ROSETTA scribe takes out the mystery.

It also takes out the complexity of eCTD specifications from the assembly and compiling process. Simple drag-and-drop operations build compliant eCTD submissions within the context of the lifecycle of an application and it does so in less time. No eCTD or XML knowledge is necessary. ROSETTA scribe pre-populates submission information from previous submissions and it intelligently prompts you for metadata when necessary. Use drag-and-drop to append, replace or delete lifecycle operations. Submission templates and attribute mapping allow an ever faster creation of eCTD backbone files. It also includes ROSETTA sceptre to fully validate submissions, ensuring compliance.