pressure
Runway is limited and every month counts. Need to get to clinic quickly without compromising quality
Built for Biotech Success
Everything biotech companies need to accelerate their regulatory journey
5-Layer Intelligence System
Enterprise-grade AI technology at startup prices. Automatic document classification (131 types), structural intelligence for tables/charts extraction, and regulatory intelligence with 3,400+ agency-specific prompts.
- 131 document types with 95% automatic classification accuracy
- Multi-modal PDF extraction for tables, charts, and figures
- 3,400+ regulatory prompts for FDA, EMA, PMDA, and more
- 50+ ICH guidelines integrated for compliance checking
5-Layer Intelligence System Demo
AI Document Generation in 30-60 Seconds
Generate complete regulatory sections with context-aware AI using RAG technology. Cite your uploaded source documents automatically and ensure ICH M4 compliance.
- Generate IND sections in 30-60 seconds (99% faster than manual)
- Automatic citation of source documents with RAG
- Quality scoring (0-100) and completeness checking
- Agency-specific formatting (FDA, EMA, PMDA terminology)
AI Document Generation in 30-60 Seconds Demo
Chat with Submission - Ask Anything
Ask questions about your submission in natural language. Get instant answers about status, compliance issues, content location, and regulatory requirements with AI-powered conversational interface.
- Natural language queries: "What sections are missing for Module 3?"
- <3 second response time with full submission context
- Proactive compliance gap identification
- Multi-turn conversations with memory
Chat with Submission - Ask Anything Demo
Startup-Friendly Pricing & Support
Pay only for what you need with month-to-month billing. Get dedicated onboarding, training, and ongoing support from regulatory experts. No long-term contracts.
- Starting at $499/month with 30-day free trial
- Dedicated onboarding specialist and video training
- Email, chat, and regular office hours support
- 89% cost reduction vs. hiring consultants ($93K savings)
Startup-Friendly Pricing & Support Demo
Your Path to IND Submission
From setup to submission in 3 months
Setup & Document Upload
Import your existing documents, set up your eCTD structure using templates, and invite your team.
Document Preparation
Use AI-powered classification to organize documents, fill gaps with templates, and ensure ICH compliance.
Review & Refinement
Review AI suggestions, fix validation issues, add cross-references, and conduct internal QC.
Final Assembly & Submission
Generate final eCTD package, run final compliance checks, and submit to FDA.
BioTech Innovations: First IND in 3 Months
The Challenge
BioTech Innovations, a Series A-funded startup developing a novel cancer therapy, needed to submit their first IND to the FDA. With a small team (5 people) and limited regulatory experience, they faced:
- ✗No prior regulatory submission experience
- ✗Limited budget for consultants
- ✗Tight timeline (6 months to IND)
- ✗Complex CMC documentation requirements
- ✗Uncertainty about ICH M4 structure
The Results
Using DossiAIr's templates and AI guidance, BioTech Innovations achieved:
- ✓Completed IND submission in 3 months (50% faster)
- ✓Saved $50K+ vs. hiring regulatory consultants
- ✓FDA approved IND on first submission
- ✓Zero major deficiencies noted
- ✓Team trained on regulatory best practices
"As a first-time IND submitter, DossiAIr was a lifesaver. The templates gave us a head start, and the AI guidance caught issues before the FDA did. We went from zero to IND in 3 months."
Affordable for Startups
Compare the cost: Traditional approach vs. DossiAIr
Traditional Approach
DossiAIr Approach
Ready to Accelerate
Your IND Submission?
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