Private by designAI That Reviews FDA Documents Faster Than Your Legal Team — At 1% of the Cost
Upload any FDA submission, drug label, or protocol document — the Regulatory Doc Validator checks every section against current FDA/EMA/ICH guidelines, flags non-compliant language, and generates a correction report with cited references.
Why Regulatory Review Is Broken
$2,000/hour legal review
Pharma companies pay specialist regulatory lawyers $2,000/hour to manually verify FDA submission documents. A single label review costs $40,000–80,000.
Guideline changes catch teams off guard
FDA guidelines update constantly. A label approved 2 years ago may now be non-compliant with new draft guidance. Manual tracking is impossible at scale.
Submission rejections delay drug launches
A Complete Response Letter from FDA for a labeling issue can delay a drug launch by 6–12 months and cost $100M+. AI catches these before submission.
How It Works
Upload Document
FDA submission, drug label, protocol, SOP, or any regulatory document.
Guideline Mapping
AI maps each section to applicable FDA/EMA/ICH guidance documents.
Compliance Check
Flags non-compliant language with exact guideline citations.
Correction Report
Generates a redline report with suggested replacements and references.