Quality Assurance

FUJIFILM Diosynth Biotechnologies provides all the necessary quality and regulatory support through our own independent quality unit to ensure your product meets international regulatory requirements.

Our Quality Assurance department is responsible for:

  • Ensuring compliance with cGMP and international regulatory requirements
  • Review and approval of all manufacturing documentation
  • Materials and vendor assurance
  • Adherence to customer quality agreement
  • Validation
  • Product disposition

Qualified Person (QP) release

For your commercial manufacture, FUJIFILM Diosynth Biotechnologies has its own Qualified Person (QP) ready to certify that your Active Pharmaceutical Ingredient (API) is suitable for release to market. For European markets and the biologics industry this is a legal requirement. Having an on-hand QP within FUJIFILM Diosynth Biotechnologies provides our customers with a huge advantage when beginning their commercial manufacture.

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