Collection: All Publications
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ICH Q10 - Pharmaceutical Quality System
Regular price $5.95Regular priceSale price $5.95 -
ICH M3(R2) - Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
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ICH E8 - General Considerations for Clinical Studies
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ICH E4 - Dose-Response Information to Support Drug Registration
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ICH E2A - Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
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Audit - 1 Day Onsite All Inclusive - U.S.
Regular price $5,995.00Regular priceSale price $5,995.00 -
GMP - PAT Handbook
Regular price $15.95Regular priceSale price $15.95 -
Eudralex - Pharmacovigilance for Medical Products Volume 9a
Regular price $19.95Regular priceSale price $19.95 -
EU GMPs with ICH Q7, Q8(R2), Q9(R1) and Q10
Regular price $14.95Regular priceSale price $14.95 -
EU GMPs with ICH Q7
Regular price $11.95Regular priceSale price $11.95 -
EU GMPs with Annex 9 Manufacture of Liquids, Creams and Ointments
Regular price $10.90Regular priceSale price $10.90 -
EU GMPs with Annex 8 Sampling of Starting and Packaging Materials
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EU GMPs with Annex 7 Manufacture of Herbal Medicinal Products
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EU GMPs with Annex 6 Manufacture of Medicinal Gases
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EU GMPs with Annex 5 Immunolgical Vet. Products
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EU GMPs with Annex 4 Vet. products other than Immuno
Regular price $10.90Regular priceSale price $10.90 -
EU GMPs with Annex 3 RadioPharma
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EU GMPs with Annex 19 Reference and Retention Samples
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EU GMPs with Annex 17 Parametric Release
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EU GMPs with Annex 16 Qualified Person and Batch Release
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21 CFR 820 - Quality Management System Regulations-SPANISH
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21 CFR Part 207 Registration
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21 CFR Parte 117 - cGMPs for Human Food - SPANISH
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510k and PMA Guidelines
Regular price $7.95Regular priceSale price $7.95