A French pharmaceutical affiliate entrusted BlueReg to support them for the whole process of submission (advice, writing activities and support for meeting with the Competent Authorities) of a cohort Temporary Authorisation for Use (cATU) request to the ANSM for a…
A European pharmaceutical company entrusted PharmaBlue (a BlueReg Company) as French «exploitant» with the responsibility of submitting, obtaining and implementing a French Early Access Program called “ATU” (Autorisation Temporaire d’Utilisation) for its orphan drug for patients in nominative and cohort…
A French pharmaceutical firm (generic products) was directed by the French Health Authorities to prepare a Supply Shortage Management Plan (SSMP) for one of its medicinal products used in the context of a temporary recommendation for use*. This was a…