Submission Planning & Tracking
Everything is easier with a repeatable process. CARA provides the tools to create consistent global submission processes, as well as the flexibility to tackle ad-hoc submissions and agency interactions
While the triggers for a new submission or regulatory initiative may come from a centralised plan or a health authority request, RIM on the CARA Life Sciences Platform provides a consistent and repeatable process for managing them.
Automate your processes
Instead of basing workflows on simple document review and approvals, CARA enables and captures your full business process including decision points, correspondence and meeting minutes. Your process is also guided, with the system providing next steps intelligently based on your type of submission and context.
See the best of regulatory content management with Submission documents on the CARA Life Sciences Platform
Act and react based on global knowledge
Throughout your submission processes, CARA provides powerful ‘Where Used’ functionality to instantly identify where any data, content, events, activities and label components might be used. There is also a ’Current Approved’ view in order to understand what submissions or variants may have gained approval globally. This, along with the out-of-the-box reporting builds a picture over successive submissions to identify corporate and process bottlenecks and improve the timelines and performance from one submission to the next.