Coordination and Regulatory support across Europe for an innovative product/orphan drug

May 12, 2022
  • Drug Development

The Vice-President Global Regulatory Affairs of a US based company developing an important innovative product (orphan drug) contacted BlueReg to seek regulatory support to discuss the different stages of development in Europe.

Our Client Objectives:

  • Understand the pathway towards approval in the proposed market and target therapeutic indication.
  • Anticipate potential discussion highlights with regulators and take advantage of pathways according to product type/category (ATMPS, ODD).
  • Prepare a robust regulatory dossier that details application in order to optimize chance of approval and success.
  • Alignment of EU with US strategy (streamline & capitalize, minimize change & cost).

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