Automated Case Intake & Processing
NLP extracts case data from narratives, literature, and social media, then triages by seriousness — with MedDRA coding suggestions.
Trusted by startups and global leaders
AI Handles the Volume. Your Safety Scientists Handle the Science.
Automated case processing, continuous signal detection, and regulatory submission management — built to the governance standards regulators now expect.
Continuous Signal Detection
ML signal detection and disproportionality analysis run continuously, surfacing correlations across literature and social media early.
Regulatory Submission Management
ICSRs auto-formatted to E2B(R3) and submitted across EudraVigilance, FDA FAERS, and CDSCO — tracked in one inspection-ready workflow.
Why Traditional Pharmacovigilance Can't Keep Up
Case volumes grow every year across more products, channels, and markets — so last year's team can't keep up next year unless the process changes.
How We Fix ThisWhat Pharmacovigilance Automation Manages
Case intake, MedDRA coding, signal detection, and regulatory submission on one platform.
What Your PV Team Works With Every Day
Five workspaces for case processors, safety scientists, signal managers, and submission teams. AI handles the volume; your team handles the judgment.
Case Processing Queue
All sources in one prioritised queue, triaged by seriousness and deadline, with NLP-extracted fields, MedDRA coding suggestions, and an AI-drafted narrative attached.
Signal Detection Dashboard
Emerging patterns scored for clinical significance and novelty. ML-detected signals run alongside disproportionality analysis, catching correlations statistical methods miss and prioritising the ones that matter.
Literature & Digital Monitor
Continuous monitoring across journals, pre-print servers, abstracts, and regional publications. Social media and patient-forum signals are screened against your case data and flagged for assessment.
Submission Tracker
Every active submission across EudraVigilance, FDA FAERS, and CDSCO — status, deadline, acknowledgement, and follow-up in one view. E2B(R3) formatting and validation automated per case.
Compliance & Audit Layer
A full audit trail for every AI output, review decision, and submission event, with GxP validation docs and model-fitness dashboards for every regulatory-facing model — assembled continuously for inspections.
Pharmacovigilance Automation: What the Numbers Showed.
Each metric ties to a real AI-driven pharmacovigilance outcome.
Book a Live Demo37,500
Person-hours saved annually at a mid-size pharma processing 15,000 ICSRs per year. Safety professionals freed for signal detection and risk management.
4h → 1.5h
Reduction in average case processing time — a permanent throughput shift without proportional headcount growth.
60–80%
Fewer hallucinations in AI-generated safety narratives via RAG. Every claim anchored to a verified source field with a full audit trail.
Hours → Minutes
Submission prep time per case. E2B(R3) formatting, validation, and multi-database submission to EudraVigilance and equivalents — automated end to end.
FDA & EMA
Joint 2026 guiding principles make AI governance in PV an inspection-ready requirement. Regulators now expect AI, with explainability and traceability.
Real-Time
Signal detection that runs continuously, not after case accumulation. For rare serious adverse events, early versus late is measured in patient exposure.
Who This Platform Serves
Built for every organisation with pharmacovigilance obligations — from post-marketing MAHs managing large ICSR volumes to clinical-stage biotechs building PV infrastructure from scratch.
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Marketing Authorisation Holders
Marketing Authorisation Holders
GVP obligations require systematic case processing, signal detection, and literature monitoring. AI meets them at lower cost and higher quality at post-marketing volumes, with the audit trail and validation docs inspectors expect.
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Contract Research Organisations with PV Services
Contract Research Organisations with PV Services
PV service performance is measured on speed, accuracy, and compliance. AI delivers all three while absorbing higher case volumes without proportional headcount growth — a direct differentiator when sponsors compare CROs.
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Clinical Stage Biotech Companies
Clinical Stage Biotech Companies
Phase I/II safety surveillance carries the same regulatory rigour as post-marketing PV. Cost-effective AI makes compliant surveillance accessible without a large in-house PV team — the operational standard of a much larger organisation.
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Generics and Specialty Pharma in India
Generics and Specialty Pharma in India
CDSCO requirements have grown more rigorous. A compliant PV operation meeting Indian and international standards — with regional-language case intake in Hindi, Tamil, Telugu, Kannada, Marathi, and Bengali — is essential for global ambitions.
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Regulatory Affairs Teams at Large Pharma
Regulatory Affairs Teams at Large Pharma
Multi-product portfolios mean obligations to EudraVigilance, FDA FAERS, and CDSCO — each with its own format, deadlines, and follow-up workflow. One platform manages all of it with an inspection-ready submission record.
Built on the Standards Your Regulatory Team Already Operates Under
Integrates with your existing safety and case management infrastructure, validated to GxP standards with a full audit trail.
Safety Databases
Safety Database Integration
Connects to leading PV safety databases within existing governance.
Regulatory Submission
Regulatory Database Connectivity
Submits to major PV databases with unified status tracking.
Coding Standards
Medical Terminology & Coding
Standard medical coding terminologies for PV case processing.
Compliance
Regulatory & GxP Compliance
Every AI model validated with GxP-compliant documentation.
Data Sources
Case Source Integration
Spontaneous, literature, digital, and trial reports via unified NLP.
Languages
Regional Language Support
NLP case intake in Indian regional languages for consumer reports.
The Safety Signal That Matters Most Is the One You Find Earliest.
Every signal found faster — or surfaced from unmonitored sources — protects patients and your product. Book a 30-minute demo to see the platform handle your case volumes, submissions, and signal detection.
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Frequently Asked Questions
[ 1 ]
How does the AI maintain compliance with GxP validation requirements for regulated PV systems?
The platform is developed and validated under GxP principles — documented lifecycle, IQ, OQ, PQ, and ongoing performance monitoring. Every regulatory-facing AI model has a validation package demonstrating fitness for purpose. The joint FDA and EMA 2026 guiding principles on AI governance in PV are reflected in its documentation and audit trail.
[ 2 ]
What happens when the AI makes a coding or narrative error?
Every AI output is reviewed by a qualified human before entering the safety database or reaching a regulator. The AI handles speed and consistency; the human handles final QA and complex judgment. It is a collaboration tool, not a replacement for qualified PV professionals.
[ 3 ]
Can the platform handle cases in regional Indian languages?
Yes. NLP models for Hindi, Tamil, Telugu, Kannada, Marathi, Bengali, and other regional languages handle case intake and literature monitoring — covering consumer reports from local channels and Indian medical publications. This supports CDSCO PvPI compliance as India's consumer reporting expands.
[ 4 ]
How is patient privacy protected in social media and digital source monitoring?
Only publicly available information is processed, and posts are not linked to identifiable patient records without consent. The platform extracts aggregate safety signals from digital sources, not individual patient profiles. All monitoring is documented in the privacy impact assessment and data processing records.
[ 5 ]
How does the platform handle multi-regional submission requirements simultaneously?
EudraVigilance, FDA FAERS, CDSCO PvPI, and others are managed in a single interface, with each database's formatting, deadlines, and follow-up workflow handled automatically. Your regulatory team gets a unified view of all submission obligations and statuses across every market.
[ 6 ]
What literature sources does the continuous monitoring cover?
PubMed, Embase, conference abstracts, pre-print servers, and regional medical journals in supported languages are monitored continuously, configured per product and indication. New papers are screened against existing case data automatically, and those with potentially new safety information are flagged within the defined review period.
Global presence
