Consulting
Life Sciences Consulting and Specialized GxP Talent
Blog Post
Get inspection ready with a mock audit. Gain confidence and experience a stress-free audit.
Trust the sourcing power of USDM Life Sciences to find just the right staff for your business needs.
USDM is a leading consulting firm with a 23-year streak in successful project support for global pharmaceutical, medical device, and biotechnology companies.
We source top talent in the life sciences industry to provide unmatched knowledge and expertise in GxP, including Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and Good Automated Manufacturing Practice (GAMP/GAMP 5).
USDM understands the importance of proactive measures to develop, validate, and oversee your projects, products, and services. We know that it requires a significant investment in tools, systems, and continuous updates. The responsibility of balancing scope, cost, and quality can be overwhelming if your teams don’t have the knowledge or industry experience to keep things running smoothly.
The integrated GxP compliance approach used by USDM aims to achieve remarkable cost savings for your organization through innovative system development methodologies, progressive risk mitigation, and enhanced operational efficiency.
As your organization adds Software-as-a-Service (SaaS) applications to its platform and the complexity and velocity of releases intensifies, be sure you’re seeing a return on investment. Outsource to USDM for SaaS validation and ongoing maintenance and let your full-time employees find greater job satisfaction by focusing on the work they really want to do.
USDM Life Sciences Consulting Business Models
We offer comprehensive GxP technology, regulatory compliance, and quality management services delivered in the business model of your choice:
- Staff augmentation: gets you the industry’s top talent for your projects. Ideal for when you don’t want to hire a full-time employee for a short-term assignment. We have the candidate pool and sourcing power to properly staff your projects.
- Managed staffing: takes over the management of an existing team in your organization. A dedicated lead addresses the team’s needs, issues, and concerns and relieves you of the day-to-day administrative tasks.
- Consulting and professional services: supports clearly defined projects with a scope, timeline, and budget. With well-defined service level agreements (SLAs), your project will be completed on time and on budget with mutually agreed-upon deliverables.
- Managed services: saves money and mitigates regulatory risk by managing your GxP compliance. For one IT system or many, we hire and manage the team, establish processes and procedures, and deliver results while you focus on other priorities.
For example, a leading life sciences supply chain software vendor wanted to scale validation capabilities without hiring full-time employees. They engaged with USDM for on-demand staff augmentation. USDM provided a team of validation engineers, validation analysts, business analysts, and project managers to support the effort. This trusted partnership enabled 50% faster validation time and a 50% decrease in validation costs.
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
For a more complete view of our talent solutions for optimizing technology and simplifying compliance in your organization, download the datasheet GxP Consulting Resources for Regulated Projects.
The Most Trusted Consultants in Life Sciences
Why engage USDM for your life sciences consulting and specialized staffing needs?
- More than 23 years of successful staff augmentation and consulting experience in the life sciences industry
- Significant time savings because we understand your business needs and know the best candidates
- Extensive screening process with practice leads and in-house subject matter experts
- Desirable training and benefits packages that strengthen our retention rates
- Dedicated and knowledgeable life sciences recruiters
Engage with the most trusted advisors and partners in the life sciences industry.
Let’s discuss your GxP project needs and requirements.
The USDM Consulting Process
Client Services Director (CSD)
& Screening
Consultant Onboarding & Performance Management
Service Fulfillment
- Engages with the client to discover project needs
- Makes recommendations for solutions, including the number of consultants required and job descriptions for candidates
- Works with our recruiting team to provide qualified consultants for client review
- Sources candidates through our extensive network and referral program
- Involves SMEs and the CSD to screen candidates
- Emphasizes quality over quantity of candidates
- Ensures an efficient process using a workflow-driven CRM system
- Maintains a 53% submit-to-interview rate
- Assists client with logistics to prepare for consultant onboarding and performance monitoring
- Handles orientation and training logistics to ensure smooth engagement and speedy ramp-up to hit the ground running
- Consultant integration period
- 1-week right-fit guarantee
Additional Resources
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Find an outsourcing solution that takes a holistic approach to your cloud vendor qualification.
Get in touch with our team to accelerate your digital transformation today.
USDM Thought Leaders
