eCTD Preparation

The electronic Common Technical Document (eCTD) has become the standard for numerous regulatory agencies across the world.

FDA has mandated the eCTD format for electronic submissions to the Center for Drug Evaluation and Research (CDER).

The European Union has declared that its 27 Member States must be capable of accepting electronic-only marketing applications in the eCTD format, starting in 2009, and Health Canada has implemented an electronic review environment for eCTD

submissions. Since 2006 our well experienced team at Team Tranquil prepared and helped submitting hundreds of successful electronic submissions to FDA in eCTD format for various types of applications such as NDA, ANDA and DMFs. Some of these submissions already received approval from the agency.

Team Tranquil is maintaining 100% success with electronic submissions. So far none of the submissions prepared by us received RTF from the agency.

What we do?

  • Team Tranquil will help our clients understand the standards and guidelines setup by various agencies.
  • Help prepare the documents compatible for electronic submissions
  • Help maintain proper structure for various modules in submission.
  • Help create bookmarks and links in PDF documents
  • Help maintain redundancy of documents within a submission or across all sequences of an application
  • Prepare XML backbone for total submission including regional xml, index xml, study tag files, SPL (structured product labeling)
  • Prepare final submission media and help test the submission for accuracy of links within the submission or across submission sequences.
  • Prepare subsequent sequences for each application such as amendments, supplements, annual reports etc.

Download our FDA Electronic Submissions Presentation

Get in touch

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Team Tranquil Software Solutions (P) Ltd.
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