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Norton Audits Government Research Opportunities
08.10.2015
To Leverage our Recent Government Experience
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Norton Audits Capabilities Statement
04.17.2015
In support of U.S. Government requests, 2015 Cap Statement released
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Consulting – Expert Advisement and Services


Whether you are a Clinical Investigator, Sponsor, CRO, IRB or other Clinical Research Organization, our independent expertise combined with direct experience in regulatory agencies and hundreds of organizations like yours allow us to provide project-based and advisement services to assist you in achieving your goals.

Our Consulting Experience and Offering Includes, but is not limited to:
  • Mock FDA Inspections
  • Site Qualifications
  • Organization Risk Assessments
  • Study Budget Preparation
  • Protocol and Associated Forms Development
  • Policy and Standard Operating Procedure (SOP) Development
  • Assisting Clinical Investigators in the process of Obtaining Clinical Trials
  • Preparing for or Responding to FDA and Sponsor Inspections and Audits
  • FDA Submission Preparation, Including:
    • Investigational New Drug Application (IND)
    • New Drug Application (NDA)
    • Pre-Market Application (PMA)
    • Medical Device 510(k)
    • Post-Market Surveillance Activities
For more information or to request our Services, please contact us.
 
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