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Regulatory Solutions

Used by hundreds of customers across thousands of trials, Aurea Compliance Manager (ACM) Regulatory Solutions let you manage submission documentation, while minimizing the demands on business and IT users.

The best in document management with regulatory expertise at the core

ACM Regulatory Document Management (RDM) delivers Life Sciences industry expertise alongside best-of-breed document management. Designed to help you avoid the high cost of ownership of custom solutions, RDM starts with our industry proven configuration, while also providing simple tools to tailor every process to your business.

Features & Benefits

Centralized Regulatory Document Management

Manage and centralize regulatory and submission documents throughout their lifecycle. ACM simplifies the management of submission documentation, and integrates seamlessly with publishing tools.

Automation of submission-ready documents

Guide users through the production of submission-ready documents by enforcing CTD standards, applying required templates, and producing PDF renditions that meet complex agency requirements.

Built through industry thought leadership

Simplify adherence to industry best-practice with ACM’s preconfigured EDM Reference Model. This taxonomy/metadata reference model – developed by Life Sciences industry experts – maps extensively to regulatory requirements.

Tap into the power of Enterprise

With Aurea Compliance Manager Enterprise, you’ll have access to all Aurea Compliance Manager solutions with one simple subscription, including Clinical, Quality Management, and Regulatory capabilities.

See why Enterprise is right for youStandardEnterprise
Regulatory Document ManagementAvailable via subscription
Clinical Module
  • Clinical Documents Module (eTMF)
  • Clinical Portal Module (TRX)
Available via subscription
Quality Management Systems
  • Change Control Solution
  • Audit Management Solution
  • CAPA Solution
  • Deviations/Non-Conformance Solution
  • Complaints Solution
Available via subscription
SOP & Training ModuleAvailable via subscription
Includes all future roadmap innovation
Standard Support
Platinum Support
  • Utilization Audit
  • Yearly Managed Upgrades
  • Performance Tuning
  • Environmental Performance Tuning
  • Annual Health Check
  • Annual Architecture Audit
  • Annual Production Readiness Assurance
  • 24x7 Support
Aurea Unlimited

Get Regulatory Solutions.
Grow with the entire library.

Like all of our products, Regulatory Solutions is part of our growing software library. Your initial subscription gives you access to each and every other product in our portfolio. Start with Regulatory Solutions to open up unlimited possibility.

Discover UnlimitedContact us

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