Compliance Program Management

In today's environment all companies should have a functioning compliance program. For smaller organizations these requirements need not be onerous and can be managed with part-time resources.

Fairmark works with clients in the later stages of clinical development to design and implement effective compliance programs in preparation for commercial launch.

 

Do we need compliance now?

  • Whistle blower lawsuits are pervasive

  • Government is looking for individuals and companies to prosecute as examples

  • Prosecutors have focused on both large and small companies

  • Functioning compliance program is expected by prosecutors

  • Most whistle blowers turn to the government only after first trying to address concerns with the company

 

 

COMPLIANCE PROGRAM
SERVICES

Compliance Program Design
     •  Code of Conduct
     •  Key Policies and SOPs
     •  Training Materials
     •  Hotline Implementation
     •  Management Plan

Compliance Program Management
     •  Employee Training
     •  Hotline Monitoring
     •  Annual Risk Assessment & Monitoring
     •  Investigations & Corrective Action
     •  Business Team Advise and Support
     •  Part-time Chief Compliance Officer
•  “Sunshine” reporting

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