Biosimilars: EMA & OJEC
Biosimilars: FDA
Biosimilars: ICH
Biosimilars: MHLW
Blood Products: EP
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Blood Products: FDA & USP
Blood Products: ISO
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Blood Products: MHLW
Cell Line Characterization EMA & EP
EMA EP*
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Many regulatory guidelines must be followed for you to meet the specific requirements of the territory in which you intend to market your product. Experience with the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the Japanese Ministry of Health, Labor and Welfare (MHLW), and other regulatory agencies allows Charles River’s technical and quality assurance personnel to have the regulatory knowledge you need to accelerate the development of your biologic.
We have compiled this online library of regulatory documents to assist you as you move through your development and release process. You can filter the documents by topic and agency below.
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EMA EP*
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