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Regulatory Compliance

  • Inspection preparedness training and readiness audits

  • 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

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