About BOUDICCA DX, LLC
Boudicca® DX is a precision medicine consulting and CRO services firm specializing in the development and commercialization of medical devices, tests, and software, with expertise in regulatory and technical compliance across the EU, US, and Rest of World. They leverage AI-assisted regulatory intelligence and have supported over 200 global trials and 1,000+ regulatory submissions.
Precision medicine test and device development (LDTs to IVDs to SaMD)Clinical biomarker and companion diagnostic strategyRegulatory and quality affairs expertise across EU, US, and Rest of WorldAI-powered biomarker and regulatory intelligenceCRO and regulatory strategy servicesSupport for global trials and regulatory submissions
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