10 Small Submissions
No more than 10 Documents per submission
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 eCTD submission process, Freyr SUBMIT PRO offers a clone option wherein the applicants can duplicate eCTD Modules 2 to eCTD module 5 structure from the already submitted dossier without any challenges aligning with the eCTD submission specifications. Thus, module cloning reduces costs per eCTD submission and saves much time. Users can also change from STF to study while cloning eCTD submissions from the US to the EU or other regions.