eCTD Readiness Assessment

Welcome to the iRegulatory eCTD readiness questionnaire. A few remarks before we begin.

• The questionnaire takes just 5-10 minutes to complete, so it should not take up too much of your time;
• The questions are of a general nature and relate to your processes for document authoring, document storage and dossier publishing. You will not be asked for any product-specific information;
• Responses are collected on a strictly anonymous basis, and are used to generate a report automatically at the end of the questionnaire.
• The questionnaire is orientated towards eCTD readiness for the European Union. Different considerations may apply to other ICH regions e.g. US, Japan, and thus the conclusions of the report may not be applicable elsewhere.

We hope that you will find this useful.