Regulatory Compliance

  • Independent Quality Assurance workgroup, reporting directly to the General Manager
  • FPRC Documentation is compliant with ICH (International Conference on Harmonisation) guidelines and global regulatory requirements.
  • FPRC developed software is compliant with 21 CFR Part 11, ICH and other applicable global regulatory requirements.
  • FPRC staff are trained in HIPAA, human subjects and regulatory compliance and follow a detailed set of policies and standard operating procedures (SOPs).
  • Expert FDA hearing support

 

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FPRC Enduring Principles

  • Intellectual Honesty
  • Quality
  • Relevance
  • Innovation
  • Staff Satisfaction

 

 

 

 

For early phase clinical trials, we offer a streamlined approach to the needs of the study and sponsor.