FDA requires all New Drug Applications (NDAs), Abbreviated NDAs (ANDAs), and Biologics License Applications (BLAs), must be submitted using eCTD format. It is FDA’s intent that submitted data be both compliant and useful for their reviewers. In FDA’s words, the data should conform to the applicable and required data standards.
EAS provides eCTD writing services and can assist your company in submitting eCTDs. Once a submission is compliant with FDA requirements, EAS may submit the file on your company’s behalf, or return the final product for self-submission through the FDA gateway.
Please contact EAS with your eCTD questions. As always, EAS is available to review your submissions prior to sending to FDA to ensure compliance and completeness, expediting FDA’s review.