New Drug Application Submission

 

New Drug Application Submission - Overview

New Drug Application (NDA) under the US FDA’s 505 b (1) and 505 b (2) pathway is the application process through which pharmaceutical medicinal products are approved for human use. An FDA NDA submission through the 505 b(1) Regulatory pathway should contain full reports of investigations on safety and effectiveness. Whereas, the 505(b)(2) FDA NDA submission Regulatory pathway is used for applications with a change in dosage form, change in strength, and change in the route of administration for the drugs that were evaluated and approved by the FDA as part of other NDAs.

For most of the sponsors, the challenge is to understand the FDA NDA submission regulations, identify the right Regulatory pathway for their drug development case, and define the right Regulatory strategy for the FDA NDA filing process. For an FDA NDA submission, all mandatory information required as per Federal Regulations must be submitted by the sponsor. In case the sponsor fails to submit adequate information, the US FDA may Refuse to File (RTF) the NDA, due to which the sponsor cannot move forward unless additional information is submitted to comply with the Agency’s requirements. Apparent knowledge of the guidance detailing the reasons for RTF of an NDA and its review process will save investment (agency fee) and an ample amount of time for sponsors during the FDA NDA filing process.

Freyr assists the sponsors with end-to-end Regulatory support for the FDA NDA filing process, starting from pre-NDA meetings to submission of NDA annual reports and further lifecycle management of the product.

New Drug Application Submission - Expertise

  • Strategic support in identifying the optimal Regulatory pathway for an FDA NDA submission.
  • Expert advice on availing agency support via expedited programs (i.e., Fast Track designation, Breakthrough Therapy designation, Accelerated Approval process, and Priority Review designation).
  • Pre-submission meeting support, including briefing package preparation, and meeting representation to discuss scientific issues with the FDA NDA filing.
  • Extensive understanding of Federal regulations and submission pathways (505(b)(1), 505(b)(2), and 505 (j)), data requirements for NDA preparation, and significant experience in the FDA NDA filing Process and NDA review process.
  • Gap analysis of developmental data/source data against the NDA submission requirements and guidance to sponsors on a risk mitigation plan for the identified Regulatory gaps.
  • Compilation and technical review of 505(b)(1) NDA and 505(b)(2) NDA packages (including preparation of Module 1 documents and other NDA application forms), publishing, and submission of application in the eCTD format via the FDA ESG.
  • NDA templates with technical information for NDA preparation and eCTD submissions.
  • Regulatory response strategy, preparation, and on-time response submission to USFDA queries/information requests.
  • Regulatory support for pre- and post-submission interactions and follow-up activities with the FDA throughout the NDA approval program.
  • NDA post-approval lifecycle management (supplements, CBE 30, CBE, annual reports, etc.).
  • Strategy and submission support in managing Complete Response Letters (CRLs) for NDAs.
New Drug Application 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​