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FDA Intelligence
Reimagined

AI-powered regulatory research for life sciences. Query drug approvals, analyze warning letters, detect safety signals, and generate detailed reports—all in natural language.

Regulatory Intelligence at Scale

Stop drowning in FDA databases. Start getting answers.

Drug Intelligence

Search NDAs, ANDAs, and BLAs. Query FAERS adverse events, drug labels, and recall databases instantly.

Device Intelligence

510(k) clearances, PMA approvals, device recalls, and MAUDE adverse event reports in one place.

Safety Signal Detection

Calculate PRR scores for drug-reaction pairs. Detect emerging safety signals before they escalate.

Clinical Trials

Search ClinicalTrials.gov with natural language. Analyze company pipelines and compare R&D portfolios.

Warning Letters

2,000+ FDA warning letters with full-text search. Track enforcement trends by office, product type, and year.

Insights Canvas

Visual workspace with charts, tables, and summary cards. Export professional Excel reports with AI analysis.

Drug Labels

Search drug labeling and package inserts. Identify boxed warnings and contraindications.

Pipeline Analysis

Compare company R&D portfolios. Track trials by phase and therapeutic area across competitors.

Ask Questions.
Get Answers.

No more digging through databases. Just ask what you need to know in plain English. Our AI understands regulatory context and delivers precise, sourced answers in seconds.

"Is there a safety signal for Ozempic and pancreatitis?"

"Compare Pfizer and Moderna clinical trial pipelines"

"Show 510(k) clearances for cardiovascular devices in 2024"

"Find CDER warning letters mentioning data integrity"

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15+

AI-Powered Tools

2,000+

Warning Letters

10+

Data Sources

< 2s

Response Time

Powered by Authoritative Sources

Real-time access to official FDA databases and ClinicalTrials.gov

openFDA

Drugs & Devices

FAERS

Adverse Events

MAUDE

Device Reports

ClinicalTrials.gov

Trial Data

510(k) Database

Clearances

PMA Database

Class III Approvals

Drug Labels

Package Inserts

NDC Directory

Drug Products

Recall Database

Safety Alerts

Warning Letters

Enforcement

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Connected
Intelligence.

Our AI doesn't just search—it connects the dots across thousands of FDA documents, identifying patterns and relationships that would take humans weeks to uncover.

◉Cross-reference adverse events with recall patterns

◎Track enforcement trends across FDA offices

●Detect safety signals with PRR analysis

⊙Generate branded Excel reports with AI insights

Example Queries

Just ask in natural language—no query syntax to learn

SafetyWhat are the most reported adverse events for GLP-1 agonists?

DevicesShow me Class I device recalls from the past 6 months

TrialsFind Phase 3 oncology trials recruiting in the US

ComplianceWhich companies received warning letters for 21 CFR Part 11 violations?

PipelineCompare Eli Lilly and Novo Nordisk diabetes pipelines

ApprovalsList all accelerated approvals for rare diseases in 2024

Business Intelligence

Identify Market
Catalysts.

Regulatory events create business opportunities. Warning letters trigger remediation projects. Pipeline shifts signal talent needs. Safety signals reshape competitive landscapes.

◉Warning letters that signal consulting opportunities

◎Pipeline expansions driving talent acquisition

●Regulatory setbacks creating competitive openings

⊙Approval milestones indicating commercialization hiring

Consulting

Find compliance challenges needing remediation

Recruiters

Track milestones driving hiring demand

Investors

Monitor catalysts affecting portfolios

Strategy

Analyze competitor setbacks in real-time

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Regulatory Workflow?

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FDA IntelligenceReimagined

Regulatory Intelligence at Scale

Drug Intelligence

Device Intelligence

Safety Signal Detection

Clinical Trials

Warning Letters

Insights Canvas

Drug Labels

Pipeline Analysis

Ask Questions.Get Answers.

Powered by Authoritative Sources

ConnectedIntelligence.

Example Queries

Identify MarketCatalysts.

Consulting

Recruiters

Investors

Strategy

Ready to Transform YourRegulatory Workflow?

FDA Intelligence
Reimagined

Ask Questions.
Get Answers.

Connected
Intelligence.

Identify Market
Catalysts.

Ready to Transform Your
Regulatory Workflow?