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QUALITY AND REGULATORY

SAFETY. QUALITY. EXCELLENCE.

We foster a culture of continuous improvement with a quality management system focused on defect prevention, customer satisfaction, and exceeding quality and regulatory compliance.

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COMMITTED TO QUALITY. COMMITTED TO YOU.

Our goal is to provide customers and consumers with the highest quality products by assuring their performance, consistency, safety, and value.

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Quality Policy

Service Driven:

  • Anticipate and support our customers’ needs through proactive communication and partnership.
  • Build strong relationships internally and externally to strengthen customer satisfaction and trust.
  • Deliver high quality products and services that consistently meet customer expectations and intended use requirements.

Creative:

  • Encourage innovation through employee engagement, collaboration, and continuous improvement across our products, services, and processes.
  • Strengthen the effectiveness of our quality management systems through problem solving, efficiency, and operational performance.

On Time:

  • Commit to on-time delivery through disciplined processes and accountability.
  • Strive to do things “right the first time” to minimize risk, waste, and disruption.

Responsive:

  • React quickly and effectively to customer, business, and regulatory needs.
  • Promote open communication, adaptability, and timely resolution of issues.
  • Continuously assess and align with evolving regulatory and market requirements across the regions we serve.

Excellent Quality:

  • Maintain the highest standards of quality, safety, and compliance with integrity in our people, products, processes, and partnerships.
  • Uphold effective quality systems that support compliance, product safety, and operational excellence.
  • Commit to continuous improvement and achievement of our quality objectives.
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Quality Management Systems and Regulatory Compliance

We have designed our quality management system (QMS) to implement effective risk assessment and risk management to ensure compliance with customer and regulatory requirements. This creates a solid foundation to provide our customers with a reliable supply of high-quality products and services.

  • We have ISO 13485:2016, ISO 9001:2015, SQF 9, and FSSC 22000 certified systems View our certifications
  • Our US FDA Drug Master Files (DMF) are available for quick reference.
  • Versions of our dosage delivery device portfolio is CE certified and UDI compliant.
  • We have seasoned and diverse regulatory support available to ensure that your pharmaceutical, healthcare, or food safety products continuously meet regulatory expectations.
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State-of-the-Art Metrology and Quality Inspection

Our ongoing investment in best practices and tools for metrology and inspection mitigates risk and guarantees consistent product quality. We have a variety of measurement systems to visualize; measure; and analyze internal components, surfaces, and complex geometries. We can also measure chemical, physical, and material properties. Our capabilities include the following:

  • Vision systems
  • Single- and multi-sensor coordinate measurement machines (CMM)
  • Computerized tomography (CT) scan
  • Fourier-transform infrared spectroscopy (FT-IR)
  • Laser micrometers
  • Force testing instrumentation
  • UV/visual spectrophotometry
  • Light transmission densitometer
  • High-speed leak testing

To address custom applications, we can also develop specialized testing equipment and approaches.

OTHER CAPABILITIES

SET YOUR POSSIBILITIES INTO MOTION

Experience the fresh thinking, engineering edge, and customer focus that helps you advance.

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