Covance Central Laboratory Services in Shanghai Helps Clients Navigate Chinese Regulatory Reform

Following the rebrand and restructure of the Chinese regulatory body, the China Food and Drug Administration (CFDA), in 2013, the regulation process now includes inspections for all multi-national and local pharmaceutical companies with drug filings in China. As a continued commitment to meet clients’ needs and conform to local Chinese …

ELISPOT Assay: A Powerful Tool in Vaccine Development and Immune Monitoring

Over the past several years, the scientific community has made tremendous progress in advancing our understanding of the immune system, from the basic functions of its various components to molecular pathways that operate within those components. With new, state-of-the-art tools and technologies, immunologists now have the ability to better understand the …

Covance Mobile Health Blog

Developing a Successful Regulatory Strategy for Mobile Health Devices and Applications

For many technology companies entering the mobile health space, meeting US Food and Drug Administration (FDA) requirements may be unfamiliar territory. The guidelines can appear convoluted and contradictory at first glance, and some devices and/or applications (apps) fall into regulatory grey areas. To make progress in this rapidly changing field, …