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Layoffs, Cost Cutting, and Economic Uncertainty

We understand that your organization is facing challenges and we empathize with the difficulties you’re experiencing. During uncertain times, adaptability and resilience become crucial for navigating change, maintaining business continuity, and emerging stronger.

USDM has exclusively supported life sciences organizations for over 23 years to solve their quality, compliance, and IT challenges. We have comprehensive solutions that address people, processes and technology needs.

Adaptive Solutions for Quality, Compliance & IT Business Continuity

PEOPLE

Having the right talent at the right time is crucial for your organization’s success. We offer on-site and remote workforce solutions, enabling you to access a wider talent pool while embracing flexibility. We will ensure that you get the best possible industry resources. From project managers to developers to validation analysts to engineers, we have experienced professionals ready to take on your GxP project.

PROCESS

Depending on your company’s maturity, you may have well-established standard operating procedures (SOPs), quality management policies, and many technologies supporting your QMS framework. Or you may be a pre-commercial company developing your SOPs and deciding what technology solution to deploy next. Wherever you are in your company’s maturity, we can help achieve and maintain compliance while streamlining critical quality processes.

Quality Management Process Support

We offer comprehensive quality management services delivered in the business model of your choice – staff augmentation, specialized consulting, professional services and managed services.

Individual services include:

Bundled services include:

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Let USDM help you accomplish more with less

Quality-as-a-Service (QaaS)

USDM provides a Quality Leader supported by a team of diverse Quality Specialists. Our QaaS model offers flexible, on-demand, cost effective quality strategy and execution services. Support is customized for your specific needs and can include the following services:

  • QMS establishment and oversight
  • Quality Event Management
  • Periodic Review Management
  • Vendor Audit Management
  • Expert advice from a brain trust of experienced quality leaders
  • Additional services customized to your unique needs

Auditing-as-a-Service

USDM can streamline your auditing processes with a seasoned team of auditors to reduce the duration of individual audits, standardize processes, and develop SLAs and reporting to ensure success. Support includes the following services:

  • All auditing logistics
  • Assess vendors and previous vendor audits
  • Assess core products manufactured from raw materials to final distribution
  • Establish a tracking system to track each audit from identification through execution and final closure

TECHNOLOGY

Cloud Assurance

Our Cloud Assurance Managed Services address the critical aspects of cloud compliance, data integrity and security. Our team works diligently to minimize risks associated with regulatory non-compliance, ensuring that your organization’s data and systems remain secure and reliable.

Technical Managed Services

We provide Technical Managed Services for GxP applications. Our experts will handle the maintenance, support and administration of your applications, ensuring optimal performance and compliance while allowing you to focus on your core business operations without having to hire or train resources to handle the administration of your systems.
We are here to help you save money and time and mitigate risk!

Contact us for a no-obligation consultation to discuss your urgent needs for business continuity.

Case Studies

At USDM, we’re committed to helping life sciences companies like yours minimize the impact of staffing changes and continue to achieve results.

See our results in action in these case studies.

Case Study

Learn how USDM's Compliance-as-a-Service model transformed a Fortune 1000 medical device company with 50% fewer resources with 60% more functionality.

Case Study

Read on to see how USDM enabled a biopharma company to work from home during the COVID-19 pandemic while making validation 90% faster.

Case Study

USDM helped a pre-commercial oncology company optimize their content management system and reduced the cost of managing SAS data sets by 50%.