eCTD/NeeS submissions

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.

Almost all EU/EEA medicines regulatory Authorities are accepting only electronic submissions of medicinal products for human use dossiers. eCTD as a standard is not obligatory (in most cases NeeS is sufficient) in the member states, though eCTD is preferred by Authorities and EMA.

JSC Sveikuva provides following services:

• New eCTD compilation;
• Continued eCTD sequences compilation (e.g. from sequence 0010)
• NeeS compilation (only for EU);
• Dossiers publishing.

Administrative and formatting services: document formatting (MS Word, PDF and etc.), scanning of paper documents, OCR, bookmarking and hyperlinking, preparation of media, validation, eCTD compilation and publishing.

eCTDs may be created using fully validated, 21 CFR Part 11 compliant software suite.

In addition we can  also publish paper copies of the dossier in such extent as it is requested by the client, or alternatively to prepare e-version of documentation, which is prepared for easy publishing.