Electronic submissions

In 2000, the ICH agreed upon the CTD, the Common Technical Document as a harmonised structure and format for product marketing applications throughout the EU, US and Japan.

The eCTD as a specific format is an electronic version of the CTD. The structure, folder and file names correspond to those of the CTD. As a submission format, however, it contains additional technical components which enable the lifecycle of individual files in the application, and the lifecycle of the product itself, to be managed. The eCTD today has become the preferred format of submissions to agencies in the EU and US.

We have extensive experience in setting-up, compiling, maintaining and the life-cycle management of eCTD submissions. We advise and assist you in creating your eCTD according to the latest regional specifications in the EU, US, and Switzerland or even compile your entire submission.

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