scientific-regulatory-science

What problem does it solve?

This skill consolidates and cross-references regulatory data from FDA, EMA, PMDA databases and IP sources to deliver a unified regulatory profile for pharmaceuticals, medical devices, and related products. It enables comprehensive visibility into approvals, recalls, safety data, quality-management requirements, and patent landscapes across agencies.

Core Features & Use Cases

• Cross-database queries across FDA Orange Book, EMA, and PMDA for approvals, classifications, safety signals, and recall histories.
• ISO 13485 CAPA planning and quality-management alignment to support regulatory compliance and risk mitigation.
• USPTO patent searches and competitive landscape analysis to identify freedom-to-operate and patent expiries.
• Use Case: Regulatory teams rapidly assemble a regulatory profile for a new device, drug, or combination product, including timelines and key regulatory milestones.

Quick Start

Query regulatory databases for a product to retrieve approval histories, recalls, CAPA requirements, and patent information, and return a unified regulatory report.