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Electronic Common Technical Document (eCTD) Publishing

Outsourced publishing solutions with quality eCTD submission capabilities and no overhead investment by your company

Our regulatory publishing expertise

We customize our solutions to fit your organization

  • Small, medium, large and virtual pharmaceutical, biotechnology and medical device companies
  • Clinical research organizations (CROs)
  • Over-the-counter (OTC) and prescription (Rx) marketers, labelers, distributors, manufacturers and packagers

  • Complete eCTD submission solutions with no overhead investment (e.g., hardware and software)  by your company
  • eCTD publishing and submission capabilities to meet PDUFA V eCTD requirements
  • Complete solutions for publishing of CSRs in eCTD-compliant and/or ICH E3 format to ensure reports are submission ready for investigational and marketing applications
  • Efficient maintenance and lifecycle management of regulatory dossiers
  • Complete solutions for outsourced publishing (full and partial dossiers)
  • Publishing deliverables prepared in your systems using your tools and processes
  • Complete solutions for paper trial master file (TMF) document indexing, scanning and archiving
  • Complete solutions for preparation and submission of electronic drug listings, establishment registrations, labeler code registrations, lot distribution reports and GDFSI files
  • Structured product labeling
  • Access to eCTD experts for submission planning, placement of content within the eCTD structure and the development of detailed submission plans/maps
  • Expert consulting services regarding FDA requirements
  • Project-based, overflow or long-term engagements

 

Gina Ross

Gina Ross

Laurie Henricks

Laurie Henricks

eCTD Publishing and Submission Services

PDF
493KB – PDF

Electronic Drug Registration and Drug Listing Services

PDF
708KB – PDF