Regulatory Intelligence

DrugCard's Regulatory Intelligence is an AI-assisted software platform that aggregates regulatory updates from health authorities across global and local markets into a single interface. It is designed for pharmacovigilance (PV) and regulatory affairs teams within marketing authorisation holders (MAHs) and contract research organisations (CROs) that need to track legislative changes, authority communications, and compliance requirements without manually checking multiple regulatory websites.

The platform currently covers 50 countries, with the ability to add any new country within one day. It applies AI processing to summarise and categorise incoming regulatory data, then delivers structured updates and alerts directly into user workflows to support faster compliance decisions.

Key Features

• Complete regulatory data visibility: Provides regulatory information across 40 countries with real-time alerts and continuous tracking of updates from regulatory agencies. Users can save key publications to Favorites for quick access to specific markets.
• Advanced search and discovery: Offers a unified cross-site search that works across differently structured regulatory websites, combined with keyword filtering. Update frequency is fully customisable, going beyond standard weekly cycles.
• Platform integration: Includes native integration with other DrugCard modules for end-to-end regulatory update monitoring, as well as API options to connect with existing compliance systems.
• Security, compliance, and data integrity: Compliant with FDA 21 CFR Part 11 for electronic records and signatures, supported by a certificate of conformity for use across EU, US, and CIS markets. Hosted in ISO/IEC 27001:2013 and SOC 2 Type II–certified data centres.
• Continuous access and automation: Provides 24/7 access from any location. An AI-powered regulatory assistant automates monitoring continuously, removing the need for manual searches or downloads.

How the Platform Works

1. Regulatory data intake: The system collects updates from all connected health authority websites.
2. AI processing: Each item is analysed, summarised, and placed into the appropriate regulatory category.
3. Delivery to your workflow: Users receive structured updates, alerts, and search-ready content to support compliance actions.

Who the Platform Is For

• Pharmacovigilance and regulatory affairs teams within MAHs and CROs.
• Departments managing regulatory intelligence, pharmacovigilance regulatory intelligence, and ongoing compliance workflows.
• Teams that need a unified feed of regulatory updates filtered by authority, topic, and country without navigating multiple external websites.

DrugCard Regulatory Intelligence is available with a free two-week trial. The platform supports deployment for EU, US, and CIS markets and integrates with existing pharmacovigilance and compliance systems via API. Same-day support response is included.