A European mid-sized pharmaceutical company specialising in orphan-designated products sought to register their anti-cancer medicinal product in Australia. Clinigen facilitated this by converting the EU eCTD format to the Australian eCTD format, ensuring compliance with TGA requirements. Their expertise in regulatory affairs and eCTD publishing, combined with efficient workflows and strong collaboration, ensured timely and precise submissions. 

Read the case study about the comprehensive support provided by Clinigen that led to the successful market entry of the orphan medicinal product in Australia.