CU Anschutz Institutional eCTD Publishing

2026-11-03

The University of Colorado Anschutz Medical Campus is seeking information from vendors capable of providing outsourced electronic Common Technical Document ( eCTD ) publishing services in support of institutionally sponsored clinical research studies submitted to the U . S . Food and Drug Administration ( FDA ). These studies , which have potential for commercialization , require highly structured eCTD formatting and submission . This Request for Information ( RFI ) is issued for informational and planning purposes only and will not result in a contract award . Participation is voluntary and non - binding . The University is interested in understanding the current marketplace , including vendor capabilities , service models , scalability , and pricing for end - to - end eCTD publishing support . Anticipated needs include document formatting , PDF publishing , hyperlink checking , preparation and validation of eCTD - compliant submission packages , and electronic submission to the FDA . Services will be requested on an as - needed basis , with expected growth in demand over time . Vendors should demonstrate the ability to utilize industry - standard eCTD publishing software , maintain compliance with FDA and ICH requirements , and provide technical troubleshooting support . This RFI does not include regulatory authoring , writing , or content quality review services . Information gathered through this RFI will be used to inform a potential future competitive solicitation . See more

Boulder

2026-05-02