Accelerate your orphan drug designation application

350 million people worldwide are living with a rare disease, but only 5% of known rare diseases have an approved treatment.1 We want to help you change that.

Accelerate your orphan drug designation application with our speciality understanding of rare diseases and regulatory pathways. Positioning you for exclusive clinical trial benefits sooner.

We have a proven record to help you succeed. Together, Coté Orphan and IQVIA are the largest submitters of FDA and EMA orphan designations, and have helped develop or commercialize 85% of all approved orphan drugs.2

Achieve orphan drug designation fast and efficiently – and make rare disease cures more common.


1. http://phrma-docs.phrma.org/sites/default/files/pdf/medicines-in-development-report-rare-diseases.pdf

2.FDA-approved orphan drug in 2015