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Labeling & AI Compliance Automation

RegX helps life sciences, consumer health, OTC, dietary supplement, and regulated product teams create product records, capture formula details, generate label content, analyze compliance risks, route reviews to Regulatory and QA teams, and release audit-ready label packages.

 
 
 
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From Manual Label Creation to AI-Powered Compliance and Controlled Release

Labeling teams often manage product details, formula inputs, ingredient lists, claims, warnings, compliance checks, translations, review comments, regulatory source updates, and approval records across disconnected tools.

RegX brings product setup, formula intake, AI compliance analysis, regulatory rule management, ingredient intelligence, translation, label generation, Regulatory review, QA approval, and release tracking into one structured workflow.

 
 
 
 
Regulatory Automation

Manual Label Preparation

Reduce manual effort by capturing product, formula, market, ingredient, dosage, claim, warning, and labeling details once and using them to support label creation.

Disconnected Formula Inputs

Bring R&D formula data, ingredients, claims, dosage form, product type, target market, and supporting files into one controlled workspace.

Static Compliance Checks

Move beyond basic checklists with AI-powered compliance analysis and configurable rules that evaluate label content against product, market, and ingredient requirements.

Ingredient Risk Visibility

Use ingredient intelligence to identify market-specific regulatory limits, warnings, restrictions, and compliance considerations across the US, Canada, EU, and Prop 65.

Translation and Version Gaps

Manage multi-language label translations tied to each label version so approved content, translated content, and release history stay connected.

Limited Release Traceability

Maintain full history of product records, formula inputs, regulatory sources, compliance analysis, review notifications, QA approvals, translations, and released label packages.

Everything Teams Need to Create, Analyze, Review, Approve, Translate, and Release Compliant Labels

Product Master Setup

Create and maintain product records with the key details needed for label generation, compliance review, and release.

  • Product Record Creation
  • Product Category Management
  • Brand and Product Details
  • Target Market Selection
  • Dosage Form Capture
  • Product Metadata Management

Maintain an ingredient library with market-specific regulatory limits, restrictions, warnings, and compliance references.

  • Ingredient Library
  • Ingredient-to-Market Mapping
  • US Regulatory Limit Support
  • Canada Regulatory Limit Support
  • EU Regulatory Limit Support
  • Prop 65 Warning Support
  • Ingredient Restriction Tracking
  • Ingredient Compliance References

Create and manage configurable compliance rules for products, ingredients, markets, claims, warnings, and label requirements.

  • Configurable Rule Creation
  • Market-Specific Rule Setup
  • Ingredient Limit Rules
  • Claim and Warning Rules
  • Product Category Rules
  • Rule Version Control
  • Rule Approval Workflow
  • Rule-to-Source Traceability

Generate label drafts using product details, formula inputs, ingredient intelligence, configured rules, warnings, claims, and approved templates.

  • Template-Based Label Generation
  • Ingredient List Generation
  • Facts Panel Support
  • Claims and Warning Language
  • Product-Specific Label Content
  • Review-Ready Draft Output

Translate label content into multiple languages while keeping translations tied to the correct label version.

  • Multi-Language Label Translation
  • Version-Based Translation Tracking
  • Source Label to Translation Linkage
  • Translation Review Support
  • Translated Label History
  • Approved Translation Records

Track label updates, formula changes, rule updates, source changes, translations, review versions, and release history across the lifecycle.

  • Label Version History
  • Formula Change Tracking
  • Rule Version Tracking
  • Regulatory Source Version Tracking
  • Translation Version Tracking
  • Change Reason Capture
  • Previous Label Comparison
  • Lifecycle Status Tracking

Give teams visibility into label status, open compliance findings, regulatory reviews, QA approvals, translations, source updates, and release readiness.

  • Label Workflow Dashboard
  • Open Compliance Findings View
  • Regulatory Review Status
  • QA Approval Status
  • Translation Status View
  • Source Update Tracking
  • Release Readiness View
  • Leadership Reporting
Formula Intake

Capture R&D formula details from structured forms or uploaded files to support label generation and compliance analysis.

  • Formula Data Intake
  • Ingredient List Capture
  • Excel / Word / PDF Upload Support
  • Formula Parsing Support
  • Product-to-Formula Mapping
  • Intake Status Tracking

Ingest and manage regulatory source data so compliance checks are backed by controlled source records instead of static rules alone.

  • FDA Source Data Ingestion
  • OEHHA Source Data Ingestion
  • Health Canada Source Data Ingestion
  • Source Review Workflow
  • Regulatory Source Approval
  • Source Version History
  • Source-to-Rule Traceability
  • Approved Source Repository

Use LLM-powered compliance analysis to review label content, formula details, ingredients, claims, warnings, and market requirements.

