Molecular Diagnostics Consulting, Inc

Molecular Diagnostics Consulting, Inc. is comprised of a team of expert consultants providing diagnostic product development consulting services to biotechnology companies in the life science industry. We specialize in guiding companies through the development process for FDA, RUO, and LDT diagnostic assays and devices. Our services meet the needs of new start-ups or established fast-growing companies at every stage of product development, from project planning to product launch. Services include molecular diagnostic assay design, project development plan, project management, clinical specimen sourcing, sample processing methods, regulatory compliance guidance and generating documentation for 510k FDA or CLIA.