Schedule a demo
Reg

End-to-end Submission Management, tracked as one process. Not stitched across tools.

One governed record spans planning, authoring, publishing, and archive, nothing re-entered, reconciled, or tracked twice.

Schedule a demo
Trusted by leading regulatory teams across life sciences
Bayer
UCB
Immunic

Standalone by design. Connected by choice

Planning, authoring, publishing and archive need nothing else. Where RIM or Labelling is also in use, archived submissions link both ways to registrations and labels go straight into submission documents.

Submission Planning & tracking

One process, however the submission starts.

No two submissions progress the same way. Some start from a centralised plan, others from a health authority request, and some are ad hoc. Each still needs one consistent global process.

  • Decision trail Capture decision points, correspondence and meeting minutes alongside approvals.
  • Guided next steps Next steps guided by submission type and context.
  • Cross-submission reporting Out-of-the-box reporting to spot bottlenecks across successive submissions.

AI

Before your team starts assembling, CARA AI assesses submission readiness (what’s complete, what’s missing) in 1–3 minutes.

Submission Documents

Authoring, metadata, and process on one record.

A global dossier shouldn’t mean rewriting it for each region. In CARA, regional dossiers derive from the global one and reuse its content, with every document classified to the DIA Reference Model.

  • Structures from the plan Built automatically from submission planning, then content is assigned.
  • Authoring and approval Multiple users editing at once, with eSignature review.
  • Publishing tools Drag and drop structures or documents into your existing tool.
  • Partner sharing Secure, time-limited access for partners and affiliates.
Submission docs datasheet

Submission Archive

Archived, and still connected.

A past submission is only useful if your team can find it, understand it and build on it. The archive completes the circle from authoring to submission, as a reference point or a starting point for the next one.

  • Publish back From tools like EXTEDO, Lorenz or Parexel, or ingest from a watched folder.
  • Linked records Source documents and RIM data, for reporting and traceability.
  • Viewing Built-in preview, plus EXTEDO, Lorenz, Qdossier and other viewers.
  • Current Approved View See your products across markets.
Submission archive datasheet

For Device Companies

Device submissions, on a process built for devices.

Device regulators expect a stringent approval process and rigorous quality standards, before and after distribution, with every record securely maintained. CARA’s device capabilities are designed from the ground up for device companies, on a pre-configured package based on the DIA reference model for medical devices.

  • One repository DHF, DMR and DHR, with structures and templates that populate automatically.
  • Traceability Versioned requirements, with test cases related automatically and a matrix generated with the versions tested.
  • Agile review Approve items individually or as sets, updating them as work progresses.
  • One-click DHF Generated at any time as a submission-ready PDF with traceability.
Medical device datasheet

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.

Proof point: £4k–£60k saved per submission

CARA AI REGULATORY USE CASE

Customer story

Immunic

“CARA will reduce manual effort, shorten submission cycles, and support our wider strategic goals."

Femke Sanders, Head of Regulatory Affairs & Pharmacovigilance at Immunic.

Read the full case study

  • A single source of truth for regulatory documentation
  • Improved submission tracking and real-time reporting
  • Full audit readiness and traceability
  • Minimal IT burden with fast, validated deployment
  • Scalability across Clinical, Safety, and Quality functions

Common Questions

Before you talk to a specialist, here's what most submission teams ask first.

We already have a publishing tool. Does CARA work with it?

Yes. CARA works with your publishing tool. Send structures or individual documents to it, then publish the finished dossier back into the CARA archive, or drop it in a watched folder for automatic ingestion.

Can we tailor the device structures to how we work?

Yes. The device package is pre-configured on the DIA reference model, and Generis can tailor its structures to your requirements, for example populating DHF, DMR and DHR templates with the placeholder documents you need. Workflows then manage and trace each step of the design phase and production.

Do we need the rest of the CARA platform to run submissions?

No. Submission management runs on its own. The applications for other functions sit on the same platform, and you license them when you want them.

Platform connectivity within Regulatory

Each capability works on its own. Used together, they share the same records.

  • With Interconnected RIM, archived submissions stay linked to RIM data.
  • Alongside Labelling and Promotional, you can see which label version was submitted where, and when.

Beyond Regulatory

Add Safety or Quality when you’re ready. They work from the same data your submissions run on, the data Safety uses for PSUR drafting and Quality for CAPA context, with no export or re-entry in between.

Already connected. Same platform. 
See what full connectivity looks like 

See a submission run end to end.

Talk to our team and see how CARA can transform your operations.
Schedule a demo
Contact us

© Copyright 2002-2026, Generis Enterprise Technology Limited, all rights reserved

Privacy Notice |   Job Applicant Privacy Notice