Quality Assurance

Our Quality Vision

The FUJFILM Diosynth Biotechnologies Quality Vision is to establish an effective pharmaceutical quality system which integrates regulatory compliance requirements with patient safety and Active Pharmaceutical Ingredients (API) quality requirements. This will be achieved by utilizing risk management and continuous improvement principles throughout the facilities and API lifecycles to foster innovation and promote ownership of quality and compliance by all employees.

 Our regulatory history includes FDA (CBER & CDER), MHRA, EMA, Health Canada, ANVISA, and certification by JMHLW, among the many agencies that have inspected our sites.
 Our Global Quality Group provides:
  • Quality Agreement followed by routine interactions with customer throughout the duration of a program
  • Regulatory support for IND/CTA submission, DMF and CMC
  • QC analysis and release of raw materials, environmental and water in-process/final, sample retention
  • Ownership and use of qualified and/or validated methods
  • QP release (Europe)

See a List of All Current FDA Regulatory Guidance Documents

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