Quality Assurance

Quality Assurance services are divided into current Good Manufacturing Practice (cGMP) and Good Clinical Practice (cGCP)/Good Laboratory Practice (GLP) services. Here are some of the services Pacific BioDevelopment offers in this arena:


  • Audit raw material vendors, control (compliance) systems, manufacturing facilities (contract and in-house), testing facilities, labeling and packaging facilities, and holding and distribution facilities.
  • Evaluate validation of facility systems, equipment, cleaning and production processes.
  • Review and assist in the preparation of the Chemistry, Manufacturing and Controls (CMC) sections of New Drug Applications.(NDAs), Biologics License Applications (BLAs) and Development Reports.
  • Preparation for pre-approval and biannual inspections, including mock FDA inspections.
  • Develop control systems and draft standard operating procedures (SOPs) specific for your company‚Äôs stage of development and consistent with cGMPs and the principles described in ICH Q8, Q9, and Q10.


  • GCPPerform GCP and GLP audits and complete QA review, including reports, protocols and Investigator Brochures.
  • Perform systems audits of the clinical trial safety database to assess risk management.
  • Develop GCP and GLP training programs.
  • Perform special fraud investigations.
  • Perform due diligence investigations for regulatory and clinical trial strategy assessment.


call 510-858-5600 mail_outline 510-858-5602 (Fax)
call 510-858-5600, ext. 3 call 510-858-5600, ext. 4
Pacific BioDevelopment, LLC
PO Box 2066
Davis, CA 95617

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