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The Alpha Biologics facility has been designed to be compliant
with both European and US FDA cGMP guidelines. The Alpha staff
have many years of experience in designing and operating mammalian
cell contract manufacturing and in-house manufacturing facilities
in compliance with cGMP's. They are experienced in working
with the regulatory authorities in both Europe and the United
States to ensure successful facility audits.
The Alpha
facility design underwent FDA review prior to construction
of the facility to ensure cGMP compliance, with the final
design incorporating any FDA recommendations.
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