Features
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- PharmaDoc LeafChecker checks whether created leaf files are compliant with eCTD standards.
- The created leaf files will be checked for any problems that may arise when submitting them to the Pharmaceuticals and Medical Devices Agency (PMDA) on electronic Submission Gateway.
- <Main items that are checked when submitting to PMDA on electronic Submission Gateway>
- Whether there is JavaScript in the file
- Whether there are bookmarks that exceed a certain size
- The tool will identify the exact file and pages where deficiencies are located.
- The tool allows you to check all leaf files in a folder, just by designating a folder.
- Customers can create a configuration of checked items in different leaf files based on their needs.
Thus, they can check the quality of leaf files, just by designating the names of checked items, even without understanding the details of the checked items.
PharmaDoc LeafChecker is currently used at 30 pharmaceutical companies and CROs (under annual basic support contracts).
Check items for Leaf File
PharmaDoc LeafChecker dialog
Summary Report
Result PDF
Result Text
New Functionalities
- Simplified Chinese characters are supported. Simplified Chinese can be selected for display and output languages.
- Adobe Acrobat 64-bit version is supported.
Improvements
- Added pop-up warning message when Acrobat’s protected mode is turned on.
- We have added underscores to the allowed characters in folder names in our recommended eCTDv4.0 rule sets.
- The [Forms] check item has been unchecked from our recommended check pattern in response to the removal of forms from the eCTD Validation Tool’s [PDF Annotation Check].
- Fixed the problem that the setting not to point out corrupted objects (CorruptedObject_Check=false) is unable.
- Fixed the problem that the symbol “-” is output in the result column of the summary report in case the link string is a single character and an excluded character.
- The standard bundle of PharmaDoc Quicker has been stopped.
| Version | System Requirements |
| PharmaDoc LeafChecker 6.1.0 | – Windows 8.1, Windows 10, Windows 11 |
| – Adobe Acrobat 2017, 2020, DC Continuous (x86/x64) | |
| – Microsoft Excel 2013, 2016, 2019, 2021, Microsoft 365 | |
| – Microsoft .NET Framework 4.8 | |
| – Microsoft Visual C++ 2015-2019 Redistributable Package (x86/x64) |
* PharmaDoc is a registered trademark of Planet Pharma Solutions, Inc. in Japan.
* LeafChecker is a registered trademark of Planet Pharma Solutions, Inc. in Japan.
* Acrobat® is a registered trademark of Adobe Systems Incorporated in the United States and /or other countries.