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.
- 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.