EU GMP |
http://ec.europa.eu/health/documents/eudralex/vol-4_en |
EMA |
http://www.ema.europa.eu/en |
EDQM |
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EDQM QM Documents |
https://www.edqm.eu/en/quality-management-guidelines-86.html |
EU GMP results checking |
http://eudragmdp.ema.europa.eu/inspections/gmpc/searchGMPCompliance.do |
EU eCTD submission platform |
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US FDA |
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US DMF |
https://www.fda.gov/drugs/forms-submission-requirements/drug-master-files-dmfs |
WHO Guidelines |
http://www.who.int/medicines/areas/quality_safety/quality_assurance/guidelines/en/ |
PIC/S |
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ISPE |
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ISO |
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ICH |
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MHRA |
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NMPA |
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CNCA |
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CDE |