We provide global Quality and Compliance consulting services to develop programs and compliance processes that promote continuous improvements to productivity and quality.

Includes

• GxP Quality Systems reviews
• Product quality and trending analysis
• Root-cause analysis; FMEA
• Impact analysis
• Batch Record and SOP reviews
• QMS audits, risk assessments
• CSV Part 11 quality assurance audits
• Annual Product Quality Review (APQR)
• Annual review preparation and evaluation
• Data integrity audits
• Internal/external GMP, GLP and GCP audits
• Quality Agreements