Regulatory Publishing

Streamline approvals and ensure compliance with our expert regulatory publishing solutions.

Regulatory Publishing

Streamline approvals and ensure compliance with our expert regulatory publishing solutions.

Simplifying Compliance: Your Partner for Effective Publishing

A typical regulatory submission contains thousands of pages of data and documentation that need to be compiled, formatted, linked and indexed, and meticulously reviewed for accuracy to properly meet the regulatory agency’s current standards for approval. At Accorto Regulatory Solutions, our team specializes in managing eCTD submission criteria, supporting your application throughout the documentation lifecycle, and meeting your organization’s goals on expediting your path to market.

Full PMTA Development

Our subject matter experts are ready to tackle your regulatory and Masterfile submissions.

Speak with an expert and learn how Accorto can help you reach your business goals today.

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to learn more about how Accorto can assist with your publishing needs.

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Regulatory Publishing Solutions

Consult

Submission Consultation

  • Regional regulatory consultation
  • Submission assessment, including eCTD readiness review and gap analysis
Component Preparation

Submission Component Preparation

  • Scanning services and paper document conversion
  • Document and report publishing
    • Summaries
    • Cover Letters
    • Reviewer’s Guide
    • Table of Contents
    • Additional documents as needed
  • Clinical Data Interchange Standards Consortium (CDISC) and U.S. Food and Drug Administration (FDA) submission data conversion services
  • Compilation and formatting of all documentation
Electronic Submissions

Electronic Submission Services

eCTD, or electronic common technical document filing, is the standard submission format for FDA regulatory application submissions. Leverage our publishing experts to comply with FDA’s standard eCTD submission format in a new application or convert an existing paper application to the required electronic format.

  • Electronic common technical document (eCTD) submission planning and tracking
  • Formatting to ensure documents meet FDA eCTD compliance standards
  • Electronic submission publishing, including eCTD and non-eCTD electronic submission and hybrid formats
  • Conversion of paper submission formats to eCTD format applications
  • Publishing clinical study reports for electronic submissions
  • Cross-document hyperlinking
  • Internal review of all documents for accuracy along with sponsor review
  • Application Submission