New Drug Application (NDA), NDA Submission, NDA Filing

New Drug Application (NDA)

New Drug Application (NDA) - Overview

The New Drug Application (NDA) is submitted to the United States Food and Drug Administration (US FDA) for approval of a new drug through the 505(b)(1) and 505(b)(2) NDA Regulatory pathways. Most sponsors find NDA submissions challenging as they must identify the right pathways for their drug development case and define the appropriate Regulatory strategy for the NDA filing process. Moreover, if the information in the NDA submission is inadequate, 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. Knowledge of the guidance detailing the reasons for an RTF of a new drug application and its review process will save the investment (agency fee) and time for sponsors during the NDA filing process.

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

New Drug Application (NDA) - Freyr Expertise

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

What Our Clients Say?

It is good for submission. And I understand today is a holiday, so I have to thank Freyr team for doing this. FDA called us and is trying to close out the CBE-30 filed in March and wanted these documents as soon as possible. So, I truly appreciate your assistance, even on a day off.

President

An Innovative 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 this point.

Quality Control and Regulatory Manager

USA-based Pharmaceutical company

The ANDA receipt is 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 look forward to working with your team on the next project!

Research and Technology based US pharmaceutical company

Excellent! Congratulations to the team for this accomplishment! Thank you everyone for your hard work on this. In addition, please let us know what is needed for the submission of the Type III DMF to Health Canada. I assume we will need to update some of the initial administrative documents, but most of the content is identical to the Type IV DMF.

Senior Research Assistant,

US based leading biopharmaceutical company

We have crossed two important milestones in two days, thanks in a large measure to all of you. We are a small company, a small set of people with big dreams. And given the industry we are in and how we operate, it is possible to realize our dreams only with the help of partners like you - who share our beliefs and push hard with their own collective might. On behalf of our organization, I would like to thank you for your competence and commitment in delivering ANDA files. Kudos to the whole team.

Operations Head,

A Privately Held Pharmaceutical Research and Development Company

Thank You Freyr team for a Fantastic 2019! The OTCDOCS TD user community feels better supported despite the technical challenges and system constraints. Thank You for being the voice to represent their ways of working and helping us design a more user friendly, effective system going forward.

System Owner,

UK multinational pharmaceutical company

Great job with your impact and for noticing that there was an error on the insert SAP code. This shows great attention to detail as well as expertise in all the other point areas that you are thoroughly investigating, regarding the QA database etc.

Graphics Manager | Global Regulatory Affairs,

Canada based, global pharmaceutical company

New Drug Application (NDA)

New Drug Application (NDA) - Overview

New Drug Application (NDA) - Freyr Expertise

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