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What dossiers are required for drug registration in China?
What dossiers are required for drug registration in China?
2020-02-03>
Why some forms need to be notarized by authority?
Why some forms need to be notarized by authority?
2019-05-09>
New FDA Guideline: Quality Aspects for Continuous Manufacturing
In February 2019, the FDA published a new draft guideline that addresses quality aspects in the continuous manufacturing of medicinal products. It covers topics related to development, process vali...
2019-03-15>
What types of DMF are not consistent with Chinese DMF requirement?
What types of DMF are not consistent with Chinese DMF requirement?
2019-02-26>
Why some APIs can be independently reviewed while others don’t?
Why some APIs can be independently reviewed while others don’t?
2018-11-13>
