© Copyright 2002-2026, Generis Enterprise Technology Limited, all rights reserved
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.
Every action, every output, every change, captured automatically.
One data model across all regulatory processes means no conflicting versions, no manual reconciliation, no integrity gaps created by moving data between systems.
You're always ready for one. Controlled lifecycles, version management, and access controls are built into every workflow.
Customer story
"Connectivity and harmonisation were both key driving factors behind our decision to choose the CARA Life Sciences Platform to consolidate our processes"
Ricardo Kressin, Global Head of IT, Cheplapharm

Running your submission dossiers, labels, and HA correspondence, extended across your entire organisation. A document isn’t useful on its own; it needs the metadata that classifies it and the process that acts on it. CARA keeps all three on one record, so a label, its version history, and the change control it’s linked to are never more than one click apart.
Saved per submission

Common Questions
That’s exactly what CARA is built to change. Instead of maintaining disconnected systems and the integrations between them, CARA becomes your single governed platform for planning, documents, RIM, and labelling connected, not stitched together. Information moves seamlessly through the regulatory process while retaining its full history, context, and metadata, ensuring a complete governed record from creation through submission.
A structured process, not a black box. It starts with workshops to capture exactly what you need and how it will work in CARA, then moves through configuration — CARA has over 40,000 configuration options, handled by our own Client Delivery team rather than external consultants — separate design, sandbox, test, and production environments, and a dedicated validation phase run by a team with decades of experience in regulated industries. Training and 24/7 support carry on from there. See our full design & implementation process →
Each one is a complete, dedicated capability — RIM manages registrations and product data down to IDMP/SPOR level, Labelling runs the full Core Data Sheet-to-market lifecycle, and Submission Management covers planning through publishing and archive. They share one data model because that’s what removes the reconciliation work between them — not because any one of them is a shortened version of a bigger tool.
Platform Connectivity

Merck KGaA
Systems consolidated
Users on one platform
© Copyright 2002-2026, Generis Enterprise Technology Limited, all rights reserved