AI-Powered Pharmacovigilance

Automate Your
Safety Reporting

Generate Health Canada Annual Safety Reports in minutes, not weeks. AI-driven data collection, regulatory compliance, and bilingual report assembly—all in one platform.

<5min
Report generation
11
API endpoints
AI
Powered analysis

Capabilities

Everything you need for pharmacovigilance

Purpose-built tools for pharmaceutical safety professionals managing post-market surveillance.

Safety Advisory Monitoring

Automatically collect and track safety advisories from Health Canada, FDA, and international regulatory bodies.

Adverse Event Processing

Ingest and analyze Canada Vigilance cases with automated MedDRA coding and signal detection.

Literature Surveillance

PubMed searches with AI-powered relevance scoring and automatic bibliography generation.

Bilingual Output

Full English and French report generation, meeting Health Canada's official language requirements.

DOCX & PDF Export

Publication-ready Word and PDF documents with structured sections, tables, and appendices.

Audit-Ready Compliance

Full provenance tracking, timestamped sources, and validation flags for regulatory inspections.

Core Product

Annual Safety Report Generator

From drug selection to a complete, bilingual ASR—our AI pipeline handles data collection, case processing, literature review, and section drafting automatically.

Automated safety advisory collection
Canada Vigilance case processing
Literature search and bibliography generation
Word/PDF report export
Compliance audit trails
Annual Safety Report
Montelukast Sodium - 2025
Complete
Section 1 - Drug Information
Section 2 - Worldwide Market Status
Section 3 - Regulatory Actions
Section 4 - Safety Variations
Section 5 - Patient Exposure
Section 6 - Case Narratives...
API Explorer
Connected
GET /drugProducts?din=02248757
200 OK - 1 result
{
"drug_product_id": 48291,
"brand_name": "SINGULAIR",
"ingredient": "MONTELUKAST",
"company_name": "ORGANON"...
}
Data Access

Canada Vigilance API Explorer

Direct access to Health Canada's adverse reaction database. Search drug products, query adverse event reports, and explore demographic data through an intuitive interface.

Drug product information
Adverse reaction reports
Patient demographic data
Report classifications
Source information

How It Works

From input to report in four steps

Our AI-powered pipeline automates the most time-consuming parts of ASR preparation.

01

Select Drug

Enter the drug name, DIN, or upload a product monograph to get started.

02

Collect Data

AI agents gather adverse events, literature, and regulatory actions automatically.

03

Review Draft

Review AI-generated sections with full source citations and provenance tracking.

04

Export Report

Download the finalized bilingual ASR as a publication-ready DOCX or PDF.

This platform has fundamentally changed how we approach annual safety reporting. What used to take our team weeks of manual data collection and writing now happens in minutes with full traceability.
JA
Jad Assaf
Pharmacovigilance Lead

Ready to streamline your safety reporting?

Start generating your first ASR today or explore the Canada Vigilance database.