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Our team of regulatory experts combines strategic FDA consulting with tactical expertise to effectively address compliance issues using a practical and proven approach.

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  • Areas of expertise:

  • Site Compliance Program (SCP)

  • Quality System Remediations

  • Investigation, Deviations and CAPA  Review & Remediation

  • Batch Record Review and or Certification

  • Onsite or Remote FDA Triggered Audits 

  • FDA Facility Registration