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 Compiler is a next generation off-the-shelf Windows software application for building error-free non-eCTD electronic submissions. NeeS Compiler provides tools for quick and intuitive construction of complex, valid non-eCTD electronic submissions.

VNeeS Compiler is a next generation off-the-shelf Windows software application for building error-free eSubmission for Veterinary Applications. VNeeS Compiler provides quick and intuitive construction of complex, valid electronic submission for a veterinary medicinal product: pharmaceutical or immunological.

EU eCTD Compiler is a next generation off-the-shelf eCTD (Electronic Common Technical Document) validation, creation, viewing, manipulation and archiving system for EU electronic submissions. The main functionality of the EU eCTD Compiler is the creation of the eCTD XML backbone (+ envelope data) along with the lifecycle management.

Swiss / CH eCTD Compiler is a next generation off-the-shelf eCTD (Electronic Common Technical Document) validation, creation, viewing, manipulation and archiving system for Swiss electronic submissions. The main functionality of the Swiss eCTD Compiler is the creation of the eCTD XML backbone (+ envelope data) along with the lifecycle management.

eCTD Lifecycle helps you understand your eSubmission lifecycle and allows for easy and quick overview of your submissions history. This intuitive tool lets you speed up your submissions and manage your approvals.

MRP/DCP Tracking Table Builder is a visual Tracking Table XML builder to be used in the context of Mutual Recognition and Decentralised Procedures, under the Module 1 of the electronic Common Technical Document (eCTD) for the European Union (EU).

eCTD Office applications are being used by pharma companies and pharmaceutical consultancy companies all over Europe (France, The Netherlands, Belgium, Poland, Spain, Czech Republic, Germany, UK, Bulgaria, Ireland, ...).