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…
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…
The French regulation on the prevention and management of stock shortages of medicinal products is part of the European legal framework defined by Directive 2001/83/EC, one article of which (81) establishes the principle of the responsibility of manufacturers and distributors…
"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…
There is a high demand around the need for antibody testing and the media frenzy surrounding the subject shows it is clear there is a poor understanding of what type of test is useful, how the test can be qualified,…