CTD Quality Consulting provides expertise in preparing your submissions in CTD and eCTD format:

• Original marketing applications for drugs and Biologics (NDA, ANDA, BLA, MAA etc.)
• Investigational applications (IND, IMPD)
• Supplements and variations to regulatory filings
• Submission-ready reports
• Customized CTD/eCTD Templates
• Drug Master Files (DMF)
• Pre-meeting packages

The Common Technical Document (CTD) ICH M4Q format is required in Europe, Japan, Canada, and is highly recommended by the FDA in the U.S. for investigational, marketing and post-marketing applications of drugs and biologics. The European DMF is also required to be in CTD format.

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.

We will ensure that your CTD and eCTD submissions meet all prescribed CTD guidelines and regional requirements for U.S., Europe, Canada, and other regions, as requested.

Improve workflow efficiency in preparation of IND and NDA submissions

Facilitate acceleration of drug development and approvals

New Course Announcement:

Easing the Transition to CTD/eCTD for INDs/NDAs

CTD Quality Consulting assists your transition to the CTD and eCTD from phase 1 IND to NDA/BLA marketing application, including maintenance of updates (life cycle management). Click here for more information.

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