The KeyPedia platform
Everything KeyPedia does.
The following page is an explication of the KeyPedia product, use cases, and product suite. For detailed pricing information, read our pricing philosophy. For detailed use cases and case studies, we suggest browsing our media page and library. For our AI guidelines, see our code of ethics.
New · RobotsAR Auditor glasses and the first fully autonomous audit and inspection robot.See the hardware →By product
This is the actual KeyPedia workspace: the same navigation your team gets on day one. Click through it, or search it.
KeyPedia
Regulatory data platform
Dashboard
Live FDA enforcement metrics and trend analysis across companies, sites, and products.
Key capabilities
- Browse 14,000+ enforcement records with filters, sort, and saved searches
- Country views across US, EU, Brazil, Canada, and China in one place
- Statistics, predictive risk, knowledge graph, and company map built in
- Real-time monitoring alerts on the searches you care about
The suite, specified
Read it top to bottom, from free to enterprise. Click a row to open it above.
| Product | Function | Industries | On the platform | Standalone | Access |
|---|---|---|---|---|---|
| Start freeSearch the record. $0, no account. | |||||
| KeyPedia LiteOpen KeyPedia Lite → | Free regulatory search | All industries | · | ✓ | Free · $0 |
| Make an accountAn account unlocks these. | |||||
| KeyPedia Agent | AI regulatory agent | All industries | ✓ | ✓ | Included with your account to start |
| Content LibraryThe media page → | Regulatory content | All industries | · | ✓ | Free with an account |
| KeyPedia HubOn the KeyPedia Lite pages → | Documents, reports & profiles | All industries | ✓ | ✓ | Pay per item |
| Chrome ExtensionGet it for Chrome → | In-browser search | All industries | · | ✓ | With Dashboard |
| Licensed suitesWhole products of their own, living on the platform. | |||||
| Valisure | Independent drug quality | Pharma, Biologics, Healthcare | ✓ | ✓ | Licensed separately |
| Devices & MAUDE by Riskbased.ai | Device risk intelligence | Medtech | ✓ | ✓ | Licensed separately |
| The DashboardYou buy the platform. Everything in this step comes with it. | |||||
| Dashboard | Regulatory data platform | All industries | ✓ | ✓ | Talk to us |
| Statistics | Enforcement trends | All industries | ✓ | · | Included in Dashboard |
| Predictive | Predictive risk | Pharma, Biologics, Medtech | ✓ | · | Included in Dashboard |
| Knowledge Graph | Relationship graph | All industries | ✓ | · | Included in Dashboard |
| Company Map | Geographic risk map | All industries | ✓ | · | Included in Dashboard |
| Audit Prep | Audit preparation | All industries | ✓ | · | Included in Dashboard |
| Document Generation | Document generation | All industries | ✓ | · | Included in Dashboard |
| FOIA Requests | FOIA management | All industries | ✓ | · | Included in Dashboard |
| Archive | Research library | All industries | ✓ | · | Included in Dashboard |
| Orange Book | Approved-drug reference | Pharma, Biologics, Healthcare | ✓ | · | Included |
| Enterprise, delivered into your stackSignals and scores where your team already works. | |||||
| ASL Intelligence | Supplier intelligence | Pharma, Biologics, Medtech, Healthcare | ✓ | ✓ | Talk to us |
| KRA | Risk scoring | All industries | ✓ | ✓ | Talk to us |
| RobotsSee the hardware → | Audit and inspection robots | Pharma, Biologics, Medtech, Food | ✓ | ✓ | Talk to us |
| Enterprise Connectors | Enterprise integrations | Pharma, Biologics, Medtech, Healthcare | ✓ | ✓ | Enterprise |
| REST API Access | Data API | All industries | · | ✓ | Enterprise |
| MCP Server | Agent connector | All industries | · | ✓ | Enterprise |
KeyPedia Agent
Chrome Extension
Valisure
Devices & MAUDE by Riskbased.aiBy industry
One record, one platform, every regulated industry.
By use case
Every use case is backed by published work: blogs, case studies, and webinars from the media library. The full use-case library →
| Use case | What it covers | Explore the work | Examples |
|---|---|---|---|
| Inspection Preparation | Know the investigator before they walk in. KeyPedia surfaces inspection histories, investigator profiles, and citation patterns across 80+ global health authorities — so your team has answers before the questions are asked. | All examples → | |
| Audit Readiness & Conduct | Whether you’re preparing to be audited or conducting a supplier audit, KeyPedia puts the regulatory evidence in your hands. Internal audit teams use it to close gaps before inspectors arrive. Auditors use it to build findings that hold up. | All examples → | |
| Observation & Report Writing | Writing a 483 response or drafting post-inspection observations requires more than good prose — it requires regulatory evidence. KeyPedia gives you the citation data to make your claims defensible and your documents inspection-grade. | All examples → | |
| Regulatory Monitoring & Intelligence | Don’t react to the inspection. See it coming. KeyPedia’s predictive analytics track warning letter trends, investigator activity, facility risk signals, and global guidance changes — so your team stays ahead of the regulatory curve, not behind it. | All examples → | |
| Supplier & Third-Party Risk | Before you sign a contract with a CMO or CDMO, pull their regulatory history. Warning letters, 483s, inspection outcomes, enforcement actions — KeyPedia surfaces everything a supplier would rather you didn’t find before the first call. | All examples → | |
| Global Market Intelligence | Regulatory intelligence doesn’t stop at the US border. KeyPedia aggregates enforcement data from 80+ health authorities — FDA, EMA, NMPA, ANVISA, Health Canada, PMDA — so your team understands the global risk picture, not just the domestic one. | All examples → | |
| FOIA & Records Access | FDA has records on every facility it has ever inspected. Most companies don’t know how to get them. KeyPedia automates anonymous FOIA requests, verifies existing records, and retrieves hard-to-find compliance documents — in three steps. | All examples → | |
| Drug Quality & Testing Intelligence | Regulatory filings don’t tell the whole story. KeyPedia integrates Valisure drug quality testing data — failed tests, contamination findings, market withdrawal signals — layered on top of enforcement history for the most complete picture of product risk available. | All examples → | |
| Device Postmarket Surveillance | MAUDE signals, device recalls, and competitor postmarket behaviour, read the way a device quality team needs it. Devices & MAUDE by Riskbased.ai watches adverse events and recalls continuously, with control charts and benchmarks on FDA device data. | All examples → | |
| Drug Quality & Procurement | Directors of pharmacy and sourcing teams use the record to buy on quality, not price alone. KRA risk scores, supplier history, and independent drug quality data sit behind every purchasing decision, so green is bought and red is avoided. | All examples → | |
| Physical Audit & Inspection | Machines, sensors and records report constantly, but someone still has to confirm what is physically on the floor. The AR Auditor and the autonomous audit robot check every asset, every shift, against what the systems claim. | All examples → |