—— FOR REGULATORY TEAMS

Your regulatory submissions. Answered in minutes.

Assembled without the manual work.

CARA manages your full Regulatory function on one governed platform, When you’re ready to go further, CARA AI answers HA queries, compares labels and much more in minutes, generate submission baselines without the rebuild.

Data never leaves CARA

Full audit trail on every AI output

One validation scope — total

Permissions apply automatically

—— 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

What your teams sees

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

Context aware search

Finds regulatory precedents and clinical correlations keyword search misses. Better decisions, complete information.

Automated classification

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

Data extraction

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

Pre-tuned for compliance

Built-in prompts for regulatory workflows. Accurate results from day one, or customise further

Your LLM

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

Source citations visible

Every output references the exact platform record it drew from.

Audit trail in the sidebar

Every output references the exact platform record it drew from.

Human review step built in

Every output references the exact platform record it drew from.

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

Regulatory use case →

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

Safety use case →

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

Quality use case →

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

Clinical use case →

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

Your regulatory submissions. Answered in minutes.

Assembled without the manual work.

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

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.

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.

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.

Regulatory capabilities

What your teams sees

Context aware search

Automated classification

Data extraction

Pre-tuned for compliance

Your LLM

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

One platform. One validation scope. No governance gaps.

What Makes Us Different?

Purpose-Built AI for Life Sciences

Your regulatory submissions. Answered in minutes.

Assembled without the manual work.

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

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.

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.

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.

Regulatory capabilities

What your teams sees

Context aware search

Automated classification

Data extraction

Pre-tuned for compliance

Your LLM

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

One platform. One validation scope. No governance gaps.

What Makes Us Different?

Purpose-Built AI for Life Sciences

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