RegX™
RegX™ is an AI regulatory platform that helps life sciences teams manage regulatory work in one connected environment. It brings together product information, controlled documents, content authoring, eCTD submissions, Health Authority interactions, and regulatory intelligence, with human review built into critical decisions.
Regulatory work is growing more complex
Teams must track evolving requirements while coordinating content across products, markets, applications, and submission sequences. When information sits in separate systems, finding the right document, assessing a change, or preparing a response takes more time.
RegX™ designed to give teams a clearer view of their work and reduce manual coordination. Its modular architecture allows organizations to adopt individual capabilities or connect them across the regulatory lifecycle.
Eight connected regulatory capabilities
RIM - Regulatory Information Management
Manage product master data, applications, registrations, and lifecycle activities in a central workspace. RegX™ RIM helps teams understand regulatory status across products and markets.
DMS - Document Hub
Control regulatory documents from creation through review, approval, reuse, and submission. Metadata, classification, assignments, and lifecycle history help teams find the appropriate content and track its use.
Assisted Author - Assisted Content Authoring
Support dossier content creation and transformation with source information and governed AI prompts. Regulatory experts review drafts and retain control of approved content.
eCTD Publisher - eCTD Publishing & Submissions
Prepare submission content, generate eCTD packages, run validation checks, and review sequences before submission. Connected publishing workflows help teams identify issues and follow document lifecycle history.
HA Interact - Health Authority Interaction Management
Coordinate Health Authority correspondence, deficiency questions, responses, and commitments. Keep requests, supporting information, ownership, and response history together.
RegIntel - Regulatory Affairs Intelligence
Monitor regulatory developments and Health Authority expectations. Turn relevant findings into insights that teams can evaluate for their products and submissions.
Change Assessor - Regulatory Change Assessment Intelligence
Assess how internal or external changes affect regulatory information, documents, applications, and commitments. Record the impact, assign actions, and track their completion.
SPL Author - Structured Content Authoring
Prepare and validate structured regulatory content, including labeling and product information. Maintain content through review and lifecycle changes to support applicable publishing requirements.
Connected Regulatory Capabilities Across the Product Lifecycle
Regulatory master data, applications, registrations, lifecycle, and market-status management
Centralized document control with metadata, classification, versioning, review, and approval workflows
AI-assisted dossier authoring using approved content and trusted regulatory knowledge
eCTD publishing, validation, PDF compliance, and submission sequence management
Structured content preparation, validation, reuse, and publishing
Health Authority correspondence, deficiency responses, commitments, and deadline tracking
AI-enabled regulatory intelligence using guidance monitoring, agency feedback, and trend analysis
End-to-end traceability, dashboards, reporting, and audit trails
Built for regulated life sciences operations
RegX™ connects data, processes, and people while preserving oversight of regulatory decisions. Organizations can use modules independently or integrate them with existing systems through a flexible architecture.
RegX™ provides a connected foundation for managing information, preparing submissions, and responding to change. It brings together the workflows expected of regulatory platform for life sciences without requiring every team to adopt every module at once.
See RegX™ in action
Explore how RegX™ can help your team manage regulatory content, improve submission readiness, and maintain visibility across the product lifecycle