Originally posted on Regulatory Focus – a RAPS publication The new EU Clinical Trials Regulation represents the most significant overhaul...
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Posts Tagged - EU Regulatory
EU Regulatory References
EMA–European Medicines Agency EMA Quality Guidelines EMA Biologic Guidelines EudraLex – Volume 3 Scientific guidelines for medicinal products for human use EudraLex...
Global GMPs Guidance Documents
US GMPs Background: Overview of US GMPs for Active Pharmaceutical Ingredients (API) References: Code of Federal Regulations (US GMP’s) 21 CFR 58 – Good Labratory...
US Regulatory References
FDA – U.S. Food and Drug Administration Guidance, Compliance: Regulatory Information (Biologics) US BIOLOGIC REGULATIONS The final regulations published in the Federal...
Global Process Validation Guidance
FDA Guideline On General Principles Of Process Validation WHO Supplementary Training Modules: Validation, Water, Air Handling Systems FDA’s Process Validation Guidance EMEA...
