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Our Best Sellers:
| 21 CFR 11 - Electronic Records with Scope & Application |
| 21 CFR 210/211 - Drug GMPs |
| 21 CFR 820 - Quality System Regulations |
| 21 CFR 11, 210/211, 820 - Electronic Records with Drug and Device GMPs |
| 21 CFR 11, 210/211, 820, ICH Q7 - Good Manufacturing Practice Handbook |
| 21 CFR 11, 50, 54, 56, 807, 812, 814, 820, 510K & PMA - Medical Device Combination |
| 21 CFR 11, 50, 54, 56, 312, 314, ICH E2A, E6(R1) - Good Clinical Practice Handbook |
| 21 CFR 11, 58, 210/211, 600, 601, 610, 820 - Multi-US GMPs |
| US, EU and Japanese GMPs |
Complete Product Listing
| 21 CFR 11 - Electronic Records with Scope & Application & Computerized Systems used in Clinical Investigations |
| 21 CFR 11 - Electronic Records with Scope & Application and Part 11 Checklist |
| 21 CFR 11 - Electronic Records with Scope & Application and Preambles |
| 21 CFR 11 - Electronic Records with Scope & Application |
| 21 CFR 11, 101, 110, 120, 123 - GMPs for Fish Industry with Food Labeling |
| 21 CFR 11, 110 - Electronic Records with Food GMPs |
| 21 CFR 11, 110, 111 - Food and Supplment GMPs |
| 21 CFR 11, 110, 120, 123 - GMPs for Fish Industry |
| 21 CFR 11, 111 - Electronic Records with Dietary Supplement GMPs |
| 21 CFR 11, 203, 205 - PDMA with Electronic Records |
| 21 CFR 11, 210/211 - Electronic Records with Drug GMPs |
| 21 CFR 11, 210/211 - Electronic Records with Drug GMPs-ENGLISH/SPANISH |
| 21 CFR 11, 210/211 - Electronic Records with Drug GMPs-SPANISH |
| 21 CFR 11, 210/211 with Keyword Index |
| 21 CFR 11, 210/211, 606, 820 - Electronic Records with Drug, Blood and Device QSR Industry GMPs |
| 21 CFR 11, 210/211, 700/701 - Cosmetic with "Is It Soap or a Drug" |
| 21 CFR 11, 210/211, 820 - Electronic Records with Drug and Device GMPs |
| 21 CFR 11, 210/211, 820 - Electronic Records with Drug and Device GMPs -ENGLISH/SPANISH |
| 21 CFR 11, 210/211, 820 - Electronic Records with Drug and Device GMPs-SPANISH |
| 21 CFR 11, 210/211, 820 with Audit Checklists - GMP Auditor’s Basic Handbook |
| 21 CFR 11, 210/211, 820, ICH Q7 - Good Manufacturing Practice Handbook |
| 21 CFR 11, 50, 54, 56, 312, 314, ICH E2A, E6(R1) - Good Clinical Practice Handbook |
| 21 CFR 11, 50, 54, 56, 807, 812, 814, 820, 510K & PMA - Medical Device Combination |
| 21 CFR 11, 58 - Electronic Records with Scope & App. and GLP |
| 21 CFR 11, 58, 210/211, 600, 601, 610, 820 - Multi-US GMPs |
| 21 CFR 11, 58, 210/211, 820 - Master GMP Trainer: Guidance Doc. GMPs for the 21st Century & Quality Syst. Approach to GMPs |
| 21 CFR 11, 58, 210/211, 820, ICH E6(R1) - GMP 2 Combination Handbook |
| 21 CFR 11, 58, 820 - Electronic Records with GLP and QSR |
| 21 CFR 11, 606 - Electronic Systems with Blood Industry GMPs |
| 21 CFR 11, 820 - Electronic Records with Quality Systems Regulations |
| 21 CFR 101, 110 - Food Labeling Combination |
| 21 CFR 106, 107, 110 - Infant Formula Regulations |
| 21 CFR 108, 110, 113, 114 - GMPs for Low-Acid Foods |
| 21 CFR 110 - Food GMPs |
| 21 CFR 110 - Food GMPs-ENGLISH/SPANISH |
