FDA


Role of FSMA in Shaking the Food Safety Practices of APAC and ROW Markets

Role of FSMA in Shaking the Food Safety Practices of APAC and ROW Markets

“Why let people sick and respond to it while we could actually prevent it with resources we have?” – Perhaps this was the thought the USFDA regulators had when they were drafting the Food Safety Modernization Act (FSMA). When I was conducting my research on the food safety testing market, […]


Computer System Validation

Computer System Validation (CSV): An AcuBiz Perspective

By Vimal Kumar, December 14, 2015   Computer System Validation (CSV) requirement has not received much attention as part of regulatory compliance process by many Southeast Asian companies. This is an often-neglected aspect, which is addressed much later in the product development and commercialization processes by the companies. However, lack […]


CE Marking or FDA? A Rapid Test Developer’s Dilemma in Malaysia

  By Syamala Ariyanchira,    November 22, 2015 CE marking does not guarantee market acceptance of a rapid test in #Malaysia. Click To Tweet “CE marking is not good enough. In fact, we would prefer a rapid test with FDA approval.” I was exploring the interests of a medical device […]