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Document number GP4.96 Initial document release 20161031 Revision date 20211103LOGISTIC GUIDELINES NOTED AB and its subsidiaries1/13Document number GP4.96 Initial document release 20161031 Revision
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How to fill out ectd v40 comprehensive table
How to fill out ectd v40 comprehensive table
01
Access the eCTD software tool
02
Create a new submission and select the Comprehensive Table template
03
Fill in the required metadata information such as submitting organization details
04
Add the necessary information for each section of the Comprehensive Table, including product details, modules, and lifecycle information
05
Review and verify all the filled out information before finalizing the submission
Who needs ectd v40 comprehensive table?
01
Regulatory agencies require pharmaceutical companies to submit the eCTD v4.0 Comprehensive Table as part of the drug approval process
02
Pharmaceutical companies developing new drugs or submitting applications for regulatory approval need to provide the Comprehensive Table in their eCTD submissions
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What is ectd v40 comprehensive table?
eCTD v4.0 comprehensive table is a document used to provide detailed information on the contents of an electronic Common Technical Document submission.
Who is required to file ectd v40 comprehensive table?
The pharmaceutical companies and regulatory authorities are required to file eCTD v4.0 comprehensive table.
How to fill out ectd v40 comprehensive table?
You can fill out eCTD v4.0 comprehensive table by providing detailed information on each section of the electronic Common Technical Document submission.
What is the purpose of ectd v40 comprehensive table?
The purpose of eCTD v4.0 comprehensive table is to facilitate the review and assessment of the submission by regulatory authorities.
What information must be reported on ectd v40 comprehensive table?
The eCTD v4.0 comprehensive table must report information on each module, section, and document included in the electronic Common Technical Document submission.
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