Freyr SUBMIT PRO, an eCTD Software, Suits All Your Submission Requirements

Across the Globe and All Regional eCTD Formats

Freyr SUBMIT PRO, an eCTD Software, Suits All Your Submission Requirements

    Freyr SUBMIT PRO - a proven eCTD software for the life sciences industries.
    Pharmaceutical | Biotechnology


    Freyr SUBMIT PRO, an eCTD tool, supports diverse range of submission templates and formats required by the health authorities world-wide
    INDs | NDAs | ANDAs | MAA | NDS


    Freyr SUBMIT PRO, a cloud-based eCTD submission software, aligns with all major health authority regulations

What Makes Our eCTD Tool Different?

Commitment l Technology l ROI

Cost Per Submissions

Cost Per Submissions

Freyr SUBMIT PRO, a comprehensive eCTD tool helps you lower the costs associated with each eCTD submission as it is designed keeping in mind the process improvements such as cloning, parallel submissions, etc.

Pay-per-use Model Cloud

Pay-per-use Model “Cloud”

eCTD solutions and services from the secure certified cloud, pay-per-use model on usage volume with minimal investment.

Integrated Support System

Integrated Support System

It is all at one place, Freyr SUBMIT PRO – a comprehensive eCTD software makes the entire process hassle-free as it includes an inbuilt eCTD validator and PDF manager, submissions tracker, and HA query management tool.

Freyr SUBMIT PRO Features

With comprehensive and custom-built unique features, Freyr SUBMIT PRO acts as a one-stop eCTD solution for all your eCTD submissions.

Freyr SUBMIT PRO Features
Inbuilt eCTD Validator

Inbuilt eCTD Validator

The inbuilt eCTD validator in our eCTD publishing tool supports all the regional and ICH validation criteria and can identify as many as 800+ error scenarios.

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Submission Tracking

eCTD Submission Tracking

Reporting system that can track the number of eCTD submissions, deadlines, and helps you decide on priority submissions.

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Health Authority Query Management

Health Authority Query Management

Manage and track all the Health Authority queries at one place, thereby enabling speedy approvals.

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Integration with Leading rDMS

Integration with Leading rDMS

Seamlessly integrated rDMS helps in centralization and easy access of data.

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Global Submissions, Simplified

Enabling Organizations Effortlessly Address their Submission Requirements

What Our Community Says About Us

We are using Fryer Software eCTD Submission Tool since 2016. It is very user-friendly and time to time updating as per regulatory requirements and for software improvisation. Customer Support from Fryer is Very Satisfactory.

- Deputy General Manager Regulatory Affairs
Leading Indian Pharma Company

The Freyr Submit Pro software is user friendly and easy to use for submission of DMF to the Regulatory authorities like US, and EP.

- Senior Manager Corporate QA & RA
Largest manufacturers of Microcrystalline Cellulose worldwide

Submit Pro is user friendly and very easy to use.

- Regulatory Affairs Head
Top Contract Research Organization of Greece

A huge thanks to Freyr for the excellent support in turning around 100 (approx..) lit references, which were needed in a short period in support of a New Drug Application (NDA) submission. Really appreciate Freyr’s dedication and hard work in making this possible. This is a critical submission for us and therefore I wanted to take the time to let you know that the submission team recognize your contribution and are extremely grateful for your support not only for these but also for the hundreds of reports, which you’ve republished to make submission-ready for this major submission.

- Submissions Manager
Switzerland based, Global Pharmaceutical Company

This project, eCTD DMF conversion, was against a very tight schedule and required dedicated resources. Freyr provided dedicated resources needed to meet our immediate regulatory filing requirements. Freyr was always on schedule/or exceeded the dates outlined in the project plan. All changes were handled within 24 hours and notifications of changes were promptly provided.

- Quality Control and Regulatory Manager
US based, Global Innovator Products Manufacturer

We have accomplished one more major filing of PMA submission for devices on time. This submission US PMA (22nd April 2016) is one of our Milestones targeted for this year. Special note to mention that published output for this submission includes Paper Copy (-2500 pages) and eCOPY (150 document), which was independently handled by Freyr resource without any quality issues. Thank you for the outstanding work and quick turnaround to get it published on time, which enabled project team to achieve the milestone. Keep up the good work going.

- Global Franchise Head
Submissions Switzerland based, Global Pharmaceutical Company

Please let us take this opportunity to thank the entire Freyr team for their kind support. We are using Freyr SUBMIT PRO with an increasing confidence and getting used to the advantages of the technology. We would appreciate Freyr’s continuous support for this year and other years to come. Thank you.

- CEO and Principal Consultant
A Japan-based Leading Pharmaceutical Consulting Company

Thank you for the timely support over the weekend, which allowed us to resubmit quickly after being notified by the GRA Lead. This continuously demonstrates Freyr’s commitment towards our company’s milestones, keeping the patient in mind.

- Director
Global Regulatory Affairs – Operations India based,
Global top 5 Generic Pharma Company

During the past several years, I’ve had the pleasure of working with Freyr Solutions in the publication, validation, and electronic submission of regulatory documentation to the US FDA. The Freyr team had provided excellent professional service. The staff is knowledgeable, responsive, and offers fast turn-around and accurate e-publication services at a reasonable cost. I have no hesitation in recommending them to my clients.

- President
Leading regulatory and quality consulting company