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 you | Standard | Enterprise |
|---|---|---|
| Regulatory Document Management | Available via subscription | |
Clinical Module
| Available via subscription | |
Quality Management Systems
| Available via subscription | |
| SOP & Training Module | Available via subscription | |
| Includes all future roadmap innovation | ||
| Standard Support | ||
Platinum Support
|
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.
