Transforming the FDA's Regulatory Submissions Program: A Story of Innovation and Excellence

The regulatory landscape is evolving rapidly, with an increasing focus on health data interoperability, adopting industry standards, and using real-world data. In this context, the FDA’s Electronic Submissions Gateway (ESG) stands as a vital platform, handling over 10 million transactions annually and processing files ranging from 100GB to 1TB. ASSYST is critical in supporting the FDA’s mission to process data from the major Trading Partners, including AERS, CDER, CBER, CDRH, CVM, OC, CTP, ACA, GDUFA, CFSAN, and Health Canada. ESG Handles Large File Processing and supports Multiple Data and File Formats, including HL7, FHIR, and XML.

As regulatory requirements grow more complex, the demand for seamless data exchange and integration across systems is becoming increasingly important. The shift towards health data interoperability reflects broader industry trends, emphasizing the need for consistency and accuracy in data handling. Moreover, the increasing reliance on real-world data enhances regulatory decision-making and public health outcomes.

ASSYST’s initiatives within ESG align with these industry trends, providing a scalable and secure platform that meets current regulatory needs while adapting to future demands for data interoperability and evidence-based insights. By integrating emerging standards and leveraging real-world data, ASSYST ensures the ESG remains central in navigating the complex and dynamic regulatory environment.
 

A Vision of Seamless Integration and Security

ASSYST’s work with the FDA extends beyond support, involving key Bureaus like CDER, CBER, CDRH, OC, and Health Canada. Our vision was to create an ESG that meets and exceeds expectations in scalability and security. Leveraging AWS services, including a multi-AZ strategy and Amazon Elastic Kubernetes Service (EKS), we developed a resilient and adaptable infrastructure that ensures peak performance, even during partner onboarding and with massive data loads.

Security is a top priority. Through DevSecOps, we integrated security throughout every development phase, employing automated security scans, compliance checks, and continuous monitoring. This approach meets stringent federal standards such as FISMA and FedRAMP, protecting the system from threats while ensuring compliance.
 

Streamlining Operations with Automation

Efficiency is central to our strategy, and we leverage a robust suite of AWS services to enhance the FDA’s Electronic Submissions Gateway. We utilize CI/CD pipelines with CodeCommit, CodeBuild, and CodeDeploy, transforming code deployment and management, reducing errors, and accelerating updates. Amazon Elastic Container Service (ECS) and Elastic Container Registry (ECR) streamline the deployment of containerized applications, while Elastic Load Balancer (ELB) and Auto Scaling Groups (ASG) ensure optimal performance and scalability.

Security is reinforced with Security Groups (SG) for network protection, and continuous monitoring is maintained through CloudWatch and CloudTrail, providing operational insights and compliance tracking. The infrastructure is further supported by RDS for Oracle, PostgreSQL, and MySQL and managed within a secure VPC environment. CloudFormation orchestrates the deployment and management of these resources, ensuring consistency and efficiency throughout the ESG system.

Enhancing User Experience with Human-Centered Design

Our commitment to the FDA also includes a focus on user experience. By applying Human-Centered Design (HCD) principles, we redesigned the ESG interface to be more intuitive and responsive. Using tools like React.js, we created a modern, user-friendly experience that simplifies the submission process, improves accuracy, and reduces operational overhead. ASSYST also provides end-to-end facilitation for FDA Partner support through self-service tools and a Help Desk.

A Commitment to Excellence

ASSYST’s enhancements to the ESG were particularly crucial during the COVID-19 pandemic, ensuring the system’s high availability when needed most. Our work in scaling the infrastructure, automating processes, and enhancing the user experience has led to smoother and more efficient regulatory submissions, benefitting public health and safety on a broad scale. One of the innovation initiatives, ASSYST, developed a proof of concept for FDA ESG to help end users find answers to their questions easily and quickly using an AI-powered chatbot that operates 24/7 and can be handed over to live agents during business hours. The purpose of the prototype solution was to improve help desk support and reduce costs. This initiative and our commitment to excellence have demonstrated our ability to deliver impactful solutions, even in challenging circumstances.

Impact Delivered

ASSYST’s transformation of the FDA’s ESG has resulted in significant improvements across the regulatory submission process. By enhancing time efficiency, we’ve enabled same-day submissions that were previously unattainable. Reducing reliance on paper-based processes has minimized administrative overhead and cut down on shipping costs. Our system optimizations have facilitated seamless electronic acknowledgments, ensuring timely confirmations of successful transmissions. This comprehensive approach has aligned regulatory processes with modern digital practices and significantly enhanced overall efficiency and effectiveness in safeguarding public health, leaving a lasting impression on the industry.
 

About ASSYST

ASSYST is a key partner in technology modernization for government agencies across important sectors. Serving clients like the CMS, CDC, PSC, ONC, HRSA, IRS, EEOC, and NRC, we use our Green Accelerator program to support multi-cloud adoption, streamline processes, and cut technology overhead. Our extensive experience and expertise in technology modernization instill confidence that government systems are in good hands, ready for today’s demands and future success.