Freyr SUBMIT PRO

A smart, cloud-based eCTD software for creating, validating, and publishing the eCTD Submissions data.

Freyr SUBMIT PRO Features

Inbuilt eCTD Validator

The Inbuilt eCTD validator supports all the regional and ICH validation criteria and can identify as many as 800+ error scenarios. It enables user/s to validate their submissions for various health authorities and their eCTD requirements. The eCTD software’s inbuilt validator simplifies the steps of submission and increases overall efficiency by providing a comprehensive validation report.

Inbuilt eCTD Validator

eCTD Submission Tracking

Freyr SUBMIT PRO, an eCTD publishing software, allows you to track the entire status of your submission right from creating, updating, and reviewing the data to submitting it. It notifies the applicants if there is any need for a change of follow up. The eCTD publishing software allows the users to collaboratively review the submission and configure alerts for the important events for the particular submission. The intelligent reporting system can track the number of submissions, deadlines, and helps you define priority tasks; thus, you can eliminate the risk of missing the submission deadline. It also offers user-perspective tracking and allows for a comprehensive outlook of the entire submission procedure.

Submission Tracking

Health Authority Query Management

Timely communication with health authorities (HA) is necessary to gain a speedy approval. Freyr SUBMIT PRO allows the user/s to manage and track all the HA queries at one place for each product. The HA query management helps the user/s to decode what type of query has been raised, when is it received, who is the responsible person and what are the associated deadlines, and how many of them have been resolved.

Health Authority Query Management

Integration with Leading rDMS

Freyr SUBMIT PRO, a cloud-hosted eCTD publishing software, is built with a solid combination of flexibility and security. It facilitates seamless integration with leading Regulatory Document Management Systems (rDMS), the client is using, in a secured manner so that the applicants can assuredly call their confidential data into Freyr SUBMIT PRO eCTD tool without any need to create any extra folders.

Integration with Leading rDMS

Collaborative Submissions, Preparation and Review

Freyr SUBMIT PRO, an eCTD publishing and submission software assists you to manage multiple submissions in parallel. The eCTD software enables you to create easy to review documentation for quick product approvals and on-time product launches. At times, to meet the stringent deadlines, multiple users may have to work on the same document/module /application simultaneously. In such a scenario, Freyr SUBMIT PRO offers an easy-to-manage environment for the users to share the work and complete the task within the required time. All the documents can be uploaded and reviewed concurrently to meet the agency deadlines successfully.

Collaborative Submissions, Preparation and Review

Inbuilt eCTD viewer

Freyr SUBMIT PRO helps you to understand how the documents appear to the authorities in a specified eCTD format, thus to avoid 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 to review legacy submissions of the product within the system without installing additional software.

Inbuilt eCTD viewer

Inbuilt PDF Manager

Freyr SUBMIT PRO offers the inbuilt PDF manager which allows users to maintain documents in a specified format. It enables users to create bookmarks, internal and external hyperlinks within the eCTD software. The PDF manager also helps in securing the submission document with specified access controls for editing and viewing, making the eCTD submissions more manageable and safer.

Inbuilt PDF Manager

Import Utility

Import utility helps the users to migrate any pre-owned dossier from another platform to Freyr SUBMIT PRO with ease. For example, if there exists a version of your submission in any external platform or tool, our eCTD solution allows you to migrate the same submission documents into the current system without hindering any procedure, which indeed enables better life cycle management.

Import Utility

Module Cloning

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 submission process, Freyr SUBMIT PRO offers Clone option wherein applicants can duplicate Module 2 to 5 from the already submitted dossier without any challenges aligning with eCTD requirements.  Thus, to reduce costs per each submission and saving a lot of time.

Module Cloning

Cross Reference

Similar to the Clone feature, Freyr SUBMIT PRO offers cross referencing wherein applicants can actually mention the path of the physical files instead of duplicating or cloning. It helps applicants to link objects that are relative. You can create references within the document which can lead to supportive elements of previous submissions.

Cross Reference