The guidance on marketing applications for drugs and biologics, known as the Common Technical Document (CTD), was finalized by the International Conference on Harmonization (ICH) in 2003.  Today the CTD format is mandatory for marketing applications in Europe, Japan, Canada, and other regions, and is highly recommended by FDA. 

In January 2008, all electronic submissions to CDER must be in the eCTD format.

The European DMF is also required to be in CTD format.

ELC provides expertise in preparing your submissions in CTD and eCTD format:

• Conversion of current submissions to CTD or eCTD
• Supplements and variations to regulatory filings
• Submission-ready reports
• Guaranteed CTD and eCTD compliance with the latest regulatory guidelines and specifications
• PIM Label conversions for EU
• Customized CTD/eCTD Templates
• Drug Master Files (DMF)
• Pre-meeting packages
• Regulatory operations consulting including CTD structuring, document formatting, PDF conversions for Agency Submissions across the globe including , FDA, EU, Health Canada, Singapore and Australia.
• Training Workshop to facilitate in-house implementation of electronic submissions using eCTD

With our expertise in Chemistry, Manufacturing, and Controls (CMC) and medical/technical writing, we can assist you in preparation of Modules 1-5 of your CTD/eCTD.