Precision’s team of experts have deep scientific understanding and significant experience in all aspects of bringing diagnostics, companion diagnostics, and their associated therapeutics to market – including assay development, clinical trial design and execution, regulatory strategy, registration, and commercialization.
Regulatory strategy development and execution. Our regulatory experts offer comprehensive to-market regulatory and evidence development strategies that anticipate areas of regulatory risk. We handle every facet of regulatory approval, from ISO and CLIA certification to authoring FDA, EU and rest-of-world submissions.
Market access, clinical utility, and evidence strategies. Our team both understands and can effectively present the information that payers require – including codes, fee schedules, coverage processes, and evidence – helping to provide rapid market access.
Pre-submission and marketing clearances. Precision has delivered over 250 proven market clearances and over 100 IVD pre-submissions globally, along with numerous favorable coverage and payment decisions for both diagnostics and companion diagnostics – among which are several game-changing, first-to-market innovations.