Regulatory Automation (RegX)
AI-powered regulatory platform that connects regulatory data, content, submissions, workflows, intelligence, compliance, and reporting across the entire product lifecycle.
Regulatory Operations Are Becoming More Complex
Regulatory teams are managing more products, markets, submissions, health authority interactions, and compliance expectations. RegX brings structure, intelligence, and automation to regulatory operations so teams can work faster, reduce manual effort, and improve compliance control.
Current Regulatory Challenges
Fragmented Regulatory Data
Critical regulatory information scattered across documents, drives, and disconnected systems.
Manual Submission Tracking
Spreadsheets and emails create gaps in submission readiness and milestone visibility.
Disconnected Content & Workflows
Reviews, approvals, and content reuse stall across teams, tools, and geographies.
Limited Visibility Across Lifecycle
Leaders lack a real-time view of regulatory status, risks, and operational performance.
One Platform. One Source of Truth
RegX brings together regulatory information, content, submissions, workflows, compliance activities, correspondence, intelligence, validation, and reporting into one connected operating layer.
Modular
Choose the modules your organization needs today and expand as your regulatory operations mature.
Connected
Connect regulatory data, documents, workflows, decisions, submissions, correspondence, and compliance activities across teams and systems.
Automated
Use AI-powered automation to reduce repetitive work, improve consistency, and accelerate regulatory execution.
Flexible Regulatory Automation for Your Operating Model
Standalone or Integrated Module Architecture
RegX can be deployed as a standalone regulatory automation platform or as an integrated module architecture within your enterprise ecosystem. Teams can start with selected modules and scale toward a fully connected regulatory operating model.
Organizations replacing fragmented tools
Teams building a regulatory single source of truth
Companies standardizing regulatory workflows
Businesses modernizing regulatory operations
Automation Layer for Third-Party Systems
RegX can operate as an intelligent automation layer on top of existing systems such as document repositories, RIM tools, submission systems, quality systems, correspondence platforms, and internal applications.
Organizations that want to keep existing systems
Teams looking to add AI automation on top of current tools
Businesses reducing manual regulatory tasks
Companies improving visibility across disconnected platforms
RegX can work as your core regulatory platform or as an AI automation layer that enhances your existing technology landscape.
RegX Regulatory Automation Modules
A complete suite of connected modules covering the entire regulatory lifecycle — deploy what you need, scale as you grow.
Regulatory Information Management (RIM)
Manage product information, registrations, markets, applications, submissions, milestones, commitments, regulatory activities, and document status in one connected environment.
CMC / Module 3
Authoring
Support structured CMC and Module 3 content creation, source data management, approved content reuse, version control, and submission-ready documentation
Regulatory Intelligence & Strategy
Monitor regulatory requirements, agency expectations, guidance updates, market-specific changes, and strategic submission inputs
Clinical Regulatory Document Generation
Generate clinical regulatory documents faster using templates, approved content,intelligent extraction, and AI-assisted drafting
Health Authority Correspondence & Deficiency Management
Manage health authority queries, deficiencies, responses, commitments, owners, timelines,and closure tracking with full traceability
Labeling &
SPL Management
Control labeling content, SPL activities, reviews, approvals, updates,compliance tracking, and structured outputs
Enable structured review, compliance checks, approvals, audit trails, and governance for advertising and promotional materials
Support safety documentation, regulatory reporting workflows, tracking, and compliance oversight
IRB, Ethics & Regulatory Compliance
Manage IRB submissions, ethics documentation, regulatory reviews, approvals, evidence, and inspection-ready records
DEA Validation
Support DEA validation activities with structured checks, workflows evidence management,documentation, and compliance tracking
AI-Powered Automation Across Regulatory Operations
Intelligent agents, automation, and oversight working together across every regulatory activity.
AI Agents
Task support, workflow assistance, and execution.
Regulatory Assistant Bots
Search, understand, and act on regulatory information faster.
Intelligent Data Extraction & Classification
Extract, classify, and organize regulatory data.
Content Generation & Authoring
Reuse approved templates with AI-assisted drafting.
Impact Analysis & Recommendations
Assess impact of regulatory changes and updates.
AI Search
Intelligent search across documents, submissions, and records.
Redaction & Sensitive Data Protection
Controlled redaction of confidential information.
End-to-End Traceability
Connect data, workflows, approvals, and audit history.
Human Review & Attestation
Review, approval, and oversight checkpoints.
Governance & Compliance Controls
Permissions, audit trails, and inspection readiness.
Built on a Strong Regulatory Platform Foundation
Enterprise-grade controls, governance, and visibility — engineered for Life Sciences compliance.
Structured Content Management
Manage regulatory content in controlled, reusable, and structured formats.
eSignatures & Approval
Support controlled approvals and electronic signatures for regulated processes.
Security
Protect sensitive regulatory data, documents, submissions, and business information.
Audit Trail & Data Lineage
Maintain complete audit history and data lineage across regulatory actions and changes.
Dashboards, Analytics & Reporting
Provide visibility into regulatory status, workloads, submissions, risks, queries, and operational performance.
Workflow & Collaboration
Enable cross-functional task ownership, reviews, comments, approvals, and regulatory collaboration.
Validation
Support validation-driven operations with checks, controls, evidence, and documentation.
Access Control
Use role-based permissions to control access across modules, records, and workflows.
Inspection Readiness
Keep regulatory evidence, documents, decisions, workflows, and approvals organized for audits and inspections.
Compliance Alignment
Designed to support Life Sciences regulatory environments aligned with 21 CFR Part 11 and ICH M4 expectations.
RegX Intelligence Impact
RegX combines AI-powered automation with a strong regulatory platform foundation to help teams convert fragmented information into actionable insights, connected operations, and measurable business outcomes.
Actionable Insights
Turn fragmented regulatory information into decisions you can act on with confidence.
Connected Operations
Unify teams, systems, and data into one connected regulatory operating model.
Compliance-Ready Execution
Operate with governance, traceability, and inspection readiness built in by design.
Business Outcomes of Regulatory Automation with RegX
RegX combines AI-powered automation with a strong regulatory platform foundation to help teams convert fragmented information into actionable insights, connected operations, and measurable business outcomes.
Accelerated Regulatory Submissions
Reduce manual effort, improve submission readiness, and move packages forward faster.
Reuse Regulatory Knowledge & Content
Reuse approved content across products, markets, and submissions.
Improved Quality & Content Consistency
Standardize content, workflows, metadata, and reviews to reduce errors.
Reduced Compliance & Inspection Risk
Strengthen governance, audit trails, evidence management, and inspection readiness.
Faster Response to Health Authority Queries
Track queries, owners, responses, and timelines in one visual workspace.
Lower Operational Cost & Manual Effort
Automate repetitive regulatory tasks and reduce spreadsheet dependency.
Increased Regulatory Team Productivity
Allow teams to focus on strategy, review, quality, and faster decision-making.
Enhanced Visibility And Decision-Making
Use dashboards, analytics, traceability, and intelligence for better decisions.
Why Choose RegX for Regulatory Automation?
RegX helps Life Sciences organizations modernize regulatory operations without forcing a one-size-fits-all transformation. Whether deployed as a complete regulatory automation platform or as an AI automation layer on top of existing systems, RegX connects people, processes, data, documents, workflows, submissions, and decisions across the regulatory lifecycle.
Modular platform architecture
AI-powered automation
Connected regulatory data and content
Human review and governance
Compliance-focused workflows
End-to-end traceability
Faster submissions and better visibility
Flexible deployment model
Transform Regulatory Operations with AI-Powered Regulatory Automation
RegX helps regulatory teams operate with greater speed, control, consistency, and confidence. Move beyond fragmented tools and manual processes with a connected regulatory operating model powered by intelligence, automation, and compliance-ready workflows.