1

Your cart is empty.



Celebrating 23 YEARS of Regulatory Excellence!
Go with the Most-Trusted Regulations & Guidelines Books on the Market.


Now Taking Orders for Our April 1, 2025 Books!        ALSO Check Out our Books with the ICH E6(R3) GUIDELINE FOR GOOD CLINICAL PRACTICE       See our BOOKSTORE Drop-Down Menu for included titles

Select from All Books

Enter the quantities of all of the books that you want, then click the "Add to the cart" button.  If you click on a book's title to review its content, use the BACK ARROW on your browser or the "Return to Previous Page" link to return to this form so that you do not erase your order quantities.  You can always adjust your quantities in your shopping cart.

Book CG1:  2025 Comprehensive Clinical Research Desk Reference for Drug and Medical Device Trials Book CG1: 2025 Comprehensive Clinical Research Desk Reference for Drug and Medical Device Trials - $ 45.95
Book CG1-E6R3:  2025 Comprehensive Clinical Research Desk Reference for Drug and Medical Device Trials (With ICH GCP E6(R3)) Book CG1-E6R3: 2025 Comprehensive Clinical Research Desk Reference for Drug and Medical Device Trials (With ICH GCP E6(R3)) - $ 46.95
Book 1A:  2025 Selected Regulations & Guidance for Drug Studies Book 1A: 2025 Selected Regulations & Guidance for Drug Studies - $ 22.95
Book 1A-E6R3:  2025 Selected Regulations & Guidance for Drug Studies (With ICH E6(R3)) Book 1A-E6R3: 2025 Selected Regulations & Guidance for Drug Studies (With ICH E6(R3)) - $ 24.95
Book 1B:  2025 FDA Good Clinical Practice Guide Book 1B: 2025 FDA Good Clinical Practice Guide - $ 24.95
Book 1B-E6R3:  2025 FDA Good Clinical Practice Guide (With ICH GCP E6(R3)) Book 1B-E6R3: 2025 FDA Good Clinical Practice Guide (With ICH GCP E6(R3)) - $ 26.95
Book 1C:  2025 Good Clinical Practice Regulations in the US & the EU Book 1C: 2025 Good Clinical Practice Regulations in the US & the EU - $ 22.95
Book 1C-E6R3:  2025 Good Clinical Practice Regulations in the US & the EU (With ICH GCP E6(R3)) Book 1C-E6R3: 2025 Good Clinical Practice Regulations in the US & the EU (With ICH GCP E6(R3)) - $ 24.95
Book 2:  2025 Selected Regulations and Guidance for Medical Device Studies Book 2: 2025 Selected Regulations and Guidance for Medical Device Studies - $ 19.95
Book 2-E6R3:  2025 Selected Regulations and Guidance for Medical Device Studies (With ICH GCP E6 (R3)) Book 2-E6R3: 2025 Selected Regulations and Guidance for Medical Device Studies (With ICH GCP E6 (R3)) - $ 21.95
Book 3A:  2025 Selected Regulations and Guidance on Protection of Human Subjects:  Clinical Investigator, IRB & Sponsor Responsibilities Book 3A: 2025 Selected Regulations and Guidance on Protection of Human Subjects: Clinical Investigator, IRB & Sponsor Responsibilities - $ 22.95
Book 3B:  2025 Selected Documents on International Ethical Conduct, Federalwide Assurances, & OHRP Compliance in Academic Research Book 3B: 2025 Selected Documents on International Ethical Conduct, Federalwide Assurances, & OHRP Compliance in Academic Research $ 17.95
Book 3C:  2024 The Official Investigator's Handbook for Conducting Cancer Clinical Trials Book 3C: 2024 The Official Investigator's Handbook for Conducting Cancer Clinical Trials $ 18.95
Book 3D:  2025 Common Terminology Criteria for Adverse Events (CTCAE) Book 3D: 2025 Common Terminology Criteria for Adverse Events (CTCAE) - $ 13.95
Book 4:  2025 Selected Regulations/Guidance on Good Manufacturing Practice Book 4: 2025 Selected Regulations/Guidance on Good Manufacturing Practice $ 18.95
Book 4B:  2025 International Reference on Cleaning Validation under Good Manufacturing Practice Book 4B: 2025 International Reference on Cleaning Validation under Good Manufacturing Practice $ 18.95
Book 4C:  2025 Good Manufacturing Practice in the European Union, Reference Guide Book 4C: 2025 Good Manufacturing Practice in the European Union, Reference Guide $ 18.95
Book 5A:  2025 Administrative Simplification Provisions of HIPAA: The Act, Regulations and DHHS (OCR) Guidance Book 5A: 2025 Administrative Simplification Provisions of HIPAA: The Act, Regulations and DHHS (OCR) Guidance - $ 17.95
Book 5B:  2024 HIPAA Privacy for Researchers: Guidance from the NIH Book 5B: 2024 HIPAA Privacy for Researchers: Guidance from the NIH - $ 17.95
