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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

The regulatory submission experts at Cardinal Health Specialty Solutions have four decades of experience preparing, compiling, reviewing and publishing electronic and paper-based regulatory submissions. We also have expertise with preparing and submitting electronic drug listings, labeler code registrations, structured product labeling, drug establishment registration and generic drug firm self-identification (GDFSI) files.

Our regulatory publishing expertise

  • 130+ eCTD original submissions to FDA and global regulatory agencies
  • 1,750+ lifecycle submissions to FDA and global regulatory agencies
  • 160+ regulatory dossiers under maintenance and lifecycle management
  • 10,000+ regulatory publishing deliverables for a single global biopharmaceutical client
  • 100+ clinical study reports (CSRs) published in eCTD/ICH E3 format
  • 3,500+ electronic drug listing and establishment registration submissions

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

Managing Director, Regulatory Submissions and Administrative Operations

Laurie Henricks

Laurie Henricks

Director, Regulatory Submission Operations – Publishing

eCTD Publishing and Submission Services

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493KB – PDF

Electronic Drug Registration and Drug Listing Services

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708KB – PDF