Deciding where a document should begin and end is one of the key considerations when drafting certain documents which are to be submitted as part of an eCTD submission. For the most part, the eCTD structure allows no legroom when deciding where and how to include a document as part of an eCTD. For example, your Cover Letter (section 1.0) and Application Form (section 1.2) cannot be submitted as one merged PDF document in either section.
For More Information Please click here: Apex Regulatory's Blog: Document Granularity within the eCTD Structure
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