lsafety

Safety Submissions & Distributions

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

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

Save Time With Easy Distribution

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

Full Documentation Management

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

Simplified Access

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

Complete Oversight of Safety Documents

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 – Seamlessly Connected

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

Save Time With Easy Distribution

Full Documentation Management

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

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

Simplified Access

Complete Oversight of Safety Documents

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

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 – Seamlessly Connected

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

Latest Resources

Case Study

Pfizer Case Study

Learn how CARA enabled a global Pharmaceutical company to move away from legacy systems and improve user experience.

Read More »

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