Orphan Diseases
QbD can support you in the development of medicines for patients suffering from rare diseases. Orphan drug designation (ODD) in Europe provides a number of incentives for pharmaceutical companies including prolonged market exclusivity, reduced agency fees, and access to protocol assistance.
How we support you
- QbD can author or provide support for ODD applications including pre-submission meetings before filing your ODD application and response to questions/oral explanations during the procedure.
- Beyond designation, QbD can support the required obligations for orphan drugs including annual reports and the application for the maintenance of ODD at the time of marketing authorization.
Why QbD Group?
Benefit from our team of highly qualified consultants. ​
Full support from pre- to the post-marketing phase.​
QbD Group operates on a global scale, with offices strategically located across Europe and South America. This extensive network allows us to efficiently execute projects in diverse locations worldwide.
Constant evaluation, transparency and clear objectives.​
Contact us
Contact us for more information or to request a free, no-obligation proposal.
