Regulatory Intelligence

FDA guidance, ICH references, clinical trials, drug approvals, patents, labels, FAERS, and PGx

11 tools

Explorers

8 tools

explorer

Regulatory Guidance Explorer

Search and compare regulatory guidances across FDA, EMA, ICH, and Health Canada with AI summaries and cross-agency comparison

AI
explorer

Clinical Trial Intelligence

Search ClinicalTrials.gov with intelligent PK study type classification, endpoint extraction, and competitive landscape analysis

AI
explorer

Global Drug Approval Explorer

Search and compare drug approvals across FDA, EMA, and Health Canada with interactive timelines and cross-agency comparison

AI
explorer

Orange Book & Patent Intelligence

Analyze Orange Book patents and exclusivities with generic entry date calculation, patent thicket scoring, and Paragraph IV opportunity identification

AI
explorer

Drug Label Intelligence

Search, navigate, and compare FDA drug labels with section-level SPL parsing, AI-powered diff, and cross-links to PK calculators

AI
explorer

FAERS Safety Signal Explorer

Analyze FDA FAERS adverse events with PRR/ROR disproportionality metrics, signal detection, trend charts, and AI interpretation

AI
newexplorer

EMA Drug Database

Search EMA Open Data for EU-authorized medicines with authorization dates, therapeutic areas, ATC codes, and EPAR links

AI
newexplorer

Biosimilar Explorer

Explore FDA Purple Book data. Find biosimilars, check interchangeability status, view reference product relationships, compare pricing.

AI