Simplifying the Drug Application Management for a Federal Regulatory Program
Back to Success StoriesOverview
A federal drug and biologics regulatory program is responsible for tracking, reporting, and maintaining records related to pharmaceutical and biological product applications. These records support mandatory reporting to legislative oversight bodies against defined industry-funded regulatory performance programs and related compliance mandates.
The program’s legacy tracking and archiving tools had become outdated, prompting the development of a centralized document archiving, reporting, and regulatory tracking platform. This multi-tier, web-based enterprise system was designed to streamline application intake, document management, and standardized report generation across the application lifecycle.
The program’s legacy tracking and archiving tools had become outdated, prompting the development of a centralized document archiving, reporting, and regulatory tracking platform. This multi-tier, web-based enterprise system was designed to streamline application intake, document management, and standardized report generation across the application lifecycle.
Goal
The primary goal of the centralized tracking platform was to consolidate multiple fragmented functions into a single system that would enable the regulatory program to efficiently manage, track, and archive application submissions. The solution also needed to generate standardized documentation during the review process and support legislative reporting requirements tied to multiple drug, biologics, and generics regulatory performance frameworks such as Prescription Drug User Fee Act (PDUFA), Biosimilar User Fee Act (BSUFA), and Generic Drug User Fee Act (GDUFA).
Challenge
The regulatory program’s legacy systems were technically obsolete and unable to support evolving business processes and emerging application types. Integrating the capabilities of several standalone legacy applications into a unified, flexible, and scalable platform posed a significant challenge.
Additionally, the program required enhancements to streamline review workflows and support new submission categories for a large and diverse user base of more than 4,000 regulatory staff members.
Additionally, the program required enhancements to streamline review workflows and support new submission categories for a large and diverse user base of more than 4,000 regulatory staff members.
Solution
Sky Solutions implemented a modernized solution by providing comprehensive operations and maintenance support, leading development and testing for enhancement requests, and establishing continuous integration and delivery (CI/CD) pipelines using Jenkins and Git.
Sky developed REST-based web services leveraging existing enterprise application models, enabling seamless integration and future modernization without disrupting ongoing operations. By adopting an Agile Development Life Cycle (ADLC) with Scrum practices, Sky ensured transparency, collaboration, and iterative delivery across stakeholders.
Sky developed REST-based web services leveraging existing enterprise application models, enabling seamless integration and future modernization without disrupting ongoing operations. By adopting an Agile Development Life Cycle (ADLC) with Scrum practices, Sky ensured transparency, collaboration, and iterative delivery across stakeholders.
- Conducted operations and maintenance for the centralized regulatory tracking application
- Managed development, testing, and release management for defect resolution and enhancement requests
- Developed REST web services to modernize the program’s application architecture using existing enterprise models
- Supported technical and functional integrations, including feasibility assessments for future modernization initiatives
- Leveraged the Oracle ADF tech stack on WebLogic, Oracle DB on-premises, and REST web services
Technologies/Methodologies
- Oracle Application Development Framework: Used to develop business components and user interfaces following the MVC pattern
- Oracle Fusion Middleware (WebLogic, OHS): Provided the application server environment for hosting the system
- Oracle DB (On-Premises): Served as the primary database for storing and managing the application data
- REST Web Services: Enabled integration and incremental modernization
- Jenkins: Implemented automated CI/CD pipelines
- Git Hub: Used for version control and source code management
Outcome
The centralized regulatory tracking system was significantly enhanced, resulting in a more flexible, scalable, and maintainable platform for managing pharmaceutical and biologics applications. Automated CI/CD pipelines replaced manual deployments, streamlining release cycles, reducing downtime, and improving overall system reliability.
The introduction of REST-based services enabled gradual architectural modernization while maintaining acceptable system performance. As a result, the federal regulatory body improved its ability to track, report, and archive submissions, strengthened compliance with legislative reporting requirements, and enhanced operational efficiency across the enterprise.
The introduction of REST-based services enabled gradual architectural modernization while maintaining acceptable system performance. As a result, the federal regulatory body improved its ability to track, report, and archive submissions, strengthened compliance with legislative reporting requirements, and enhanced operational efficiency across the enterprise.