Support for the marketing authorisation application through the centralised procedure 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, 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.
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