regulatory ectd

regulatory ectd module-2

eCTD Module 2

The International Conference on Harmonisation (ICH) developed the electronic Common Technical Document (eCTD) standard format to facilitate submission of data and information by pharmaceutical companies to regulatory agencies. The eCTD holds information according to sections, documents, and modules such as eCTD Module 2.

MasterControl Registrations for eCTD is a product registration and eCTD management solution designed for pharmaceutical companies seeking FDA drug approval or pursuing marketing authorization application (MAA) in the European Union and other countries. These companies are required to follow the eCTD standard format, including eCTD Module 2, Modules 3, 4, and 5, while Module 1 is region-specific.

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