The Electronic Common Technical Document (eCTD) allows for the submission of regulatory documentation by pharmaceutical companies to the regulatory authorities. The eCTD specification is an international standard for submitting electronic NDAs (New Drug Applications). The eCTD was developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) as a standard format for regulatory submissions in the Europe, USA and Japan.

The eCTD is defined as an interface for industry to agency transfer of regulatory information while at the same time taking into consideration the facilitation of the creation, review, lifecycle management and archival of the electronic submission.
The eCTD Specification is based on XML technology. An eCTD submission is a collection of data objects that follows the eCTD specification. The main function of the eCTD submission is data exchange. The eCTD submission is composed of the following: folder structure, XML eCTD instance and content files.

The eCTD differs from other electronic submission formats because it is defined by an XML backbone - electronic dossier. While this feature greatly enhances the organization of the submission, it can also be daunting for those involved in its preparation. To generate such a dossier the pharmaceutical industry would need to use special compilation software.

eCTD Office includes the following tools:

NeeS Validator is an off-the-shelf 2-step Non-eCTD electronic Submissions (NeeS) validation system. Nees Validator allows for import of the NeeS folder / file structure to report whether the structure conforms to the NeeS format.

eCTD Builder is an off-the-shelf eCTD (Electronic Common Technical Document) validation, creation, viewing, manipulation and archiving system for electronic submissions. eCTD Builder lifecycle management features history view of submission sequences, allowing the user to approve documents, search, preview, etc.

eCTD Office provides the following functionality:

• off-the-shelf 2-step eCTD validation system,
• 3-step NDA sequence submission management system,
• a very fast validation system supported by standard NeeS / eCTD requirements,
• an easy-to-use intuitive user interface,
• auto creation and packaging of eCTD compliant Electronic Submissions for regulatory agencies,
• automatic MD5 checksum generation,
• predefined (customizable) list of countries and languages allowed in country/language directories (CC/LL),
• customizable validation requirements to accept NeeS submission, document approval, report display and printing,
• architecture to allow multiple users operate on submission sequences simultaneously,
• integration with a web browser to enable quick preview of a dossier to be submitted to the authorities.

All tools are regularly updated in the light of changes in the ICH eCTD specification.