| 21 CFR 110 - Food GMPs-SPANISH |
| 21 CFR 110, 111 - Food and Supplement GMPs |
| 21 CFR 110, 130, 131, 133 - Milk and Dairy |
| 21 CFR 111 - Dietary Supplement handbook |
| 21 CFR 115 and 118 Egg Products |
| 21 CFR 1270 - Human Tissue Intended for Transplantation |
| 21 CFR 1270, 1271 - Cell Tissue |
| 21 CFR 1271 - Human Cells, Tissues, Cellular and Tissue… |
| 21 CFR 13 - Public Hearing |
| 21 CFR 200 - General Drug |
| 21 CFR 200, 201 - General Drug & Drug Labeling Combination |
| 21 CFR 203 - Prescription Drug Marketing |
| 21 CFR 205 - Guidelines for Licensing of Wholesale Drug |
| 21 CFR 210/211 - Drug GMPs |
| 21 CFR 210/211 - Drug GMPs-ENGLISH/SPANISH |
| 21 CFR 210/211 - Drug GMPs-SPANISH |
| 21 CFR 210/211 with Drug Preambles |
| 21 CFR 210/211 with GMP Audit Check List |
| 21 CFR 210/211 with Keyword Index |
| 21 CFR 3 - Combination Product Basic Handbook - Definition, FAQ's & GMPs |
| 21 CFR 3, 11, 210/211, 820, ICH Q7 - Combination Product Handbook 2-Definition, FAQ's & GMPs |
| 21 CFR 312 - Investigational New Drug Application |
| 21 CFR 312, 314, 511 - Human and Animal Drug Approval |
| 21 CFR 314 - Applications for FDA Approval to Market a New Drug |
| 21 CFR 316 - Orphan Drugs |
| 21 CFR 50 - Protection of Human Subjects - Includes the June 24th, 2011 Changes |
| 21 CFR 50, 54, 56 - GCP Drug Approval Handbook |
| 21 CFR 54 - Financial Disclosure by Clinical Investigators |
| 21 CFR 56 - Institutional Review Boards |
| 21 CFR 58 - Good Laboratory Practice |
| 21 CFR 58, 606 - Good Laboratory Practice for Blood Industry |
| 21 CFR 58, 820 - GLP and QSR |
| 21 CFR 600 - Biological Products: General |
| 21 CFR 600, 601, 610 - Biologic GMP |
| 21 CFR 601 - Licensing - Biologics |
| 21 CFR 606 - Blood Industry |
| 21 CFR 610 - General Biological Products Standards |
| 21 CFR 640 - Add. Standards for human blood and blood products |
| 21 CFR 660 - Add. Standards for Diagnostic Substances for Lab. Tests |
| 21 CFR 680 - Additional Standards for Miscellaneous Products |
| 21 CFR 801 - Labeling - Medical Device |
| 21 CFR 803 - Medical Device Reporting |
| 21 CFR 806 - Medical Devices; Reports of Corrections and Removal |
| 21 CFR 807 - Est. Reg. and Device Listing for Manu... |
| 21 CFR 809 - In-Vitro Diagnostic Products |
| 21 CFR 810 - Medical Device Recall Authority |
| 21 CFR 812 - Investigational Device Exemptions |
| 21 CFR 814 - Premarket Approval of Medical Device |
| 21 CFR 820 - Quality System Regulations |
| 21 CFR 820 - Quality System Regulations-ENGLISH/SPANISH |
| 21 CFR 820 - Quality System Regulations-SPANISH |
| 21 CFR 820 with Medical Device QSIT Manual |
| Canadian GMP Guidelines 2009, Version 2 - Effective March 4, 2011 |
| Clinical Master Reference Guide |
| Electronic Systems Master Handbook 1 |
| EU and US GMPs with Q7 API |
| EU and US GMPs with Annex 1 |
| EU and US GMPs with Annexes 11 and 15 |
| EU and US GMPs with ICH Q7, Q8(R2), Q9, Q10 |
| EU GMPs Chapter 1 - 9 |
| EU GMPs with Annex 1 Sterile Medicinal Products |
| EU GMPs with Annex 2 Biological |
| EU GMPs with Annex 3 RadioPharma |
| EU GMPs with Annex 4 Vet. products other than Immuno |
