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Remediation

Remediation in drug manufacturing: At HG, we specialize in providing comprehensive support for remediation projects aimed at addressing compliance issues and ensuring regulatory conformance. Whether you're dealing with legacy facilities, regulatory challenges, or quality concerns, our team of seasoned remediation experts and skilled professionals is dedicated to guiding you towards compliance and success.

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Offerings Include:

  • Compliance Issue Assessment and Prioritization

  • Remediation Strategy Development and Implementation

  • Corrective and Preventive Action (CAPA) Planning and Execution

  • Regulatory Liaison and Communication (483 response support)

  • Data Integrity Restoration

  • Process and Documentation Remediation

  • Staff Augmentation for Remediation Projects (including support for Manufacturing Oversight)

FAQs

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