Contact our experts today
Composed of proven experts from the pharmaceutical industry, our team is ready to answer to your needs in any area of product development, commercialisation and early access programs, and life cycle management
BlueReg (BR) was involved in the elaboration of a well-established use (WEU) dossier for an orphan drug in a life threatening and debilitating condition for the European Medicines Agency (EMA). BR initiated a systematic review of the literature on clinical aspects to support the WEU justification and updated it in line with regulatory requirements. BR also structured the non-clinical and clinical overview sections of this Common Technical Document (CTD). A regulatory risk / mitigation assessment was conducted for each WEU eligibility criteria in view of an EMA pre submission meeting.
Thank you for your interest in BlueReg.
The file will be sent to you by email.