Regulatory Intelligence Dashboard
One platform covering 59 regulatory agencies across 71 markets. Automated daily monitoring, AI-assisted analysis, and inspection intelligence – without an enterprise budget or a months-long implementation project.
784K+
Regulatory Events
59
Agencies Monitored
3,013
Guidelines
71
Markets Covered
Inspection and Enforcement Depth
266K+
FDA Inspections
272K+
FDA Citations
20K+
EU GMP Certificates
1,100+
Warning Letters
26+
Years of Data
Platform Capabilities
Built for regulatory affairs professionals, not IT departments.
01
Event Monitoring
784,000+ regulatory events: approvals, recalls, safety alerts, warning letters, guideline updates, and import refusals. Severity-classified and fully searchable, with daily automated ingestion across all 59 agencies.
02
AI-Assisted Analysis
On-demand plain-language summaries and impact assessments for individual events or agency-level overviews. Reduces triage time from hours to minutes without depending on external analyst availability.
03
Inspection Intelligence
266,000+ FDA facility inspections, 272,000+ citations with 21 CFR references, 20,000+ EU GMP certificates with expiry monitoring, and 1,100+ warning letters linked to facilities and FOIA documents.
04
Guidelines Library
3,013 regulatory guidelines from 36 agency sources. Full-text search, ICH cross-agency comparison matrix, market watch with automated notifications, and coverage spanning EU GMP Annexes through OECD GLP.
05
Surveillance and Alerts
Product, substance, and manufacturer watchlists with configurable alert rules. Email digest notifications, webhook integration for Slack and Teams, and compliance calendar with deadline tracking.
06
Analytics Suite
Eight modules: geographic heatmap, agency trend analysis, product risk scoring, seasonality detection, hotspot identification, cross-region comparison – plus twelve curated regulatory mega-themes.
07
Reporting and Export
CSV and PDF export for audit documentation and management reporting. Branded report templates for enterprise accounts. Full API access with 55 documented endpoints.
08
Multi-Language Support
Automated title translation across seven languages: English, German, French, Spanish, Portuguese, Japanese, and Chinese. Original-language content preserved alongside translations.
09
Security and Compliance
SSO via Keycloak (OIDC), role-based access control (owner / admin / member), comprehensive audit trail, Content Security Policy headers, tier-based rate limiting, WCAG 2.1 accessibility.
Global Coverage
59 agencies across 71 markets. Automated daily monitoring of every major pharmaceutical and medical device regulatory authority worldwide.
North America
FDA, FDA-ORA, Health Canada, COFEPRIS
EU / EEA / CH
EMA, EudraVigilance, EDQM, PIC/S, AGES/BASG, BfArM, PEI, ANSM, AIFA, AEMPS, CBG-MEB, HPRA, HALMED, JAZMP, OGYEI, SUKL, Ravimiamet, ZVA, URPL, EOF, FIMEA, DMA, Luxembourg, MMA, Swissmedic
Asia-Pacific
PMDA, NMPA, MFDS, TGA, Medsafe, HSA, CDSCO, BPOM, NPRA, Thai FDA, TFDA
International / Rest of World
MHRA, ANVISA, ANMAT, INVIMA, SFDA, EDA, SAHPRA, NAFDAC, MCAZ, PPB, NDA-UG, DGDA, BDA, DRAP, ANMDMR, ICH, WHO
Market Context
Feature coverage comparable to established enterprise tools – at a price point accessible to companies of any size.
| Capability | APS Dashboard | Enterprise Tool A | Enterprise Tool B | Enterprise Tool C |
|---|---|---|---|---|
| Annual starting price | €2,250 | ~$50,000+ | ~$30,000+ | ~$25,000+ |
| Free evaluation tier | Available | Demo only | Demo only | Demo only |
| Self-service signup | Immediate | Sales process | Sales process | Sales process |
| Event database | 784,000+ events | Curated summaries | Enforcement-focused | Country requirements |
| Agencies monitored | 59 agencies | 80+ markets | 200+ sources | 120+ markets |
| Inspection data | 266K+ records | Limited | Core strength | Not available |
| AI analysis | Included | Included | Included | Included |
| Implementation timeline | Same day | 4–8 weeks | 4–6 weeks | 2–4 weeks |
Start monitoring today
Free account in two minutes. No credit card required, no sales process, no implementation timeline.
Disclaimer: The Regulatory Intelligence Dashboard aggregates publicly available regulatory information. Its content does not replace legal or official regulatory advice. For binding information, please consult the responsible authority or qualified counsel directly. Austrian Pharma Services does not warrant the completeness or up-to-the-minute accuracy of every data point.