Know exactly what FDA needs — before you submit.
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Trusted by regulatory teams worldwide
One PDF in. 100+ documents processed. 2,000+ pages read. 1,000 rules checked.
Get started freeUpload any preclinical study, get structured data
Drop in your toxicology, safety pharmacology, genotoxicity, or PK/ADME study reports. Regfo accepts PDF and DOCX files of any size and processes them in seconds, not hours.
12 pages or 300 — the AI reads the whole thing. No spreadsheets. No copy-paste. No templates.
What you can upload
- ✓Preclinical toxicology study reports (acute, subchronic, chronic)
- ✓Safety pharmacology studies (cardiovascular, CNS, respiratory)
- ✓Genotoxicity study reports (Ames, in vivo micronucleus)
- ✓PK/ADME and reproductive toxicology reports
“We found 4 critical gaps in our preclinical package that would have cost us a 6-month delay. Regfo caught them in 20 seconds.”
46 data points extracted from every study
Gemini 2.5 Flash reads each document and extracts structured data: study type, species, strain, GLP status, dose levels, NOAEL/LOAEL, target organs, histopathology findings, exposure margins, and 40 more fields.
In our benchmarks, it extracted 54 studies from a 298-page FDA review with 95%+ accuracy. You review the extracted data; the AI does the tedious reading.
Scored against 24 guidelines, 1,054 rules
Your study package is checked against ICH M3(R2), S7A, S2(R1), S5(R3), S1A, S9, Q3A, and 16 more guidelines. Every gap cites the specific rule section so you can verify it yourself.
Requirements are phase-aware and drug-type-specific. A Phase 1 small molecule IND has different requirements than a Phase 3 biologic BLA. Regfo knows the difference and adjusts automatically.
How scoring works
- ✓Each rule maps to a severity: Critical, Major, or Minor
- ✓Score 0-100 based on weighted gap analysis
- ✓Prioritized action items tell you exactly what to fix first
- ✓Citations link directly to the guideline section
“I use Regfo for every new client engagement. The citation-level detail gives me confidence that nothing is missed across 24 guidelines.”
Share compliance reports in one click
Generate a shareable link and send it to your regulatory team, CRO partners, or investors. Everyone sees the same compliance dashboard with real-time updates as you upload new studies and fix gaps.
No more emailing spreadsheets or PDFs back and forth. One source of truth for your entire submission readiness.
50 requirements that hold up Phase 1 submissions — by CTD module, linked to ICH/FDA sources.
Download PDF — free, no email →See it in action
From upload to submission-ready
Upload
- ✓Create your workspace and set drug type
- ✓Upload your first batch of study reports
- ✓See extracted data appear in real time
Analyze
- ✓Review AI-extracted fields for accuracy
- ✓Get your first compliance score with gaps
- ✓Share a report link with your team
Act
- ✓Upload your complete study package
- ✓Map studies to CTD sections automatically
- ✓Generate prioritized action items for gaps
Stop guessing. Start knowing.
Simple, transparent pricing
Start free. Upgrade when you need more.
Monthly billing · Annual save 20%
- ✓1 workspace
- ✓5 document uploads
- ✓Phase 1 compliance check
- ✓CTD Library access
- ✓Unlimited workspaces
- ✓Unlimited uploads
- ✓Phase 1-3 + NDA
- ✓All indication modifiers
- ✓Team sharing
- ✓Priority support
- ✓Everything in Pro
- ✓10 team members
- ✓Multiple programs
- ✓Document generation
- ✓Audit trail
- ✓Custom onboarding
What teams are saying
“We found 4 critical gaps in our preclinical package that would have cost us a 6-month delay. Regfo caught them in 20 seconds.”
“Went from 3 weeks of manual guideline cross-referencing to an instant compliance report. My team can focus on science instead of paperwork.”
“I use Regfo for every new client engagement. The citation-level detail gives me confidence that nothing is missed across 24 guidelines.”
Frequently asked questions
Preclinical study reports in PDF or DOCX — toxicology, safety pharmacology, genotoxicity, PK/ADME, reproductive toxicology, and carcinogenicity studies.
ICH M3(R2), S7A/B, S2(R1), S5(R3), S1A, S9, Q3A, Q6A, E1, E3, and FDA-specific IND guidance. 24 guidelines parsed, 1,054 rules.
We use Gemini 2.5 Flash which processes full documents natively. In our benchmarks, it extracted 54 studies from a 298-page FDA review with 95%+ accuracy on key fields.
Yes. Drug type modifiers automatically adjust requirements — ICH S6(R1) for biologics, FDA gene therapy guidance for gene therapy, ICH S9 for oncology.
Documents are processed but not stored permanently. We use Google Cloud infrastructure with encryption in transit and at rest. No data is used for model training.
Ready to check your compliance?
Upload your first study and get a compliance score in under 30 seconds.