eCTD Dossiers Preparation

Electronic Common Technical Document (eCTD) format is an international standard for presentation of medicines dossier structure, modules. sections and documents.

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), USA and Japan.

All EU Health Authorities, including European Medicines Agency (EMA), accepts medicines dossiers submissions in eCTD format.

Sveikuva provide following services:

  • eCTD dossiers (sequences) preparation for national, mutual recognition and decentralised procedures.
  • eCTD dossiers (sequences) preparation according non-EU countries requirements.
  • Reformatting medicines dossiers to eCTD
  • Electronic dossiers paper copies publishing

eCTD sequences created using EXTEDO eCTDmanager software. Following request, we are using clients software.

Administrative and formatting services: document formatting (MS Word, PDF and etc.), scanning of paper documents, text recognition (OCR), bookmarking and hyperlinking, eCTD sequence validation, quality control of the sequences.

eCTD Dossiers Preparation

Electronic Common Technical Document (eCTD) format is an international standard for presentation of medicines dossier structure, modules. sections and documents.

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), USA and Japan.

All EU Health Authorities, including European Medicines Agency (EMA), accepts medicines dossiers submissions in eCTD format.

Sveikuva provide following services:

  • eCTD dossiers (sequences) preparation for national, mutual recognition and decentralised procedures.
  • eCTD dossiers (sequences) preparation according non-EU countries requirements.
  • Reformatting medicines dossiers to eCTD
  • Electronic dossiers paper copies publishing

eCTD sequences created using EXTEDO eCTDmanager software. Following request, we are using clients software.

Administrative and formatting services: document formatting (MS Word, PDF and etc.), scanning of paper documents, text recognition (OCR), bookmarking and hyperlinking, eCTD sequence validation, quality control of the sequences.