Goldbug Strategies Llc

Goldbug Strategies is a regulatory consulting firm that works with select clients engaged in developing and marketing molecular therapies, in-vitro diagnostics, and innovative digital technologies. We provide strategic insight, planning and implementation to enable our clients to successfully drive the development, commercialization, and ongoing marketing of their new and modified products. We use the collective genius of our team to drive customer value by creating unprecedented solutions to regulatory barriers. Our expert consultants focus on a niche segment of the U.S. Food & Drug Administration (FDA) across different IVD technologies and platforms (NGS, PCR, Immunoassays, Flow Cytometry, etc.), therapeutic areas (oncology, infectious diseases, neurodegenerative disorders, etc.) and clinical use areas (single site IVD, distributed kits, direct to consumer (DTC), over the counter (OTC), laboratory developed tests (LDTs)). Our approach to client projects incorporates an entrepreneurial perspective with the necessary expertise to meet company’s consulting needs in an evolving marketplace and regulatory policy environment. Our expert consulting services create benefits that convert into tangible results for companies that have the desire to disturb the industry with innovations.