Our client is a biotechnology company that has recently entered phase II clinical studies for a medicinal product for a rare disease. They were seeking guidance on how to navigate the EU regulatory environment to ensure that their product could be registered in the future.

The client is a small US-based company that has set up an affiliate in Europe and been granted SME status. The company wishes to file an Orphan Designation in Europe and benefit from the SME incentives offered for this process. They require strategic EU regulatory support, publishing assistance, and help setting up EU submission portals.