Regulatory Excellence

An Impressive and Successful Regulatory Track Record

Ajinomoto Bio-Pharma Services’ quality management teams are focused on continuous improvement, ensuring we are inspection ready at all times, whether it’s our internal audit team, a regulatory agency, or a customer inspection.

Drug Master Files and a Biologics Master Files are maintained with CDER and CBER, respectively, and Site Master Files are available for regulatory review. Our regulatory support team 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.

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