We understand that no life sciences company is the same. Our experience implementing thousands of life science systems provides us with the ability to ensure our solutions are designed to meet your unique quality and regulatory needs.
For over 20 years, we’ve partnered with hundreds of life sciences companies to deliver business value and operational excellence. Discover how we’ve helped our clients achieve their business goals and create tangible results.
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Whether you need one validation engineer or a team to manage your entire service
From webinars to white papers, read or listen to the latest thinking from our life science industry leaders
Thoughts on the 2020 Physician Fee Schedule Final Rule
Transformation and Innovation in Compliance and Technology
Life Sciences consulting firm with over 20 years experience in global compliance and technology. We offer bold solutions that accelerate innovation and compliance.
We offer a broad range of strategic solutions to meet the needs of life science organizations. Our consultants provide the experience & expertise to guide our clients to operational excellence.
USDM’s Emerging division helps hundreds of pre-commercial Life Sciences customers reach commercialization faster. We leverage pre-packaged accelerators and organizational change management to make our customers streamlined and compliant.
Our Biotech / Pharmaceutical division streamlines processes and platforms while creating a simplified approach from the multitude of compliance requirements.
Our Medical Device division helps our customers bring their products to market faster, monitor their products in the field, and handle post-market surveillance while addressing a variety of regulatory challenges unique to the Medical Device industry.
From informative consulting to full-service strategy, let our regulatory experts help develop a customized plan for your FDA response needs.
Thought Leadership from Life Science Industry Leaders.
Update from the FDA on CSV Changes
How to Ensure Your QMS is Ready for EU MDR
Life Sciences Trends for 2020
Most Misunderstood and Misapplied UDI Requirements
Computer Software Assurance: What You Need to Know About FDA's Upcoming Guidance
Data Lakes, Artificial Intelligence, and Machine Learning
The Cannabis Industry; Compliance and Enforcement in an Ever-Changing Regulatory...
Meet the USDM Life Sciences Thought Leaders.
Vice President of Digital Trust and Transformation
Head of Alliances and Digital Transformation
Vice President of Regulatory Compliance
Head of Delivery and Project Management
Vice President of Cloud Compliance
Director of Organizational Change Management
Vice President of Cloud Assurance
Vice President of Medical Device Solutions
Vice President of Lab and Manufacturing
Vice President of Unique Device Identification Solutions
Vice President of Life Science Solutions
Managing Director USDM Europe GmbH
Vice President of Emerging Life Sciences
Vice President of Global Regulatory Compliance, Quality Assurance and Auditing
Vice President of Quality Initiatives
Celebrating 20 Years in Business
Countries Impacted by Our Work
We understand the value in powerful alliances. At USDM, we work jointly with our partners to ensure regulatory compliance is met with leading edge technology.
GxP Compliant Content Management
Enterprise Platform for Manufacturing
Creating impactful changes together.
The Never Ending Journey for Excellence
Pacira Pharmaceuticals, Inc.—Russell Owen
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