FUJIFILM Diosynth Biotechnologies

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cGMP Manufacturing at 1000L scale

Regulatory Support

We are committed to helping our customers meet their product goals and provide regulatory support, including assistance with the compilation of relevant sections of an IND/CTA submission and/or BLA/MAA submission.

Our regulatory history includes FDA (CBER and CDER), MHRA, EMA, Health Canada, ANVISA and certification by JMHLW. This means that whatever your target market, our track record enables us to provide appropriate and timely regulatory support.

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