The implementation of the European Medical Device Regulation, Regulation (EU) 2017/745 (MDR) and the publication of numerous guidelines could increase the already existing confusion about the association of medicinal product or medicinal substance with medical device. The objective of this…
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…
A global specialty-driven biopharmaceutical group focused on innovation and specialty care, entrusted to BlueReg the the preparation and coordinateion of 60 eCTD Baseline submissions for registration in Europe through the National Procedure (NP).
A company entrusted BlueReg to support them to prepare their first local market product launch in Europe, to allow the patient to obtain the medicine at the earliest point possible.
