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COURSE APPLICATION CHECKLIST Bridging Module: Chemistry SECTION A: COURSE APPLICATION CHECKLIST Please complete this checklist and submit them together with the required documents listed in Section
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What is bridging module chemistry section?
Bridging module chemistry section is a section of a regulatory filing that provides detailed information about the chemistry of the bridging module.
Who is required to file bridging module chemistry section?
Companies or individuals developing a bridging module for regulatory submission are required to file the bridging module chemistry section.
How to fill out bridging module chemistry section?
To fill out the bridging module chemistry section, you need to provide information on the chemical composition, synthesis process, and characterization of the bridging module.
What is the purpose of bridging module chemistry section?
The purpose of the bridging module chemistry section is to provide regulatory agencies with a detailed understanding of the chemical properties and quality of the bridging module.
What information must be reported on bridging module chemistry section?
The bridging module chemistry section must include information on the chemical structure, purity, impurities, and stability of the bridging module.
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