White Papers
KNOWLEDGE CENTER

CER : new MEDDEV 2.7.1 REV 4: Why is This More Complex Now

In July’2016, the EU has published Rev.4 of MEDDE V2.7.1 on clinical Evaluation for medica l devices.The new guidance document describes the requirement in a more detailed



Central Monitor: A Key Driver of Centralized Monitoring, published in Applied Clinical Trials

Centralized monitoring offers many of the capabilities of on-site monitoring as well as additional capabilities. With the advent of various eClinical technologies, analytical and visualization tools.



An Article published by RAPS: SouthEast Asian Regulatory Environment for Pharmaceuticals Part -I

This Study attempts to capture some of the key elements that companies should consider when planning to enter ASEAN markets of Brunei, Vietnam, Laos, Myanmar (Burma) and Cambodia.



Have Questions? Need Info/Quotes?