TTI continues its ongoing efforts in support of FDA’s Electronic Submission Program (ESP) by providing Requirements Analysis, O&M and new development activities to support the receipt, processing, and review of Drug and Biologic electronic submissions received by FDA CDER and CBER. This includes program updates to support new requirements for Module 1 (M1) eCTD message specifications for first line processing of e-submissions, identifying eCTD submissions from non-eCTD submissions and calling the current (and new M1) Global Submit (GS) COTS Validate tool to validate all e-submissions in the eCTD format. TTI continues its ongoing efforts in support of FDA’s Electronic Submission Program (ESP) by providing Requirements Analysis, O&M and new development activities to support the receipt, processing, and review of Drug and Biologic electronic submissions received by FDA CDER and CBER. This includes program updates to support new requirements for Module 1 (M1) eCTD message specifications for first line processing of e-submissions, identifying eCTD submissions from non-eCTD submissions and calling the current (and new M1) Global Submit (GS) COTS Validate tool to validate all e-submissions in the eCTD format.