EXTEDO
16 Case Studies
A EXTEDO Case Study
Qilu, an Active Pharmaceutical Ingredient manufacturer based in China, faced the challenge of migrating their numerous global ASMF and DMF submissions into the eCTD format. To meet regional regulatory requirements, they turned to the vendor EXTEDO for help, using their eCTDmanager solution.
By implementing EXTEDO's eCTDmanager, Qilu was able to simplify the process of transferring their legacy submissions. This solution reduced errors and saved the company hundreds of hours of work, enabling them to comply with global regulatory practices more efficiently.