At Sirius Regulatory Consulting we have extensive experience in supporting clients to successfully navigate through the EU orphan designation procedure, including:

• Strategic input and support
• Protocol assistance (scientific advice)
• Compilation of applications for orphan designation
• Successful hearings with the Committee on Orphan Medicinal Products

We have particular expertise in preparing critical elements of applications for orphan designation to ensure that these will meet regulatory expectation.

Sirius Regulatory Consulting will work with you to achieve successful orphan designation approval.