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Sharan Murugan
- Nov 30, 2023
- 1 min
Health Canada: Guidance on Validation rules for Regulatory Transactions in the eCTD Format
Health Canada recently published an updated guidance on "Validation rules for regulatory transactions provided to Health Canada in the...
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Sharan Murugan
- May 9, 2023
- 1 min
South Africa's SAPHRA: Validation Template For ECTD Variation Applications, QOA & QIS
Recently (05 May 2023) the South African Health Products Regulatory Authority (SAPHRA) released the template "Validation Template For...
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Sharan Murugan
- Feb 14, 2023
- 1 min
EMA Checklist: Updated Validation checklist for Type II quality variations
Recently on 10th February 2023, the European Medicines Agency (EMA) updated and released their "Validation checklist for Type II quality...
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Sharan Murugan
- Apr 4, 2022
- 1 min
ICH's updated Draft Guidelines on Analytical Method Development
Two draft guidelines were issued by the International Council for Harmonization (ICH) on 31 March 2022 (Thursday), intended to support...
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