Regulatory Intelligence Dashboard
Verified data sources from 120+ authorities across 7 industry modules: FDA, EMA, MHRA, BfArM, Swissmedic, Health Canada, PMDA, NMPA, MFDS, TGA, ANVISA and many more. Over 2.5M+ regulatory events since tracking began, 800+ new entries daily, 30+ original languages with on-demand translation – automated, audit-ready, with daily updates.
2.5M+
Regulatory Events
120+
Authorities across 7 modules
800+
New entries daily
30+
Original languages
Data Depth & Coverage at a Glance
2.5M+
captured events
120+
Authorities across 7 modules
800+
New entries daily
30+
Original languages
7
Industry modules
Platform Capabilities
Built for regulatory affairs professionals, not IT departments.
01
Event Monitoring
2.5M+ regulatory events from verified data sources: market approvals (510(k), PMA, CE, etc.), recalls & safety alerts, warning letters & inspection outcomes, guideline updates & consultations, pricing & reimbursement (HTA), and supply-chain notices. Intelligent severity categorization and fully searchable – with daily updates from 120+ authorities across 7 industry modules.
02
Automated Analysis
On-demand plain-language summaries and impact assessments for individual events or agency-level overviews. Intelligent categorization reduces triage time from hours to minutes without depending on external analyst availability.
03
Inspection Intelligence
FDA facility inspections, citations with 21 CFR references, EU GMP certificates with expiry monitoring, and warning letters linked to facilities and FOIA documents – all from verified data sources with daily updates.
04
Guidelines Library
Regulatory guidelines from verified data sources across 30+ agencies with daily updates. 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
On-demand translation from 30+ original languages, including English, German, French, Spanish, Portuguese, Japanese, and Chinese. Original-language content is preserved alongside the 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
120+ authorities across 7 industry modules worldwide. Automated daily monitoring from verified data sources covering every major pharmaceutical and medical device regulatory authority.
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 | 2.5M+ events | Curated summaries | Enforcement-focused | Country requirements |
| Agencies monitored | 120+ authorities (FDA, EMA, PMDA et al.) | 80+ markets | 200+ sources | 120+ markets |
| Inspection data | 2.5M+ events, audit-ready 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.
Frequently Asked Questions about the Regulatory Dashboard
What is the Regulatory Dashboard?
The Regulatory Dashboard is a curated overview of current developments in GMP, pharmacovigilance, quality management and authority inspections that are relevant for pharmaceutical, biotech and medical device companies in the DACH region.
Which topics does the Dashboard cover?
Focus areas include changes to the EU GMP Guide, Annex revisions, MDR/IVDR updates, inspection trends and guidance from EMA, FDA, BASG and Swissmedic.
How often is the Dashboard updated?
Content is continuously reviewed by our team and updated regularly whenever relevant regulatory changes are published.
Does the Dashboard replace individual regulatory advice?
No. The Dashboard is intended as orientation and does not replace project- or product-specific assessment by our experts. For specific questions we offer individual consulting.
Who can I contact regarding the content?
For content questions or specific consulting requests please contact us at office@austrianpharmaservices.com or via our contact form.