Variations are any change to the currently approved content of a Marketing Authorisation (MA) dossier and are essential in the lifecycle management of a medicinal product. For human use, this mainly concerns articles 8(3), 9, 10, 10a, 10b, 10c of…
A big pharmaceutical company entrusted BlueReg (BR) to assist its regulatory team in regulatory activities in SSFSA.
BlueReg made recommendations to a US based client on which Health Authorities in the European Union (EU) would be most relevant to consult throughout the development of their product. Following these recommendations, the client subsequently entrusted to BlueReg the authoring…
A global pharmaceutical company specialising exclusively in the research, development and marketing of medical solutions for dermatology entrusted BlueReg (BR) to validate its Publishing Software. With the objective to proceed with a major upgrade of their Publishing tool, and…
"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…