Freyr SUBMIT PRO helps to understand how the documents appear to the authorities in a specified eCTD format , thus avoiding any missed-out publishing elements for the reduction of 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 submissions 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 eCTD format standard 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 ASEAN 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. 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
There are different views to review and manage the submissions using Freyr’s in-built eCTD viewer
- The user can view all the modules with their respective documents, lifecycle operations and folder structure in cumulative view (with all sequences) by default.
- The user can view all the sequences as main nodes with their respective documents and folder structure.
Regulatory Activity View
- The user can view the sequence and its related sequences in the Regulatory activity view section.
- The user can view all the sequences with their respective documents and folder structure.
- The user can view M4 and M5 modules with views like outline, category and list of studies.