CoreLEX will support your local registration roll out in ICH and non-ICH regions by providing you with guidance and regulatory services on the various important steps of your regulatory plans. We provide flexible operational platforms to meet your company’s needs for any pharmaceutical forms of drugs, medical devices and biological products.
Medical devices are products or equipment intended for a medical purpose. In the European Union (EU) they must undergo a conformity assessment to demonstrate they meet legal requirements to ensure they are safe and perform as intended. They are regulated at EU Member State level, but the E...
