Product Development & Commercialization
Actionable & immediate guidance on developing & commercializing precision medicine clinical tests (LDTs, 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 experiences, clinical assay development know-how & deep technical acumen across diverse biomarkers, specimens, technologies & therapeutic indications. Clinical Operations support for all stages.
Global Regulatory & Quality
Unparalleled continuous regulatory insights & intelligence supporting clients with global clinical trials & regulatory submissions with RegOps in both the US (Boudicca DX™, LLC) & EU (Boudicca DX™ Limited). Support ANVISA, EMA, EU IVDR, EU MDR, Health Canada, MEDSAFE, MFDS, NMPA CMDE, PMDA, UK MHRA, US FDA, & TGA submissions.