Consulting

GxP Managed Services

Proactive Support for Compliance, Efficiency, and Innovation

At USDM Life Sciences, our Managed Services model offers continuous, tailored support to maintain compliance, optimize operations, and enable seamless digital transformation. Unlike traditional consulting or staffing models, our managed services provide ongoing, proactive solutions designed to ensure uninterrupted performance in highly regulated environments.

What Sets Managed Services Apart?

Continuous Compliance and Monitoring

Our Managed Services model delivers end-to-end support to ensure your organization stays audit-ready and compliant with global regulations. From cloud environments to quality systems, we continuously monitor and validate your systems, reducing risks and allowing you to focus on core business objectives.

Scalable and Flexible Solutions

With managed services, you can access a dedicated team of experts who scale services according to your organization’s evolving needs. Whether it’s ongoing validation, lifecycle management, or proactive risk monitoring, we adapt to meet operational demands without needing internal resource allocation.

Predictable Costs and ROI

By choosing managed services, you avoid the unpredictable costs of ad hoc consulting or the overhead of in-house teams. Our subscription-based or project-aligned offerings provide transparency and measurable ROI, enabling smarter resource management.

Benefits of the USDM Managed Services Model

Continuous GxP Compliance

Our experts ensure your systems, workflows, and data management processes comply with evolving global standards, including FDA, EMA, GxP, and ISO regulations. We maintain audit readiness through tools like Cloud Assurance while reducing manual effort.

Risk Mitigation and Data Integrity

Proactively protect your organization from compliance risks with real-time monitoring and robust data governance frameworks. Our solutions enable secure data pipelines, automated testing, and lifecycle validation, reducing errors and safeguarding your operations.

Operational Optimization

Our managed services extend beyond compliance to enhance your business operations. We streamline workflows, enable advanced automation, and integrate cutting-edge technologies like AI and machine learning, driving efficiencies across all domains.

Ongoing Technology Enablement

Stay ahead of the curve with expert support for new technologies. From validating cloud platforms to implementing AI-powered tools, we ensure your systems remain cutting-edge and aligned with your long-term business goals.

Key Features of USDM Managed Services

Lifecycle Validation Management

Automate and manage the full lifecycle of system validations, focusing on GxP compliance. Our continuous validation solutions ensure seamless upgrades, efficient audit readiness, and reduced downtime.

Automated Workflow Optimization

Streamline quality, manufacturing, and regulatory workflows with advanced tools like ProcessX. Our managed automation solutions reduce manual tasks, minimize errors, and improve process efficiency.

Real-Time Monitoring and Reporting

Receive 24/7 system monitoring and actionable insights. Our proactive approach identifies and resolves potential issues before they impact operations, ensuring smooth and compliant processes.

Flexible Engagement Models

Whether you need ongoing support for specific systems or a fully outsourced compliance and technology management team, we offer customizable service packages to fit your unique needs.

By offering highly adaptable models alongside advanced capabilities across compliance, automation, data management, and digital transformation, USDM ensures that life sciences organizations can scale operations efficiently and drive significant business impact. Whether for targeted short-term initiatives or comprehensive long-term transformations, USDM’s talent solutions and managed services empower organizations to stay compliant, optimize processes, and remain competitive in a dynamic regulatory landscape.

Why Choose USDM Managed Services?

Global Expertise: 900+ customers, including top-tier pharma and medical device companies, rely on our managed services to maintain compliance and operational excellence.

Proprietary Solutions: Cloud Assurance and other frameworks are specifically designed for life sciences to ensure seamless compliance in dynamic environments

Outcome-Driven Approach: Every service is tailored to deliver measurable improvements, from efficiency gains to cost savings.