regulatory-submissions

【文档与办公】Audit a pharmaceutical regulatory submission system -- evaluate eCTD backbone assembly and XML validation, CTD module completeness (Modules 1-5), FDA ESG and EMA CESP gateway integration, document authoring and publishing workflows, ICH M4/M8/E3 guideline compliance, pre-submission validation rules, 21 CFR Part 11 audit trails, and post-submission li…

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