Reference guide on Medical Devices Regulation 26 May 2020 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…
Evaluation of the risk of nitrosamine impurities 6 May 2020 White papers "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…
Global Regulatory Affairs (GRA) Outsourcing Platform 18 February 2020 Case studies 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…
Expert CMC advice on quality dossier preparation in support of a Compassionate Use Program in France. 28 May 2019 Case studies In the context of PRIME, a European biotechnological company entrusted BlueReg CMC team with the task of bringing the available quality data package of a synthetic peptide to global registration prerequisites for the next steps of development (the Compassionate use…
