Know exactly what FDA needs — before you submit
Upload preclinical study reports. Get instant compliance analysis against ICH/FDA requirements. See what's missing, what's ready, and what to do next.
The preclinical compliance problem
Biotech companies lose time and money discovering regulatory gaps too late. Manual processes create bottlenecks that delay FDA submissions.
40%
Protocol Amendments
of IND submissions require protocol amendments due to preclinical data gaps identified too late in the process.
200+ hrs
Manual FDA Cross-Referencing
spent manually cross-referencing study reports against ICH guidelines and FDA requirements for each submission.
6-12 mo
IND-Readiness Bottleneck
average delay when compliance gaps are discovered during IND preparation rather than during study planning.
Your regulatory team is cross-referencing study reports against ICH M3, S7A, S2, and a dozen other guidelines — manually, in spreadsheets, over weeks. One missed requirement doesn't just mean a revision. It means a clinical hold. A delayed trial. Months of lost time. And you won't know until FDA reviews your package.
Know what's missing before FDA does.
Upload your preclinical study reports. In minutes, Regfo extracts key data, maps it against ICH/FDA requirements, and gives you a compliance score with specific gaps and action items.
Start FreeHow it works
From document upload to compliance report in four steps.
Upload Study Reports
Upload PDF or DOCX preclinical study reports — toxicology, safety pharmacology, PK/ADME, genotoxicity. Our AI processes each document automatically.
Upload Study Reports
Upload PDF or DOCX preclinical study reports — toxicology, safety pharmacology, PK/ADME, genotoxicity. Our AI processes each document automatically.
AI-Powered Data Extraction
AI reads each report, identifies study type, species, GLP status, key findings, NOAEL/LOAEL values, and structures the data for compliance analysis.
Automated Compliance Analysis
Your study package is evaluated against ICH M3(R2), S7A/B, S2, and other FDA requirements. Get a compliance score, identify gaps, and see prioritized actions.
Share with Your Team
Generate a shareable link to your compliance report. Regulatory affairs, project managers, and CROs can review the analysis without creating an account.
Your Regulatory Intelligence Dashboard
See compliance scores, gap analysis, risk assessment, and action items — all in one workspace. Every document processed, every requirement tracked.
Score
73
Nearly Ready
Documents
5
All processed
Gaps Found
3
1 critical
Actions
7
Prioritized
Study Coverage
Critical Gaps
Missing repeat-dose toxicity in non-rodent species
Cardiovascular safety (hERG) not GLP-compliant
PK repeat-dose study needed
Compliance Score
Real-time 0-100 score based on ICH/FDA requirements coverage for your target development phase.
Gap Analysis
Automatically identifies missing studies, insufficient species coverage, and GLP compliance issues.
Risk Assessment
Severity-rated risks with regulatory references and specific mitigation recommendations.
Action Items
Prioritized list of studies to conduct and data to gather, with timeline estimates.
Why regulatory teams choose Regfo
Real regulatory citations
Not generic AI advice. Every finding references specific ICH guidelines and FDA requirements.
46 data points per study
Study type, species, GLP status, NOAEL, target organs — extracted automatically from PDF/DOCX.
Share with one click
Send compliance reports to your team or CRO. No account required for viewers.
Pricing
Choose the plan that fits your regulatory needs
Free
$0
Pro
$4,990 /year
Team
$14,990 /year
Frequently Asked Questions
Common questions about Regfo and regulatory compliance analysis.
Start analyzing your preclinical package
Upload study reports, run compliance analysis against ICH/FDA requirements, and see exactly what your IND submission needs.
Free plan includes 1 workspace and 5 documents. No credit card required.