Precision Medicine Product Development
Immediate & actionable guidance on developing & validating precision medicine testing products & innovative medical devices spanning diverse applications with over a decade of experience developing testing for clinical biomarkers, clinical laboratories (LDTs), IVD manufacturers (kits & single-site IVDs), & innovative medical devices (digital health, digital pathology & medical imaging).
Clinical Biomarker & Companion Diagnostic Development
Pragmatic clinical biomarker & CDx co-development guidance based on extensive Biopharma CDx experiences, direct IVD industry CDx know-how, deep assay development technical acumen & contemporary CDx regulatory insights across diverse biomarkers, specimen types, technologies & indications.
Global Precision Medicine Regulatory Strategy
Deep regulatory insights & intelligence from global Rx & Dx product development experiences, regulatory submissions for global clinical trials, IVDs & medical device regulatory marketing submissions.