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Integrated Preclinical Drug Discovery and Development Services FOCUS Preclinical Research SHANGHAI EDITION INC.COMPANY PROFILE From its inception in 2004, Shanghai Edition Inc. (STAR Market, stock
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A high quality integrated drug refers to a pharmaceutical product that is developed through comprehensive research, adhering to stringent quality standards, and ensuring safety and efficacy for patients.
Manufacturers of pharmaceuticals and biopharmaceuticals that meet the criteria for high quality integrated drugs are required to file.
To fill out a high quality integrated drug submission, entities must complete the necessary forms detailing the drug's formulation, clinical data, manufacturing processes, and quality control measures.
The purpose of high quality integrated drugs is to ensure that pharmaceutical products meet regulatory standards for safety, quality, and efficacy, thus improving patient health outcomes.
Information required includes drug composition, manufacturing processes, clinical trial results, labeling information, and stability data.
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