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Capability

AI-assisted regulatory intelligence

Suppliers
1
States & provinces
1
Countries
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1 ai-assisted regulatory intelligence supplier across 1 states and provinces in 1 country. Profiles show capabilities, materials, certifications, and facility locations so you can compare shops and build a shortlist.

Suppliers

BOUDICCA DX, LLC

BRENTWOOD, TN

Boudicca® DX is a transatlantic precision medicine consulting and CRO firm with business operations legally established in the EU and US (Brentwood, Tennessee, US and Dublin, Ireland, EU). Founded by Dr. Kelly Gordon, it provides regulatory strategy and full-service CRO support for precision medicine tests, medical devices, and targeted therapies across the EU, US, and Rest of World, with 10+ years in business and 169 clients.

clinical biomarker strategycompanion diagnostics developmentISO 13485IVD developmentLDT developmentQMSR complianceregulatory strategyregulatory submissionsreimbursement and market accessSaMD development

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