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Gruppo SASI offer service "eCTD-Pharma"

基本信息

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交易类型

提供服务

服务名称

eCTD-Pharma

服务提供商

规格参数

  • 服务类别: 支持制药生产运营的软件/数字系统服务,此处为"eCTD-Pharma"(由Gruppo SASI提供)。
  • 监管认证: 基于CTD/eCTD法规档案标准构建,用于药品及原料药主文件的电子提交与生命周期管理。
  • 产能规模: 该信息未披露批次/产能规模;生产定位于标准商业合同服务量级。
  • 地理覆盖范围: 总部位于意大利,销售范围覆盖中东、北美、非洲、中美洲和欧盟国家。
  • 交货周期: 该信息未说明交货周期;需在下单时与供应商直接确认。

其他信息

补充描述:

eCTD-PHARMA is software for designing, implementing and electronically submitting medicinal product dossiers according to CTD/eCTD organizational standards, and for managing their subsequent lifecycle, with equally thorough support for Drug Master File active substance dossiers. It functions as a regulatory compliance management system for complex organizations governing a broad portfolio of registration dossiers, oriented around project management of intricate, multi-phase work; project managers can build the dossier's content management structure online and define access and data security plans during implementation, with the workflow supporting coordination of all related activities.
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Gruppo SASI offer service "eCTD-Pharma" | PharmaCountry