Regulatory Intelligence Dashboard
Live data from FDA, EMA, MHRA, BfArM, Swissmedic, Health Canada, PMDA, NMPA, MFDS, TGA, ANVISA and many more agencies across 70+ markets worldwide. Over 917,000 captured events, around 23 years of historical depth, and twice-daily automated updates – without an enterprise budget or a months-long implementation project.
900K+
Regulatory Events
114
Regulatory Sources
3,430
Guidelines
72+
Markets Covered
Inspection and Enforcement Depth
917,775
captured events
70+
markets worldwide
24,517
critical-severity events
17,977
events in the last 30 days
~23
Years of Data
Platform Capabilities
Built for regulatory affairs professionals, not IT departments.
01
Event Monitoring
898,000+ regulatory events: approvals, recalls, safety alerts, warning letters, guideline updates, and import refusals. Severity-classified and fully searchable, with daily automated ingestion across all 70+ markets (FDA, EMA, PMDA et al.).
02
Automated 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
268,000+ 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
3,430 regulatory guidelines from 30+ agency sources, with 12 actively updated daily. 782 guidelines were updated in the last 30 days. 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
114 regulatory sources across 72+ 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 | 917,775+ events | Curated summaries | Enforcement-focused | Country requirements |
| Agencies monitored | 114 regulatory sources | 80+ markets | 200+ sources | 120+ markets |
| Inspection data | 917K+ events, ~23 years history | Limited | Core strength | Not available |
| Automated analysis | Included | Included | Included | Included |
| Implementation timeline | Same day | 4–8 weeks | 4–6 weeks | 2–4 weeks |
Product Modules
Five modules, additively bookable per organization. Strict module isolation – no bleed-over between Pharma and MedTech customers.
Pharma & Biotech
Drug approvals, recalls, safety alerts, GMP inspections, and pharmacovigilance – the standard module for pharmaceutical manufacturers.
MedTech (MDR/IVDR)
Notified Bodies (NANDO/SMCS), EUDAMED devices and certificates, FDA 510(k)/PMA/MAUDE, IMDRF, MDCG, Team-NB, and UKCA Approved Bodies.
SaMD / AI / Cyber
FDA AI/ML PCCP tracker, EU AI Act, IEC 62304, and IMDRF SaMD risk categorization for software-based and AI-driven medical devices.
ATMP (Cell / Gene / Tissue)
Specialized module covering EMA-CAT, FDA-CBER, MHRA-ATMP, HSA-CTGTP, ANVISA-ATMP, MFDS-ABIO, and PMDA-RegMed for cell and gene therapies.
HTA & Reimbursement
NICE-TA (UK), G-BA (DE), HAS-CT (FR), CMS-NADAC and CMS-ASP (US), DE-GKV-AMNOG, and FR-BDPM for reimbursement and Health Technology Assessment.
Plans
Four tiers to match your needs: Free for 14d testing, Starter and Pro for active use, and Enterprise with extended history, higher API limits, and SLA.
Compliance & Security
A GxP-validatable framework with audit trail, signed export envelopes, and event-level change tracking.
21 CFR Part 11
Audit trail with cryptographically chained hashes, signed export envelope, and complete change tracking.
EU GMP Annex 11
Validatable computer-system architecture suitable for use in regulated environments.
GAMP 5
IQ, OQ, and PQ documentation set available to support customer-side validation projects.
ISO 27001 / SOC 2
Certifications in preparation. Already in place: comprehensive web-security hardening, HSTS preload, and hardened webhook delivery.
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.