The submission routes for Combination Products can be overwhelming. Read here the hack to the submission routes with the FDA for Drug-/Device-/Biologics Combination Products. the… Read More »FDA Combination Product submission routes
Ever wondered what the differences between the consultation procedure and the Notified Body opinion is or are you confused on the terms? Then read on…… Read More »The difference between Consultation Procedure and Notified Body Opinion
You might have come across the terms electronic Quality Management System (eQMS) and electronic Document Management System (eDMS). But what exactly is the difference between… Read More »What is the difference between eQMS and eDMS
Data mining – which has evolved from a buzz-word to a real tool, can support in business process and procedure optimization. Learn here how this… Read More »Mine the gap – modern business process optimization
GTIN, the Global Trade Identification Number has attention in the health care industry and is on the rise. Does the GTIN offer a valuable alternative… Read More »GTIN a potential alternative to the pharmacode and the UDI?