AI-Powered Submission Authoring for Module 3 and Beyond

AI-Powered Submission Authoring for Module 3 and Beyond: Introducing RegWriter

The regulatory submission process for pharmaceutical, biotechnology, and medical device industries can be a challenging experience. Tight budgets, limited resources, and strict deadlines all create hurdles. Add increased scrutiny from regulatory bodies, and teams are basically expected to work miracles.

What if there was a way to use the newest technology, including AI and Machine Learning (ML), to revolutionize the process, increase efficiency, and free up your team to focus on more important work?

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A New Solution to the Regulatory Process

RegWriter™ is a next-generation AI-powered document authoring automation platform developed by Global Exponential Technologies (GxT). RegWriter™ uses AI and ML to assist in regulatory documentation creation by extracting data and facilitating document drafting. In addition, RegWriter™ contains a host of document organization, data verification (DV), and data traceability capabilities.

Authoring documents can be cumbersome, especially when needing to flip between windows to edit and call back to source documents. RegWriter™ offers a unique dual-pane interface that provides users with a side-by-side view of the document you are authoring and the associated source documents. This allows authors to easily view and switch between multiple source materials regardless of format (e.g., PDF, Word documents, spreadsheets) while compiling the final submission.

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AI as Your Partner in Writing

The intuitive layout supports the interactive AI-augmented authoring support capabilities, including AI-powered suggestions that help users quickly create documents by analyzing source materials and suggesting relevant content for each section. This is not unique to RegWriter. Today many tools are available for document generation, even regulatory document generation. However, you may have observed that these tools do not work well for Module 3 content generation.  

Traditional generative AI tools often struggle with extracting data from tables and representing it accurately in a new document, especially in table formats. To address this challenge, RegWriter™ features a unique AI system specifically geared towards understanding, extracting, and correctly representing data from tables. For instance, while working on a document such as an eCTD section or report, RegWriter™ analyzes the data and suggests up to 20 options for inclusion based on the source content. Users can either review and choose the best suggestion themselves or let RegWriter™ automatically pick the top option and fill it in for them. This saves time and ensures that the right content is used based on the specific context of the document. This information is displayed in real-time within the interface, allowing users to seamlessly review and transfer AI-proposed content, significantly reducing manual data extraction while improving accuracy.

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Data Viewing and Mapping with Ease

When authoring regulatory documents, it can be difficult to maintain sources for data. With RegWriter™, you can utilize “Snap-to” Data Viewing, which enables authors to instantly trace any data point in the target document to its source for quick verification and context. When a user clicks on a given value, the system automatically highlights the original location in the source document. Quick and easy!

You can also utilize bulk data movement with precise data mapping, enabling authors to instantly trace any data point in the target document to its source for quick verification and context. Furthermore, RegWriter™ performs direct data transfer, minimizing transfer errors. For bulk data transfers (by the AI or otherwise), the user can trace each value back to its source location. The author can edit the data point or content if needed, but upon transfer, the content will exactly match the source. No more wasted time searching for the original source!

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Instant Audit Transparency

Managing data audit compliance documentation can be a time-consuming task. RegWriter™ simplifies this by automatically generating a visible and transparent audit trail. Any new content or modifications made within the document are logged by RegWriter’s authoring engine, which accelerates the review process. With one-click audit review, users can click on any data point in the final document and trace it back to its exact source for an in-context review. The system displays the specific page, table, and cell where the data originated, ensuring full transparency during regulatory reviews or audits. Additionally, RegWriter™ logs all data transfer events and changes, making all data traceable and verifiable. This dramatically reduces the time and effort required to create data change logs while maximizing transparency.

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Increase Speed and Accuracy with Predictive Data Retrieval

At the core of RegWriter™'s advanced functionality is its specialized AI system that has been fine-tuned specifically for regulatory submissions. This innovative AI approach predicts what data or text a user is likely to add next by analyzing patterns and context from source documents. Before the author begins writing, RegWriter™ pre-scans uploaded source documents to identify the most relevant data points. These are then presented in order from most relevant to least, allowing for user selection or automatic authoring. This approach minimizes repetitive searches and speeds up the entire authoring process, providing an efficient and targeted solution. Unlike many other tools, RegWriter™ does not use large language models (LLMs) for generating Module 3 content, which often struggle with the specific requirements of structured regulatory content.

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Improved Data Consistency

The GNN's ability to recognize patterns across documents helps ensure consistency between submissions, significantly reducing the likelihood of discrepancies or errors. RegWriter™ can maintain a high degree of accuracy across heterogeneous source documents.

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Adaptability Born from Simple Training

An often-cited struggle with AI and ML is the extensive datasets necessary for training. Not everyone has the time or the amount of data needed to create success with these types of systems. The RegWriter™ AI model stands out for its ability to be trained on a given document or eCTD section using just a single template document or example. RegWriter's AI learns efficiently from limited inputs, making it highly adaptable.

This creates out-of-the-box functionality. RegWriter™ can start producing immediate results without requiring extensive or expensive model training or dataset preparation, making it both easy to deploy and use. Furthermore, the AI for a given document is generated specifically for that document. Unlike other tools, such as traditional generative AI tools, RegWriter™ does not leverage large language models (LLMs) to facilitate this functionality.

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Crucial Data Accuracy

Data accuracy within regulatory submissions is critical. Many companies and consultants require a 100% independent data check or DV process. RegWriter™ has a module designed specifically to support that. After the authoring process, RegWriter™’s DV module ensures that all content meets compliance and accuracy standards. This dedicated module provides a host of features designed to remove many of the time-consuming manual steps associated with DV. As regulatory bodies across the world ratchet up scrutiny of data and consequences for data errors, this module is more valuable than ever.

RegWriter™ has a module specifically dedicated to streamlining DV. This module allows users to quickly access any data point and either accept or reject the content. The DV module provides a color-coded status for each cell, indicating whether content has been approved, rejected, or still needs verification. Every action is automatically recorded, creating a comprehensive log that can be exported as part of a detailed audit trail.

Users can export a complete audit trail for every data point, including its original source, where it appears in the document, whether it was accepted or edited, along with details of who authored it and who reviewed it. This export provides a full traceable history for all content, making compliance and audit readiness effortless. An author and/or reviewer can add comments or flag specific sections for review, allowing for smooth collaboration between team members during the submission process.

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Scalable and Flexible

Whether handling an annual update or managing multiple biologic license applications (BLAs) simultaneously, RegWriter™ is designed to scale with your organization’s needs. It supports authoring of partial documents to full eCTD submissions. With cloud-based architecture, RegWriter™ scales as your submission needs grow, maintaining performance and compliance at any scale.

RegWriter™ offers solutions to the challenges of the regulatory submission process, identifying roadblocks that affect authors and directly addressing them with accuracy and efficiency. Learn more and reach out for a demo on our Product page.

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