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Regulatory Intelligence & Strategy

RegX Regulatory Intelligence & Strategy helps life sciences teams monitor agency updates, extract regulatory obligations, assess impact across products, SOPs, templates, submission packages, and active filings, and convert intelligence into accountable actions with clear traceability.

 
 
 
 
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From Reactive Monitoring to Controlled Regulatory Intelligence

Regulatory teams track guidance updates, health authority notices, market expectations, quality changes, labeling updates, and submission requirements across many sources. Manual review often creates delays, missed obligations, spreadsheet trackers, unclear ownership, and late impact discovery. RegX brings monitoring, extraction, assessment, ownership, review, and reporting into one connected intelligence workflow.

 
 
 
 
Regulatory Automation

Manual Agency Monitoring

Reduce the effort of checking regulatory websites, tracking new guidance, and reviewing long documents manually.

Missed Regulatory Obligations

Use AI-assisted extraction to identify key requirements, obligations, topics, impacted regions, and regulatory domains.

Limited Portfolio Impact Visibility

Assess how each update affects products, SOPs, templates, submission packages, active filings, timelines, and commitments.

Disconnected Action Tracking

Convert findings into owned actions with responsible users, due dates, severity, source links, and closure status.

Weak Decision Traceability

Maintain source history, version comparison, audit trails, review status, and decision evidence.

Everything Regulatory Teams Need to Monitor, Assess, Assign, and Report Regulatory Impact

Regulatory Source Monitoring

Monitor configured global regulatory sources and capture new or updated guidance documents.

  • FDA Source Monitoring
  • EMA Source Monitoring
  • ICH Guidance Monitoring
  • PMDA Update Tracking
  • Health Canada Monitoring
  • Internal / Manual Source Support
  • Background Crawler Logs
  • Source Run History

Convert long regulatory documents into structured, reviewable requirements and obligations.

  • AI Document Summary
  • Key Topic Extraction
  • Requirement Identification
  • Must / Should / Recommended Obligation Capture
  • Impacted Region Identification
  • Regulatory Domain Classification
  • Risk Level Assessment

Assess how regulatory changes affect business-critical assets across the portfolio.

  • Product Impact Assessment
  • SOP Impact Assessment
  • Template Impact Assessment
  • Submission Package Impact Assessment
  • Active Submission Impact Assessment
  • Assess-All Workflow
  • Impact Severity Rating

Identify whether regulatory updates create filing, timeline, labeling, or commitment risks.

  • Submission Timeline Risk
  • Labeling Impact Review
  • Health Authority Commitment Conflict
  • Filing Strategy Review
  • Variation / Supplement Trigger Review
  • Active Submission Impact
  • Readiness Warning Support

Preserve source history, version changes, decision evidence, and regulatory knowledge for reuse.

  • Source-to-Requirement Traceability
  • Source Version History
  • SHA-256 Version Detection
  • Side-by-Side Change Comparison
  • Decision History
  • Review Status
  • Audit Trail

Provide executive-ready visibility into impact, risk, actions, source coverage, and compliance basis.

  • High-Impact Changes Report
  • Open Actions Report
  • New Updates Report
  • Crawl Activity Report
  • Product Impact Report
  • Submission Package Impact Report
  • Version History Report
  • Compliance Basis Report
Manual Import & Source Intake

Support controlled intake for blocked sources, manually supplied guidance, URLs, or uploaded documents.

  • Manual Document Import
  • URL-Based Source Intake
  • Text Import Support
  • Blocked Source Handling
  • Source Metadata Capture
  • Source Processing Status
  • Found / Processed / Skipped / Failed Logs

Map extracted requirements to responsible functions and submission sections.

  • CMC Tagging
  • Quality Tagging
  • Regulatory Operations Tagging
  • Labeling Tagging
  • Safety Tagging
  • eCTD Section Mapping
  • CTD Module Classification

Connect regulatory changes to affected CTD modules and CMC sections.

  • CTD Module 1 to Module 5 Impact
  • Module 3 / CMC Impact Mapping
  • 3.2.S Section Relevance
  • 3.2.P Section Relevance
  • Stability Impact Review
  • Specifications Impact Review
  • Manufacturing Impact Review
  • Analytical Methods Impact Review

Turn regulatory intelligence into controlled tasks that teams can track to closure.

  • Regulatory Action Creation
  • Owner Assignment
  • Due Date Tracking
  • Severity Assignment
  • Source Linkage
  • Status Tracking
  • Closure Evidence
  • Alerts & Notifications

Allow teams to monitor focused regulatory topics based on business priorities.

  • Topic-Based Monitoring
  • Stability Topic Tracking
  • Nitrosamine Topic Tracking
  • Biosimilar Topic Tracking
  • Market-Specific Alerts
  • Function-Specific Subscriptions

From Intake to Controlled Monitoring

Detect

Monitor configured agency sources and capture new or changed regulatory documents with source history.

Extract

Use AI to summarize guidance, identify obligations, classify topics, and tag impacted functions.

Assess

Evaluate impact across products, SOPs, templates, submission packages, active filings, and CTD modules.

Assign

Create owned actions with responsible users, due dates, severity, source links, and review status.

Review

Allow regulatory experts, CMC teams, submission teams, quality, labeling, and SMEs to confirm applicability.

Report

Provide leadership with impact summaries, open actions, version history, risk status, and compliance basis.

Connect Intelligence to the Teams That Execute Regulatory Change

RegX supports execution workflows by identifying regulatory impact and connecting CMC, Submission Package, Quality, Labeling, and Regulatory Operations teams to the right actions.

 

CMC Impact Support

Show regulatory impact while teams review or update Module 3 content.

  •  
  • Module 3 Impact Alerts
  • Stability Requirement Review
  • Specification Change Impact
  • Manufacturing Update Impact
  • Analytical Method Impact
  • SME Applicability Decision
  • CMC Review Checklist

Submission Package Readiness Support

Convert regulatory impact into submission-level visibility and action tracking.

 

 

  • eCTD Artifact Impact Badges
  • Readiness Warnings
  • Sequence Planning Support
  • Amendment / Supplement / Variation Impact
  • Lifecycle-Aware Audit Trail
  • Submission Risk Visibility

Smarter Regulatory Decisions with Stronger Ownership and Traceability

Faster Regulatory Triage

Reduce time spent reviewing guidance manually and move faster from update to impact assessment.

Better Obligation Visibility

Identify regulatory requirements, impacted regions, topics, functions, and eCTD sections in a structured format.

Stronger Portfolio Control

Understand how each change affects products, SOPs, templates, submission packages, and active filings.

Clear Action Ownership

Assign high-impact findings to responsible teams with due dates, severity, source links, and closure status.

Improved CMC & Submission Package Readiness

Help CMC and submission teams see regulatory impact before content updates or submission planning.

Reduced Submission Risk

Identify timeline, labeling, health authority commitment, filing strategy, and variation risks earlier.

Better Knowledge Reuse

Preserve source versions, requirement history, decisions, and prior assessments for future reference.

Executive-Level Visibility

Give leadership clear reports on high-impact changes, open actions, product impact, submission package impact, and compliance basis.

Built for Regulatory Intelligence, Regulatory Affairs, CMC, Submission, Quality, and Leadership Teams

Regulatory Intelligence Teams

Monitor sources, review updates, extract obligations, classify topics, and maintain intelligence records.

Regulatory Affairs Teams

Assess product impact, submission relevance, market expectations, and required regulatory actions.

CMC Teams

Review quality, stability, manufacturing, specifications, analytical methods, and Module 3 impact.

Submission & Publishing Teams

Track affected submission artifacts, CTD sections, readiness warnings, and sequence planning actions.

Quality Teams

Review SOP impact, process changes, compliance basis, and controlled action closure.

Labeling Teams

Assess labeling impact, market requirements, health authority updates, and related action items.

Portfolio Leadership

Review product-level exposure, high-risk updates, market implications, and regulatory priorities.

Executive Leadership

Monitor regulatory risk, open actions, portfolio impact, readiness status, and strategic decision progress.

Turn Regulatory Intelligence into Owned Portfolio Action

Monitor agency updates, extract obligations, assess impact across products and active filings, connect CMC and submission teams, assign accountable actions, and give leadership real-time regulatory visibility with RegX.

 
 
 
 
 
 
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