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Services

Vast experience across the industry, leading to a wide array of service offerings to benefit your unique situation. 

  • Complex remediation

  • Warning Letter and 483 response

  • Pre-approval and routine inspection readiness

  • PMA, 510(k), NDA, ANDA readiness

  • Quality System Architecture

  • Design control/CAPA/Validation/Laboratory/DI

  • Risk Management

  • Supplier Management

  • Internal Audits

  • Training

  • Quality Culture

PHARMA | DEVICE | COMBO | BIOTECH | BIMO

PREPARE | EXECUTE | RESPOND | REMEDIATE

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