In the context of PRIME, a European biotechnological company entrusted BlueReg CMC team with the task of bringing the available quality data package of a synthetic peptide to global registration prerequisites for the next steps of development (the Compassionate use…

A US-based customer contacted BlueReg (BR) for assistance in reviewing the CMC and non-clinical development package in view of a FIH clinical trial that will be conducted in Europe.

  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…