Consulting

Technology &Compliance Specialized Talent Solutions

GxP Resources for Regulated Projects in Life Sciences

USDM Life Sciences offers a comprehensive approach to supporting life sciences organizations across all domains by providing specialized talent, whether fractionally or at scale, to meet critical business objectives. USDM’s talent solutions are an integral part of our broader service offering, ensuring life sciences companies have access to specialized, compliant, and scalable professionals. By aligning our talent solutions with our consulting, managed services, and digital transformation offerings, we help clients achieve their strategic goals while maintaining the highest standards of regulatory compliance. This comprehensive, end-to-end approach makes USDM a trusted partner for life sciences companies looking to grow and modernize in highly regulated environments.

USDM's Talent Solutions

Specialized GxP-Regulated Talent: USDM provides expert talent for GxP-regulated environments, covering key areas like regulatory and quality management, clinical operations, IT and cloud support, and manufacturing and supply chain expertise, ensuring compliance and operational excellence.

Flexible and Scalable Solutions: USDM offers adaptable talent models, from short-term engagements to full teams for large-scale projects, implementations and deployments to continuous compliance monitoring and validation through managed services that support long-term efficiency and innovation.

Enhancing Digital Solutions: USDM’s talent supports the implementation and validation of cloud-based and automated systems, ensuring compliance while leveraging AI and automation for improved efficiency.

Proactive Risk Management: USDM’s talent helps mitigate regulatory risks and ensure audit-readiness, using AI-driven compliance frameworks and predictive analytics.

Quantifiable Business Outcomes and ROI Measurement: USDM’s talent solutions are designed to deliver measurable outcomes including efficiency gains, risk mitigation and cost optimization.

Capabilities to Support Cross-Domain Business Initiatives

USDM delivers end-to-end solutions that integrate various domains to address broad business challenges, including:

Compliance and Validation

Validation services for cloud platforms (e.g., Box, DocuSign) and ERP systems such as Oracle SCM.
Ongoing compliance monitoring and automated testing through platforms like Cloud Assurance to ensure seamless operations even with frequent updates.
Comprehensive support for GxP systems validation across clinical, manufacturing, and supply chain domains.

Data Governance and Digital Transformation

Data governance frameworks with master data management (MDM) and metadata tagging for seamless data integration.
Support for AI-powered governance and automation, helping companies optimize processes and comply with complex regulations.
Tailored data strategies and real-time analytics using tools like Power BI to provide actionable insights.

Quality and Post-Market Surveillance

Automated CAPA systems, integrated QMS platforms, and supplier quality management solutions to maintain high product quality.
Post-market surveillance and safety monitoring services that leverage UDI and traceability solutions for rapid response to adverse events.

Supply Chain and Manufacturing Optimization

Expertise in implementing ERP, MES, and SCM systems for real-time visibility and supply chain optimization.
Fractional support for process validation, lean manufacturing initiatives, and AI-driven demand forecasting to enhance operational efficiency.

Specialized GxP Roles We Support

What kind of support does your organization need? We source candidates that have the knowledge, experience, and domain expertise to deliver transformative outcomes that exceed your expectations. Roles that we support include:

Quality & Regulatory Affairs

Auditors, Validation Quality Review (QA), Periodic Review, CAPA, Deviation Management, Post Market Surveillance

Laboratory

Data Integrity Analysts, Technical Writers, Validation (Equipment/Lab Systems), Project Management, Risk Management

Product Development

Design Control, Project Managers, Research and Formulation Scientists. CAD/CAM Developers, SaMD/SiMD Developers

Operations

Technical Writers, Quality Engineers, Validation (Automation, Equipment, Cleaning, Utilities, and Facilities), Supply Chain Management

Engineering

Process Engineering, Automation Engineers, IOT Specialists, Control Systems, Implementation & Validation, Building Management Systems Support

Information Technology (IT)

Project Management, Business Analysis, Validation and Testing, Technical Configuration, Software Development, Training, Cloud Compliance

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.