Architecture
Regulatory Hub uses a layered enterprise architecture that separates personas, business capabilities, workflow controls, intelligence services, and compliance foundations. This design keeps operational workflows fast while preserving deterministic lineage and auditability for every regulated action. Expand each layer to inspect detailed capabilities and integration touchpoints used in submission and lifecycle operations. Use the view mode toggle to shift between full descriptions, compact cards, and layer-only navigation.
Users and Personas LayerRegulatory Affairs, Reg Ops Publishing, Labeling, Quality, Affiliate, Admin, and Inspector View personas with scoped responsibilities.
Users and Personas Layer
Regulatory Affairs, Reg Ops Publishing, Labeling, Quality, Affiliate, Admin, and Inspector View personas with scoped responsibilities.
Regulatory Affairs
Reg Ops Publishing
Labeling
Quality
Affiliate
Admin
Inspector View
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Application LayerSingle operating interface for regulatory execution.
Application Layer
Single operating interface for regulatory execution.
Regulatory Hub
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Regulatory Capabilities LayerDomain capabilities mapped to real regulatory operations.
Regulatory Capabilities Layer
Domain capabilities mapped to real regulatory operations.
Master Data
Submissions
Publishing
Dispatch
Correspondence
Commitments
Lifecycle
Variations
Labeling
Intelligence
Inspection Readiness
Governance
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Workflow and Orchestration LayerProcess controls from planning through approvals, publishing, dispatch, and attestation.
Workflow and Orchestration Layer
Process controls from planning through approvals, publishing, dispatch, and attestation.
Plan & Milestones
Content Review
Approval Gates
Publishing Queue
Dispatch and ACK
Commitment Tracking
Inspection Pack Assembly
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Generative AI and Intelligence LayerGoverned AI agents for precedent retrieval, correspondence support, and impact analysis.
Generative AI and Intelligence Layer
Governed AI agents for precedent retrieval, correspondence support, and impact analysis.
Precedent Finder
Correspondence Draft Assist
Change Impact Suggester
Dossier Summarizer
Metadata Classifier
Labeling Consistency Checker
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Data and Content LayerDeterministic repository of regulated content, labels, audit trails, and lineage snapshots.
Data and Content Layer
Deterministic repository of regulated content, labels, audit trails, and lineage snapshots.
Product and Application Master
Dossier Components
Approval Snapshots
Publishing Manifests
Dispatch Events
Audit Events
AI Run Records
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Integrations and Source Systems LayerExternal enterprise systems and regulatory channels providing controlled source signals and outputs.
Integrations and Source Systems Layer
External enterprise systems and regulatory channels providing controlled source signals and outputs.
RIM
DMS and controlled authoring
publishing engine
submission gateways where applicable
QMS and change control
safety and labeling signal systems
clinical repositories and medical writing sources
CMC systems and manufacturing quality sources
translation vendors and TMS
identity and access management
SIEM and monitoring
affiliate portals
external regulatory intelligence feeds
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Platform Governance and Security LayerABAC policy controls, retention, validation evidence, and immutable compliance telemetry.
Platform Governance and Security Layer
ABAC policy controls, retention, validation evidence, and immutable compliance telemetry.
Access Control
Retention Policies
Validation Evidence
Audit Immutability
Export Controls
Inspector Time-Boxed Access