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INSPECTION READINESS

 

Awaiting re-inspection or looking to proactively avoid costly compliance issues? We will work with you hands on to:

  • Define Inspection Readiness strategy and plan

  • Define actions and implement the plan

  • Track progress through meaningful metrics

  • Design and educate a sustaining organization 

OUR SERVICES

QUALITY MANAGEMENT SYSTEMS 

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  •  Competitive Quality Management Systems 

    • ​Design of new or optimization / integration of existing systems 

  • Customized Compliance Remediation Activities

    • 483, Warning Letter and regulatory observation support:

      • Strategy

      • Responses​

      • Corrective actions

AUDITS

 

Let us take care of all of your auditing needs, allowing you to focus on continuous improvement and your customers: 

  • Internal audits

  • Supplier audits

  • Due diligence audits

  • Mock FDA and Regulatory Body audits / inspections

  • Gap assessment audits

 

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TRAINING AND EDUCATION

 

Knowledgeable employees are one of your most valuable assets. Our trainings and education programs help you invest in your success:

  • FDA Regulations 

  • International Regulatory Standards

  • "Being Inspection Ready"

  • Customized Education and Training Programs

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