Freyr SUBMIT PRO, an eCTD Software, Suits All Your Submission Requirements
Across the Globe and All Regional eCTD Formats
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
ANDS | DMF | ASMF | IMPD | BLAs
Freyr SUBMIT PRO, a cloud-based eCTD submission software, aligns with all major health authority regulations
US FDA | EMA | HEALTH CANADA | SWISSMEDIC
SFDA | SAHPRA/MCCZA | TGA
What Makes Our eCTD Tool Different?
Commitment l Technology l ROI
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”
eCTD solutions and services from the secure certified cloud, pay-per-use model on usage volume with minimal investment.
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 one-stop eCTD solution for all your eCTD submissions.
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.
Reporting system that can track the number of submissions, deadlines and helps you decide on priority submissions.
Health Authority Query Management
Manage and track all the Health Authority queries at one place, thereby enabling speedy approvals.
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.
Leading regulatory and quality consulting company
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 an 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.
Switzerland based, Global Pharmaceutical Company
This project, eCTD DMF conversion, was against a very tight schedule and required dedicated resources. Freyr provided the 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. This project is not yet complete but has been very successful at his point.
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.
Submissions Switzerland based, Global Pharmaceutical 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.
Global Regulatory Affairs – Operations India based,
Global top 5 Generic Pharma Company