Streamlining eCTD Submissions for Biotech and Pharmaceutical Products: Best Practices

Abstract

The eCTD is a means of improving compliance, efficiency, and timeline for authoring and regulatory submissions of common application documents for the pharmaceutical and biotechnology industries. In this paper, discussed the challenges and practices of the automation, accuracy of the document, and functional team collaboration in eCTD submissions. Based on Merck KGaA, Shenzhen Hepalink Pharmaceutical and Fresenius Kabi case studies, The integration and compliance strategies benefit based on these cases. Using automation, structured workflows and parallel to international rules of enforcement increases accuracy whilst reducing delay in submissions. However, this will be integrated with AI, security risk, and comparative analysis of regulatory agency to optimise the eCTD submission process even more.