10 Small Submissions
No more than 10 Documents per submission
No more than 10 Documents per submission
No more than 75 documents per submission
Open Text Documentum, Veeva Vault, and Master Control and Freyr rDMS
Our customer support covers 3 time zones: America, Europe & Africa and Asia
Experienced publishers who have completed 200,000+ global submissions over the past 12+ years supporting 100s of small-mid Bio Pharma companies and several Top 20 large Bio pharma companies. 24 x 5 global publishing teams across 20 locations.
Someone to assist you in your submissions journey.
Our services and technology team are up to date with any Regulatory market intelligence and the transfer of knowledge reflects on the platform swiftly
If you wish to add more Health Authorities to your bundle, it costs an additional $1450
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, the best eCTD software, 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 software, aligns with all major health authority regulations
US FDA | EMA | HEALTH CANADA | SWISSMEDIC
SFDA | SAHPRA/MCCZA | TGA | EAEU | JFDA | Thai FDA | ASEAN | NMPA
Commitment l Technology l ROI
Freyr SUBMIT PRO, a comprehensive eCTD Software 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.
It is all at one place, Freyr SUBMIT PRO - a comprehensive eCTD submission software makes the entire process hassle-free as it includes an inbuilt eCTD validator and PDF manager, submissions tracker, and HA query management tool.
With comprehensive and custom-built unique features, Freyr SUBMIT PRO acts as a one-stop eCTD solution for all your eCTD submissions.
The inbuilt eCTD validator in our eCTD publishing software 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 eCTD submissions, deadlines, and helps you decide on priority submissions.
Manage and track all the Health Authority queries at one place, thereby enabling speedy approvals.
With our very own eCTD submissions solution suite, Freyr SUBMIT PRO seamlessly integrates with rDMS that helps in centralization and easy access of data.
Enabling Organizations Effortlessly Address their Submission Requirements
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
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
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
Phone: +1 908 483 7958 | Email: hello@freyrdigital.com