—— FOR SAFETY OPERATIONS

Your safety data.

Working for you.

Not against you.

CARA AI runs across your full Safety function, generating PSMFs from live data in minutes, drafting PBRER sections audit-ready from creation, responding to Medical Inquiries in under 20 minutes. One platform. No data exports. No separate governance scope.

Data never leaves CARA

Full audit trail on every AI output

One validation scope — total

Permissions apply automatically

Built on unified safety data

Trust, control, confidence by design

Productivity that was impossible before

Your Safety team produces a lot of documentation. CARA AI makes sure none of it holds them back.

Across the full Safety function from aggregate reports and signal assessments to RMPs, DHPCs, and inspection packs your team writes, compares, summarises,
and translates the same content, in different formats, on repeat. CARA AI is the intelligence layer that handles that burden, so your experts stay focused on oversight.

OUTCOMES

The numbers that matter to Safety.

Minutes

PSMF generation; was 3 weeks

50-70%

Faster PBRER/PSUR drafting

5-20 min

Medical Inquiry response was 2 days

0 External AI tools. No parallel governance scope.

GENERATE

PSMF ready before the deadline, not the night before it

Your PSMF is generated directly from the live, governed safety data already on the platform. Safety, Regulatory, and Quality records exist on the same data model; so there is no extraction, no reconciliation across systems, no manual assembly sprint. The output arrives audit-ready from the moment it's generated

3 weeks → minutes

COMPARE

Medical Inquiry responses that don't require a day of research

An incoming Medical Inquiry used to mean a specialist spending a day pulling relevant product information, safety data, and regulatory records from separate systems. CARA AI draws on your full governed safety layer to surface the right information in minutes — so your team reviews and responds rather than searches and assembles.

1–2 days → 1 minute

PREDICT

Label–RMP–CCDS alignment checked automatically, not manually

Label updates in one market used to trigger a manual safety review initiated by email. CARA AI detects cross-market discrepancies between your label, RMP, and CCDS simultaneously — running the alignment check against the current live version before submission, not after.

Manual assessment → Automated

Safety capabilities

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 safety data.

Working for you.

Not against you.

Built on unified safety data

Trust, control, confidence by design

Productivity that was impossible before

Your Safety team produces a lot of documentation. CARA AI makes sure none of it holds them back.

OUTCOMES

The numbers that matter to Safety.

Minutes

PSMF generation; was 3 weeks

50-70%

Faster PBRER/PSUR drafting

5-20 min

Medical Inquiry response was 2 days

0

External AI tools. No parallel governance scope.

GENERATE

PSMF ready before the deadline, not the night before it

COMPARE

Medical Inquiry responses that don't require a day of research

PREDICT

Label–RMP–CCDS alignment checked automatically, not manually

Label updates in one market used to trigger a manual safety review initiated by email. CARA AI detects cross-market discrepancies between your label, RMP, and CCDS simultaneously — running the alignment check against the current live version before submission, not after.

Safety capabilities

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 safety data.

Working for you.

Not against you.

Built on unified safety data

Trust, control, confidence by design

Productivity that was impossible before

Your Safety team produces a lot of documentation. CARA AI makes sure none of it holds them back.

OUTCOMES

The numbers that matter to Safety.

Minutes

PSMF generation; was 3 weeks

50-70%

Faster PBRER/PSUR drafting

5-20 min

Medical Inquiry response was 2 days

0

External AI tools. No parallel governance scope.

GENERATE

PSMF ready before the deadline, not the night before it

COMPARE

Medical Inquiry responses that don't require a day of research

PREDICT

Label–RMP–CCDS alignment checked automatically, not manually

Label updates in one market used to trigger a manual safety review initiated by email. CARA AI detects cross-market discrepancies between your label, RMP, and CCDS simultaneously — running the alignment check against the current live version before submission, not after.

Safety capabilities

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.