eCTD Management

Simplifying Regulatory Submissions

Simplify regulatory submissions with an efficient eCTD management system that prepares, validates, and tracks documents for faster approval timelines.

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Here's how ACE® can
transform your eCTD management

Efficient eCTD Preparation

Regulatory submissions require precision and organization. ACE RIMS helps life sciences organizations prepare, validate, and submit electronic Common Technical Documents (eCTDs) effortlessly.

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Connected and automated workflows
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Structured Submission Workflows

Organize modules, sections, and documents in accordance with FDA, EMA, and ICH guidelines.

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Validation Tools

Ensure eCTDs are error-free and compliant before submission with automated validation checks.

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Submission Tracking

Monitor submission statuses and address feedback promptly through a centralized dashboard.

Compliance and Traceability

ACE RIMS ensures eCTD processes meet global regulatory requirements and maintain full traceability.

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Comprehensive Audit Trails

Record all changes, submissions, and approvals for regulatory inspections.

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Secure Document Handling

Protect sensitive data with robust access controls and encryption.

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Integrated Quality Processes

Link submission documents to CAPA, change control, and risk management workflows.

Streamlining the Submission Process

ACE RIMS reduces submission timelines, enabling faster regulatory approvals and market access.

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Document Reuse and Updates

Reuse and update existing documents efficiently for subsequent submissions.

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Analytics and Reporting

Gain insights into submission timelines and identify areas for process improvement.

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Collaboration Across Teams

Facilitate seamless collaboration between regulatory, quality, and R&D teams.

Ready to get started?

Maximize the value of your eCTD management with ACE®.