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’s 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.