White Papers

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.

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