Boudicca Dx.
Precision medicine product development accelerator offering on-demand consulting in assay and companion diagnostic development, regulatory strategy for US and EU submissions, clinical operations support, and software compliance for medical/diagnostic software. Services emphasize assay development and analytical validation, translational science, and commercialization/reimbursement strategy for academic groups, diagnostics companies, biotech, clinical laboratories and device developers.
Industries
Nr. of Employees
small (1-50)
Boudicca Dx.
Brentwood, Tennessee, United States, North America
Services
On-demand expert consulting for precision medicine product development, delivered as short engagements or programmatic support for academic groups, diagnostics companies, biotech, clinical labs and device developers.
Support for regulatory strategy and preparation of submissions and interactions with authorities in the US and EU, including investigational and commercial pathways.
Practical support for assay development, analytical validation planning and execution, and selection of appropriate technologies and vendors.
On-demand expert consulting for precision medicine product development, delivered as short engagements or programmatic support for academic groups, diagnostics companies, biotech, clinical labs and device developers.
Support for regulatory strategy and preparation of submissions and interactions with authorities in the US and EU, including investigational and commercial pathways.
Practical support for assay development, analytical validation planning and execution, and selection of appropriate technologies and vendors.
Expertise Areas
- Companion diagnostic and biomarker development
- Assay development and analytical validation
- Clinical trial planning and clinical operations
- Regulatory strategy and submissions (US & EU)
Key Technologies
- Next-generation sequencing (NGS)
- Immunohistochemistry (IHC)
- RT-PCR and qPCR
- FISH (fluorescence in situ hybridization)
News & Updates
Default blog post present on the site.
Default blog post present on the site.