FUJIFILM Diosynth Biotechnologies

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cGMP Manufacturing at 1000L scale

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:



Our quality systems are under continuous assessment through a combination of internal, customer and regulatory authority audits.

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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