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Norton Audits to Present at SoCRA Device Research Workshop
03.05.2008
'Emerging Trends in Device Audit Findings' on June 27 in San Diego
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Norton Audits to Present at ACRP 2008 Global Conference
01.23.2008
'Advanced Auditing: CSI (Clinical Science Investigations) and The Code' Highlight 5th Year
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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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