eCTD Publishing Services & Regulatory Submissions

Our eCTD publishing services include:

  • Customizable, FDA compliant document templates in an eCTD format for meeting requests and packages, INDs, BLAs, NDAs, ANDAs, Drug Master Files, Form FDA 3500A (MedWatch), and electronic Medical Device Reporting (eMDR)
  • Reliable and secure transmission to FDA through our Electronic Submissions Gateway (ESG)
  • Maintenance of submissions throughout the eCTD publishing services lifecycle, including remaining current on FDA ESG submission updates
  • Transitioning of paper submissions to electronic submissions in eCTD format