eCTD Submit

eCTD Submit is eCTD Office's exclusive representative in the United States.

eCTD Office is an off-the-shelf suite of integrated eCTD / NeeS / VNeeS software products for the creation, validation, publishing, viewing and manipulation of regulatory documentation for electronic submissions by pharmaceutical companies to regulatory authorities. Various tools included in the package ensure your work continues flawlessly.


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Representative in USA

eCTD Submit is a team of highly experienced regulatory, publishing, documentation, and eCTD experts with a strong focus on regulatory compliance and customer service. eCTD Submit is able to provide additional support in the form of US-based training, consulting, regulatory affairs and any other support in the actual usage of eCTD Office. This support is provided by US-based staff and longtime eCTD Office users, who have utilized eCTD Office for hundreds of submissions over the past several years. Should you need additional support, it can be provided remotely or on-site is possible as well.

Common areas of this support level include:

  • Staff training workshop on eCTD Office, or eCTD format in general
  • Expert review and quality checking of submission files and documents to confirm they adhere to format, structure and placement within the submission based on current FDA guidelines.
  • Quality Control of the published documents for submission formatting and structure to ensure Compliance with FDA Standards.
  • Creation of SOPs, validation or any other technical documentation that is needed to implement publishing software