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 pharmaceutical company contacted BlueReg to help them manage the change of address of the Marketing Authorisation Holder (MAH). In Europe, they had several products registered via centralized procedures (CP) and several products registered via Mutual Recognition Procedures (MRP). They…