Book 6:  2024 Clinical Trials in The EU: Selected Legislation, Guidelines and the Declaration of Helsinki Book 6: 2024 Clinical Trials in The EU: Selected Legislation, Guidelines and the Declaration of Helsinki $ 19.95
Book 7:  2025 Selected Laws/Regulations/Guidance on Drug Marketing, Advertising, and Labeling Book 7: 2025 Selected Laws/Regulations/Guidance on Drug Marketing, Advertising, and Labeling - $ 17.95
Book 8:  2025 Clinical Research Dictionary & Introduction to the FDA Drug Approval Process Book 8: 2025 Clinical Research Dictionary & Introduction to the FDA Drug Approval Process $ 17.95
Book 9:  2025 Regulations/Guidance on Good Laboratory Practice and Nonclinical Research Book 9: 2025 Regulations/Guidance on Good Laboratory Practice and Nonclinical Research - $ 17.95
Book 10:  2025 Selected Regulations/Guidance on Biologics, Blood Products and Good Tissue Practice Book 10: 2025 Selected Regulations/Guidance on Biologics, Blood Products and Good Tissue Practice $ 18.95
Book 13:  2025 FDA Guidance on Clinical Study Reports and Statistical Principles for Clinical Trials (Copy) Book 13: 2025 FDA Guidance on Clinical Study Reports and Statistical Principles for Clinical Trials (Copy) - $ 17.95
Book 14:  2025 Selected Recently-Finalized FDA Guidance Documents Book 14: 2025 Selected Recently-Finalized FDA Guidance Documents $ 18.95
Book 16:  2025 Preambles to Good Clinical Practice Regulations Book 16: 2025 Preambles to Good Clinical Practice Regulations $ 28.95
Book 17:  2025 Preambles to Good Manufacturing Practice Regulations Book 17: 2025 Preambles to Good Manufacturing Practice Regulations $ 24.95
Book 19:  2024 Preambles to Good Laboratory Practice Regulations Book 19: 2024 Preambles to Good Laboratory Practice Regulations $ 22.95
Book 20:  2025 ORI Introduction to the Responsible Conduct of Research Book 20: 2025 ORI Introduction to the Responsible Conduct of Research $ 17.95
Book 22:  2025 Frequently Asked Questions and Guidance on Clinical Research from the OHRP Book 22: 2025 Frequently Asked Questions and Guidance on Clinical Research from the OHRP $ 17.95
Book 23:  2025 Part 11 & Drug Development:  Regulation, Preamble & FDA Guidance on Electronic Records & Electronic Signatures Book 23: 2025 Part 11 & Drug Development: Regulation, Preamble & FDA Guidance on Electronic Records & Electronic Signatures $ 17.95
Book 24A:  EU 2025 Guideline on Good Pharmacovigilance Practices, Vol. I: Modules Book 24A: EU 2025 Guideline on Good Pharmacovigilance Practices, Vol. I: Modules $ 28.95
Book 24B:  EU 2025 Guideline on Good Pharmacovigilance Practices, Vol. II: Annexes Book 24B: EU 2025 Guideline on Good Pharmacovigilance Practices, Vol. II: Annexes $ 28.95
Book 25:  2025 Laws, Regulations, and Guidance on Pediatric Studies Book 25: 2025 Laws, Regulations, and Guidance on Pediatric Studies - $ 17.95
Book 27:  2025 FDA Investigations Operations Manual Book 27: 2025 FDA Investigations Operations Manual $ 45.95
Book 28: Clinical Laboratory Improvement Amendments of 1988 (CLIA): Survey Procedures and Interpretive Guidelines Book 28: Clinical Laboratory Improvement Amendments of 1988 (CLIA): Survey Procedures and Interpretive Guidelines $ 21.95
Book 29:  2025 Canadian TRI -COUNCIL POLICY STATEMENT Ethical Conduct for Research Involving Humans Book 29: 2025 Canadian TRI -COUNCIL POLICY STATEMENT Ethical Conduct for Research Involving Humans $ 19.95
Book M1:  2025 Mini Pocket-Sized (3" x 5") ICH Guidelines for GCP (E6) and Clinical Safety Data Management (E2A) Book M1: 2025 Mini Pocket-Sized (3" x 5") ICH Guidelines for GCP (E6) and Clinical Safety Data Management (E2A) - $ 12.95
Book M2:  2025 Mini Pocket-Sized (3" x 5") Code of Federal Regulations on Good Clinical Practice, 21 CFR Parts 11, 50, 54, 56, 312 (Does not include Part 314 or any ICH Guidelines) Book M2: 2025 Mini Pocket-Sized (3" x 5") Code of Federal Regulations on Good Clinical Practice, 21 CFR Parts 11, 50, 54, 56, 312 (Does not include Part 314 or any ICH Guidelines) - $ 12.95
Book M4:  2025 Mini Pocket-Sized (3" x 5") Clinical Research Dictionary Book M4: 2025 Mini Pocket-Sized (3" x 5") Clinical Research Dictionary $ 12.95