A Japanese mid-sized pharmaceutical company specialising in innovative rare genetic disorder treatments faced multiple challenges in expanding their product globally. Clinigen provided regulatory strategy, compliance support, and strategic assistance, including obtaining key designations from the US FDA and EMA. This partnership enabled the company to navigate complex regulatory landscapes and focus on core activities, ultimately increasing the treatment’s availability to patients.

Read the case study to learn how Clinigen’s expertise in global regulatory environments and unlicensed supply regulations helped ensure the product’s successful global expansion.