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Gruppo SASI offer service "eCTD-Pharma"

Basic Information

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31
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3.9(7)

Trade Type

Offer Service

Service Name

eCTD-Pharma

Service Provider(s)

Specifications

  • Service Category: Software/digital systems service supporting pharmaceutical manufacturing operations, here "eCTD-Pharma" from Gruppo SASI.
  • Regulatory Certification: Built around the CTD/eCTD regulatory dossier standard for electronic submission and lifecycle management of medicinal product and drug master file documentation.
  • Capacity Scale: Batch/capacity scale is not disclosed in the listing; production is positioned for standard commercial contract-service volumes.
  • Geographic Coverage: Based in Italy, with sales reach across the Middle East, North America, Africa, Central America and the EU.
  • Lead Time: Lead time is not specified in the listing; it is confirmed directly with the supplier at the time of order.

Other Information

Additional Description:

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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