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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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Overview


Quality Systems-Focused Professionals providing the expertise to meet your Pharmaceutical and Medical Device Clinical Research Trial objectives in:
  • Training – Skill-Based GCP, GMP and Regulatory Law Compliance Education for Auditors, Monitors, Coordinators and Investigators
  • Auditing – Risk, Compliance, 21CFR and GCP Audits of Your Protocols, Procedures and Activities
  • Consulting – Expert Advisement and Services for Sponsors, CROs, IRBs and Investigator Sites
  • Publications – How-To Manuals, Reference Guides and Standard Operating Procedures
  • Clinical Investigator Services – Obtaining Trials, Infrastructure, Training and Procedures for the Experienced and Start-Up Investigator
NAI Professionals have experience in all of our Services Areas and thus offer our clients a Big Picture of Compliance within the individual Services we provide. For example, our Trainers also Monitor and Audit, and thus can bring real world case studies to the class room.

From a Compliance Standpoint, NAI retains in-depth knowledge of all of your Regulatory and Industry Standards including:
  • FDA Regulations, 21 CFR Parts 11, 50, 54, 56, 312, 314 (Pharmaceuticals) 812, and 814 (Medical Devices)
  • Office of Inspector General (OIG) Mandates
  • FDA Compliance Programs 7348.809, 7348.810, and 7348.811 U.S.C. Title 18
  • International Conference of Harmonization (ICH) Guidelines
  • FDA Quality System Inspection Technique (QSIT)
  • Good Clinical Practices (GCP)
  • Good Manufacturing Practices (GMP)

 
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