Simplify, standardise, and automate your Regulatory processes with CARA AI

CARA Regulatory AI gives your team the speed they need without sacrificing the rigor submissions demand. Compare global labels instantly. Generate Module 2 summaries that used to take weeks in just minutes.

Everything stays governed. Everything stays connected.

Modern regulatory operations, minus the manual burden

Resolve label differences in minutes

Identify structural and semantic differences across global labels without manual cross-checking.

Detect cross-document conflicts early

See where submissions diverge across modules, markets, or versions before review cycles stall.

Reclaim expert time per submission

Reduce manual summarisation and document hunting so regulatory experts focus on strategy and review.

Track connected filings automatically

Monitor label and CMC changes across the lifecycle to avoid missed updates and last-minute surprises.

Built-in, not bolt-on

Your content stays inside CARA.

Permissions and audit trail apply automatically.

Completely Compliant

No external AI tools needed.

Outcomes for Regulatory

70–1,000+

Hours saved per submission cycle

£4k–£60k

Saved per submission

Faster cycles

Across teams; fewer handoffs

Lower audit exposure

With provable lineage

Hours back to experts

Not reconciliations

Leveraging CARA AI for Regulatory processes

From manual processes to AI-powered efficiency

Label alignment

Analyse SmPCs, PLs, CCDSs, and local labels to identify differences in wording, structure, and intent.

Submission prep

Generate summaries and draft components from existing dossiers and regulatory content.

HA responses

Locate prior responses and related content across submissions to assemble consistent answers.

RIM enrichment

Extract and reuse structured data from dossiers and submissions to keep RIM systems current.

Regional adaptations

Adjust global regulatory content for local requirements while preserving meaning across regions.

Before

After

From regulatory content to connected executionCARA AI operates directly within your Regulatory environment.

Regulatory documents remain in controlled systems
AI analyses content based on structure, context, and intent
Related submissions, labels, and records are linked automatically
Drafts and comparisons are generated within existing workflows

No parallel tools. No content exports. No revalidation cycles.

Trust & Proof

Users

0 +

Enterprise Clients

0 +

SLA

0 %

Expert Support

0 /7

Largest Life Science companies

0 of 10

“CARA will reduce manual effort, shorten submission cycles…”

“Moving from a system with no versioning … was a real breath of fresh air.”

What Makes Us Different?

See CARA AI automate classification, extraction, summarization and generation across R&D, Regulatory, Safety and Quality