Cost-effective Quality & Regulatory Compliance Management
How Can We Assist You?
Outsourcing
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Temporary or "as needed" consulting for QMS compliance and regulatory affairs.
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Internal and Supplier Quality Audits
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CAPA System Oversight and Management
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Monitoring quality metrics and key performance indicators for
Management Review -
Quality System and other training as needed
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Complaint Handling and Adverse Event Reporting
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Document control and maintenance of the quality system.
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Responding to FDA 483 Observations, Warning Letters and Notified Body audit findings.