Regulatory & safety intelligence for life sciences From medical devices, drugs and biologics to safety, compliance, clinical trials, coverage and standards, worldwide.

Premarket submissions, registrations and device identifiers.

• FDA 510(k), De Novo, PMA, HDE and Emergency Use Authorizations (EUA)
• FDA product codes and classification, with regulatory assessment
• 510(k) predicate trees
• GUDID (US UDI), EUDAMED (EU) and the GUDID–EUDAMED crosswalk
• FDA device and establishment registration and listing
• PMDA approved devices (Japan)

Approvals, labels, products, substances and shortages.

• Drugs@FDA approvals and approval documents, including complete response letters
• Orange Book, DailyMed labels and the NDC directory
• UNII substances and inactive ingredients
• FDA approved vaccines and their documents
• FDA drug establishment registrations
• Drug shortages (FDA and ASHP)
• PMDA approved drugs (Japan)

Adverse events and recalls, with safety-signal analytics.

• MAUDE medical device adverse event reports
• FAERS drug and biologic adverse event reports
• VAERS vaccine adverse event reports
• FDA recalls for devices and all other product types, and FDA recall alerts
• Adverse events, recalls and field safety notices from regulators outside the US
• Safety signals by device brand and manufacturer, drug and manufacturer, and vaccine and lot

The inspection and enforcement history behind FDA-regulated sites.

• FDA inspections and their classifications
• Inspection citations by CFR section
• 483, EIR and CRL documents
• Warning letters
• FEI establishment profiles and Compliance Assessment Reports
• FDA investigator profiles
• Compliance Program Guidance Manuals (CPGM)

Inspections, certificates, licences and registrations beyond the FDA.

• EU
• UK
• Canada
• Switzerland
• Japan
• WHO

• Health Canada inspections, citations, establishments and licences
• MHRA (UK) GMP and GDP, paediatric investigation plans and e-cigarettes
• EMA EudraGMDP certificates and inspections, sites and API registrations
• Swissmedic GMP and GDP
• WHO prequalification inspections
• PMDA (Japan) inspections and establishments
• UK NHS Freedom of Information data

Study designs, sites and outcomes, plus the peer-reviewed evidence.

• ClinicalTrials.gov studies, with facilities, contacts and outcome measures
• WHO International Clinical Trials Registry Platform (ICTRP)
• Peer-reviewed literature

How US insurers cover devices, drugs and procedures.

• Aetna
• Anthem
• Cigna
• Empire Blue
• UnitedHealthcare

• Clinical and medical coverage policies
• Linked to the devices, trials and literature they reference

The rules, guidance and consensus standards behind every submission.

• FDA guidance documents
• FDA recognized consensus standards
• MDCG, IMDRF/GHTF and ICH guidance
• Regulations and guidance from regulators worldwide
• FDA dockets on Regulations.gov
• The Orca1 document library

One profile per company, with its activity across the datasets.

• The Orca1 company index (OMI)
• FDA device and drug establishments
• The Global Facility Directory of manufacturers, suppliers, labs and CROs (Enterprise)