1

Your cart is empty.



Celebrating 21 YEARS of Regulatory Excellence!
Go with the Most-Trusted Regulations & Guidelines Books on the Market.


Now Taking Pre-Orders for our APRIL 1, 2023 Books, Shipping in Mid-May.       APRIL 1, 2022 Books are still available!

Select From All 2022 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:  2022 Comprehensive Clinical Research Desk Reference for Drug and Medical Device Trials Book CG1: 2022 Comprehensive Clinical Research Desk Reference for Drug and Medical Device Trials $ 45.95
Book 1B:  2022 FDA Good Clinical Practice Guide Book 1B: 2022 FDA Good Clinical Practice Guide $ 19.95
Book 1A:  2022 Selected Regulations & Guidance for Drug Studies Book 1A: 2022 Selected Regulations & Guidance for Drug Studies $ 19.95
Book 2:  2022 Selected Regulations and Guidance for Medical Device Studies Book 2: 2022 Selected Regulations and Guidance for Medical Device Studies $ 19.95
Book 3A:  2022 Selected Regulations and Guidance on Protection of Human Subjects:  Clinical Investigator, IRB & Sponsor Responsibilities Book 3A: 2022 Selected Regulations and Guidance on Protection of Human Subjects: Clinical Investigator, IRB & Sponsor Responsibilities $ 18.95
Book 3B:  2022 Selected Documents on International Ethical Conduct, Federalwide Assurances, & OHRP Compliance in Academic Research Book 3B: 2022 Selected Documents on International Ethical Conduct, Federalwide Assurances, & OHRP Compliance in Academic Research $ 17.95
Book 3C:  2022 The Official Investigator's Handbook for Conducting Cancer Clinical Trials Book 3C: 2022 The Official Investigator's Handbook for Conducting Cancer Clinical Trials $ 18.95
Book 3D:  2022 Common Terminology Criteria for Adverse Events (CTCAE) Book 3D: 2022 Common Terminology Criteria for Adverse Events (CTCAE) $ 13.95
Book 4:  2022 Selected Regulations/Guidance on Good Manufacturing Practice Book 4: 2022 Selected Regulations/Guidance on Good Manufacturing Practice $ 18.95
Book 4B:  2022 International Reference on Cleaning Validation under Good Manufacturing Practice Book 4B: 2022 International Reference on Cleaning Validation under Good Manufacturing Practice $ 18.95
Book 4C:  2022 Good Manufacturing Practice in the European Union, Reference Guide Book 4C: 2022 Good Manufacturing Practice in the European Union, Reference Guide $ 18.95
Book 5A:  2022 Administrative Simplification Provisions of HIPAA: The Act, Regulations and DHHS (OCR) Guidance Book 5A: 2022 Administrative Simplification Provisions of HIPAA: The Act, Regulations and DHHS (OCR) Guidance $ 17.95
Book 5B:  2022 HIPAA Privacy for Researchers: Guidance from the NIH Book 5B: 2022 HIPAA Privacy for Researchers: Guidance from the NIH $ 17.95
Book 6:  2022 Clinical Trials in The EU: Selected Legislation, Guidelines and the Declaration of Helsinki Book 6: 2022 Clinical Trials in The EU: Selected Legislation, Guidelines and the Declaration of Helsinki $ 19.95
Book 7:  2022 Selected Laws/Regulations/Guidance on Drug Marketing, Advertising, and Labeling Book 7: 2022 Selected Laws/Regulations/Guidance on Drug Marketing, Advertising, and Labeling $ 17.95
Book 8:  2022 Clinical Research Dictionary & Introduction to the FDA Drug Approval Process Book 8: 2022 Clinical Research Dictionary & Introduction to the FDA Drug Approval Process $ 17.95
Book 9:  2022 Regulations/Guidance on Good Laboratory Practice and Nonclinical Research Book 9: 2022 Regulations/Guidance on Good Laboratory Practice and Nonclinical Research $ 17.95
Book 10:  2022 Selected Regulations/Guidance on Biologics, Blood Products and Good Tissue Practice Book 10: 2022 Selected Regulations/Guidance on Biologics, Blood Products and Good Tissue Practice $ 18.95
Book 11: 2022 Clinical Research Guide for Drugs, Devices, and Natural Health Products in Canada Book 11: 2022 Clinical Research Guide for Drugs, Devices, and Natural Health Products in Canada $ 18.95
Book 13:  2022 FDA Guidance on Clinical Study Reports and Statistical Principles for Clinical Trials Book 13: 2022 FDA Guidance on Clinical Study Reports and Statistical Principles for Clinical Trials $ 17.95
Book 14:  2022 Selected Recently-Finalized FDA Guidance Documents Book 14: 2022 Selected Recently-Finalized FDA Guidance Documents $ 18.95
Book 16:  2022 Preambles to Good Clinical Practice Regulations Book 16: 2022 Preambles to Good Clinical Practice Regulations $ 28.95
Book 17:  2022 Preambles to Good Manufacturing Practice Regulations Book 17: 2022 Preambles to Good Manufacturing Practice Regulations $ 24.95
Book 19:  2022 Preambles to Good Laboratory Practice Regulations Book 19: 2022 Preambles to Good Laboratory Practice Regulations $ 22.95
Book 20:  2022 ORI Introduction to the Responsible Conduct of Research Book 20: 2022 ORI Introduction to the Responsible Conduct of Research $ 17.95
Book 22:  2022 Frequently Asked Questions and Guidance on Clinical Research from the OHRP Book 22: 2022 Frequently Asked Questions and Guidance on Clinical Research from the OHRP $ 17.95
Book 23:  2022 Part 11 & Drug Development:  Regulation, Preamble & FDA Guidance on Electronic Records & Electronic Signatures Book 23: 2022 Part 11 & Drug Development: Regulation, Preamble & FDA Guidance on Electronic Records & Electronic Signatures $ 17.95
Book 24A:  EU 2022 Guideline on Good Pharmacovigilance Practices, Vol. I: Modules Book 24A: EU 2022 Guideline on Good Pharmacovigilance Practices, Vol. I: Modules $ 28.95
Book 24B:  EU 2022 Guideline on Good Pharmacovigilance Practices, Vol. II: Annexes Book 24B: EU 2022 Guideline on Good Pharmacovigilance Practices, Vol. II: Annexes $ 28.95
Book 25:  2022 Laws, Regulations, and Guidance on Pediatric Studies Book 25: 2022 Laws, Regulations, and Guidance on Pediatric Studies $ 17.95
Book 27:  2022 FDA Investigations Operations Manual Book 27: 2022 FDA Investigations Operations Manual $ 31.95
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 $ 19.95
Book 29:  2022 Canadian TRI -COUNCIL POLICY STATEMENT Ethical Conduct for Research Involving Humans Book 29: 2022 Canadian TRI -COUNCIL POLICY STATEMENT Ethical Conduct for Research Involving Humans $ 19.95
Book M1:  2022 Mini Pocket-Sized (3" x 5") ICH Guidelines for GCP (E6) and Clinical Safety Data Management (E2A) Book M1: 2022 Mini Pocket-Sized (3" x 5") ICH Guidelines for GCP (E6) and Clinical Safety Data Management (E2A) $ 12.95
Book M2:  2022 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: 2022 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:  2022 Mini Pocket-Sized (3" x 5") Clinical Research Dictionary Book M4: 2022 Mini Pocket-Sized (3" x 5") Clinical Research Dictionary $ 12.95
e-Books: Multiple 1-year Licenses Only $ 17.95