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USDM Life Sciences is the leading global professional services firm focused on increasing the capacity of Life Science and Healthcare organizations to accelerate innovation and maximize productivity.

FDA Focus on QMS

A One thing there is definitely no shortage of – regulations.  It doesn’t matter where you are or what you do, there are regulations with which you are required to comply.  Sarbanes-Oxley, HIPAA, 21 CFR Part 11, FDA GxPs, EU Directives, ICH Guidelines, Pharmaceutical Inspection Cooperation Scheme (PIC/S), Patriot Act – to name just a few.  With so many to navigate, it often seems like we are drowning in a sea of regulations.

Learn how you can:

  • Replacing "layers and silos"
  • Yielding significant financial benefits in compliance savings, share price improvement and legal liability avoidance
  • Achieving increased regulator and stakeholder confidence that the business is being run in a reliable, compliant and sustainable manner



  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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