10 reviewers of Rimsys have provided feedback on this feature.
Tracks submissions plans for products to report against milestones and progress. Streamlines the entire dossier lifecycle and tracks the status of all submissions.
Tech Files
This feature was mentioned in 10 Rimsys reviews.
Supports the creation of technical files and essential principles checklists.
Submission Planning
10 reviewers of Rimsys have provided feedback on this feature.
Provides templates and tools to create all planned regulatory content for a product.
Archiving
As reported in 10 Rimsys reviews.
Stores all previously submitted documents for use in audits or future submissions.
Product Management (5)
Audit Trails
As reported in 11 Rimsys reviews.
Enables traceability into the entire pre- and post-market lifecycle to monitor milestones, time to completion, and updates and approvals.
Label Management
10 reviewers of Rimsys have provided feedback on this feature.
Prepares and submits labels and UDI submissions for products, validated accordingly to regional regulatory requirements.
Live Dashboards
As reported in 10 Rimsys reviews.
Maintains up-to-date dashboards for overseeing every task, deadline, project status, and workflow.
Collaborative Authoring
10 reviewers of Rimsys have provided feedback on this feature.
Allows multiple users to collaborate on documents and flag errors or updates.
Product Information
This feature was mentioned in 12 Rimsys reviews.
Centralizes and tracks detailed product information, such as registration status and selling status for each location and market.
Regulatory Affairs (4)
Automated Notifications
Based on 11 Rimsys reviews.
Tracks key deadlines for submissions, renewals, and audits, and streamlines the document retrieval process for each activity.
Post-Market Surveillance
Streamlines post-market product data collection and analysis for safety, sentiment, and future product improvements.
Communication Tools
Fields internal team and external agency messages or tickets related to regulatory concerns, and inboxes all correspondences.
Regulatory Intelligence
This feature was mentioned in 10 Rimsys reviews.
Connects to regulatory databases and market sources to monitor upcoming changes that may impact product selling status.
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