Preparing Compliant eCTD Submissions

The document discusses the preparation of compliant eCTD submissions, emphasizing the importance of content, process, standards, and technology for success. It outlines a case study involving a small biotech company that faced challenges during its NDA submission to the FDA, including a 'refuse-to-file' designation due to compliance issues. Key factors are highlighted, such as the significance of accurate file organization and the understanding of regulatory requirements for eCTD submissions.