CDx & IVD Consulting
Fast-track your commercialization with end-to-end companion diagnostic (CDx) to laboratory-developed tests (LDT) and invitro-diagnostic (IVD) strategic insights.
Acutis Biosciences provides support and knowledge base across the full development spectrum of drug and IVD device development from discovery through registration and lifecycle management.
Our team of experts have validated hundreds of assays on different technologies/platforms including NGS, Sanger, PCR, gene microarray, IHC, ISH, flow cytometry, LC/MS, CTC, cfDNA and single/multiplex immunoassays using effective tools for mitigating biological, pre-analytical, and analytical variables.
We offer full proficiency in GLP, GCP, GCLP, GMP, FDA, CLIA, CAP and ISO regulations and guidelines as well as PK for small and large molecules, ADA assays, and PK/PD data analysis and interpretation.