CTD Quality Consulting provides expertise in regulatory strategy, training, and 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

• Drug Master Files (DMF)

• Pre-meeting packages

CTD Quality Consulting can help you improve efficiencies in the drug development process, saving significant time and resources:

• Training on eCTD authoring

• Customized CTD/eCTD templates

• eCTD mapping, TOC facilitation

• Gap analysis and Key Messaging, Target Product Profile

• Granularity and Life Cycle Management planning

• Submission-ready reports and Content Design

• Team communication, including contract facilities and partners

We are a small virtual consulting firm, personal, attentive, and high-value. We bring in the best resources as needed, and work efficiently as a team. With our expertise in Chemistry, Manufacturing, and Controls (CMC) and medical/technical writing, we can assist you in quality 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.

We recommend eCTD for your marketing applications and also for investigational applications. 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, and FDA is requesting electronic DMFs in eCTD format.

Improve workflow efficiency in preparation of IND and NDA submissions

Facilitate acceleration of drug development and approvals

This Site Is Protected by: SpamStop.org