Pharmacovigilance, Reimagined with AI
The modern safety database that reduces case processing time by 70%. Enterprise-grade compliance at a fraction of the cost of legacy systems.
Case Dashboard
47 cases requiring attention
Open Cases
Due Today
AI Processed
AI Coding
MedDRA 27.0
E2B Validated
Ready to submit
Compliant with Global Regulatory Authorities
Everything You Need for Modern Drug Safety
A complete pharmacovigilance platform that replaces Oracle Argus, Veeva, and bolt-on tools with one integrated solution.
AI-Powered Case Processing
Automatic data extraction from emails, PDFs, and call transcripts. AI suggests MedDRA codes and generates narratives.
70% faster processingNative E2B(R3) Support
Generate ICH E2B(R3) XML with one click. Automatic validation ensures 99%+ first-submission acceptance.
99% acceptance rate21 CFR Part 11 Compliant
Complete audit trails, electronic signatures, and access controls built for regulated environments.
Audit-readySignal Detection
AI-powered disproportionality analysis with PRR, ROR, and BCPNN algorithms. Automated signal prioritization.
Earlier detectionMulti-Authority Submission
Submit to FDA, EMA, PMDA, Health Canada, MHRA, and TGA from a single platform.
6+ authoritiesExpedited Case Tracking
Never miss a deadline. Automatic calculation of reporting timelines with smart reminders.
Zero missed deadlinesFollow-up Management
Track information requests, generate follow-up letters, and manage response workflows.
Complete trackingWorkflow Automation
Configurable case workflows with role-based routing, auto-assignment, and escalation rules.
Custom workflowsIntelligent Search
Find any case instantly with full-text search across all fields, attachments, and narratives.
Sub-second searchPSMF & SDEA Included
Integrated Pharmacovigilance System Master File and Safety Data Exchange Agreement management.
All-in-oneSmart Notifications
Get alerts for approaching deadlines, workflow changes, and regulatory updates that matter.
Stay informedLightning Fast
Modern architecture built for speed. No more waiting for screens to load or reports to generate.
10x faster UISee how Quantum PV compares to your current system
View detailed comparison →From Intake to Submission in 4 Simple Steps
AI handles the tedious work so your team can focus on what matters: patient safety and medical decision-making.
Receive
Cases arrive via email, portal, EDC, or partner systems. AI automatically extracts key information from any format.
- Email intake with PDF/MSG parsing
- API integration with EDC systems
- Partner portal for CROs
Process
AI codes events to MedDRA, identifies products in WHODrug, calculates timelines, and generates draft narratives.
- 90%+ MedDRA coding accuracy
- Automatic seriousness assessment
- AI-generated case narrative
Review
Medical reviewers validate AI suggestions, assess causality, and finalize cases with electronic signatures.
- Naranjo & WHO-UMC assessment
- Guided medical review workflow
- 21 CFR Part 11 e-signatures
Submit
Generate E2B(R3) XML, validate against ICH standards, and submit to any health authority worldwide.
- One-click E2B generation
- Pre-submission validation
- ACK tracking & reconciliation
Simple, Transparent Pricing
No per-case fees. No hidden costs. Predictable pricing that grows with your business.
Save 50-80% compared to Oracle Argus or Veeva Vault. See our detailed
Essentials
For emerging biotech with first product or limited case volume.
- Up to 500 cases/year
- Up to 5 users
- Core case management
- E2B(R3) export
- Basic reporting
- Email support
- AI-powered features
- Signal detection
- Custom integrations
Growth
For growing companies with expanding portfolios.
- Up to 2,500 cases/year
- Up to 15 users
- Everything in Essentials
- AI coding assistance
- Basic signal detection
- PSMF module
- Priority support
- Custom workflows
- Dedicated CSM
Professional
Full AI capabilities for mid-size organizations.
- Up to 10,000 cases/year
- Up to 50 users
- Everything in Growth
- Full AI suite (coding, narratives)
- Advanced signal detection
- SDEA management
- Custom integrations
- Dedicated CSM
- On-site training
Enterprise
For large pharma with global operations.
- Unlimited cases
- Unlimited users
- Everything in Professional
- Multi-region deployment
- Custom AI model training
- Dedicated infrastructure
- 24/7 premium support
- Regulatory consulting
- Custom SLAs
Need a custom solution for your organization?
Trusted by Drug Safety Teams
See why pharmacovigilance professionals are switching to Quantum PV.
"Quantum PV cut our case processing time by 65%. The AI coding suggestions are incredibly accurate - our team now focuses on medical review instead of data entry."
VP of Drug Safety
Mid-size Biotech
"We evaluated Argus, Veeva, and ArisGlobal. Quantum PV gave us the same functionality at 40% of the cost, and implementation took 6 weeks instead of 6 months."
Head of Pharmacovigilance
Specialty Pharma
"The E2B validation catches errors before submission. Our acceptance rate went from 94% to 99.5% after switching. FDA and EMA submissions are now worry-free."
Director of Regulatory Affairs
Global Pharmaceutical
Frequently Asked Questions
Still have questions?
Contact our team →Ready to Transform Your Drug Safety Operations?
Join 50+ companies that have switched to modern pharmacovigilance. See why teams are saving 70% of their time with AI-powered automation.
No commitment required · Free migration assessment · Implementation in weeks, not months