Capability Model
The Regulatory Hub capability model maps 12 core functional capabilities across the regulatory operations domain. Each capability is rated on a 5-point maturity scale and lists its constituent features. This model serves as the basis for gap analysis, roadmap prioritisation, and system configuration decisions.
CAP-01
Master Data Management
Centralised repository for Products, Substances, Markets, Authorities, Organisations, and Sites with full version history and golden record governance.
Product masterSubstance registryMarket/Authority catalogueGS1/IDMP alignment
CAP-02
Regulatory Intelligence & RIM
Application tracking, dossier registry, procedure management, and submission history across all markets and authority portals.
Application registryProcedure trackingMulti-market RIMTimeline management
CAP-03
Publishing & Sequence Management
End-to-end eCTD publishing from content assembly through validation, rendering, and final submission package generation.
eCTD builderVersion set mgmtLorenz/EXTEDO validationQC automation
CAP-04
Dispatch & Gateway Tracking
Automated dispatch to authority portals (FDA ESG, EMA CESP, PMDA, MHRA) with acknowledgement tracking and resubmission workflow.
Multi-gateway dispatchACK trackingResubmission workflowSLA monitoring
CAP-05
Correspondence Management
Inbox-style management of authority questions, queries, deficiency letters, and information requests with response assembly and risk scoring.
Query inboxResponse packagesDue date trackingRisk classification
CAP-06
Commitment Tracking
Post-approval commitment management with evidence collection, overdue alerting, and authority reporting dashboards.
30/60/90 day bucketsEvidence managementEscalation alertsAuthority reporting
CAP-07
Lifecycle & Change Management
End-to-end management of product changes from initiation through impact assessment, variation filing, and post-approval monitoring.
Change initiationImpact assessmentVariation linkingLifecycle timeline
CAP-08
Variation Management
Type IA/IB/II variation workflows with automatic classification assistance, fee estimation, and authority-specific filing requirements.
Type IA/IB/IIAuto-classificationFee calculatorMulti-authority filing
CAP-09
Labeling & Artwork Management
SmPC, PIL, and PI lifecycle management with statements library, core data sheet governance, and market-specific adaptation tracking.
SmPC/PIL/PIStatements libraryCore data sheetMarket adaptations
CAP-10
Regulatory Intelligence & AI
AI-powered regulatory intelligence including guideline monitoring, precedent search, gap analysis, and autonomous drafting agents.
Guideline trackerPrecedent searchLLM draftingSignal monitoring
CAP-11
Inspection Readiness & Quality
GxP-grade inspection readiness scoring, pack builder, audit trail management, deviation tracking, and validation evidence management.
Readiness scoringInspection packs21 CFR Part 11 auditCSV validation
CAP-12
Governance & Access Control
Attribute-based access control, policy engine, data residency enforcement, GxP compliance controls, and records retention management.
ABAC policiesData residencyRecords retentionAudit & compliance