Regulatory Publishing

The success GlobalSubmit has achieved in regulatory publishing can be credited to the innovative mixture of three ingredients – people, technology and process. By providing stakeholders and business owners visibility to all aspects of regulatory publishing projects, we have built an effective model for communication, internal accountability and improved client satisfaction. As a result, we’ve lowered project costs for our clients and delivered higher quality submissions, all while submitting on schedule or early, with no late nights or weekends.

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Our innovative process provides flexibility when managing complex projects that, whether we like it or not, often diverge from well-intended plans and require intelligent adjustments as they progress toward completion.

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Expert People

Each project is structured to include three (3) client-facing team members – a Submission Owner, Submission Coordinator and Publishing Lead – thus providing continuity and multiple points of contact throughout the project. Each project is overseen by our Senior Management Team all of whom possess a deep knowledge of regulatory publishing and are considered Subject Matter Experts (SMEs) in the industry.

The Submission Owner is responsible for deliverables and oversight throughout the course of a project including:

  • Regular communication and project status
  • Resource allocation and management for all publishers involved
  • Generate and update the eCTD Submission Tracker that will identify each component and track status at the file level
  • Generate and update the Issues Log to track issues through to resolution at the file level
  • Overall project risks and issues will be tracked and communicated in monthly status reports
  • Review of all project components for eCTD readiness
  • Deficiency reporting on eCTD related issues
  • Act as technical contact to FDA for submission related inquiries
  • Obtaining application number from FDA (if necessary)

In terms of project types, complex regulatory matters, and issue resolution, there are very few circumstances, if any, that GlobalSubmit as an organization has not encountered and successfully solved.

Technology

GlobalSubmit’s Submissions Management suite, deployed in the GlobalSubmit Cloud, is used by our regulatory publishing team to complete all compilation, publishing, and quality assurance activities.

Our PUBLISH software automates many tasks in the eCTD workflow, such as applying regulatory compliant properties to PDF documents, thus improving submission quality and reducing the amount of steps in the overall process. Rework is nearly eliminated by using Live Validation to identify and address technical errors in real time and delta publishing to process only documents that have changed during the last mile. PUBLISH is compliant with FDA Module 1 v2.3 specifications (DTD 3.3), which provides our clients the ability to take advantage of functionality for grouped submissions, updated metadata categories and Advertising and Promotional submissions in eCTD format to CDER.

The GlobalSubmit Cloud deployment not only gives a client access to eCTD Submissions Management suite without having to build and maintain on-site infrastructure, the technology also allows clients to monitor up-to-the-minute progress of a regulatory publishing project.

Logging into REVIEW provides a client’s regulatory team transparency as to the progress of publishing-related activities. Clients can also use the GlobalSubmit Cloud to transfer files and reengage with GlobalSubmit’s Regulatory Services team in the future.

GlobalSubmit REVIEW User ExperienceGlobalSubmit CROSSCHECK allows our regulatory publishing team to perform 100% QC of all bookmarks and hyperlinks. When sponsors have compared the performance of CROSSCHECK against traditional methods, the data shows that the tool is 8X faster and 3X more accurate.

Agile Project Management Methodology

Since adopting Agile for Regulatory Submissions, GlobalSubmit’s regulatory publishing team has completed 75% of its projects ahead of the submission deadline. By submitting earlier or on time, while requiring no late nights or weekends, the overall project cost is reduced.

Agile Principles prioritize effective communication and a constant flow of deliverables, as opposed to a few bulk offloads of documents during the lifetime of a project. We’re able to review deliverables, performing 100% QC of bookmarks and links, on a rolling basis and completely close out sections of documents well in advance of the final deadline.

This graphic depicts the innovative Agile Regulatory Publishing process

Clients not using GlobalSubmit’s software technology in tandem with Agile Principles delay submission review until the later stages of the project. Even the most skilled and experienced team will uncover issues.

As is the case with all regulatory publishing projects we undertake, the collective goal we share with the client is to ensure that patients are able to benefit from new medicines as quickly as possible. By retrofitting Agile Principles to regulatory submissions and completing projects ahead of schedule, our clients have been able to achieve their goals, and more importantly, patients are gaining access to new medical treatments earlier.

Advantages of Agile

  • Submit On Schedule or Earlier with Higher Quality
  • No Weekends or Late Nights
  • Visual Representation of Project Status
  • Client Receives Constant, Clear Communication
  • 100% QC of Bookmarks and Hyperlinks
  • Added Visibility Allows for Rolling Delivery of Submission-Ready Documents and Adjustments