ECTD TRAINING

Customized Courses

We provide eCTD training courses, webinars and workshops. We work closely with the sponsor to tailor our training to meet our client’s specific needs.

 

The following are general topics that are covered:

  • Overview of the FDA's electronic submission  guidance

  • Preparing for eCTD

  • Basic Definitions 

  • Electronic Formats

  • Metadata

  • Granularity and Lifecycle Management

  • eCTD Validation and Processing

  • eCTD Challenges/Process Impacts