To administer an Investigational Medicinal Product (IMP) on human population in the EU countries, the sponsors must submit a Clinical Trial Authorization (CTA) application and Investigational Medicinal Product Dossier (IMPD) along with the detailed scientific information on the IMP as per the legislation.
Preparation of a compliant IMPD submission as per the EU requirements and managing the challenges for different types of products require a special set of Regulatory expertise. Therefore, to obtain optimal planning and a 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 CTA applications for different types of medicinal products, such as new drugs, recombinant protein products, vaccines, stem-cell based products, etc.
- Regulatory strategic support in identifying the optimal IMPD 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.
- Advice for appointment/consultation of QP to address GMP related issues and for the release of IMP lots intended for clinical trials.
- Regulatory response strategy, preparation, and on-time submission of response to Health Authority (HA) queries pertaining to IMPD.
- Extensive understanding on MAA registration requirements and data correlations from IMPD application to deal with future MA applications.
- Follow-up with Regulatory agencies as needed 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.