How we supported the client
Provided guidance on the benefits and incentives of SME status in the EU for the orphan designation application process
Offered strategic oversight and guidance on the EU orphan designation application process and best practices for navigating the submission process
Assisted in the submission of the Orphan Designation including publishing through our partner network
Assisted in preparing and submitting the application through the appropriate EU portals, including IRIS (a secure online platform for handling product-related scientific and regulatory procedures with the European Medicines Agency (EMA))
Strategically laid out options when and where to go for scientific advice in Europe by weighting national versus central advice based on client`s needs and planned development program
Wrote the scientific advice package
/ orphan designation as well as reviewed
Advised on opportunities of acceleration options in Europe
Submitted a request for a SME
(micro, small and medium-sized enterprises)
Strategic
Regulatory
Advice
Interactions with Health Authorities
Submission
Management
Partnering with industry experts
