CARA AI for Regulatory | CARA Life Sciences Platform

—— FOR REGULATORY TEAMS

Regulatory operations that are faster because they're safer.

Every manual step is a delay you pay for twice. CARA runs your full regulatory operations on one platform. CARA AI handles the heavy lifting: HA queries answered, change impacts mapped, submission baselines generated. In minutes. Inside your governance framework, not around it.

• Data never leaves CARA

• Full audit trail on every AI output

• One validation scope — total

• Permissions apply automatically

For architecture, model transparency, and technical governance detail — See full AI Overview →

—— THE PROBLEM

Regulatory work runs on expert time. Every manual step is a delay you pay for twice

Your team knows the documents & data. They spend most of their week finding it, moving it, and reformatting it instead of using it.

Head of Reg Ops · Regulatory Affairs · Submissions Lead

A Health Authority query lands on Monday. Two to five days of expert time later, the response is ready — not because the answer was complex, but because the data lived in three different systems.

Built on unified Regulatory data

Trust, control, confidence by design

Productivity that was impossible before

OUTCOMES

The numbers that matter to Reg Ops.

Minutes

HA Q&A response — was 2–5 days

1 min

Label comparison across all markets

£4k–£60k

Saved per submission

0 External AI tools. No parallel governance scope.

GENERATE

HA query responses that don't require a day of research

A Health Authority query lands. CARA AI draws on your live submission records, safety data, and label history in one governed layer — and drafts a compliant response with full source citations. Your team reviews and submits. No cross-system data pull required.

2–5 days → 20 minutes

COMPARE

Label alignment checked across every market. Automatically.

Label updates in one market used to mean manual exports, version spreadsheets, and cross-referencing by hand. CARA AI detects differences across all markets simultaneously — running the comparison against the current live version before submission, not after.

1–2 days → 1 minute

PREDICT

Submission readiness assessed before your team starts assembling

Instead of discovering gaps mid-compilation, CARA AI surfaces submission readiness against your regulatory data layer before the process begins. Your team starts with a clear picture of what's complete, what's missing, and what needs attention.

Manual assessment → 1–3 minutes

Regulatory capabilities

CARA AI Section

What your team sees

One governed AI layer across Regulatory, Safety, Quality, and Clinical,
full traceability on every output.

Context-aware search

Surfaces regulatory precedents and clinical correlations that keyword search misses.

Automated classification

Every document tagged, categorised, and enriched automatically. Instant retrieval, every time.

Pre-tuned for compliance

Built-in prompts for regulatory workflows. Accurate from day one, customisable further.

Your LLM

Choose the model that fits. All processing stays in our secure framework. Your IP stays yours.

Data extraction

Pulls structured data from messy PDFs and clinical reports. Analysis-ready in seconds.

Schedule a demo AI Playlist

Source citations

Linked to the exact platform record

Full audit trail

Every action logged in the sidebar

Human review

Built into every workflow step

What becomes possible when all
your data is on one platform.

CARA AI runs on one platform. One validation scope.The AI capabilities extend what the platform already does,
no separate system, no separate contract, no separate validation cycle.

The more of your operations run on CARA, the more your AI can do. Regulatory, Safety, Quality, and Clinical on one platform
means AI that works across your entire function not just in silos.

REGULATORY

For Regulatory Affairs & Reg Ops

Draft. HA query responses in 20 minutes

Generate. Submission dossiers from live data

Compare. Labels across all markets in 1 minute

SAFETY

For Pharmacovigilance & PV teams

Generate. PSMF from live data, 3 weeks to minutes

Draft. PBRER and DSUR across your safety layer

Monitor. Signal detection across your full PV data

QUALITY

For QA Managers & Quality Operations

Draft. SOPs and quality docs 50-80% faster

Detect. Change control, regulatory variation trigger

Audit. Full trail on every AI-generated output

CLINICAL

For Clinical Operations & eTMF leads

Structure. eTMF AI classification and completeness

Inform. Regulatory submissions from eTMF data

Review. Trial master file gaps surfaced automatically

60%
of top pharma

1M+
Users

99.9%
Uptime SLA

Built on a platform that enterprise pharma already trusts

CARA AI runs on the same unified foundation already deployed across the world’s leading pharmaceutical companies. The platform that makes this AI possible has been proven in production, at scale, under inspection, across every major life sciences function.

25 +

Years in regulated life sciences

24/7

Expert Support

— PLATFORM ARCHITECTURE

One platform. One validation scope. No governance gaps.

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

HA Q&A answered in minutes — not days

A Health Authority query draws on live submission records, Safety data, and Quality records in a single response. No cross-system data pull. No manual reconciliation. One platform, one governed layer.
Metric: 2–5 days → 20 minutes
Label beneath metric: Based on internal benchmarks