Case Studies

Proven Results, Real Impact

Explore how we've helped Fortune 500 companies solve complex technology, regulatory, and operational challenges.

IT & Technology

Enterprise Technology Solutions

AI & Automation

AI-Powered Document Classification for Pharma Quality Systems

Designed and deployed a machine learning pipeline to automate classification and routing of 50,000+ quality documents across a global pharma company's EDMS.

85% reduction in manual document review time
99.2% classification accuracy across 40+ document types

The Challenge

A global pharmaceutical company's quality team was spending 200+ staff hours per week manually classifying, tagging, and routing documents within their Electronic Document Management System (EDMS). Error rates were climbing and audit findings were increasing.

Our Approach

We designed a machine learning pipeline using OpenAI GPT models integrated with the company's EDMS. The system auto-classifies documents across 40+ types, flags anomalies, and routes them to the correct review queues. We trained the model on 3 years of historical data and built a human-in-the-loop validation workflow for edge cases.

Technologies

OpenAI GPT-4, Azure Cognitive Services, Python, Power Automate, SharePoint EDMS, Azure ML

Enterprise Mobility

Zero-Trust Endpoint Deployment for Life Sciences Enterprise

Led an enterprise-wide rollout of Workspace ONE and Microsoft Intune across 3,000+ endpoints for a Fortune 500 diagnostics company.

3,000+ endpoints migrated with zero downtime
40% reduction in IT helpdesk tickets

The Challenge

A Fortune 500 diagnostics company was running a legacy MDM solution that couldn't enforce zero-trust policies. Shadow IT was growing, helpdesk tickets were overwhelming the support team, and a security audit flagged critical gaps in endpoint compliance.

Our Approach

We designed and executed a phased migration to Workspace ONE and Microsoft Intune across 3,000+ endpoints. Implemented zero-trust conditional access policies, automated device enrollment with self-service onboarding, and built a portal that let employees resolve common issues without calling IT.

Technologies

VMware Workspace ONE, Microsoft Intune, Azure AD Conditional Access, JAMF (macOS), PowerShell automation

Cybersecurity

DevSecOps Pipeline & Security Hardening for State Agency

Built a full DevSecOps CI/CD pipeline for a state government health agency, embedding automated vulnerability scanning and SAST/DAST testing into every deployment.

NIST 800-53 compliance achieved in 90 days
Mean time to remediate: 45 days → 72 hours

The Challenge

A state health agency was deploying applications with no automated security testing. Vulnerability remediation took an average of 45 days, and the team had failed two consecutive NIST audits. Leadership needed a modern DevSecOps pipeline to pass the next compliance review.

Our Approach

We built a CI/CD pipeline with security baked into every stage — SAST/DAST scanning on every commit, container vulnerability scanning, and automated SBOM generation. Implemented SIEM monitoring with real-time alerting and conducted a full penetration test to validate the hardened infrastructure.

Technologies

GitHub Actions, SonarQube, OWASP ZAP, Trivy, Terraform, Splunk SIEM, Docker, Kubernetes, NIST 800-53 controls framework

FDA Regulatory

Regulatory & Compliance Engagements

Product Launch

Design History File for Disposable Medical Device

Created a comprehensive Design History File (DHF) for a new disposable medical device for a Fortune 500 medical device company.

Successful FDA submission and market clearance

The Challenge

A Fortune 500 medical device company needed a complete Design History File for a new disposable device to support FDA 510(k) submission. Internal teams lacked bandwidth and the submission deadline was 4 months out.

Our Approach

We embedded a dedicated regulatory consultant who built the DHF from scratch — design inputs, outputs, verification and validation protocols, risk analysis per ISO 14971, and design transfer documentation in full compliance with FDA 21 CFR 820.

Post-Market Surveillance

Risk Management for Infusion Pump Devices

Created and maintained risk management files for a line of infusion pump devices, including hazard analysis and risk control measures per ISO 14971.

Maintained full compliance with ISO 14971 standards

The Challenge

A major infusion pump manufacturer needed to overhaul their risk management files after an FDA inspection flagged gaps in post-market surveillance documentation and traceability.

Our Approach

We rebuilt the risk management files per ISO 14971, conducted a full hazard analysis, implemented risk evaluation matrices, and established an ongoing post-market surveillance process that fed real-world data back into risk assessments.

FDA Consent Decree

Characterization and Validation of Therapeutic Assays

Under an FDA consent decree, completed comprehensive characterization and test method validation for multiple therapeutic assays.

Successful completion of consent decree requirements

The Challenge

Operating under an FDA consent decree, the company needed to fully characterize and validate multiple therapeutic assays within a strict regulatory timeline. Failure to meet the deadline risked further enforcement action.

Our Approach

We developed validation protocols from scratch, executed the studies including accuracy, precision, linearity, range, and specificity testing, and prepared detailed validation reports that demonstrated method suitability to the FDA's satisfaction.

FDA Warning Letter

Warning Letter Remediation for Legacy Devices

Led the remediation effort in response to an FDA warning letter, including DHF creation and process validation for manufacturing equipment.

FDA warning letter successfully closed

The Challenge

After receiving an FDA warning letter, the company needed to demonstrate comprehensive remediation across multiple legacy consumable devices that had been manufactured without proper design controls or process validation.

Our Approach

We crafted the formal warning letter response, retroactively built Design History Files for all affected legacy devices, and executed full IQ/OQ/PQ process validation for the associated manufacturing equipment — all within the FDA's required timeline.

Client Feedback

What Our Clients Say

"Riya Interactive modernized our entire endpoint management infrastructure in under 90 days. Their team's depth in Workspace ONE and zero-trust architecture gave us confidence from day one. We've seen a measurable drop in security incidents and helpdesk volume."

— VP of IT, Fortune 500 Diagnostics Company

"Riya Interactive's regulatory team was instrumental in helping us navigate a complex consent decree. Their deep understanding of FDA requirements and hands-on approach made all the difference in meeting our compliance milestones."

— Quality Director, Fortune 500 Medical Device Company

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