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 submissions by December 2009. From January 2010 eCTD will be the mandatory format for submissions in the Centralised Procedure.
Many pharmaceutical manufacturers have found the cost involved in implementing in-house eCTD publishing prohibitive, however the benefits of eCTD are obvious. Simplified document lifecycle management, faster processing times and reduced authority fees all provide clear incentives to the industry and authorities.
At TRAC we can create the eCTD for you and manage electronic submissions. We offer a range of services depending on your requirements. We have used this pioneering submission method frequently since it became available and our regulatory affairs specialists have become extremely proficient in creating and submitting dossiers in this format.
Download our detailed eCTD PDF which will help you understand the requirements and assess the benefits of this fast developing new method of submission. If you have any further questions regarding eCTD please Contact Us or complete and submit an Enquiry Form.
Guide: eCTD
This guide, as well as other information can be downloaded from our download centre.
