Investigational Medicinal Product Dossier (IMPD)

To administer the Investigational Medicinal Product (IMP) on human population in the EU countries, the Sponsors must submit clinical trial authorization application and Investigational Medicinal Product Dossier (IMPD) and the detailed scientific information on the IMP as per the legislation.

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

Freyr assists sponsors in handling and submission of Clinical Trial Authorization (CTA) applications for different types of medicinal products, such as New drugs, Recombinant Protein Products, Vaccines, Stem Cell-based Products, etc.

Freyr Expertise

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

What Our Clients Say?

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)

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What Our Clients Say?

Quality Control and Regulatory Manager

Senior Research Assistant,

Operations Head,

System Owner,

Graphics Manager | Global Regulatory Affairs,

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Investigational Medicinal Product Dossier (IMPD)

Freyr Expertise

Latest Resources

Blogs

White Papers

Webinars

What Our Clients Say?

Quality Control and Regulatory Manager

Senior Research Assistant,

Operations Head,

System Owner,

Graphics Manager | Global Regulatory Affairs,

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Get in Touch

USA

UK

GERMANY

INDIA

More Locations

Quick Inquiry