AI monitors FDA, EMA, PMDA, NMPA, and 3 more agencies 24/7. Get instant alerts on guideline changes, compliance trends, and emerging requirements—before they impact your submissions.
Comprehensive regulatory monitoring across guidelines, trends, announcements, and cross-agency patterns
Track new and revised guidelines from ICH, FDA, EMA, PMDA, NMPA, and other agencies
Alert: FDA published draft guidance on "CMC Considerations for Gene Therapy Products" (Nov 2025) → Affects 3 of your submissions
Analyze approval patterns, deficiency trends, and regulatory hotspots across agencies
Trend: FDA issuing 40% more deficiencies on Section 3.2.P.5 (stability data) in Q4 2025 → Update your prompts
Monitor agency news, policy changes, and implementation schedules
Update: EMA mandates eCTD v4.0 for all new MAAs starting July 2026 → Validate your technical specs
Track approval patterns and requirement harmonization across global agencies
Insight: Product approved by EMA for Indication X → FDA likely to follow within 6 months based on historical pattern
Multiple delivery channels ensure you never miss critical updates
Intelligence feed widget on your main dashboard showing latest updates relevant to your submissions
Weekly digest of changes + immediate alerts for critical updates affecting your active submissions
Contextual alerts while editing (e.g., "FDA updated requirements for this section in Nov 2025")
See how new guidelines affect your compliance scores with suggested improvements
Ask questions like "Any new NMPA requirements for biologics?" and get current answers
Real-world scenarios showing how regulatory intelligence prevents delays
ICH publishes M12 (Drug-Device Combination Products)
You receive alert: "ICH M12 published - 15 prompts updated for Module 3. Review Section 3.2.P.7 for combination products."
FDA rejects 40% of NDA submissions for insufficient stability data in Section 3.2.P.8
You receive trend alert: "FDA stability deficiencies up 40% in Q4 2025. Your Section 3.2.P.8 compliance: 87%. Suggest adding forced degradation data."
EMA updates eCTD v4.0 validation rules
You receive validation alert: "EMA updated eCTD 4.0 schema. 2 of your submissions have compatibility issues. Auto-fix available."
See how DossiAIr's regulatory intelligence keeps your submissions current, compliant, and ahead of the curve.