Industry

Solutions for CROs and CMOs

Streamline your research, development, and manufacturing processes, ensuring compliance and operational excellence at every stage.

The biopharmaceutical industry is experiencing significant growth, with the Contract Research Organization (CRO) and Contract Manufacturing Organization (CMO) market projected to reach $65.36 billion by 2033. This expansion underscores the increasing reliance on specialized partners to drive innovation and efficiency in drug development and manufacturing.

Better Regulated Data Management

Trust and Compliance for CROs and CMOs

USDM offers specialized regulatory compliance solutions for CROs and CMOs to maintain audit readiness and remediate quality processes. We provide tailored services to navigate complex regulations, ensuring audit success and continuous compliance with global standards.

Data Strategy & GxP Technologies for the Future

USDM helps CROs and CMOs future-proof their data strategies with cloud-native solutions, real-time data integration, and advanced analytics. Leveraging data lakes, AI insights, and automation, we enhance data governance, ensure compliance, and transform data into a strategic asset.

Optimize Your Data for AI Readiness

USDM’s data management and data science solutions improve data quality, governance, and compliance for CROs and CMOs. With advanced analytics, AI, and machine learning, we help derive actionable insights, streamline operations, and ensure data integrity while meeting standards like GDPR and CCPA.

Intelligent Workflow Automation

USDM streamlines business processes for CROs and CMOs through AI-driven automation and advanced digital tools. By rethinking workflows and integrating intelligent solutions, we enhance operational efficiency, foster scalability, and drive sustainable value, transforming everyday processes.

Why USDM Stands Apart

Unlike typical consulting companies, USDM doesn’t just provide recommendations—we become a partner in your journey to digital transformation. Our strength lies in our unique blend of regulatory expertise, cutting-edge technology integration, and an adaptive approach customized to your organization’s needs. With over 20 years exclusively focused on the life sciences sector, we understand the complex challenges of biopharma compliance and leverage our regulatory partnerships with agencies like the FDA and EMA to provide proactive, compliant solutions.

Discover a digital-forward approach to harmonize compliance and innovation.

Read this white paper on USDM's approach.

Your Trusted Partner in Compliance and Innovation

When you choose USDM, you’re choosing more than a consulting firm. You’re choosing a partner committed to your success, with a proven track record in GxP excellence. Our deep domain expertise, strategic industry partnerships, and commitment to innovation set us apart as a leader in compliance and operational excellence.

Why USDM for CROs and CMOs:

  • Life Sciences Expertise: Over 20 years dedicated to supporting CROs and CMOs in the life sciences sector.
  • Proven Track Record: Thousands of GxP projects completed globally.
  • Industry Trust: Trusted by over 900 biotech, pharma, and medical device clients, including CROs and CMOs.
  • Compliance Solutions: Innovative cloud compliance and GxP automation solutions that enhance efficiency and maintain regulatory standards.
  • Cloud Assurance: Ensures continuous compliance, audit readiness, and automated testing for effective risk management.
  • Technology Partnerships: Collaborations with top technology providers to deliver GxP-ready functionality that meets CRO and CMO needs.
  • Digital Transformation: Full support for integrating technology, people, and processes to maximize return on investment and enhance operations.
  • Flexible Engagement: Managed services, consulting, and staff augmentation to fit unique needs.

Ready to transform your GxP operations? Let’s connect.