CHAPTER 2: Introduction: Regulatory Development Hurdles for Biomarker Commercialization: The Steps Required to Get a Product to Market
Published:10 Jun 2013
Taking a product from discovery to commercialization is a complex process. It is a process that requires familiarization and expertise in the regulatory arena and general understanding of quality‐system requirements. This chapter addresses the steps required to get a product to market and the considerations from a regulatory and quality perspective.