Two pharmaceutical companies sought solutions for review of promotional and non-promotional materials to ensure compliance with the European Union (EU) and national country legislation and guidelines for medicinal products. The objective for BlueReg was to provide provide a sustainable,…
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…
In this White Paper, we will be sharing all the Q & A’s from our previous Webinar on ‘How to accelerate your medicinal product launch in Europe’. We have divided the Q & A’s into 4 main topics...