A small biotechnology company entrusted BlueReg (BR) to prepare and coordinate their MAA for registration in Europe through the centralised procedure (CP) including full regulatory and scientific writing support.   This project consisted in support for MAA in Europe,…

  BlueReg (BR) was engaged to assist a start-up company with the preparation of their orphan drug designation application dossier in Europe and to provide regulatory support during the procedure.    Challenges: Timelines: the client contacted BR a short time…