• Inspection preparedness training and readiness audits

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• Inspection/audit facilitation 

 

• Post-inspection CAPA development, implementation and/or management

 

• Regulatory consultation ('How can we...?, 'What does this mean to us?')

 

• Compliance and regulatory training

 

• Change management

 

• GCP, FDA, ICH, MHRA, EU, HIPPA/EU Data Privacy, Privacy Shield, ISO, NYSDOH, CAP/CLIA