Certified Women-Owned Research and Development in Biotechnology (except Nanobiotechnology) in Washington

• Provide strategic, operational, procurement, quality, regulatory, and CMC, talent development and leadership mentoring in the fields of Biotechnology, Pharmaceutical R&D, Analytical Testing & Clinical Trials from early-, mid-, and late-stage of clinical development through to commercial licensure of biologics, and drugs including monoclonal antibodies, fusion antibody proteins, recombinant human coagulation factors, cytokines, growth factors, therapeutics, vaccines, cell and gene therapy products. • Subject Matter Expertise in arenas of biologics, vaccines, cell and gene therapy: process development, scale up, global technology transfers, facility DQ, IQ, OQ, PQ, validation & start up, commercialization, drug launches, and large-scale CGMP manufacturing from clinical through to commercial manufacturing & distribution, quality & compliance, analytical testing strategy, regulatory submissions and inspections with world-wide health authorities and regulatory agencies.

BioSynchronicity Corporation is a Woman Owned Small Business (WOSB) focused on Biotechnology Research and Development, design and manufacturing of diagnostics for the medical, dental, and veterinary industries, as well as laboratory services, next generation genomic sequencing, including preventative early cancer screening, surveillance, and recurrence testing. Our flagship BioSynchronicity C-Sync™ Lateral Flow Assay technology platform was launched in 2020. Our C-Sync™ COVID 19 multi target rapid antigen test detecting both nucleocapsid and spike proteins was granted an EUA by the FDA in 2023. A new innovative multiplex combination test for COVID and Flu, as well as an assay for Avian Influenza are in development. Graphene based electrochemical biosensor assays for the early quantitative detection of infectious diseases and other biomarkers are in the pipeline.