Hi everybody,
I hope everything is going well.
Today I have a question related to the establishment of tightened specification with the cdmo when the drug substance/ drug product will be supplied to global market, example, US, Japan and Europe. The purpose is to have the more restrictive specification to be able to attend all markets. Do tou have this experience? What is your approach and points of cons and pros?
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Maria Pinto
Master
Aaslmeer
Netherlands
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