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In Vitro Diagnostics 2017/746 Medical Devices
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ICH Q2(R2) and ICH Q14 Analytical Validation
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ICH E6(R3) - Good Clinical Practice
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EU GMPs with Annex 1 Sterile Medicinal Products
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21 CFR 814 - Premarket Approval of Medical Device
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21 CFR 606 - Blood Industry
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21 CFR 210/211 with Drug Preambles
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21 CFR 11, 58, 210/211, 820, ICH E6(R3) - GMP 2
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21 CFR 11, 58, 210/211, 600, 601, 610, 820 - Multi-US GMPs
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21 CFR 106, 107, 110 and 117 - Infant Formula Regulations
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Master Reference Desk Set - Drug, Dietary & Medical Device
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21 CFR Parts 210/211 with EU Annex 1
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Japanese GMP for Drugs and Quasi-drugs - 2005
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ICH Q12 Pharmaceutical Product Lifecycle Management
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GLP QMSR Master Handbook
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EU Medical Device Regulation 2017-745
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21 CFR 820 - QMSR-Spanish
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Canadian - SOR98-282 Medical Devices Regulations
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21 CFR 806 - Medical Devices; Reports of Corrections and Removal
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21 CFR 205 - Guidelines for Licensing of Wholesale Drug
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21 CFR 112 - ENGLISH/SPANISH
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21 CFR Part 112 with FDA Guidance
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21 CFR 115 and 118 Egg Products
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21 CFR 11, 210/211 with Keyword Index
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2023 National Conference on Interstate Milk Shipments (NCIMS) 4 Book Set
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21 CFR Part 821 Medical Device Tracking Requirements
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21 CFR Part 860 Medical Device Classification Procedures.
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Medical Device Quality Systems Manual with 820 and QMSR Audit Checklist
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Medical Device QSIT Manual with 11 and 820
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ICH Q7, Q8(R2), Q9(R1), Q10 and Q11
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ICH Q7, Q8(R2), Q9(R1) and Q10 with FAQ
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ICH Q7 with Q7 Auditors Check List
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ICH M10 Bioanalytical Method Validation
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EU GMPs with Annex 2 Biological
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EU GMPs with Annex 15 Qualification and Validation
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21 CFR Parts 11, 203, 205 - PDMA
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Collection: All Publications
The complete Food, Drug, Pharmaceutical, Medical Device, Dietary Supplements, Cosmetics, Blood, Cell, Tissue, Regulations and Guidance supporting U.S. FDA, EU EMA, and international guidance and strandards.