Investigational Medicinal Product Dossier - 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 - 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.
- Expert advice on mitigation plans for product developmental issues/submission risks.
- IDMP Submission strategy
- Extensive understanding of MAA registration requirements and data correlations from IMPD applications to deal with future MA applications.
- The 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 Qualified Person to address GMP-related issues and the release of IMP lots intended for clinical trials.
- Regulatory response strategy, preparation, and on-time submission of responses to Health Authority (HA) queries pertaining to IMPD.
- 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.
