eCTD application

The eCTD format was developed by the International Council for Harmonisation (ICH) to ensure that pharmaceutical and biotechnology companies submit regulatory dossiers in a uniform, machine-readable format. It is now mandatory for many authorities, including the FDA, EMA and MHRA.

An eCTD application is divided into modules that include administrative, quality, nonclinical and clinical data. Each module follows strict technical specifications and must conform to regional submission standards. Because these documents are often translated into multiple languages, linguistic accuracy and formatting consistency are essential for regulatory acceptance. RWS supports eCTD submissions through its Regulated Content Services, combining domain expertise, linguistic precision and intelligent technology. Our in-market experts and specialist linguists ensure that translated content meets eCTD structure and terminology requirements, while Trados and Language Weaver enable consistent, traceable multilingual document management.