Interconnected RIM. Built on one record. Current everywhere.

CARA replaces spreadsheets and separate trackers with one governed regulatory record that every global process reuses, so work is faster and more precise.

Trusted by leading regulatory teams across life sciences

Bayer

UCB

Applications & Registrations

See what is applied or authorised where, with everything linked to it.

Tracking applications and registrations is a core mission of a complete RIM system. CARA takes this further by tying application and authorisation information to your submission structures and even down to individual documents. This means you are never more than a click away from complete context.

Application tracking Follow each application from its event to authorisation, with status updated automatically.
Global product progress See the global progress of your products to market.
Traceability both ways Start from a registration, product or document: traceability always runs both ways.
Where Used Pull up linked events, activities and products without searching.

AI

CARA AI assesses submission readiness against your live regulatory data in 1–3 minutes, flagging gaps and missing documents at the outset.

Submission Planning & Tracking

Run every submission on a guided, repeatable process, and improve with each one.

Everything is easier with a repeatable process, whether a submission starts from a centralised plan or a health authority request, ad-hoc submissions included. CARA captures decision points, correspondence and meeting minutes, not just document approvals, and guides your team to the next step by submission type and context.

Where Used Trace any data, content, event, activity or label component across submissions.
Current Approved view See which submissions or variants have gained approval globally.
Bottleneck reporting Spot corporate and process bottlenecks across successive submissions, out of the box.

See how End-to-End Submission Management runs planning through to authoring and publishing

Events, Activities & Commitments

Eliminate double-work: start from the templates and content you already have.

Global Events with templated core and local submission structures can save weeks of planning and communication, and give your global submissions consistency downstream.

Standardised variations Handle variations within one standardised approach, even when two submissions progress the same way.
Templated content plans Drive authoring from templated submission content plans, so authors get context and guidance.
Best practice process package Adopt a best practice process package from Generis to structure how your team operates.

Product Management: IDMP, SPOR & xEVMPD

Meet IDMP and SPOR requirements as part of the regulatory work you already do.

New standards such as IDMP, SPOR and xEVMPD are often owned by different groups on different systems, making them hard to prepare for and keep up with. CARA keeps that data common, searchable and constantly updated, with automation supporting its maintenance.

Process-led data collection Let your processes drive data collection, with automation supporting master data and standards maintenance.
Standards enforcement Enforce data standards in your processes, with compliant structures and linking maintained behind the scenes.
EMA SPOR alignment Stay aligned with EMA's SPOR database, with notifications when subscribed items are updated.
Shared SPOR vocabularies Use SPOR vocabularies across RIM, Clinical and Safety, or push them to SAP via the REST API.

Health Authority Correspondence

Take every Health Authority question from receipt to response in one connected process.

There can be hundreds of questions for different teams to answer, with initial responses due within 24 hours in some cases. CARA automates the manual handling, so every question is processed faster and more consistently and your teams can focus on the quality of each answer.

Multi-channel ingestion Ingest correspondence by scan and OCR, fax to digital, or email attachments and bodies.
Question extraction Extract questions into individual records with template-based recognition rules, linked to the original submission.
Subject-based routing Route each question to the team responsible for the subject, translated on ingestion where needed.
Global answer search Search similar questions and answers from other authorities worldwide, in your own language, to assemble responses.

AI

Drafts a compliant response from your live submission records, safety data and label history, with full source citations. Internal benchmark: 20 minutes, down from 2 to 5 days.

AI underneath it all

Impact analysis, submission readiness, HA query drafting, every AI feature on this page reads and writes to the same regulatory data you already work in. No export, no separate tool, no parallel governance scope.

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

Customer story

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 RIM system. Why replace it instead of integrating it?

CARA removes the technological, operational and financial drawbacks of running a network of individual systems. Your processes, data and content sit on one platform, so users can create, locate and reuse information in any process across the organisation, with greater accuracy.

Do we have to buy the whole platform to get RIM?

CARA is one platform for Regulatory, Quality, Safety, Clinical and Enterprise processes. You can start with Regulatory. The other applications are already part of the platform, and you license them when you need them.

Platform Connectivity

One governed submission record. Connected to your tools, and to the rest of Regulatory.

Regulatory data in CARA is the same data Safety uses for PSUR drafting and Quality uses for CAPA context, so when you are ready to connect them the records are already on one platform, with no exported snapshots between them. Other systems, such as SAP, can query CARA or receive data from it through the REST API.

Already connected
Same platform