eCTD

eCTD (electronic Common Technical Document) is increasingly becoming the preferred method of submission of regulatory information amongst competent authorities worldwide. All EU authorities are committed to accepting eCTD submission by December 2009.

The benefits of the eCTD are obvious. Document lifecycle management, faster processing times and reduced authority fees all provide clear incentives to industry and authorities.

In addition there is a significant reduction in printing and paper usage which provides further costs savings as well as having a positive environmental impact.

Many pharmaceutical manufacturers have found the cost involved in implementing in house eCTD publishing prohibitive. This is where TRAC services come in. We can create the eCTD for you and manage eCTD submissions. We offer a range of services depending on your requirements;

Provide advice on developing house styles and templates for document preparation
Convert existing dossiers to eCTD ready documents
Generate the eCTD
Submit the eCTD on clients behalf

eCTD

Services