Food Safety


Auk experts can help you comply with new Food Safety and Modernization Act (FSMA) requirements, including:

  • Risk Analysis

  • Quality Management Processes

  • Training

  • Mock FDA inspections

Medical Devices


Auk has years of experience helping firms achive FDA compliance for medical device development and manufacture.  Our expertise includes:

  • Quality Management and Good Manufacturing Practices

  • Device Premarket approval (510(k) development)

  • Mock FDA inspections

  • Training

  • Initial Importer and US Agent Services

  • Software development processes and validation


Our staff's expertise covers the entire spectrum of quality and compliance, and including former FDA regulators and state regulators


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