Regulatory Compliance Solutions

USDM has been helping life sciences companies ensure compliance with worldwide regulations for over 20 years.

Whether you’re looking for:
  • Medical Device Compliance
  • Pharmaceutical Compliance
  • Cannabis Regulatory Compliance
  • FDA Compliance
  • EU MDR/IVDR Compliance
You can be sure that USDM will help you establish the internal infrastructure to acheive top to bottom risk management. We ensure resources are aligned, maximizing profitability, and minimizing regulatory exposure. We ensure regulatory compliance.
With USDM’s Regulatory Compliance division, you can trust in knowing that your organization is in compliance with all global regulatory requirements.
Ensure Regulatory Compliance. Contact USDM.


Regulatory Compliance and Validation Services: 

From GxP employee training and procedures to system change documentation and CAPAs being closed in a timely manner, we will ensure your compliance program is operating at peak performance.

Reactive compliance is not sustainable. To move to a strategy of quality and compliance that is forward-thinking, efficient, and effective, you need experts. We’ll train your team, set up audits and assessments, and validate your processes and equipment to make sure they’re in compliance with your local, national, and international legislative bodies.
Regulatory compliance tracking, regular compliance auditing, and validation of processes by a third party helps keep your company FDA compliant.
Our compliance programs have saved companies hundreds of thousands of dollars in fines and inefficiencies. You can read our newest case study on how we saved one company $570k, reduced their validation costs 25%, and decrease the time to onboard a site by six months here.

Why Choose USDM for your Life Science Company’s Regulatory Compliance 

  • We’ve been in business for 20 years, working with medical device companies, pharmaceutical companies, and startups - just like your company.
  • We exclusively focus on the life science industry. We’ve seen all sorts of exceptional cases and unique issues, and we’re ready to work with yours.
  • We’ve completed thousands of GxP projects globally. We’re used to multinational compliance solutions, from small startups to international corporations.
  • We get repeat business from over 85% of our customers. We build a relationship that works for your company and can help you continue to improve and optimize your organization's GxP processes.
  • We bridge the gap between Quality and IT - helping you focus on delivering an excellent product, while we help you make sure you stay compliant.
Fill out our brief contact form and tell us about your needs.


Areas of Focus

Regulatory Compliance

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Thought Leaders

Leading experts in Regulatory Compliance

Learn More
Bob Lucchesi
Bob Lucchesi

Vice President of Global Regulatory Compliance, Quality Assurance and Auditing

Jay Crowley
Jay Crowley

Vice President of Medical Device Solutions and Services

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