Reg

Every regulatory process. One platform. Zero silos.

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.

60% of top 20 global pharma
Bayer
UCB
BioNTech
Merck KGaA
AbbVie
Theramex
Pfizer
Biogen
Faster regulatory submissions
0 %
Labelling efficiency improvement
0 %
Of top 20 global pharma run on CARA
0 %
Years in regulated life sciences
0 +

Everything your Regulatory function needs. On one platform.

One Regulatory deployment. Connected capabilities not separate systems to license and stitch together.

Built for regulated environments.

Designed to meet 21 CFR Part 11 · EU Annex 11 · GxP · eCTD · IDMP · GDPR

Audit trails that already exist

Every action, every output, every change, captured automatically.

Data integrity by design

One data model across all regulatory processes means no conflicting versions, no manual reconciliation, no integrity gaps created by moving data between systems.

Inspection readiness as default

You're always ready for one. Controlled lifecycles, version management, and access controls are built into every workflow.

Customer story

Cheplapharm

"Connectivity and harmonisation were both key driving factors behind our decision to choose the CARA Life Sciences Platform to consolidate our processes"

  • Multiple disconnected systems replaced with a single governed platform
  • Data entered once, reused across all regulatory functions
  • Full traceability and impact analysis across the regulatory lifecycle
  • Unify RIM, IDMP, Quality and more
  • Streamlined Regulatory intelligence 

One Platform for Content, Data, and Process Management.

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.

AI underneath it all

CARA AI generates from your live, governed regulatory content with a complete audit trail, all within your current governance framework, without extra tools, exports, or revalidation.

£4k–£60k

Saved per submission

Common Questions

Before you explore further

What happens to the systems we already run?

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.

What does implementation actually look like?

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 →

Is this actually deep in RIM, labelling, and submissions — or just broad?

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

Regulatory data that doesn't stop at Regulatory.

When your regulatory records live on the same platform as Safety, Quality, and Clinical, everything accelerates. PSUR drafting draws from live regulatory data. Labelling changes flow into Quality workflows automatically. Submissions reference safety cases without a single manual cross-check. One platform. One data model. No reconciliation.
  • Already connected
  • Same platform 

Merck KGaA

12 siloed systems. One platform. Every function connected.

Merck KGaA replaced disconnected systems across Regulatory, Quality, Safety, and Clinical with a single CARA deployment, maintaining 21 CFR Part 11 compliance throughout. No integration overhead. No reconciliation between functions.

12→1

Systems consolidated

85K

Users on one platform

Ready to see it in action?

Talk to our team and see how CARA can transform your operations.