Documents

A French pharmaceutical firm (generic products) was directed by the French Health Authorities to prepare a Supply Shortage Management Plan (SSMP) for one of its medicinal products used in the context of a temporary recommendation for use*.  This was a…

Discover our reference guide on Medical Devices Regulation developed by our expert ! Regulation (EU) 2020/561 amending the dates of application of certain of provisions of Regulation (EU) 2017/745 is entered into force on April 24th, 2020. As specified in…

"During the summer 2018, authorities become aware of the presence of some nitrosamines in API – (Valsartan – presence of N- nitrosodimethylamine (NDMA) - other sartans – presence of N-nitrosodiethylamine NDEA).   These nitrosamines were already known as probable carcinogenic compounds…

A global biopharmaceutical company entrusted to BlueReg the management of daily regulatory activities for a large portfolio of medicinal products in various therapeutic areas, the objective being to focus their internal resources on strategic projects. The outsourced activities encompassed development…