Publishing and Submission

Amplify your generic drug approval success with Freyr's ANDA publishing and submission expertise. From strategic planning to lifecycle management, we provide comprehensive eCTD services to overcome Regulatory challenges and expedite market entry.

Publishing and Submission - Overview

Abbreviated New Drug Application (ANDA) publishing and submission must be made following the standard Regulatory procedures and formats as recommended by the USFDA. The generic applicant is required to submit all documents and other information in a CTD format and due to the enormous amount of information present in the ANDA, the USFDA has made it mandatory for all the manufacturers to adopt the eCTD submission process instead of paper submission for a faster Regulatory review process.

Many industries face a challenge in compiling and managing vast information to be compiled during generic medicine publishing and submission. Therefore, effective strategic planning and prerequisites should be taken into consideration along with a proper understanding of the FDA’s requirements and the latest updates on the

Freyr, with qualified Regulatory publishing and submission experts and robust submission software, helps clients overcome Regulatory submission challenges to ensure error-free submissions and timely approval of generic medicines.

We provide our clients with various models of service depending on their requirements:

  • Freyr technology and Freyr resource support
  • Client technology and Freyr resource support
  • Client technology and client resource support

Publishing and Submission - Expertise

  • End-to-end generic medicine application Regulatory submission and publishing including submission level and document level publishing activities
  • Regulatory submissions in the eCTD format
  • Conducting multi-level QC checks and reviews of documents before submitting them to the clients/HA
  • Continuous project monitoring
  • eCTD submission strategy right from the initial submissions to lifecycle management in alignment with ANDA submission requirements of the HA
  • Creation of a detailed tracker for the changes made throughout the publishing lifecycle
  • Freyr SUBMIT PRO - Regulatory publishing and submission tool
Publishing and Submission

Celebrating Customers Success

 

Medicinal Products

Regulatory Affairs

India

Thank you for the timely support over the weekend, which allowed us to resubmit quickly after being notified. This continuously demonstrates Freyr's commitment towards our company’s milestones.

Director - Global Regulatory Affairs – Operations

India-based, Global Top Generic Pharma Company

 

Medicinal Products

Publishing

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!

Sr. Director, Head of Regulatory Operations

Ireland-based, Global Specialty Pharmaceutical Company

 

Medicinal Products

Regulatory Affairs

USA

Please relate to the team the excellent job they have done on the IND reactivation. Specifically, the high-quality module 3, written by Freyr. It was very comprehensive, very few revisions were required, and we had no questions from Health Canada or FDA. No CMC questions: that was a first for me. So very responsive to my many requests, which I am sure can be frustrating but always helpful while producing excellent work.

Thank you for always being available and responding quickly and comprehensively to all my requests.

What a great team you have, Freyr.

Lynne McGrath

Regulatory Consultant

 

Medicinal Products

Regulatory Affairs

USA

Congratulations!!! ​

Thanks for your great support for a successful ANDA filing, especially to the publishing team. Heartfully appreciate their last hours of hard work.

Assistant Manager​

US-based, Leading, Complex Generic Pharmaceutical Products Company​

 

Medicinal Products

Regulatory Affairs

USA

Thank you all for the great support!​

CEO

US-based, Leading Innovative Pharmaceuticals Company​

 

Medicinal Products

Regulatory Affairs

USA

The ANDA receipt has been received! Thank you very much for your hard work, patience, and support for our work over the last couple of months. We are delighted that we were able to meet the timeline and hit an important corporate goal of our young company. ​

Thank you again, and we look forward to working with your team on the next project!

Senior Director of Business and Product Development​

US-based, Leading Innovator Pharmaceuticals Company​