Inquiry Maker is a Microsoft® Word add-in tool designed to automatically segment inquiries. By utilizing this tool, the process of dividing inquiries can be performed accurately and efficiently.
Inquiries refer to questions sent by the regulatory authority regarding the documents submitted by applicants (pharmaceutical companies) for the approval of new drugs. Applicants respond to these inquiries in writing, and the timeframe for creating response document is typically very short, ranging from a few days to two weeks. Especially for foreign companies, timely response is crucial, and there may be cases wheresupport and approval from their headquarters are necessary for certian responses.
To smoothly submit responses within the specified timeframe, cooperation from the respondent is essential. In addition to that, tasks such as segmenting inquiries for each respondent and consolidating created response documents into one file with a table of contents need to be considered. These additional tasks often consume a significant amount of time.
This add-in tool focuses on efficiently and accurately handling the mentioned additional tasks, providing effective support for the approval of application and response document creation process.
Open the inquiry files (in PDF format) received from regulatory authorities as Word documents and load the inquiries.
Specify split units and designate content (product name, etc.) for the cover page and header/footer.
Split the inquiries by branch numbers or combine branches into a single response form for output.
Create a table of contents for inquiries based on the inquiry files split by Inquiry Maker.
Edit (add/remove files) the table of contents generated during the splitting process afterward.
Merge individual inquiry files generated during the splitting process into a single one afterward.
The recommended operating environment for Inquiry Maker is shown as below.
Operating System | Microsoft Windows 10, Microsoft Windows 11 |
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Microsoft Office | Microsoft Office 2016, Microsoft Office 2019, Microsoft Office 365 |
Runtime Library | Microsoft .NET Framework 4.7.2 Microsoft Visual Studio 2010 Tools for Office Runtime |
HDD | Hard disk with 1 GB or more free space |
Memory | 1 GB or more, in addition to the operating system requirements |