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ECTD stands for Electronic Common Technical Document. It is an electronic submission standard for regulatory submissions to health authorities.
Companies in the pharmaceutical and biotech industries are required to file ECTD for regulatory submissions.
ECTD is filled out using specialized software that organizes the submission into the required format for regulatory authorities.
The purpose of ECTD is to standardize and streamline the submission process for regulatory authorities, making it easier to review and approve new medical products.
ECTD requires detailed information on the safety, efficacy, and quality of a medical product, as well as information on manufacturing processes and clinical trial data.
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