Investigational New Drug (IND) Application, IND Submission, IND Application

Investigational New Drug (IND) Applications

Investigational New Drug (IND) Applications - Overview

For conducting clinical trials with investigational drugs or drugs not approved for the intended use, the sponsor must submit an Investigational New Drug Application (INDA) to the United States Food and Drug Administration (US FDA) and obtain the Agency’s acceptance. Post the Investigational New Drug (IND) Application’s approval, the drug is transported or distributed across the US for use in clinical programs. What if the sponsor fails to submit adequate information in the IND application to assure product quality, safety, and scientific evidence on the proposed efficacy profile? In that case, the US FDA may issue a clinical hold (full clinical hold or partial clinical hold), restricting sponsors to move forward unless the issues are addressed.

Freyr assists sponsors with end-to-end Regulatory support in IND programs, from pre-IND meetings to Regulatory compliance and management of late-phase submissions when the IND goes effective.

Investigational New Drug (IND) Applications - Freyr Expertise

Gap analysis of IND drug development data against the current Regulatory requirements for conducting human clinical trials and identifying potential clinical hold issues (Critical & Major).
Regulatory support for pre-IND meetings and other Agency communications (Type A, Type B, Type C, and Biosimilar Biological Product Development (BPD) meetings).
Request for Orphan Drug Designation (ODD) or expedited review program designations.
Strategic support in identifying the optimal Regulatory approach for an intended clinical program(s) and IND submission.
Expert advice on Regulatory mitigation plans for identified data deficiencies and clinical hold issues during the IND approval process.
Extensive understanding of NDA/BLA submission requirements and data correlations, from the IND to future Marketing Authorization Applications (MAAs).
Publishing and eCTD submission of initial INDs and subsequent submissions (IND annual reports, amendments, etc.).
Regulatory response strategy, preparation, and timely response submission to the US FDA queries/information requests.
Consulting support for IND inactivation or IND re-activation.
US agent services.
Preparation, technical reviews, and submission of CMC, nonclinical & clinical packages for initial IND submission, IND amendments, safety reporting, and IND annual reports submission in the eCTD format for different types of medicinal products (new chemical entities, vaccines, biosimilars, and other biological products like tissue and gene therapy products, etc.).
Investigational New Drug Application submission templates in eCTD format.

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

Investigational New Drug (IND) Applications

Investigational New Drug (IND) Applications - Overview

Investigational New Drug (IND) Applications - Freyr Expertise

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