Quality

Dedicated to Providing Our Customers Quality Products

Our quality management system is overseen by Ajinomoto Bio-Pharma Services in Belgium. Together, we focus on continuous improvement, through routine reviewing and trending of operational metrics and in developing actions to drive optimization of processes.

We are proactive in our communication with regulatory and industry organizations in regards to industry improvements and establishing policies.

We take a collaborative audit approach with our customers and encourage feedback and suggestions.

We strive to provide our customers with a strong yet responsive strategy and show our customers that we are inspection ready at all times. This approach nurtures open communication and allows us to maintain a culture of transparency.

Proactive Quality Practices

  • Continuous improvement program – Operational Excellence
  • Quality policies, standards and well-defined SOPs
  • Efficient electronic quality systems
  • Broad base of GMP qualified vendors, thereby reducing material procurement risks
  • Dedicated staff for internal audit compliance programs
  • cGMP training programs
  • Highly trained and experienced staff: internal calibration, validation, QC, QA, document control
  • Global compliance program

Our Approach to Regulatory Excellence

  • Continuous improvement philosophy- trending, quality metrics, management review
  • PDA, ISPE Leadership assures leading-edge policies
  • Inspection ready for customers and regulatory agencies
  • Multinational compliance program – Maximizing clinical flexibility
  • Timely response to regulatory agency observations
  • Transparent customer and regulatory agency communication

Drug Master Files are maintained with CDER and Site Master Files are available for regulatory review. Our regulatory support team is overseen by Ajinomoto Bio-Pharma Services in Belgium and has assisted with and contributed to numerous clinical and marketing application submissions, and is ready to help with your regulatory submissions, clinical filings, and commercial launches.