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Gather all necessary information and documents that are relevant to the eCTD submission.
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Who needs ectd technical conformance guide?

01
The eCTD Technical Conformance Guide is needed by regulatory authorities, pharmaceutical companies, and other stakeholders involved in the electronic submission of drug applications.
02
Regulatory authorities use the guide to ensure that submitted eCTD packages meet necessary technical requirements.
03
Pharmaceutical companies need the guide to accurately prepare their electronic submission packages and meet regulatory guidelines.
04
Other stakeholders, such as contract research organizations and regulatory consultants, may also require the guide to support their clients in eCTD submission processes.
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The ectd technical conformance guide provides instructions and requirements for electronic submissions in the Electronic Common Technical Document (eCTD) format.
Drug manufacturers and sponsors who submit electronic applications to regulatory authorities are required to follow the ectd technical conformance guide.
The ectd technical conformance guide typically includes specific instructions on how to format and submit electronic documents in the eCTD format.
The purpose of the ectd technical conformance guide is to ensure that electronic submissions are consistent, high quality, and meet regulatory requirements.
The ectd technical conformance guide may require information such as document organization, file naming conventions, and technical specifications for electronic submissions.
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