Freyr SUBMIT PRO, with the help of its document viewer functionality, helps to understand how the documents appear to the authorities in a specified eCTD format, thus avoiding any missed-out eCTD publishing elements for the reduction in eCTD review time. It allows the user to view submissions in a cumulative table of content, Regulatory and study views. Hence, users can minimize their errors before submitting to the Agency. Inbuilt eCTD viewer also allows reviewing legacy eCTD submission of the product within the system without installing additional software.

The in-built eCTD viewer ’s design enables users to review the Regulatory submissions prepared in the standard eCTD format used by the life sciences industry and the Regulatory authorities.

It assists users in viewing the USFDA, EU, CH, CA, GCC, JFDA, TH, ZA, TGA, and CN applications in different views such as table of contents view, sequence view, Regulatory activity view, folder view and study view.

Highlights of eCTD viewer

• Designed to view eCTD submissions specifically for users who do not need to know the technical aspects of the eCTD compliance. Most users can start using eCTD viewer without any training
• Freyr’s in-built eCTD viewer can easily handle smart eCTD view to review eCTD format documents/submissions quickly
• Freyr’s in-built eCTD viewer is compliant with the latest eCTD specifications and in line with the recent agency-specific guidelines