Documents

  A small biotechnology company entrusted BlueReg (BR) to prepare and coordinate their MAA for registration in Europe through the centralised procedure (CP) including full regulatory and scientific writing support.   This project consisted in support for MAA in Europe,…

  BlueReg (BR) was engaged to assist a start-up company with the preparation of their orphan drug designation application dossier in Europe and to provide regulatory support during the procedure.    Challenges: Timelines: the client contacted BR a short time…

  During the 1990s, new types of innovative medicinal products emerged i.e. tissue-engineered medicinal products and cell therapies.  At this time, these innovative products were regulated under national law in each European Member State with different regulatory statuses (i.e. medicinal…

  The first common regulatory framework on Clinical Trials (CT) in the European Union (EU) has been established in April 2001 following the adoption of the Directive 2001/20/EC (hereafter referred to as “the Directive”).   The scope of the Directive…