Transforming Regulatory Affairs
Simplify, standardise, and automate your regulatory processes with a data-driven, cloud platform for Regulatory Affairs. The CARA Life Sciences Platform allows for a seamless, end-to-end regulatory process from submission planning & tracking, to labelling and promotional material management, to submission archival.
A comprehensive guide to Regulatory Information Management on the CARA Life Sciences Platform
Regulatory Information Management (RIM)
- Applications & Registrations
- Submission Planning & Tracking
- Events, Activities & Commitments
- Product Management including IDMP, SPOR, and xEVMPD
- Health Authority Correspondence
Submission Documents
Manage authoring, review and approval of submission documents and integrated publishing.
Labelling
Manage the entire lifecycle of labels from CCDS through labels and their translations, ongoing simultaneous variations, and artwork including Change Requests and print shop sharing via the CARA Hub.
Submission Archive
Submission Archive provides a way to archive published submissions, giving you both a reference point or a starting point to succeed in future submissions.
Promotional Materials
With full support for image and video formats, you can collaboratively review materials, share with colleagues and publish all within CARA. With our preview panel, and the seamlessly integrated annotation and review tools, storing, processing, and tracking content in one system is simple.
Medical Device Submissions
Accelerate device development & shorten implementation time to support device submissions and post-approval maintenance.
The CARA Life Sciences Platform provides an accurate and secure repository for maintaining DHF, DMR, & DHR, serving as a central hub…
SPOR Subscription
Our SPOR Subscription module is a module that allows companies to map their data to SPOR master data, including notifications and updates. Designed for companies of any size, and directly providing the master data vocabularies to the rest of the CARA Life Sciences platform or other third party systems in-house.
Product Information Mangement
Data is the core driver of consistent content, planning, tracking, efficiency, and automation. CARA acts as your enterprise Master Data Management system, including pulling values from industry (IDMP, MedDRA etc) and creating IDMP / xEVMPD submissions.
