eCTD Builder

About eCTD Builder

Mono eCTD Builder allows for import of the eCTD folder structure to report whether the structure conforms to the eCTD format.
Once the NeeS structure has been imported, a wizard is used to construct a valid eCTD XML instance along with EU envelope (country specific) data.
It includes access to submission sequences allowing the user to search, view or print any required document in the submission lifecycle management. Mono eCTD Builder features history view of a drug product submission sequences, allowing the user to approve documents, search for documents, preview changes, etc.

The main functionality of the Mono eCTD Builder is the creation of the eCTD XML backbone (electronic dossier submission) along with the dossier submission lifecycle management.
By using the Mono Auto eCTD Builder and its change control process, several topics including study report structure, lifecycle management, and consistency with the eCTD XML DTD are addressed and resolved.

Mono eCTD Builder runs on various Windows based IT structures and provides:

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.

Mono eCTD Builder is regularly updated in the light of changes in the ICH eCTD specification.

eCTD - Electronic Common Technical Document

The Electronic Common Technical Document 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.