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Mastering IND and IMPD Submissions with Precision and Avoiding Mistakes

Updated: Sep 20, 2024

In the dynamic landscape of pharmaceutical development, the successful submission of IND applications to the FDA and IMPDs to the EMA is pivotal. These submissions mark critical milestones in the journey from preclinical research to clinical trials, laying the groundwork for regulatory approval and eventual market authorization. However, navigating the regulatory pathways associated with IND and IMPD submissions can be fraught with challenges, leading to common submission issues that may delay or derail the drug development process.

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