eCTD Office

About NeeS Validator / Checker

NeeS Validator is an off-the-shelf Non-eCTD electronic Submissions (NeeS) validation system. The Mono Nees Validator allows for import of the NeeS folder / file structure to report whether the structure conforms to the NeeS format.

NeeS Validator runs on various Windows based IT infrastructures and provides:

• off-the-shelf 2-step NeeS validation system,
• super fast and accurate NeeS validation procedure,
• an easy-to-use intuitive user interface,
• batch validation - validate several submissions at one time with auto error report generation,
• customizable validation requirements to accept NeeS submission specific to your country,
• auto generation of the CTD-TOC (Table Of Content) and module TOC files (ctd-toc.pdf, m1-toc.pdf, m2-toc.pdf, m3-toc.pdf, m4-toc.pdf, m5-toc.pdf),
• validation result report display and printing.

A list of some of the NeeS Validator structure / naming error messages:

• Wrong folder structure: "m1" - "m5" only subfolders.
• First folder under "m1" must be "eu".
• Character "_" is not allowed in a file name.
• File names must be in lower case.
• The maximum length of the name of a single folder or file is 64 characters.
• File names can not include two hyphen ("--") characters.
• File names must include only one dot (".") character.
• Wrong Country/Language combination.
• Country folder at the wrong level.
• Language or Country not found.
• Folder M1 (2,3,4,5) is missing the „m1-toc.pdf“ file.

A list of some of the customizable Mono NeeS Validator structure error messages:

• PDF documents only allowed.
• PDF document must be version 1.4.
• PDF document is password protected.
• Maximum file size is 100 MB.
• PDF document contains broken external links.
• PDF document not optimized for "Fast Web View".
• Folder M1 (2,3,4,5) is missing the „m1-toc.pdf“ file.

Finalize your eSubmission

When the NeeS structure has been validated, you can start working on the eCTD submission lifecycle management using eCTD Builder.

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