Strategic Regulatory Advice : We provided strategic guidance on the best timing and options for conducting scientific advice in Europe. We considered the advantages and disadvantages of both national and central advice and recommended the option that best suited the client's needs and planned development program.

Writing support: We assisted the client in writing the scientific advice package and Orphan Designation package, drawing on our expertise in rare disease products and regulatory requirements .

SME support: We assisted the client in submitting a request for SME status, which can provide additional support for micro, small and medium-sized enterprises in the EU regulatory environment.

Health Authority Engagement: We provided guidance on how and when to engage with the health authorities in relation to scientific advice and Orphan Designation application, and assisted in any interactions during the review process .

Outcome: Our client was able to successfully submit their Orphan Designation application and scientific advice package, and was granted SME status.

Overall, our strategic advice and operational support helped the client navigate the EU regulatory environment with confidence and speed up the development of their product. Additionally, our support in health authority engagement helped to ensure the interactions and submissions were successful.