eCTD Suite Overview

eCTD Suite is a comprehensive document control software solution designed to streamline the submission process for regulatory filings. It helps life sciences organizations manage electronic Common Technical Document (eCTD) submissions required by regulatory agencies such as the FDA, EMA, and Health Canada. The software supports the creation, organization, and submission of regulatory documents in the eCTD format, ensuring compliance with the latest industry standards and regulations. eCTD Suite simplifies the management of complex submission processes by providing version control, automated document tracking, and easy collaboration between teams. The platform also offers features such as metadata tagging, document validation, and submission history tracking, making it easier to prepare and manage regulatory filings. Whether for pharmaceuticals, biologics, or medical devices, eCTD Suite ensures that your regulatory submissions are efficient, accurate, and in full compliance with the required regulatory guidelines.

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Contact Details

  • Vendor Name eCTD Global
  • Founded
  • Location United States

Support

    NA


Training

  • NA

Licensing & Deployment

  • Proprietary Proprietary
  • Cloud Hosted Cloud Hosted
  • Web-Based Web-Based

Typical Customers

  • Self-Employed Self-Employed
  • Small-Business Small-Business
  • Midsize-Business Midsize-Business

Languages Supported

English


Industries

Computer Software, Design, Information Technology & Services, Internet

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eCTD Suite Features

  • Arrow Icon Compliance Management
  • Arrow Icon Electronic Signature
  • Arrow Icon Change Management
  • Arrow Icon Archiving & Retention
  • Arrow Icon Version Control

eCTD Suite Pricing

Pricing Type

  • Pricing Type Contact Vendor

Preferred Currency

  • USD ($) USD ($)

Free Trial

  • NA

Free Version

  • NA

Payment Frequency

  • NA

eCTD Suite FAQs

eCTD Suite is a comprehensive document control software solution designed to streamline the submission process for regulatory filings. It helps life sciences organizations manage electronic Common Technical Document (eCTD) submissions required by regulatory agencies such as the FDA, EMA, and Health Canada. The software supports the creation, organization, and submission of regulatory documents in the eCTD format, ensuring compliance with the latest industry standards and regulations. eCTD Suite simplifies the management of complex submission processes by providing version control, automated document tracking, and easy collaboration between teams. The platform also offers features such as metadata tagging, document validation, and submission history tracking, making it easier to prepare and manage regulatory filings. Whether for pharmaceuticals, biologics, or medical devices, eCTD Suite ensures that your regulatory submissions are efficient, accurate, and in full compliance with the required regulatory guidelines.

  • No, eCTD Suite does not offer a free version.

  • Yes, eCTD Suite offers a free trial.

  • No, Credit Card details are not required for the eCTD Suite trial.

  • No, eCTD Suite does not offer an API.

  • eCTD Suite supports the following languages:
    • English

  • Following are the typical users of the eCTD Suite:
    • Self-Employed , Small-Business , Midsize-Business

  • eCTD Suite supports the following deployment:
    • Cloud Hosted

  • eCTD Suite supports the following devices and operating systems:
    • Web-Based