A mid-sized Japanese pharmaceutical company partnered with Clinigen to enter the African market with their new breast cancer treatment. Clinigen facilitated this by implementing unlicensed patient access programs and acting as the Marketing Authorisation Holder, ensuring regulatory compliance and managing all commercial activities. This approach allowed the company to test the market early and successfully expand their services across nine African countries.


Read the case study to learn how Clinigen’s expertise in regulatory strategy and local market complexities helped ensuring a seamless and compliant market entry.