If you are developing an orphan drug, you may want to apply for Orphan Medicinal Product Designation. An Orphan Medicinal Product Designation gives you incentives such as reduced fees and early Scientific Advice. Bronsing develops the required documentation, applies for Orphan Medicinal Product Designation, and helps you defend your product in oral explanations.
Is my drug eligible for Orphan Medicinal Product Designation?
Bronsing helps you decide if application for OMPD is useful on the basis of available guidance and, if applicable, competitor products.
When should I apply for Orphan Medicinal Product Designation?
You can apply for OMPD at any stage of product development; during exploratory clinical trials or at a later stage. However, Phase I or II (the early clinical trial phases) are a good moment for this important designation in order to get interactions with EMA started in an early stage of development.