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What regions/countries are supported in Freyr SUBMIT PRO today?
The eCTD format is supported in the US, Europe, Canada, Switzerland, Australia, GCC countries, Jordan, Thailand, South Africa, EAEU, China, and the ASEAN region.
What submission formats are supported in Freyr SUBMIT PRO?
The submission formats supported in Freyr SUBMIT PRO are eCTD format and NeeS format
Are paper submissions supported in the tool?
In the current eCTD format, paper submissions are not supported, but it's a planned roadmap item for next year.
Does Freyr SUBMIT PRO integrate with any third-party DMS?
Yes - It integrates with the following:
SUBMIT PRO can be integrated with other third-party DMS as well. We continue to add other renowned DMS to this list based on the requests we receive from our clients.
- Veeva DMS
- Master control
- Freyr DMS
We currently are not using any DMS. How can we bring our documents into Freyr SUBMIT PRO?
Users can bring their documents from SharePoint, FTP, and local drives into Freyr SUBMIT PRO. However, Freyr has its own rDMS that meets all your document needs and that comes along with out-of-the-box integration with Freyr SUBMIT PRO.
Where can we archive the final eCTD submissions?
The final submission packages can be stored within Freyr SUBMIT PRO configured location. In case needed, users can store copies of archived packages in a location of their choice through FTP.
Does Freyr SUBMIT PRO have the capability to validate the submissions?
Yes, Freyr SUBMIT PRO has the eCTD validator built in. It validates the submission against all the criteria set forth by health authorities and generates a report to help you with mitigating the identified issues in submissions post-validation.
Does Freyr SUBMIT PRO have viewing capabilities for others to view/review the eCTD submission?
Yes, it has an eCTD viewer built-in to review the submissions.
How frequently do you incorporate any change in regulations into the tool?
We are one of the niche providers of Regulatory technology and services across the globe. Keeping a constant tab on any Regulatory changes is key to our business. We have homegrown Regulatory intelligence tools and in-house subject matter experts who work on various global submissions that bring any plans of Health Authorities to change the guidelines. Health Authorities generally notify the industry about the change and provide a timeline for the change to come into force. Freyr ensures that such changes are always factored in as and when they come well before the timelines.
Prerequisites for using this tool (on-cloud)?
The pre-requisite requirement for using this eCTD tool is just a browser
How long does it take to implement from the present eCTD tool to another?
The implementation from the present eCTD publishing software to another is a standard cycle of 4-6 weeks, including training, approvals, and validation
Where are the submissions archived in Freyr SUBMIT PRO?
The eCTD Submissions can be archived into the submission repository. The repository is configurable to rDMS or share drive.
We are currently using a different system for eCTD publishing. How can we migrate our existing submission data?
Freyr offers you the migration service, and our team can migrate your existing data into Freyr SUBMIT PRO. There is a separate cost involved for migration that varies based on the number of sequences that needs to be migrated.
What deployment models does Freyr SUBMIT PRO support?
As of now, it supports two deployment models, the on-premises model and the cloud model.
If anyone is currently not using any DMS, how can we bring our documents into Freyr SUBMIT PRO?
Users can also bring their documents from SharePoint, FTP, and local drives into Freyr SUBMIT PRO. However, Freyr has its own rDMS that meets all your eCTD submission needs, and that comes along with out-of-the-box integration with Freyr SUBMIT PRO.
How do we manage the transition between the formats within a single application? That is moving from eCTD v3.0 to eCTD v4.0.
Forward compatibility should be used for any dossier that has v3.2.2 content where the application is being converted to an eCTD v4.0 message, which will enable seamless presentation between the two (02) versions, continuous reference with the previous version, and document reuse.
Does Freyr SUBMIT PRO support eCTD v4.0?
Support for eCTD v4.0 is currently in the works, and very soon, Freyr SUBMIT PRO will start supporting eCTD 4.0 as well.
How will the present eCTD v3.2.2 structure change in v4.0?
The hierarchy setup of the eCTD structure in the present v3.2.2 will alter and become a flat structure in eCTD v4.0. The context of use and keywords will be used instead of definitions within any eCTD tables of the content generated by the viewing tools.
How much do we know about how many different regions are planning to implement eCTD 4.0?
The plan to implement the instructions in respective regions will take a phased approach. Not all aspects of eCTD v4.0 are expected to be implemented from day one.
For suppose there is submission that is approved in one region (EU-EMA) and decided to submit the same submission to US FDA but in eCTD version 4.0,is it easy to support this?
Yes. Freyr SUBMIT PRO has the capability to clone eCTD submissions from one format to another format. Users can clone the submission, which is prepared in ICH v3.2.2 to eCTD v4.0 and hence make it an FDA electronic submission.
How do you handle SLP/DLP validations/checks that are not present in the current eCTD version 4.0 validation criteria?
The submissionunit.xml is used to organize both the ICH and regional sequence content, including the region-specific administrative/envelope information, metadata, and study data.
As there is no region-specific XML file, how is the region-specific administrative/envelope information submitted in eCTD version 4.0 for any given region? The submissionunit.xml is used to organize both the ICH and regional sequence content, including the region-specific administrative/envelope information, metadata, and study data.
How can submissions in the latest eCTD version 4.0 be reviewed without a stylesheet?
We aren't sure about other vendors, but Freyr SUBMIT PRO, in the eCTD submission process, will be supporting the review without a stylesheet.