Electronic Common Technical Document (eCTD)


Information or proposal request: eCTD Services

To request more information or a proposal for eCTD services, please complete this form.

Beckloff Associates understands the Electronic Common Technical Document (eCTD), and is ready to help you unlock the full lifecycle value of electronic content and submission management. Our robust and validated system is ready to handle the most complex and challenging submission assignments. Use our system today instead of, or in advance of, building your own. And at the same time, tap into our quality, expertise and unique focus on successful outcomes.

Preparation and submission of eCTDs and more
Electronic Common Technical Document (eCTD) preparation and submission are part of Beckloff?s broad range of regulatory publishing and content management services. While designed for eCTD, our system also efficiently supports printed output formats.

 

Features:

  • 21 CFR Part 11 validated hardware/software system including robust publishing, electronic content management (ECM) and electronic labeling (SPL/PLR) components,
  • professional, project-managed publishing process based on 32 years regulatory experience,
  • templates (over 1000) and tools to ensure content and output quality, consistency and ease of navigation


 

What are some of the potential benefits ? to the applicant - of using the eCTD now?

  • compliance with the agency preference for this format
  • reduced application review and approval time
  • reuse of documents and content for amendments and for global submissions ? efficient lifecycle management


 

What are the potential benefits to the regulatory agencies?

  • increased reviewer efficiency and effectiveness
  • more consistent review
  • electronic workflow