Investigational Medicinal Product Dossier (IMPD), IMPD Submission

Investigational Medicinal Product Dossier (IMPD)

Investigational Medicinal Product Dossier (IMPD) - Overview

To administer an Investigational Medicinal Product (IMP) to the human population in the EU countries, the sponsors must submit a Clinical Trial Authorization (CTA) application and Investigational Medicinal Product Dossier (IMPD) along with detailed scientific information on the IMP.

Preparing a compliant IMPD submission per the EU requirements and managing the challenges for different types of products require Regulatory expertise. Therefore, to achieve optimal planning and smooth execution of Regulatory submissions for complex clinical programs, sponsors must consult a Regulatory expert with prior experience in EU Regulatory submissions and handling IMPD submission requirements.

Freyr assists sponsors in submitting CTA applications for different types of medicinal products, such as new drugs, recombinant protein products, vaccines, stem-cell-based products, etc.

Investigational Medicinal Product Dossier (IMPD) - Freyr Expertise

Regulatory strategic support in identifying the optimal Investigational Medicinal Product Dossier (IMPD) submission approach for conducting clinical trials in multiple member states (EU) as per the proposed clinical program.
The compilation, technical review, and submission of CTA applications/IMPD dossier and IMPD updates/amendments for different types of medicinal products.
Expert advice on mitigation plans for product developmental issues/submission risks.
Advice for appointment/consultation of Qualified Person to address GMP-related issues and the release of IMP lots intended for clinical trials.
IDMP Submission strategy
Regulatory response strategy, preparation, and on-time submission of responses to Health Authority (HA) queries pertaining to IMPD.
Extensive understanding of MAA registration requirements and data correlations from IMPD applications to deal with future MA applications.
Follow-up with Regulatory agencies for the clinical trial program.
Gap analysis of developmental data for IMPD application submission, identify Regulatory deficiencies and recommend IMPD submission strategy to mitigate risks.

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 Medicinal Product Dossier (IMPD)

Investigational Medicinal Product Dossier (IMPD) - Overview

Investigational Medicinal Product Dossier (IMPD) - Freyr Expertise

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