  • LLM-Powered Label Compliance Analysis
  • Ingredient Compliance Review
  • Claim and Warning Analysis
  • Market Requirement Review
  • Compliance Risk Identification
  • AI Findings Summary
  • Suggested Issue Classification
  • Evidence-Linked Compliance Results

Route label content and compliance results to Regulatory users through role-based review notifications, comments, and status tracking.

  • Regulatory Review
  • Role-Based Review Notifications
  • Comment Capture
  • Review Status Tracking
  • Compliance Finding Review
  • Issue Resolution Tracking
  • Approval History

Allow QA teams to approve compliant label packages and prepare final outputs for downstream use.

  • QA Review
  • QA Approval Tracking
  • Final Label Package Release
  • Release Status Management
  • Approved Output Export
  • Full Audit Trail

Maintain complete visibility across product setup, formula intake, source data, rules, AI compliance findings, reviews, approvals, translations, and release evidence.

  • Audit Trails
  • Review History
  • Approval Records
  • Compliance Evidence
  • Decision Tracking
  • Source-to-Rule Traceability
  • AI Finding Traceability
  • Inspection-Ready Records

End-to-End Automation — from Product and Formula Intake to AI Compliance, Review, Translation, Approval, and Release

Create Product

Define product master record, category, brand, target market, dosage form, product metadata, and labeling requirements.

Formula Intake

Upload or enter R&D formula details, ingredient information, claims, warnings, supporting files, and product-specific source data.

Generate Label

Create label drafts using approved templates, product data, formula inputs, ingredient rules, claims, warnings, and market-specific requirements.

Analyze Compliance

Use ingredient data, regulatory sources, rules, and AI analysis to identify label risks, limits, warnings, and required checks.

Regulatory Review

Notify Regulatory users by role, capture comments, review AI compliance findings, resolve issues, and confirm label readiness before QA.

Translate & Version

Generate and manage multi-language translations tied to the correct label version, review translation status, and maintain translated label history.

QA Approval & Release

Approve the final label package, export approved outputs, preserve full audit trails, and maintain release-ready label records.

Faster Label Creation with AI-Powered Compliance, Stronger Rule Control, and Audit-Ready Release

Faster Label Turnaround

Move from product setup and formula intake to review-ready label drafts faster with structured data reuse and template-driven generation.

Reduced Manual Effort

Reduce duplicate data entry, manual copying, disconnected compliance checks, manual translation tracking, and spreadsheet-based review management.

Stronger AI Compliance Review

Use LLM-powered compliance analysis to identify label risks, ingredient issues, claim concerns, warning gaps, and market-specific compliance findings.

Better Rule Control

Use configurable rule building to manage product, ingredient, claim, warning, market, and regulatory requirements without relying only on static checklists.

Stronger Ingredient Oversight

Use ingredient intelligence to review market-specific limits, restrictions, warnings, and regulatory considerations across the US, Canada, EU, and Prop 65.

Better Source-Backed Compliance

Ingest FDA, OEHHA, and Health Canada regulatory data with approval workflows so compliance checks are supported by controlled source records.

Improved Translation Traceability

Keep multi-language translations connected to the correct label version, review status, approval history, and release record.

Better Release Readiness

Give teams clear visibility into unresolved compliance findings, Regulatory review status, translation status, QA approval status, and final package readiness.

Controlled Version History

Maintain label versions, formula changes, rule changes, source updates, translation history, reviewer decisions, approval records, and lifecycle status.

Audit-Ready Evidence

Preserve regulatory sources, rule decisions, AI compliance findings, review history, QA approvals, translation records, release evidence, and inspection-ready traceability.

Built for Labeling, R&D, Regulatory, Compliance, QA, Translation, and Product Teams

Labeling Teams

Create label drafts, manage label updates, track review status, maintain label versions, and prepare release-ready outputs.

R&D / Formula Teams

Provide formula details, ingredient information, product data, and supporting inputs for label generation and compliance analysis.

Regulatory Affairs Teams

Review regulatory alignment, market requirements, AI compliance findings, rule outputs, source references, and label readiness.

Compliance Teams

Configure rules, review compliance findings, manage exceptions, monitor source-backed requirements, and support issue resolution.

QA Teams

Approve compliant label packages, confirm release readiness, review audit evidence, and maintain quality records.

Translation Teams

Manage multi-language label translations, review translated label versions, and maintain translation history.

Product Managers

Track product labeling status, formula updates, market readiness, version updates, and release progress.

System Administrators

Manage users, roles, review notifications, rule access, source approvals, dashboards, and platform configuration.

Executive Leadership

Monitor label workflow performance, compliance risk, translation status, source update impact, QA readiness, and release progress.

Strengthen Labeling & AI Compliance Automation with RegX

Create products, capture formula inputs, manage ingredient intelligence, ingest regulatory sources, build configurable rules, analyze labels with AI compliance, translate label versions, coordinate Regulatory review, complete QA approval, and maintain audit-ready release evidence in one connected platform.

 
 
 
 
 
 
 
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