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LINKS

  • Related link

SERVICES

  • GMP consultancy and execution services
  • Drug registration support services
  • Audit services
Links

  EU GMP

  http://ec.europa.eu/health/documents/eudralex/vol-4_en

  EMA

  http://www.ema.europa.eu/en

  EDQM

  https://www.edqm.eu/en

  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

  https://cespportal.hma.eu/Account/Login?ReturnUrl=%2f

  US FDA

  https://www.fda.gov/

  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

  https://www.picscheme.org/en/publications

  ISPE

  http://www.ispe.org/ispe-news

  ISO

  https://www.iso.org/standard/53394.html

  ICH

  http://www.ich.org/home.html

  MHRA

  http://www.mhra.gov.uk/#page=DynamicListMedicines

  NMPA

  http://www.nmpa.gov.cn

  CNCA

  http://www.cnca.gov.cn/

  CDE

  http://www.cde.org.cn/welcome.do?method=execute

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