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
PMS and IDMP: Latest Guidance and What You Need to Do to Prepare
Our recent webinar with Remco Munnik, Director at IPERION, a Deloitte Business, Jack Kelleher, Head of Innovation at Generis, and Karolina Rogowska, Head of Marketing
PMS and IDMP: Latest Guidance and What you Need to Do to Prepare
Our recent webinar with Remco Munnik, Director at IPERION, a Deloitte Business, Jack Kelleher, Head of Innovation at Generis, and Karolina Rogowska, Head of Marketing
