Product Development & Commercialization
Actionable & immediate guidance on developing & commercializing precision medicine clinical tests (LDTs/IHTs, IVDs & Functional Testing), healthcare tools (Clinical Decision Support Tools, Digital Health Technologies & SaMDs), digital pathology software, drug development tools, medical devices & radiological imaging devices spanning diverse clinical applications.
Clinical Biomarkers & Companion Diagnostics
Pragmatic & strategic co-development guidance from decades of clinical biomarker & CDx development experience, assay development & validation know-how & deep technical acumen across diverse biomarkers, specimens, technologies & therapeutic indications.
Navigate Global Regulatory & Quality Compliance
Unparalleled continuous regulatory insights & intelligence supporting global clinical trials & regulatory submissions with RegOps in both the US (Boudicca DX™, LLC) & EU (Boudicca DX™ Limited). Support global clinical trial (investigational) & commercial regulatory submissions & apply Quality by Design.