Industry
Customized Biotechnology and Biologics Solutions
Explore your options to harmonize regulated processes and technology and maximize operational efficiency in your organization.
USDM Life Sciences offers unparalleled expertise for IT and Quality leaders in the biologic and biotechnology industries, delivering compliance-focused solutions that empower innovation while ensuring regulatory adherence. We understand that navigating the complex landscape of biologics requires more than just consulting—it demands industry-specific expertise and innovative solutions that are both reliable and forward-thinking. Our deep domain knowledge, combined with technology-first strategies, allows us to deliver customized solutions that not only meet but exceed your operational goals.
Why USDM Stands Apart
Unlike many consulting companies, USDM doesn’t just provide recommendations—we embed ourselves as partners in your journey to digital transformation. Our differentiator lies in our unique blend of regulatory expertise, cutting-edge technology integration, and an adaptive approach tailored to your organization’s needs. With over 20 years of dedicated experience in the life sciences sector, USDM understands the intricate challenges of compliance in biologics, and we leverage our regulatory partnerships with agencies like the FDA and EMA to provide proactive, compliant solutions.
Our holistic approach integrates IT and Quality seamlessly. We offer end-to-end validation services, cloud assurance, and workflow automation solutions that are built specifically for biologics. Our partnership with major cloud providers, along with our proprietary frameworks like Cloud Assurance, ensures that our solutions are scalable, secure, and GxP-compliant. Whether you’re a biotech startup navigating your first clinical trial or a mature enterprise looking to optimize quality and IT processes, USDM delivers the tools, strategy, and support needed to stay compliant and competitive.
Discover a digital-forward approach to harmonize compliance and innovation.
Key Services for IT, Quality and Life Sciences Leaders
- Cloud Assurance and Compliance: USDM’s Cloud Assurance ensures your cloud environments, such as AWS, Azure, and GCP, are validated and continuously compliant. We help you navigate regulatory requirements while benefiting from the agility of the cloud.
- Data Integrity & Quality Management: Our data integrity programs ensure your critical data is accurate, traceable, and compliant. With real-time monitoring and AI-driven insights, we help you maintain impeccable quality standards throughout the data lifecycle.
- Quality Workflow Automation: Leveraging automation tools such as Robotic Process Automation (RPA) and AI, USDM streamlines critical quality workflows like deviation management, CAPA, and document control—reducing manual errors and accelerating processes.
- GxP Validation & Managed Services: We offer specialized GxP validation services for IT systems, including eQMS, ERP, LIMS, and MES. Our managed services model means you don’t just meet compliance once—you maintain it continuously.
- Advanced Cybersecurity for Biologics: Protecting sensitive biologic data is critical. USDM offers advanced cybersecurity solutions tailored to life sciences, including multi-layer encryption, secure cloud configurations, and continuous security assessments.
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 biologics and biotechnology. 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 Biotech:
Deep Life Sciences Focus: Over 20 years dedicated to life sciences, providing expertise to emerging biotech and biologics companies.
Extensive GxP Experience: Thousands of GxP projects completed globally, tailored to regulatory needs of biotech and biologics.
Industry Trust: Trusted by over 900 customers, including top pharma, leading medical device firms, and numerous emerging biotech organizations.
Proprietary Compliance Solutions: Innovative cloud compliance and GxP automation solutions leveraging domain expertise to boost efficiency.
Cloud Assurance: Trusted by hundreds of life sciences companies for compliance, audit readiness, and risk management.
Technology Partnerships: Collaborations with best-in-class providers to deliver GxP-ready functionality for biotech operations.
Digital Transformation: White-glove support for digital transformation, integrating people, process, and technology to maximize ROI.
Flexible Engagement Models: Flexible delivery options to suit unique needs, including managed services, consulting, and staff augmentation.
Ready to transform your IT and quality operations? Let’s connect and drive progress forward.
USDM Thought Leaders
