QAI has established and implemented over 100 GLP programs. Clients include:

  • Research and discovery units required to conduct specific regulatory studies
  • Existsing CROs and Start-up companies preparing to conduct regulatory studies
  • Sponsor laboratories requiring an individual GLP structure
  • University laboratories needing to develop GLP capabilties
  • Government laboratories needing to develop GLP capabilities

Tasks include:

  • Perform gap analysis of existing quality system
  • Develop an implementation plan with management
  • Develop and customize an entire SOP manual
  • Harmonize SOPs with other Quality Systems (ISO, OECD, GMP)
  • Conduct GLP training of all study personnel
  • Develop customized documentation forms
  • Assist management and QAU during the implementation
  • Assist client during Regulatory GLP inspection

Case Study