Gaining Orphan Drug Designation
The Client…
- was a medium-sized US-based company with offices in the UK and Europe
- wanted to prepare their first application for Orphan Drug status
- had no in-house medical writing resource
- was undergoing major internal change that was threatening the ability to deliver the application
…so what we did was…
- review of the disease area from ~50 literature articles and reviews
- develop a template for the submission
- collate and review the available in-house data and write the application
- liaise with the EMA on the Client’s behalf to address EMA questions
- manage the entire project during a period of personnel changes within the Client company
…and the outcome was…
- submission delivered despite a period of significant change within the Client
- Orphan Drug status was granted by the EMA with no delays
- Spectrum’s services were recommended to another company with similar needs who commissioned a project with us
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