Auditing

Jeiven Pharmaceutical Consulting, Inc. (JPC) conducts GMP, GCP, GLP, GTP, DEA, and QSR audits worldwide. We have auditors on the ground in the US, Canada, China, Europe, India, and South America. Our experienced team of auditors can:

• Audit and qualify CMOs
• Assist in setting up CAPA programs
• Audit clinical sites
• Audit packaging and labeling contractors
• Audit toxicology and analytical labs
• Audit facilities for DEA compliance
• Audit client sites or device developers for QSR compliance
• Conduct Due Diligence audits

GMP Audits

• Audits of contract manufacturing, testing, packaging, labeling and distribution facilities
• Sponsor - JPC can help prepare your company for FDA and EU inspections by:
  • Conducting mock audits
  • Pre-Approval Inspections (PAI) audits
  • Preparing a CAPA program, if needed. 

GCP Audits

• CRO
• Clinical site
• Data Management (IVRS vendor and electronic records management systems)
• Mock Bioresearch Monitoring (BIMO)

GLP Audits

• Toxicology labs, facilities, studies and reports
• Analytical labs and associated data                  
  

DEA Audits

• Evaluation of the receipt, storage, handling, shipping, security, documents and record keeping (including SOPs)

QSR (Quality System Regulation) Audits

• Audits for medical device products including:
  • Design history file
  • Quality Systems
  • Design controls

We can also conduct audits of your site to determine your company's readiness for an FDA inspection.