e-CTD and NeeS generation

The electronic Common Technical Document (eCTD) is an interface for the pharmaceutical industry to agency transfer of regulatory information.

The content is based on the Common Technical Document (CTD) format developed by the International Conference on Harmonisation (ICH) Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG).

The eCTD has five modules

  • 1 Administrative Information and Prescribing Information
  • 2 Common Technical Document Summaries
  • 3 Quality
  • 4 Nonclinical Study Reports
  • 5 Clinical Study Reports

Answers to commonly-asked questions about the e-CTD and the “Non e-CTD electronic Submission” (NeeS) formats can be found on the EMA site but as submission pros know all too well, there are multiple additional requirements pertaining to the file format. Archemin is using the Extedo eCTDmanager. and employs the most recent version of the NeeS (v3.0) as well as eCTD validation criteria (v4.1).

Avoid complications by getting assistance from specialists who are familiar with both the ICH requirements and the specific requirements of the national authorities.

Want to know more / require a quote ?

Send your request to regulatory [at] archemin.eu