Regulatory Solutions

Seamless management of submission documentation, with minimal IT demands.

Category Life Sciences
Comparable to Veeva

The best in document management with regulatory expertise at the core

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

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.

Get up and running fast with fully-included onboarding

Your Unlimited subscription includes a four-phase onboarding package for every new solution. Depending on the complexity of the product, you can expect a successful deployment in 6-12 weeks.

PHASE 1
KICKOFF

PHASE 2
DEPLOYMENT

PHASE 3
TRAINING

PHASE 4
PILOT

See why Enterprise is right for you

StandardEnterprise
Regulatory Document Management
Available 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 Module
Available via subscription
Includes all future roadmap innovation
Standard Support
Platinum Support

Unlimited ways to unlock value

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