CARA is a regulatory management software that allows companies to plan, track, and register products. It enables users to create products, regulatory applications for multiple markets, events associated with each application, and submission packages. CARA also helps users manage correspondence, commitments, and close events once approved, while registering products and tracing them back to source documents.

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www.generiscorp.com
CARA for RIM -
Planning,Tracking
and Registration

2. Process flow in
CARA
Create product
Create Regulatory
Application(s)
Create Regulatory
Event(s)
Create
Submission(s)
Correspondence /
Commitments
Close EventsRegister
Latest Approved
Versions
Create product objects,
and manage them in
CARA as the Master
Data Management
System
Create individual
applications which can
be for multiple products
/ markets
From an application,
automatically generate
individual regulatory
events and assign them
Create a submission
package of documents
automatically based on
the submission plans
Find the most elusive
thing of all: what is the
latest approved
document for a
particular market?
Register products on each
market and track the
registration while tracing
through to source
documents
Close events and
associated
documentation once
they are health authority
approved
Receive and respond to
regulatory
correspondence and
manage associated
commitments