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.