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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T: 585-943-3702

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