Document Control Assessment

• Compliance auditing (GMP,GLP, GCP, ISO & QSR)
• Compliance risk assessment and corrective action plan evaluation
• Regulatory mock inspections (FDA/ EMEA/ PMDA)
• Quality assurance support
• Quality control and analytical support
• QP support
• Analytical method development and validation
• Design controls and quality systems
• Strategic compliance advice
• Development and implementation of corrective action plans (CAPA)
• Regulatory action
• Remedial and strategic solutions