USDM can help you implement a GxP-compliant framework for every layer of your tech stack and maintain your validation. Let our team alleviate your compliance headaches and let your team focus on innovating.
USDM and our strategic partners meet your requirements for business optimization, quality, and compliance. Whether you are an emerging biotech, an established medical device manufacturer, or somewhere in between, we have solutions for you.
From webinars to white papers, read or listen to the latest thinking from our life science industry leaders
EP 1: Adapting Computer System Validation to Accommodate Evolving FDA Guidance
Transformation and Innovation in Compliance and Technology
We are a life sciences consulting firm with over 20 years experience in global compliance and technology. We offer bold solutions that accelerate innovation and compliance.
Three Reasons to Outsource Cloud Vendor Validation [PDF]
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.
Life Sciences Trends for 2020
Update from the FDA on CSV Changes
How to Ensure Your QMS is Ready for EU MDR
Most Misunderstood and Misapplied UDI Requirements
The Cannabis Industry: Compliance and Enforcement in an Ever-Changing Regulatory...
Meet the USDM Life Sciences Thought Leaders.
Vice President of Medical Device Solutions and Services
Vice President of Global Regulatory Compliance, Quality Assurance and Auditing
Vice President of Quality Initiatives
Vice President of Cloud Compliance
Vice President of Business Development – Europe
Project Manager at USDM Life Sciences
Head of Delivery and Project Management
Director of Emerging Compliance
Vice President of Regulatory Compliance
Head of Alliances and Digital Transformation
Director of Product Management, Digital and Cloud Solutions
Vice President of Lab and Manufacturing
Director of Customer Engagement
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
Job Opening: Talend / ETL / AWS Developer