Investigational Medicinal Product Dossier

 

Investigational Medicinal Product Dossier - Overview

In order to administer the Investigational Medicinal Product (IMP) on human population in the EU countries, the Sponsors must submit a Clinical Trial Authorization (CTA) application and an Investigational Medicinal Product Dossier (IMPD) as per the legislation, and the detailed scientific information on the IMP. Some of the challenges in conducting clinical trials in the EU are:

  • Strategy and planning of IMPD submissions in applicable member states where clinical trials are planned.
  • Integration of clinical material manufacturing, GMP compliance, QP release, import logistics with IMPD submission, and conduct of clinical trials.
  • Planning of IMPD submissions considering the implementation of the new EU Regulation No. 536/2014.
  • Trial execution in multiple sites/multiple member states and subsequent reporting/updates to the IMPD.

Preparation of compliant IMPD Regulatory submission as per the EU requirements and managing the challenges for different types of products requires a special set of Regulatory expertise. Therefore, to obtain optimal planning and smooth execution of IMPD 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 the handling and submission of 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 - 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.
  • 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 the risks.
  • Extensive understanding on the MAA registration requirements and data correlations from IMPD application to future MA applications.
  • Compilation, technical review, and submission of CTA applications/IMPD dossier, and IMPD updates/amendments for different types of medicinal products.
  • Advice for appointment/consultation of QP to address GMP related issues and for release of investigational medicinal product lots intended for clinical trials.
  • Follow-up with Regulatory agencies as needed for the clinical trial program.
  • Regulatory response strategy, preparation, and on-time submission of responses to Health Authority (HA) queries pertaining to an IMP dossier.
Investigational Medicinal Product Dossier

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​