BlueReg supported a US‑based client with its promotional launch campaign in Europe for their new medicinal product.BlueReg provided full coverage for all aspects of setting up and coordinating the global and local reviews of the various promotional items of the…
A pharmaceutical company contacted BlueReg experts on promotional material for review of a non-promotional website and associated chatbot. The chatbot is an interactive tool with which the user can interact. Different information, in relation with the website on which the…
BlueReg was engaged to assist a biopharmaceutical company based in France with the preparation and the submission of transfer of marketing authorisation applications for a product authorised through the Mutual Recognition Procedure.
BlueReg was involved in the review of a Hybrid Application for a medicinal product in Ophthalmology to be submitted to the European Medicines Agency (EMA). BlueReg reviewed the Module 3 (Quality) as well as the Quality Overall Summary (QOS), Non-Clinical Overview…
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…