Supporting FDA's Regulatory Submission Systems When They Are Needed Most


Guarding Regulatory Submission Systems When They Are Needed the Most



Khalil Zebdi, Executive Vice President - Federal Business Development | LinkedIn


Governments are taking accelerated steps to mitigate the impact of COVID-19 to support the industry, markets, and citizens. The response to the crisis is resulting in new government legislation, policies, rules, grants, and funding. The situation has fast-tracked innovation, research, and development initiatives in the near term and long term solutions. Government and regulatory agencies require critical technology-enabled capabilities to collect data securely from market participants, receive regulatory submissions for review, monitoring, reporting, and dissemination.


ASSYST is a strategic partner supporting the US Food and Drug Administration (FDA). FDA is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation. FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.


Electronic Submissions Gateway (ESG), which is the Agency-wide solution for accepting electronic regulatory submissions, functions as the central receipt point for sending information electronically to the FDA. ASSYST supports a global external user community including industry partners, Gateway specialists, regulatory operations professionals, regulatory affairs personnel, Information Technology staff, and archive specialists. ASSYST maintains and operates transaction partner account information, and assists the FDA Center technical staff with Gateway integration, establishing connectivity with Transaction Partner systems, routing of submissions to appropriate Center holding areas, and routing outbound submissions from Centers. ASSYST maintains ESG which supports several regulatory mandates that are critical to both the FDA and Industry. It supports several FDA centers including the Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), the Office of the Commissioner (OC) and Health Canada. We streamline the business process and deliver customer support to meet and exceed the goals set by the agency. Our team has directly contributed to reducing the submission times, increasing the volume of same-day submissions, scaling to support large-sized file transfers, reducing errors and acknowledgments.


ASSYST uses Human Centered Design (HCD) and the Agile approach to reimagine the Industry Partner engagement and touchpoints to facilitate Account Set up, User Onboarding, and Self-Service. Using modern User Interface design techniques, we delivered the highest level of service quality to the submitters.


ASSYST brought a security-centric mindset and approach to the FDA ESG environment by utilizing DevSecOps toolchains. We use a framework that looks at code in components, identifying vulnerabilities and isolating those quickly. Additionally, telemetry is generated in real-time to deliver context for developers, analysts, and engineers to make targeted updates. We plan, code, build, test, release, deploy, operate and monitor systems in the AWS cloud using containers and microservices along with other open technology.


ASSYST is a trusted partner for technology modernization for government agencies responsible for regulation, monitoring, and enforcement of sectors such as Banking, Financial and Capital Markets, Healthcare, Pharmaceuticals, Revenue, Tax Collection, and Nuclear Energy. Our customers include the Securities and Exchange Commission (SEC), Centers for Medicare and Medicaid Services (CMS), Food and Drug Administration (FDA), Health Resources and Services Administration (HRSA), Internal Revenue Services (IRS), Equal Employment Opportunity Commission (EEOC) and Nuclear Regulatory Commission (NRC).


ASSYST’s Green Accelerator program enables government systems to adopt multi-cloud capabilities. It includes reusable components, common coding standards, and a refactoring toolset for rapid adoption and migration of the next generation of technology. Our implementation approach is helping customers innovate and automate their business processes, reduce cost redundancy, and decrease technology overhead.