| EU GMPs with Annex 5 Immunolgical Vet. Products |
| EU GMPs with Annex 6 Manufacture of Medicinal Gases |
| EU GMPs with Annex 7 Manufacture of Herbal Medicinal Products |
| EU GMPs with Annex 8 Sampling of Starting and Packaging Materials |
| EU GMPs with Annex 9 Manufacture of Liquids, Creams and Ointments |
| EU GMPs with Annex 10 Inhalation Products |
| EU GMPs with Annex 11 Computerized Systems |
| EU GMPs with Annex 11, 15 - Computerized Systems and Validation |
| EU GMPs with Annex 11, 15, 16, 18, 19 |
| EU GMPs with Annex 11, 15, 16 and ICH Q7 |
| EU GMPs with Annex 12 Ionizing Radiation |
| EU GMPs with Annex 13 Investigational medicinal Products |
| EU GMPs with Annex 14 Human Blood or Plasma Products |
| EU GMPs with Annex 15 Qualification and Validation |
| EU GMPs with Annex 16 Qualified Person and Batch Release |
| EU GMPs with Annex 17 Parametric Release |
| EU GMPs with Annex 19 Reference and Retention Samples |
| EU GMPs with ICH Q7 |
| EU GMPs with ICH Q7, Q8(R2), Q9 and Q10 |
| Eudralex - Pharmacovigilance for Medical Products Volume 9a |
| GLP Master Handbook |
| GMP - PAT Handbook |
| ICH E2A - Clinical Safety Data Management: Definitions and Standards for Expedited Reporting |
| ICH E4 - Dose-Response Information to Support Drug Registration |
| ICH E6(R1) - Good Clinical Practice |
| ICH E8 - General Considerations for Clinical Trials |
| ICH M3(R2) - Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals |
| ICH Q10 - Pharmaceutical Quality System |
| ICH Q1A(R2) - Stability Testing of New Drug Substances and Products |
| ICH Q1E - Evaluation of Stability Data |
| ICH Q2(R1) - Validation of Analytical Procedures: Test and Methodology |
| ICH Q5E - Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process |
| ICH Q7 with Q7 Auditors Check List |
| ICH Q7, Q8(R2), Q9 and Q10 Combination |
| ICH Q7, Q8(R2), Q9 and Q10 with FAQ |
| ICH Q8(R2) - Pharmaceutical Development |
| ICH Q9 - Quality Risk Management |
| ICH S2(R1) - Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use |
| ICH S6 - Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals |
| ICH S7A - Safety Pharmacology Studies for Human Pharmaceuticals |
| Japanese GMP for Drugs and Quasi-drugs - 2005 |
| Medical Device Clinical with EU Directive |
| Medical Device Combination 2 |
| Medical Device QSIT Manual with 11 and 820 |
| Medical Device QSIT Manual with 11, 803, 806, 820 and 821 |
| Medical Device Quality Systems Manual with 11, 210/211, 820 and QSR Audit Checklist |
| Medical Device Quality Systems Manual with 820 and QSR Audit Checklist |
| 510k and PMA Guidelines |
| TSA Basics Handbook |
| TSA Management Handbook |
| US and Canadian GMPs with ICH Q7, Q8(R2), Q9, Q10 |
| US, EU and Canadian Medical Device Combination |
| US, EU and Japanese GMPs |
| Chinese GMPs -SFDA - State Food & Drug Administration P.R. CHINA |
| Audit Fee US |
| In Vitro Diagnostics 98/79/EC Medical Devices |
| VICH GL9 Animal GCP |
| ICH Q7, Q8, Q9, Q10 and Q11 |
| In Vitro Diagnostics Master Handbook |
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