Approximately 400 million people worldwide suffer from an orphan disease. With 8000 known rare diseases it is an area of a high unmet need from diagnosis to treatment.
In our capacity as a purpose-driven organisation we have been very keen to support organisations with acquiring the orphan designation in Europe and the US.
Our epidemiologists work very closely with our regulatory team to review all available data and complete the regulatory application for designation.
With the market exclusivity associated with orphan indications we have an inclusive integrated solutions to optimise success of projects in adult and paediatric populations.