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Inquiry Maker Overview

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Inquiry Maker is a Microsoft® Word add-in product that helps to automatically create response sheets to the inquiry file from regulatory authority. With IQM, the creation of response sheets turns more efficient and accurate.

Inquiries are questions from local regulatory authority (e.g. PMDA) during the review of a submitted drug application. Usually, responses to those questions will need to be prepared within a limited time from several days to 2 weeks top. Especially for foreign‐affiliated company, unlike domestic one, to answer certain questions will acquire support and approval from the headquarters abroad, which makes it even a harder work.

To make sure the responses to the local regulatory authority go smoothly during the above limited time, support from owners is important. However, equally essential on the other hand, is collateral documentation work to create response sheets, which usually consumes much more time in the whole process.

Inquiry Maker focuses specifically on such detailed documentation work. By reducing manual operation as much as possible through the process, it aims to upgrade the efficiency and the quality of response sheets created.

What does Inquiry Maker do

• Split an inquiry PDF into several Word documents with a user-specified unit
• Apply house styles to the split documents
• Complete meta information (e.g. product name) for headers and footers
• Specify file names for the split documents
• Create a cover page for response sheets