Regulatory Publishing and Submissions

Transform compliance barriers into springboards for exponential growth ensuring seamless submissions and crafting market expansion strategies. With Freyr’s submission experts streamline the approval processes, adhere to regulatory guidelines, and increase the likelihood of successful product approval.

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Regulatory Publishing and Submissions - Overview

The Global Health Authorities are accepting Regulatory submissions in the electronic format, the need of the hour is to deploy robust and ever-updated Regulatory publishing and submission tools to manage region-wise Regulatory submission Documents and region-specific formats. Freyr ensures error-free Regulatory submissions with the utmost quality and has proven itself to on-time Regulatory publishing and submission services for all acceptable formats such as paper, electronic submissions, eCTD, and NeeS.

Freyr assists Life Sciences organizations to streamline the entire Regulatory Publishing and Submissions management process. The Regulatory Filing process initiates right from dossier development, including Regulatory Submission Management and Regulatory Submission planning, tracking, Regulatory publishing, and making the final regulatory submissions to Health Authorities (HAs) including delivery confirmation/acknowledgment for their Regulatory approvals.

With extensive regional experience in North America (USA and Canada), Europe, LATAM, MEA, ROW, and 260+ submission experts, our team supports organizations with end-to-end delivery in eCTD, NeeS, and Paper submissions.

Apart from deploying experienced experts to provide Regulatory publishing and submission services, Freyr offers industry-proven eCTD publishing and electronic submission software, Freyr SUBMIT PRO, to enable companies to effectively meet all their specific and unique Regulatory publishing and submission services requirements for quick reviews and faster approvals of their products such as drugs, biologics, and medical devices from the Regulatory Authorities.

Quick Facts

149999

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Total Submissions
260

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Team of Global Publishers
200

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Global Customers

Partnering with Leading Organizations

 

Medicinal Products

Publishing and Submission

UK

I am sure you have heard by now that we have received our first-ever approval from the FDA for our Brands division. This is a major milestone for us as well as for my team here in Reg Ops. I would be remiss if I didn’t point out that we would not have been able to do this without the help of your dedicated team. From the original filing, then the following year of responses, all helped get us to final approval.

Thank you Freyr team for a job well done!

Michael Bellero

Sr. Director, Head of Regulatory Operations

 

Medicinal Products

Publishing and Submission

UK

We would like to appreciate Freyr’s quick TAT to push through an urgent submission required by the FDA. Their efficiency, diligence, excellence, sense of urgency, and priority are deeply flexibility.

Please keep up the great work as we have many milestones to achieve over the next year.

Ed Venkat

Global CMC Technical Lead

 

Medical Devices

Publishing and Submission​

USA

Communication and on the ground knowledge or RA requirements - this has been our experience for India. Quick to response and willing to have calls to explain requirements. Very happy with the RA work conducted in India, would use for other markets. We are satisfied. ​

Director of Regulatory Affairs​

France-based, Leading Global Supplier of Women Healthcare Products Company​