Electronic Common Technical Document (eCTD) format is an international standard for presentation of medicines dossier structure, modules, sections and documents of the Medicinal Products.
The eCTD format was developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) as a standard dossier format for marketing authorisations, renewals and variations applications. Currently eCTD format is used for regulatory submissions in the European Union (EU), United States of America (USA) and Japan.
All EU Health Authorities, including European Medicines Agency (EMA), accepts dossier submissions of Medicinal Products in eCTD format.
Sveikuva provides following services:
We publish eCTD sequences using EXTEDO eCTDmanager software. Upon request, we use client’s software.
Administrative and formatting services:
Electronic Common Technical Document (eCTD) format is an international standard for presentation of medicines dossier structure, modules, sections and documents of the Medicinal Products.
The eCTD format was developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) as a standard dossier format for marketing authorisations, renewals and variations applications. Currently eCTD format is used for regulatory submissions in the European Union (EU), United States of America (USA) and Japan.
All EU Health Authorities, including European Medicines Agency (EMA), accepts dossier submissions of Medicinal Products in eCTD format.
Sveikuva provides following services:
We publish eCTD sequences using EXTEDO eCTDmanager software. Upon request, we use client’s software.
Administrative and formatting services: