Module Cloning

While you plan to market the same product in different regions, it is well known that except eCTD Module 1, i.e., region-specific information, the information in all other eCTD Modules 2 to 5, i.e., ICH-specific information remains the same. In such a scenario, to ease the submission process, Freyr SUBMIT PRO offers a clone option wherein the applicants can duplicate Module 2 to 5 from the already submitted dossier without any challenges aligning with the eCTD specifications. Thus, module cloning reduces costs per submission and saves much time. Users can also change from STF to Study while cloning submissions from the US to the EU or other regions.