About BioIntel.io
Purpose-built intelligence for the biotech regulatory landscape
BioIntel.io was created to solve a specific problem: the biotech and regenerative medicine industries generate an enormous volume of regulatory signals — FDA actions, clinical trials, enforcement patterns, research publications, funding rounds — and no existing tool synthesizes them into actionable intelligence. We built the platform we wished existed.
Democratize regulatory intelligence
Regulatory intelligence has historically been locked behind six-figure enterprise contracts, fragmented across dozens of government databases, and delivered in formats that require specialized training to interpret.
BioIntel.io makes institutional-grade signal detection, compliance analysis, and technology scouting accessible to every organization in the biologics and regenerative medicine ecosystem — from two-person startups to enterprise compliance teams.
Platform Pillars
Four layers of intelligence
Signal Detection
Continuous monitoring of FDA actions, FTC enforcement, clinical trial registrations, patent filings, funding rounds, and peer-reviewed research across the entire biologics and regenerative medicine landscape.
Compliance Analysis
AI-powered claim screening against 21 CFR 1271, FDA 351(a)/351(k) pathways, FTC Act Section 5, DSHEA, and state-level regulations — with specific citations and compliant alternative language.
Technology Momentum
Proprietary composite scoring that ranks emerging technologies by research velocity, trial activity, venture funding, regulatory signals, and commercial traction — updated continuously.
Predictive Intelligence
Pattern recognition across regulatory timelines, enforcement trends, and funding cycles to surface actionable insights before they become consensus.
Built For
Who uses BioIntel.io
Compliance Officers
Screen marketing claims against FDA/FTC frameworks before they become enforcement targets.
Regulatory Affairs
Track FDA guidance, pathway changes, and enforcement actions in real time.
Biotech Investors
Identify technology momentum shifts and regulatory risks before they move markets.
Clinical Operations
Monitor trial landscape changes, competitor filings, and regulatory pathway updates.
Executive Leadership
Strategic intelligence briefs that synthesize signals into actionable board-level insights.
Legal Counsel
Evidence-backed regulatory risk assessments with specific citation chains.
Ready to see what you're missing?
Start with a free claim analysis or explore the live intelligence feed.