OUR SERVICES

• Outsourcing alternative (Interim Management, Short-term Staffing)

• Procedure Development and Implementation

• Development of new Quality Management Systems

• QMS System upgrade

• QMS Mergers (acquisitions)

• Temporary QMS Support (Hands on)

• Product and Quality System Standard Implementation

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• Internal Auditing

• Supplier Audits

• FDA Readiness/Mock Inspections

• Due diligence audits

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• Internal Auditor

• Quality Management System Overview

• Training on Standard Requirements

• Risk Management

• 21CFR820

• 21CFR803

• 21CFR600 & 610

• 21CFR210 & 211

• 21CFR1271

• ISO 13485

• ISO 9001

• AATB

• 483 Warning Letter Response

• FDA Investigation Preparation

• FDA Remediation