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…
Our experts at BlueReg are covering the Early Access Programs specific to France (ATU), and how to take advantage of it. The different subjects discussed in the webinar are : Why Early Access (ATU) for new innovative drugs in France…
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…
Our experts at BlueReg are covering the different pathways to accelerate your medicinal product launch in Europe. The different subjects covered are : 1. Regulatory Strategy - How to prepare the regultory launch sequence for your first medicinal product in…