Development & Strategy eCTD Publishing

eCTD Publishing

CTI has developed several Investigational New Drug (IND) applications utilizing electronic-Common Technical Document (eCTD) formats. We offer a seamless process from the earliest stages of drug development consulting through formal submission of documents electronically to regulatory agencies.

Serial submissions to the IND in eCTD formatOngoing eCTD maintenance includes but is not limited to:

  • Uploads of regulatory archives of US Food and Drug Administration (FDA)/European Medicines Agency (EMA) submissions
  • Ongoing guidance and foresight to keep sponsor aware of required updates
  • Publishing and validation of submission in eCTD format

CTI has the expertise needed to help our sponsors understand and comply with document submission requirements.

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