© Copyright 2002-2026, Generis Enterprise Technology Limited, all rights reserved
Providing Regulatory teams a unified platform with built-in, compliant AI that keeps content consistent across markets, reducing drift, review cycles, and manual reconciliation without adding new systems or validation overhead.
CARA’S semantic comparison finds structural differences across markets in minutes. No more 1-2 day manual cross-checks.
AI flags semantic drift across submissions and labels automatically. Your team sees where dossiers diverge without the manual hunt.
Generate Module 2 summaries, PSMF logs, and HA responses from existing content. Review in hours, not write for weeks.
Lifecycle monitoring detects related label and CMC changes. Automated alerts before deadlines, auto-populated RIM systems.
Hours saved per submission cycle
Saved per submission
Across teams; fewer handoffs
With provable lineage
Not reconciliations
From manual processes to AI-powered efficiency
CARA AI provides an analyzed comparison in 1 minute, identifying differences in wording or intent across SmPCs, PILs, CCDS, and local labels to ensure global alignment
Cut authoring time by 70%. Your senior staff review and refine strategy instead of spending weeks summarizing data. Reclaim expert capacity for high-value regulatory work.
Turn 2-5 day manual searches into automated lookups. Build consistent global response strategies by identifying where agencies ask overlapping or contradicting questions. Respond faster without sacrificing quality.
Eliminate tedious manual data entry. Accelerate IDMP compliance without rekeying information from old dossiers. Your RIM systems stay current without the administrative overhead.
Accelerate local submissions without creating semantic gaps between regions. No risk of misinterpretation that delays approval or creates pharmacovigilance issues across borders.
CARA’s AI keeps everything inside the platform so content never leaves, permissions stay enforced, and every action is traceable, auditable, and inspection-ready.
You gain speed without risking data integrity, validation, or signoff processes.
“CARA will reduce manual effort, shorten submission cycles…”
“Moving from a system with no versioning … was a real breath of fresh air.”
See CARA AI automate classification, extraction, summarization and generation across R&D, Regulatory, Safety and Quality
© Copyright 2002-2026, Generis Enterprise Technology Limited, all rights reserved
