Focus on quality

At Kyowa Kirin North America, we foster a culture where a strong commitment to quality runs through all product- and patient-related activities at all levels of the organization. Our core values are embedded in everything we do and are integrated into the Kyowa Kirin Global Quality Policy.

We commit to putting the patient first in all our decisions and actions, and to ensuring quality in our products and processes at all stages – from early-stage development to clinical trials, approval, and commercialization. Our goal is to ensure high standards and flawless execution – delivering results right, the first time.

Guided by this commitment and working as a global quality team, we strive to contribute to patients’ lives by ensuring that the highest-quality commercial and clinical medicines are available and by always adhering to these safety and compliance principles:

We utilize people, process, systems, and technology to conduct reliable and ethical activities in alignment with our compliant and effective GxP quality management system.

  • We maintain healthy relationships with all stakeholders.
  • We comply with all GxP global laws, guidelines, and industry rules in our activities.  
  • We utilize data and risk principles to drive decisions based on long-term outcomes, while always keeping our patients at the center of our decisions. 
  • We foster a positive quality culture and always strive to continuously improve. 
Woman at microscope

Quality Assurance

Our Global Quality Policy guides what we do, at all times, for patients, physicians, decision makers, and partners. It informs who we engage, what audits we conduct, and how we manage external manufacturers, laboratories, distributors, and clinical research organizations. Our aim is to nurture and sustain positive relationships with all parties on the basis of a strong shared commitment to quality, transparency, and integrity.

Intertwined Highways

Logistics

We contract with a global network of third-party service providers to manage the transportation of key materials and finished products. Cold-chain or temperature-controlled shipments are monitored with the appropriate active and/or passive cold-chain technology.

In line with the latest technology, GPS tracking and location services are evolving – and enabling shipment visibility. Kyowa Kirin continues to work with its partners and service providers to constantly provide the best capabilities to ensure the safety, security, and resilience of its supply chain.

Filing in a lab

Distribution

Distribution ensures that our medicines are delivered through “the last mile” — to patients and customers.

With delivery fill rates in line with best practices for healthcare, Kyowa Kirin leverages business partners to support resilient and secure product delivery, order management, billing, and customer service/support. We create product- or application-specific supply-chain designs, and we implement fit-for-purpose solutions to meet the needs of our markets, our products, and our patients. 

Supply chain management 

To fulfill our goal of answering patients’ unmet medical needs, we need a seamless and robust supply chain that ensures a stable supply of high-quality medicines.

We rely on teamwork and collaboration and operate regionally – using logistics to coordinate all aspects of the end-to-end value chain. This includes:

  • Planning
  • Manufacturing
  • Transport and delivery
  • Product support, science, technology
  • Artwork and packaging
  • Clinical trial supply
  • CMO management and procurement
  • Digitization and systems
  • Business performance


The Kyowa Kirin Corporate Social Responsibility (CSR) Guidebook explains how we achieve our CSR procurement with the understanding and cooperation obtained from suppliers, and consists of the Kyowa Kirin Group Procurement Policy, the Supplier Code of Conduct, and the Supplier Hotline. 

Smiling doctor wearing glasses

Our commitment to pharmacovigilance  

Our mission is to protect public health by ensuring the safe and effective use of our innovative therapies across the world. We are dedicated to providing timely and accurate information to healthcare professionals, regulatory bodies, and our patients.

Innovative pharmacovigilance practices are rooted in every aspect of our work and include robust operating processes, and an in-depth understanding of applicable global regulations. We work with patient safety as our priority across the product life cycle, from discovery through maturity in all our markets.  

Learn more about our Ethics and Transparency

Questions or concerns?

If you have any questions or concerns about the quality of one of our products, contact us immediately at: 1-844-768-3544