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