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Regulatory Information Management (RIM)

RegX RIM helps life sciences teams manage product registrations, submission planning, eCTD readiness, regulatory archives, document control, commitments, and reporting across global markets.

 
 
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From Fragmented Regulatory Tracking to Connected Regulatory Operations

Regulatory teams manage products, markets, submissions, variations, renewals, documents, commitments, and health authority expectations across multiple systems. RegX brings regulatory data, workflows, documents, and compliance visibility into one connected platform.

 
 
Regulatory Automation

Fragmented Regulatory Data

Centralize product, market, registration, submission, and commitment information in one source of truth.

Limited Lifecycle Visibility

Track approvals, variations, supplements, renewals, post-approval changes, and market status across the product lifecycle.

Manual Submission Planning

Plan milestones, dependencies, deliverables, resources, and submission timelines with real-time visibility.

Compliance & Archive Gaps

Maintain audit-ready records, submission history, document versions, correspondence, and inspection evidence.

Everything Regulatory Teams Need to Manage Connected RIM Operations

Registrations & Product Lifecycle Management

Manage global registrations, licenses, approvals, products, indications, markets, variations, renewals, and commitments.

  • Global Registrations
  • Licenses & Approvals
  • Product and Market Lifecycle
  • Variations & Renewals
  • Regulatory Commitments

Support structured eCTD preparation from document assembly to publishing, validation, metadata control, and submission readiness.

  • eCTD Authoring
  • Submission Assembly
  • Publishing & Packaging
  • XML Backbone Management
  • Technical Validation

Manage regulatory documents with version control, search, collaboration, review workflows, reuse, and audit trails.

  • Document Repository
  • Version Control
  • Enterprise Search
  • Review & Approval Workflows
  • Content Reuse
Submission Planning & Tracking

Plan and monitor regulatory submissions with clear milestones, deliverables, dependencies, ownership, and portfolio visibility.

  • Submission Planning
  • Milestone Tracking
  • Deliverable Management
  • Dependency Tracking
  • Executive Reporting

Preserve submission history, lifecycle traceability, correspondence, approvals, version comparisons, and regulatory knowledge.

  • Submission History
  • Lifecycle Traceability
  • Correspondence Archive
  • Version Comparison
  • Knowledge Preservation

Provide real-time visibility into submissions, renewals, commitments, market status, timelines, and compliance risks.

  • Submission Dashboards
  • Renewal Tracking
  • Commitment Reports
  • Market Status Views
  • Compliance Risk Visibility

From Regulatory Data Capture to Inspection-Ready Visibility

Capture

Centralize product, market, registration, document, submission, and commitment data.

Plan

Define submission milestones, deliverables, timelines, dependencies, and responsible teams.

Prepare

Assemble content, manage documents, structure eCTD sequences, and validate submission readiness.

Submit

Track submission activity, publishing history, health authority interactions, and status updates.

Maintain

Manage approvals, variations, renewals, lifecycle events, post-approval changes, and commitments.

Govern

Preserve audit trails, archive history, dashboards, compliance reports, and inspection-ready evidence.

Stronger Control Across Regulatory Data, Submissions, and Lifecycle Operations

Improved Regulatory Visibility

Gain a real-time view of submissions, registrations, approvals, commitments, and market status.

Faster Submission Execution

Reduce manual tracking and improve coordination across planning, document assembly, publishing, and validation.

Better Product Lifecycle Control

Manage variations, renewals, approvals, supplements, and post-approval changes across global markets.

Stronger Compliance Readiness

Maintain audit trails, version history, correspondence, evidence, and inspection-ready records.

Reduced Manual Effort

Replace spreadsheets, duplicate data entry, shared folders, and manual reconciliation with structured workflows.

Better Executive Reporting

Give leadership clear dashboards for submission status, renewal timelines, open commitments, and compliance risk.

Built for Regulatory Leadership, Managers, Operations, and Supporting Teams

Executive Leadership

Monitor regulatory performance, portfolio status, submission progress, market coverage, risks, and compliance readiness.

VP Regulatory Affairs

Oversee regulatory strategy, global submissions, approvals, lifecycle activities, and health authority commitments.

Regulatory Directors

Manage portfolio execution, market-level status, submission priorities, renewals, and team performance.

Regulatory Affairs Managers

Coordinate registrations, variations, renewals, submission plans, document readiness, and commitment tracking.

Submission Managers

Plan, assemble, validate, publish, and track regulatory submissions across products and regions.

Regulatory Specialists

Maintain product data, registration records, documents, submission details, commitments, and lifecycle updates.

Quality, Clinical, Safety & CMC Teams

Provide supporting content, review inputs, compliance evidence, source documents, and technical documentation.

Publishing Teams

Support eCTD structure, sequence publishing, validation reports, metadata, and submission package readiness.

Transform Regulatory Information Management with RegX

Centralize regulatory data, manage global registrations, streamline submission planning, control documents, preserve regulatory history, and strengthen inspection readiness with RegX.

 
 
 
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