Safety Submissions & Distributions
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Safety Submissions & Distributions

Managing PSURs, DSURs, EdTs, and other submissions or distributions

Safety Submissions & Distributions

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The CARA Life Sciences Platform supports the ongoing task of distributing safety information on a periodic basis to affiliates, distributors, and other third parties responsible for safety reporting to NCAs and tracking interactions. 

Benefits

Distribution

Trigger workflows for distribution of safety data and documents to affiliates and distributors - manually, or automated from external partners

Documentation

Manage the creation, review, and approval internally of PSURs, SABR Signals, Educational Materials, and other aggregate reports

Portal Access

Distributors, affiliates, and other third parties can access CARA via a simple portal to acknowledge, submit and confirm required actions with Agencies

Tracking

Central regulatory affairs has a real-time view per-product and per-country of the status of safety document receipt, submission, and registration

RIM Integration

Integrate all the data and documents seamlessly with RIM and Regulatory Documents on the CARA Life Sciences Platform

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Manufacturing information is itself linked to our RIM module

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Example Safety Distribution Workflow

Send for Processing

Acknowledge Receipt

Country HA Submission

Review & Process Comments

Confirm HA Submission

Distribute to HCPs

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