Regulatory Automation
AI-powered regulatory automation that connects data, content, submissions, workflows, intelligence, compliance, and reporting across the product lifecycle.
Regulatory Operations Are Becoming More Complex
Regulatory teams are managing increasing volumes of product information, submissions, Health Authority interactions, labeling changes, commitments, and compliance requirements across global markets. Regulatory automation helps bring greater structure, consistency, visibility, and control to these increasingly complex activities.
Current Regulatory Challenges
Fragmented Regulatory Data
Critical regulatory information is distributed across documents, spreadsheets, repositories, and disconnected systems.
Manual Submission Tracking
Manual trackers and email-based coordination can limit submission of readiness, milestone visibility, and accountability.
Disconnected Content & Workflows
Reviews, approvals, content reuse, and regulatory activities often span multiple teams, systems, and geographies.
Limited Visibility Across the Lifecycle
Regulatory teams and leadership may lack a consolidated view of product status, submissions, commitments, risks, and upcoming activities.
Connected Regulatory Automation
Bring together regulatory information, content, submissions, workflows, intelligence, compliance activities, correspondence, validation, and reporting within a connected regulatory operating model.
Modular
Adopt regulatory automation capabilities based on immediate business priorities and expand as operational needs evolve.
Connected
Connect regulatory data, documents, workflows, submissions, decisions, correspondence, and compliance activities across teams and systems.
Automated
Apply AI and workflow automation to repetitive regulatory activities while maintaining appropriate human review and oversight.
Flexible Regulatory Automation for Your Operating Model
Integrated Regulatory Operating Model
Connect regulatory data, content, workflows, submissions, intelligence, and compliance activities across the regulatory lifecycle.
Best suited for
Organizations modernizing fragmented regulatory processes
Teams establishing a regulatory single source of truth
Companies standardizing global regulatory workflows
Businesses seeking greater lifecycle visibility
Automation Across Existing Regulatory Systems
Introduce intelligent automation across existing RIM, document management, submission, quality, correspondence, and enterprise systems without requiring immediate replacement of established platforms.
Best suited for
Organizations retaining existing regulatory systems
Teams introducing AI into current processes
Businesses reducing repetitive manual activities
Companies improving interoperability across disconnected systems
Regulatory Automation Capabilities
A connected set of capabilities supporting regulatory activities across the product lifecycle.
RegX™
Unify regulatory documents, authoring, submissions, Health Authority interactions, intelligence, and changes to strengthen submission readiness.
CMC Automation
Organize drug substance and drug product information, supporting documents, and CMC content to help teams prepare Module 3 submissions.
AI-Powered Life Sciences Document Generation
RegX™ uses governed AI to generate accurate, compliant life sciences documents faster, with trusted sources, traceability, and expert human oversight.
Labeling & AI Compliance Automation
Manage labeling content and changes through controlled review workflows, with visibility into the information supporting each update.
Ad Promo Review & Compliance
Coordinate promotional material review, supporting evidence, and approval activities in a controlled workflow.
Connect safety information and pharmacovigilance activities with the regulatory processes that depend on them.
Organize documentation and review activities that support clinical research oversight and regulatory compliance.
Support controlled substance compliance by incorporating DEA validation into operational workflows.
AI-Powered Automation Across Regulatory Operations
Intelligent automation can support information-intensive and repetitive regulatory activities while preserving human accountability.
AI Agents
Support regulatory tasks, workflow execution, follow-up activities, and operational coordination.
Regulatory Assistant Bots
Search, understand, summarize, and retrieve relevant regulatory information faster.
Intelligent Data Extraction & Classification
Extract, classify, and structure information from regulatory documents and data sources.
Content Generation & Authoring
Assist regulatory content preparation using approved sources, templates, and reusable content.
Impact Analysis & Recommendations
Identify potentially affected products, documents, applications, markets, and regulatory activities when requirements change.
AI Search
Search across regulatory documents, product information, submissions, correspondence, and records.
End-to-End Traceability
Connect source information, regulatory activities, workflows, decisions, approvals, and audit history.
Human Review & Attestation
Maintain regulatory review, approval, and accountability for controlled activities.
Governance & Compliance Controls
Apply permissions, audit trails, workflow controls, and compliance oversight.
Built on a Strong Regulatory Foundation
Enterprise-grade controls, governance, traceability, and operational visibility for regulated Life Sciences environments.
Structured Content Management
Manage regulatory content in controlled, reusable, and structured formats.
Security
Protect sensitive regulatory information, documents, submissions, and business data.
Dashboards, Analytics & Reporting
Provide visibility into regulatory activities, submissions, workloads, risks, commitments, and operational performance.
Validation
Support validation-driven operations through defined checks, evidence, controls, and documented outcomes.
Inspection Readiness
Keep regulatory evidence, decisions, documents, approvals, and workflow histories organized and accessible.
eSignatures & Approvals
Support controlled approvals and electronic signatures for regulated processes.
Audit Trail & Data Lineage
Maintain traceability of regulatory changes, decisions, workflow activities, and source information.
Workflow & Collaboration
Coordinate task ownership, reviews, comments, approvals, handoffs, and cross-functional regulatory activities.
Role-Based Access Control
Control access to regulatory records, documents, workflows, and activities based on defined responsibilities.
Compliance Alignment
Support controlled regulatory processes designed around applicable Life Sciences regulatory and quality requirements.
Regulatory Intelligence Impact
Combine regulatory information, automation, analytics, and human expertise to transform fragmented regulatory activities into connected and actionable operations.
Actionable Insights
Turn regulatory information into meaningful insights that support timely assessment and decision-making.
Connected Operations
Connect regulatory teams, processes, systems, data, content, and submissions across the lifecycle.
Compliance-Ready Execution
Maintain governance, traceability, controls, and supporting evidence throughout regulatory activities.
Business Outcomes of Regulatory Automation
Accelerated Regulatory Submissions
Reduce repetitive preparation activities, improve readiness, and support more efficient submission execution.
Greater Regulatory Knowledge & Content Reuse
Reuse approved information and content across products, markets, applications, and submissions.
Improved Quality & Content Consistency
Standardize regulatory data, content, metadata, workflows, and reviews to reduce inconsistencies.
Reduced Compliance & Inspection Risk
Strengthen governance, auditability, evidence management, traceability, and inspection readiness.
Faster Response to Health Authority Queries
Improve visibility into questions, owners, evidence, response preparation, due dates, and commitments.
Reduced Manual Effort
Automate repetitive tracking, extraction, classification, reconciliation, and workflow activities.
Increased Regulatory Team Productivity
Enable regulatory professionals to focus more on strategy, interpretation, review, quality, and decision-making.
Enhanced Visibility & Decision-Making
Use dashboards, analytics, regulatory intelligence, and lifecycle traceability to support informed decisions.
Why Regulatory Automation?
Regulatory automation enables Life Sciences organizations to modernize regulatory operations without relying on fragmented manual processes. It connects people, processes, information, documents, workflows, submissions, and regulatory decisions while maintaining appropriate governance and human oversight.
Modular Adoption
AI-Assisted Automation
Connected Regulatory Data & Content
Human Review & Governance
Compliance-Focused Workflows
End-to-End Traceability
Greater Submission Readiness
Flexible Integration Approach
Transform Regulatory Operations with Intelligent Automation
Move beyond fragmented systems, repetitive manual activities, and disconnected regulatory processes. Build a more connected regulatory operating model with structured information, intelligent automation, controlled workflows, and compliance-focused oversight.