Regulatory leaders
See portfolio risk, evidence, and decisions without chasing updates across systems.
AI-powered global regulatory intelligence
Regulatory clarity for the people bringing life-science products to market.
AI-powered intelligence. Expert-led decisions.
eeRegOS gives regulatory professionals, quality teams, and product leaders one place to understand what changed, decide what matters, and move the work forward with confidence.
See how it works
Human expertise, connected
Give every regulatory decision shared context, evidence, and accountable review.
Regulatory affairsQuality & complianceProduct leadership
Decision context
Sources, owners, and next steps aligned
Traceable to authoritative evidence
9
Connected modules
16+
Priority markets
24/7
Lifecycle monitoring
Human + AI
Governed decisions
FDANew guidance and policy updatesEMARegulatory and scientific guidanceMHRAUK regulatory updatesHealth CanadaMarket and submission updatesPMDAJapan regulatory updatesFDANew guidance and policy updatesEMARegulatory and scientific guidanceMHRAUK regulatory updatesHealth CanadaMarket and submission updatesPMDAJapan regulatory updates
Built around your team
Technology for the people accountable for every regulatory milestone.
eeRegOS supports judgment instead of replacing it—giving each person shared context, traceable evidence, and a clear path to the next decision.
Regulatory professionals
Move from research to documented recommendations with sources and context intact.
Quality and RA teams
Coordinate gaps, reviews, tasks, and submission evidence through accountable workflows.
Life-sciences founders
Understand the next regulatory decision and bring the right experts in at the right time.
The regulatory problem
Regulatory information is everywhere. Intelligence shouldn’t be.
High-stakes decisions slow down when evidence, requirements, precedents, and internal knowledge live in disconnected systems.
Fragmented intelligence
Standards, precedents, and internal evidence remain disconnected.
Global complexity
One product faces different pathways and obligations.
Manual work
Teams lose time searching, comparing, and reconciling.
GuidanceEvidencePrecedentsInternal dataeeRegOS intelligence layerActionable output
Product modules
Navigate by product. Work in one regulatory system.
Select a life-sciences product family to see pathways, evidence, readiness, and regulatory context update inside the workspace.
42Source records
5Product families
16Markets
Regulatory pathway workspace
Medical Devices
Active product
CardioSense Monitor
Lead authority
FDA · CDRH
Overall readiness
86%
Recommended pathway
510(k) Premarket Notification
Based on product profile, intended use, primary mode of action, and selected market.
Available pathways
510(k)De NovoPMAIDEEU MDR / IVDR
Readiness summary
Evidence coverage86%
Open gaps3
Source records42
Conclusions are linked to authoritative sources and routed for human review.
Platform showcase
Your regulatory command center
The same operating model teams use after sign-in: products, markets, submissions, risks, and evidence in one workspace.
Portfolio-wideSee change across every active product.
Decision-readyMove from signal to assigned action.
Apex Medical Technologies
Executive command center
Regulatory operations overview
Active submissions
24
Portfolio readiness
86%
Global markets
18
Project portfolio
Live readiness and regulatory status
CardioSense510(k) · 86%
NovaGeneIND · 74%
BioValvePMA · 63%
Priority risk
2 critical gapsClinical evidence
7 actions dueThis month
AI copilot center
A regulatory AI team built around your product
Each copilot operates with specialized instructions, curated sources, dedicated retrieval domains, and validation controls inside one secure infrastructure.
Pathway and classification analysis
Submission readiness and gap review
Regulatory drafting with citations
Global Pathway Copilot
12 authoritative sources · analyzed 2m ago
Compare the regulatory pathway for our drug-device combination product across the United States, European Union, and Japan.
Product profile analyzedComplete
Jurisdiction requirements mapped3 markets
Evidence differences identified7 findings
Every conclusion links back to its source record.
Global intelligence
One product. Multiple markets. One intelligence layer.
Select a jurisdiction to compare authority expectations, classification, pathways, submission status, and regulatory change in context.
United StatesEuropean UnionUnited KingdomCanadaAustraliaJapanChinaBrazilSaudi ArabiaSingapore
Global market intelligence
CardioSense Monitor · Illustrative workspace
16 jurisdictions monitored · last analyzed 2m ago
How eeRegOS works
A connected path from product profile to maintained compliance
Information moves forward through one controlled workflow—without losing its source, owner, or regulatory context.
- 01
Define your product
Create a living Regulatory Digital Product Profile.
- 02
Select your markets
Choose jurisdictions and commercial objectives.
- 03
Map requirements
Analyze pathways, evidence, and registration requirements.
- 04
Identify gaps
Generate readiness scores, risks, and prioritized actions.
- 05
Build & review
Create controlled work products with expert oversight.
- 06
Maintain compliance
Monitor approvals, renewals, changes, and intelligence.
Regulatory intelligence
Know what changed. Know what it means. Know what to do next.
Watch a regulatory signal move from authoritative source to product-level impact and accountable action.
Regulatory intelligence pipeline
Illustrative analysis · last analyzed 2m ago01 · DETECT
FDA · Guidance updated
Cybersecurity in Medical Devices: Quality System Considerations
Published 21 Aug 2026 · Center for Devices and Radiological Health
Source verified12 citations
02 · ANALYZE
Product-level impact analysis
3
Products affected
2
Active submissions
7
Evidence links
High
Impact level
Evidence graph matched in 1.8s
03 · ACT
Recommended actions
Review clinical evidence strategyHigh
Update submission checklistAssigned
Route to regulatory leadReview
Submission readiness
Know what’s missing before the regulator does.
Turn submission completeness into an explainable readiness score with evidence-level gaps and assigned actions.
3
Critical gaps
7
Major gaps
14
Actions
Submission readiness
US NDA · Project Atlas
84%
On track
CMC
92%
Clinical
81%
Risk management
89%
Labeling
76%
Manufacturing
68%
View readiness report →
Human intelligence
AI accelerated. Human governed.
High-impact regulatory decisions require accountable expert review, documented rationale, and controlled approval workflows—not black-box recommendations.
01AI analysis
02Evidence & citations
03Risk assessment
04Expert review
05Approved output
Expert review where it matters
Accountable decisions with a durable audit trail.
Security & trust
Built for regulatory work where trust matters.
Source traceability
Role-based access
SSO / MFA
Encryption
Audit trails
AI governance
Data isolation
Human review
Certifications are only presented when formally achieved.
Plans that grow with you
Clear entry points for every organization size
Professional
Individual regulatory professionals and consultants
Core copilotsProduct workspaceReadiness assessment
View plan →Business
Regulatory teams and growing life-sciences organizations
Team workflowsMulti-market intelligencePortfolio reporting
View plan →Enterprise
Global portfolios, integrations, and advanced governance
Advanced access controlsEnterprise integrationsExpert services
View plan →Regulatory intelligence & resources
Regulatory intelligence for the decisions ahead
Explore jurisdiction- and product-specific intelligence designed to turn regulatory change into practical next steps.
Move from complexity to clarity
The future of regulatory affairs isn’t more information. It’s better intelligence.
See how eeRegOS can help your organization move from regulatory complexity to regulatory clarity.