A small US pharmaceutical company aimed to enter the French market with a late-stage haematology drug but faced funding delays. Clinigen’s Exploitant services facilitated this entry by converting the EU eCTD format to the French format, ensuring compliance with French regulations. They provided a tailored regulatory strategy, extended the compassionate use program, and maintained regulatory compliance, allowing the drug to remain available to French patients.

Read the case study and learn how Clinigen's comprehensive support ensured the drug’s market presence and operational efficiency until the company was ready for a full launch.