FAQs

Freyr SUBMIT PRO

• How about the validation and validation report for SUBMIT PRO? Do we have any confirmation from compliance? Can we share any information regarding this?
• What is the retention period of customer backup?
• What is the support model and SLA post go-live?
• Do we have built-in bookmark/link manager/auto bookmark in SUBMIT PRO?
• Does Freyr SUBMIT PRO support the ability to publish eCTD-compliant submissions in-house via a cloud-based environment for multiple regions?
• Does Freyr SUBMIT PRO have the ability to render source documents to submission-ready PDFs while maintaining bookmarks and hyperlinks according to the requirements of regional health authorities?
• Can Freyr SUBMIT PRO create Non-Clinical and Clinical Study Tagging Files for the appropriate regions?
• Does Freyr SUBMIT PRO apply live validation during the publishing of the eCTD backbone and provide detailed reports on validation issues?
• Can Freyr SUBMIT PRO generate and submit SPL labeling, REMS components, and drug listing information?
• Does Freyr SUBMIT PRO update eCTD Templates efficiently as new specifications or regional Module 1 sections are released?
• Can Freyr SUBMIT PRO clone the current view of an application from one region to another and clone a sequence from one application to another?
• Can Freyr SUBMIT PRO complete report-level publishing compatible with tools like DXC Toolbox Pharma Edition?
• Can Freyr SUBMIT PRO access Veeva Vault submission content plans and associated documents for secure publishing?
• Can Freyr SUBMIT PRO directly integrate with the Veeva Vault standard API to provide drag-and-drop document capabilities and other API functionalities?
• Can Freyr SUBMIT PRO access Health Authority electronic secure gateways locally from within the tool or provide available integrations to the gateways?
• Can Freyr SUBMIT PRO plan submissions leveraging Veeva Vault submission content planning tools and provide appropriate access to the vendor?
• Can Freyr SUBMIT PRO validate Clinical and Nonclinical data against current CDISC and health authority specifications, including FDA Study Data Technical Rejection Criteria?
• Does Freyr SUBMIT PRO support eCTD v4.0 according to ICH and regional specifications and have forward-looking support for emerging technical requirements?
• Can Freyr SUBMIT PRO integrate with Veeva RIM system to provide real-time publishing status?
• Can Freyr SUBMIT PRO publish directly from the Veeva Vault environment and into the Veeva Vault Archive, maintaining all intra-document links and relevant navigation elements?
• Does Freyr SUBMIT PRO allow a broader user base to view eCTD submissions with expected functionalities like cumulative and sequential views?
• Can Freyr SUBMIT PRO provide QC capabilities for a broader user base, including making comments, indicating broken links, and tracking issues?