Inquiry Maker is a Microsoft® Word add-in product designed to streamline and automate the division of regulatory inquiries. With this tool, you can carry out inquiry separation tasks both accurately and efficiently.
In the pharmaceutical industry, regulatory inquiries are questions issued by regulatory authorities (such as PMDA in Japan) regarding submitted documents for new drug applications. Applicants (pharmaceutical companies) must prepare written responses to these inquiries, typically within a very short time frame—ranging from a few days to two weeks. For global pharmaceutical companies, additional coordination with overseas headquarters is often required, making a swift response even more critical.
To submit responses smoothly within the limited timeframe, collaboration with internal and external stakeholders is essential. Additionally, related tasks such as separating inquiries by responder, compiling all responses into a single file, and generating a table of contents are also be performed. These auxiliary tasks can consume a significant amount of time if done manually.
Inquiry Maker focuses on simplifying and accurately executing these auxiliary processes, thereby supporting the efficient preparation of response documents and enhancing the overall drug application process.
Open and import inquiries (PDF format) received from regulatory authorities as Word documents.
Define how to split and what information to include (e.g., product name) in the cover page and header/footer.
Split inquiries by sub-number, or combine multiple sub-numbers into a single response form.
Generate a table of contents for the split inquiries based on the files created by Inquiry Maker.
Edit the generated table of contents afterward, including adding or removing linked files.
Recombine the split inquiry files into a single consolidated document as needed at any time.
The recommended operating environment for Inquiry Maker is shown as below.
| Operating System | Microsoft Windows 10, Microsoft Windows 11 |
|---|---|
| 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 |
We provide innovative solutions to the pharmaceutical industry, acting as a facilitator in the creation of application documents.
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