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, with the following constraints:

• First MAA for the client
• Tight timelines for dossier preparation and submission
• Scientific challenges due to BR’s involvement at the last stage of development in order to prepare and submit a dossier according to the applicable regulatory requirements.