Advanced Therapy Medicinal Products (ATMP) are promises medicines for untreatable and high burden diseases where conventional approaches are inadequate such as cancer, cardiovascular diseases, musculoskeletal conditions, or immune system disorders1. To allow patients timely access to these new therapies a…
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…
Our experts at BlueReg are covering the different aspects of the Paediatric Plan, specific to the European Market. The different subjects covered are : 1. Regulatory Strategy Why do we need an EU Paediatric Plan? Is a PIP…
"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…