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Simplify regulatory submissions with an efficient eCTD management system that prepares, validates, and tracks documents for faster approval timelines.
Regulatory submissions require precision and organization. ACE RIMS helps life sciences organizations prepare, validate, and submit electronic Common Technical Documents (eCTDs) effortlessly.
Organize modules, sections, and documents in accordance with FDA, EMA, and ICH guidelines.
Ensure eCTDs are error-free and compliant before submission with automated validation checks.
Monitor submission statuses and address feedback promptly through a centralized dashboard.
ACE RIMS ensures eCTD processes meet global regulatory requirements and maintain full traceability.
Record all changes, submissions, and approvals for regulatory inspections.
Protect sensitive data with robust access controls and encryption.
Link submission documents to CAPA, change control, and risk management workflows.
ACE RIMS reduces submission timelines, enabling faster regulatory approvals and market access.
Reuse and update existing documents efficiently for subsequent submissions.
Gain insights into submission timelines and identify areas for process improvement.
Facilitate seamless collaboration between regulatory, quality, and R&D teams.
Maximize the value of your eCTD management with ACE®.