Cost-effective Quality & Regulatory Compliance Management

How Can We Assist You?

Outsourcing

  • Temporary or "as needed" consulting for QMS compliance and regulatory affairs.

  • Internal and Supplier Quality Audits

  • CAPA System Oversight and Management

  • Monitoring quality metrics and key performance indicators for
    Management Review

  • Quality System and other training as needed

  • Complaint Handling and Adverse Event Reporting

  • Document control and maintenance of the quality system.

  • Responding to FDA 483 Observations, Warning Letters and Notified Body audit findings.

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