🏥 Built for Life Sciences & Pharma

Never miss an FDA deadline again. Your compliance radar, automated.

Real-time monitoring of FDA, EMA, MHRA, and health regulators worldwide. AI-powered alerts for drug approvals, guidance changes, and enforcement actions.

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$13B
FDA Fines Since 2020
4,000+
FDA Guidance Docs Active
15+
Health Regulators Tracked
24h
Faster Than Manual Review

Regulatory risk is your biggest clinical trial threat

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Gene Therapy Rules Changing Fast

FDA's CBER is issuing new guidance monthly on cell and gene therapies. One missed update can delay your IND submission by quarters.

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Multi-Market Filings

FDA, EMA, PMDA, MHRA — each with different timelines, different requirements, different formats. Your RA team can't manually track them all.

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Warning Letters Are Public

FDA Warning Letters are published online. Your competitors, investors, and partners see them. Prevention costs 0.1% of remediation.

Compliance intelligence for life sciences

💊 FDA Real-Time Feed

New drug approvals, 483 observations, warning letters, guidance drafts, and final rules — all in one feed, AI-summarized daily.

🌐 Global Coverage

FDA, EMA, MHRA, PMDA, Health Canada, TGA — monitor regulatory changes across every major pharma market simultaneously.

🔬 Therapeutic Area Filters

Oncology? Rare disease? Medical devices? Filter by your therapeutic area and only see regulations that affect your pipeline.

📋 Submission Deadline Tracking

IND, NDA, BLA, 510(k) — track every submission deadline with automated reminders. Never miss a filing window.

📊 Competitive Intelligence

Track competitor FDA interactions — approval timelines, CRLs, advisory committees. Know the landscape before your next board meeting.

🔒 21 CFR Part 11 Aware

Built with pharma compliance in mind. Audit trails, export controls, and data handling that your QA team will approve.

Your regulatory affairs team deserves better tools

14-day free trial. No credit card required. Covers FDA, EMA, and 13 more agencies.

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