Quality Assurance

Nextcea provides quality data, reporting and study integrity in accordance with Good Laboratory Practice (GLP) regulations and is certified with Registered Quality Assurance Professional in Good Laboratory Practices (RQAP-GLP) and Good Clinical Practices (RQAP-GCP)

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The Quality Assurance Unit (QAU) at Nextcea Inc. ensures data quality and study integrity in accordance with GLP regulations. Nextcea QAU staff members are Registered Quality Assurance Professionals in GLP. Each QAU staff member:

  • Registered Quality Assurance Professional in Good Laboratory Practices (RQAP-GLP)
  • Quality laboratory testing for clinical trials (GCLP)
  • Non-clinical studies (US FDA, OECD, and JMHW GLPS)
  • GLP validated bioanalytical methods
  • Expert GLP trained Scientists (managerial and laboratory)
  • Electronic Records 21 CFR Part 11
  • Safe and secure storage and archive of data, reports, samples, specimens