Submissions and Publishing

Our Regulatory Operations Team is a highly experienced group of regulatory affairs professionals that provides critical document and marketing application submission services for many of our regulatory strategy and clinical projects. Every member of this team has at least 10 years of experience in electronic publishing and production of eCTD submissions. Team members are trained in report-level publishing using the Lorenz DocuBridge and other submissions platforms, regulatory affairs, submissions project management, and eCTD-related data science.

This group routinely submits ~250 submissions per year, including multiple full marketing applications and IND submissions along with many serial maintenance submissions for ongoing programs. Additionally, this team handles report-level publishing for the numerous clinical study reports produced each year in support of our clinical trials work.

For every submission project, the lead regulatory operations expert ensures a high-quality and efficient submission process by working closely with the project lead from the initial stages of submission planning to develop and execute a detailed submission filing strategy. This close partnership allows the regulatory operations lead to guide the wider project team and sponsor through the publishing, review, and electronic filing process. As needed, the regulatory operations team also trains sponsor and 3rd party individuals involved in document generation in best practices for document authoring.

We routinely submit

250

submissions per year

Our document publishing and submissions related services, include:

  • New Investigational and Marketing Applications – BLA, IND, NDA, 510(k)
    • Initial application submission structuring strategy
    • Submission compilation, publishing, QC, validation, and submission
    • Publishing project management and build list management
    • Multi-region submissions
    • eCTD concepts and preparation training
  • Existing Investigational and Marketing Applications
    • Cumulative application review and assessment
    • Labeling submissions
    • Submission import and hosting
    • Baseline submissions
    • Lifecycle management
    • Cumulative application review training
  • Validation and Submission Services
    • Submission technical review and validation
    • STF review
    • SPL review
    • Dataset hyperlink review
    • FDA ESG submission filing
  • PDF/Word Publishing
    • Clinical study report publishing
    • Bookmarking
    • Hyperlinking
    • Submission-readiness document remediation
    • Structured document authoring training
  • Other Regulatory Operations Services
    • Conversion from Paper Dossiers to eCTD
    • Remediation of submission “legacy” documents such as flat scans of paper reports, legacy-format datasets, and literature publications
    • Application Number Requests
    • Change in Sponsorship
    • FDA Technical Contact

Marketing Application Planning Tool

If you’re interested in working with us on your marketing application, download and complete our planning tool to provide us with critical information about your program.

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