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

We can help you establish the internal infrastructure to achieve top-to-bottom risk management when you need to maintain compliance for:

USDM’s Regulatory Compliance experts will ensure that your organization is in compliance with all global regulatory requirements, and that your resources are aligned to maximize profitability and minimize regulatory exposure.

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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 and USDM can establish a strategy of quality and compliance that is forward-thinking, efficient, and effective. We’ll train your team, set up audits and assessments, and validate your processes and equipment to make sure they are in compliance with your local, national, and international legislative bodies.

Regulatory compliance tracking, compliance auditing, and process validation by a third party helps keep your company FDA compliant.

Case study: USDM saved one company $570k, reduced their validation costs 25%, and decreased the time to onboard a site by six months.

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

  • We’ve been in business for more than 20 years, working with medical device companies, pharmaceutical and biotechnology companies, and startups
  • We focus exclusively on the life sciences industry. We’ve seen exceptional cases and unique issues, and we’re ready to work with yours.
  • We’ve completed thousands of GxP projects globally. We’re proficient in 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 to help you focus on delivering an excellent product while staying compliant.

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Areas of Focus

Regulatory Compliance

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Thought Leaders

Leading experts in Regulatory Compliance

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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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