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Variation
Navigating the FDA's Guidelines for Variations in Pharmaceuticals
List of links giving access to the most relevant variation guidance published by FDA
Jeremy Jakob
Dec 1, 20231 min read
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EU Variations Guideline
Current EU Variations Regulations
Jeremy Jakob
Mar 9, 20232 min read
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Recommendation on HMA Article 5 on unforeseen variations
Recommendation on HMA Article 5 on unforeseen variations
Jeremy Jakob
Mar 9, 20231 min read
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SUPAC Guidances
List of useful CMC guidance published by SUPAC
Jeremy Jakob
Mar 9, 20231 min read
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Europe - Guidelines and Procedures for variations
Current EU Variations Regulations
Jeremy Jakob
Mar 8, 20232 min read
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EU Variations General Information
EU Variations General Information
Jeremy Jakob
Mar 8, 20231 min read
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Navigating Variation Requirements and Specific Requirements in Canada
1. Variation Requirements Notice of Compliance (NOC) Changes - Quality Guidance: The Post Notice of Compliance (NOC) Changes - Quality...
Jeremy Jakob
Feb 16, 20231 min read
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Stability Conditions for WHO Member States by Region-2021
Stability testing of Active Substances and Finished Drug Products Stability conditions for WHO Member States by Region The enclosed...
Jeremy Jakob
Jan 30, 20231 min read
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