Chosen by top LifeSciences and Medtech companies
What is a quality and regulatory intelligence (QRI) platform?
Our proprietary processes transform millions of data points and signals, from hundreds of health agencies, into meaningful answers and insights that reduce regulatory and compliance risk.
Inspection Preparation
Go from reactive to proactive with fact-based inspection preparation.
Learn More - Investigator profiles
- Inspection outcomes mapped to quality system
- Inspection types
- Industry trends mapped to GxP quality system
- Peer benchmarks
Vendor Quality
Get timely alerts about how your key vendors/suppliers are doing in their inspections
Learn More - Site and Organization profiles with full inspection history
- Monitoring and alerts for inspections and enforcement
- Vendor benchmarking
- Supplier due diligence
Regulatory Surveillance
Stay up to date with the latest regulatory updates impacting your specific areas of interest (ex. GMP, GLP, GCP, Human Drugs, etc.).
Learn More - Global GxP source coverage
- Enriched and searchable content
- Simple dashboard
- Integrated workflows
- Translations and change tracking
Inspection Records
vs.
279,000 in FDA Dashboard
vs.
279,000 in FDA Dashboard
Documents*
vs.
2,000 in FDA Dashboard
vs.
2,000 in FDA Dashboard
Searchable Observations
vs.
0 in FDA Dashboard
vs.
0 in FDA Dashboard
Inspection Reason
vs.
0 in FDA Dashboard
vs.
0 in FDA Dashboard
*483s, Warning Letters, EIRs, etc.
We’re in your corner
We partner with over 200 customers in highly regulated industries, including 19 of the top 20 pharma companies and 9 of the 10 top medical device companies.
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