eCTD Publishing

Our team has been involved to eCTD submissions since the initial launch in 2003. We have a proven track record of several thousand successful submissions – meeting even the most challenging submission deadlines. Typical eCTD publishing services include:

  • PUBLISHING of eCTD submissions for all registration procedures and product types worldwide (system docuBridge from Lorenz)
  • GENERATION of Study Tagging Files (STF) for study reports (FDA requirement)
  • VALIDATION according to latest validation criteria
  • SUBMISSION to regulatory authorities via electronic gateways
  • MANAGEMENT of eCTD lifecycle (existing lifecycle sequences can be imported)
  • MAINTENANCE of IT infrastructure required for publishing, electronic storage, transfer of files
  • PROVISION of Exalon eCTD Viewer (free of charge for our clients)

We also take care of your submission documents. Whether we talk about MS Word or PDF documents or complex Study Reports. Our document formatting and publishing services ensure that your submission documents are of a high-quality and readily formatted to ease navigation and review.

If you have your own in-house eCTD publishing system in place, we are happy to support your team on-site or remote, e.g. in case of manpower shortages.Please find out more about our eCTD services