Automated Case Intake & Processing
NLP extracts case data from narratives, literature, and social media, then triages by seriousness — with MedDRA coding suggestions.
Award-Winning Pharmacovigilance Automation
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 MAHs, CROs, and biotechs with pharmacovigilance obligations.
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Marketing Authorisation Holders
Marketing Authorisation Holders
GVP case processing, signal detection, and literature monitoring — with inspection-ready audit trails.
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Contract Research Organisations with PV Services
Contract Research Organisations with PV Services
Faster, more accurate PV services that absorb higher case volumes without added headcount.
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Clinical Stage Biotech Companies
Clinical Stage Biotech Companies
Compliant Phase I/II safety surveillance without a large in-house PV team.
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Generics and Specialty Pharma in India
Generics and Specialty Pharma in India
CDSCO-compliant PV with regional-language case intake across six Indian languages.
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Regulatory Affairs Teams at Large Pharma
Regulatory Affairs Teams at Large Pharma
One platform for EudraVigilance, FDA FAERS, and CDSCO submissions across every product.
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.
Book a PV Demo
Award-Winning AI Development & Consulting
100 Fastest Growth Companies
Global Spring Winner
Top App Development Company
AWS Partner Network
Google Cloud Partner
Highly Rated on Trustpilot
Verified Agency
Top App Development Company
ASSOCHAM Member
Frequently Asked Questions
[ 1 ]
How does the AI maintain compliance with GxP validation requirements for regulated PV systems?
Built under GxP principles — documented lifecycle, IQ, OQ, PQ, and a validation package for every regulatory-facing model.
[ 2 ]
What happens when the AI makes a coding or narrative error?
A qualified human reviews every AI output before it enters the safety database or reaches a regulator.
[ 3 ]
Can the platform handle cases in regional Indian languages?
Yes. NLP models cover Hindi, Tamil, Telugu, Kannada, Marathi, and Bengali case intake for CDSCO PvPI compliance.
[ 4 ]
How is patient privacy protected in social media and digital source monitoring?
Only public information is processed, as aggregate safety signals — never individual patient profiles.
[ 5 ]
How does the platform handle multi-regional submission requirements simultaneously?
EudraVigilance, FDA FAERS, and CDSCO PvPI run in one interface, with formats and deadlines handled automatically.
[ 6 ]
What literature sources does the continuous monitoring cover?
PubMed, Embase, conference abstracts, pre-prints, and regional journals — monitored per product and indication.
Global presence
