austrianova exceeds cGMP and FDA standards.
The austrianova site and photos of their facility leave no doubt that they are able to produce a higher standard than cGMP.
The FDA follows the same international standard as the eu and Singapore and the standards of austrianova are above FDA standards.
Austrianova is a world class operation with a world class facility. Better than cGMP standard.
cGMP approval by the FDA is not in doubt
Austrianovas website states:
Our state of the art cGMP production facilities comply with international regulatory requirements and marry a Swiss/German quality assurance system with extensive technical and regulatory expertise to provide the support you need for efficient product development.
The hi-tech facility employs a custom-built multi-unit isolator that mimics the classical GMP clean room environments but allows a higher quality, reproducible product to be made through continuous online monitoring as well as physical isolation of the product at all times from the highly skilled operator.
Crucially, the higher quality final product is achieved at lower cost than that produced in a conventional GMP facility.
This is the facility producing pharmacytes master and working bank of cells.
See the pictures on austrianovas site and be impressed.
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