1

Your cart is empty.

The Most-Trusted Regulations/Guidelines Books on the Market. Celebrating 14 Years of Excellence.

Quick Order 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 1A:  Selected Regulations & Guidance for Drug Studies Book 1A: Selected Regulations & Guidance for Drug Studies $ 15.95
Book 1B:  FDA Good Clinical Practice Guide Book 1B: FDA Good Clinical Practice Guide $ 15.95
Book 1SP:  SPANISH LANGUAGE 2012 Selected FDA Regulations and ICH Guidelines for Clinical Studies for US Drug Approval Book 1SP: SPANISH LANGUAGE 2012 Selected FDA Regulations and ICH Guidelines for Clinical Studies for US Drug Approval $ 19.95
Book CG1:  Comprehensive Clinical Research Desk Reference for Drug and Medical Device Trials Book CG1: Comprehensive Clinical Research Desk Reference for Drug and Medical Device Trials $ 44.95
Book 2:  Selected Regulations and Guidance for Medical Device Studies Book 2: Selected Regulations and Guidance for Medical Device Studies $ 15.95
Book 3A:  Selected Regulations and Guidance on Protection of Human Subjects:  Clinical Investigator, IRB & Sponsor Responsibilities Book 3A: Selected Regulations and Guidance on Protection of Human Subjects: Clinical Investigator, IRB & Sponsor Responsibilities $ 15.95
Book 3B:   	 Selected Documents on International Ethical Conduct, Federalwide Assurances, & OHRP Compliance in Academic Research Book 3B: Selected Documents on International Ethical Conduct, Federalwide Assurances, & OHRP Compliance in Academic Research $ 15.95
Book 3C:  The Official Investigator's Handbook for Conducting Cancer Clinical Trials Book 3C: The Official Investigator's Handbook for Conducting Cancer Clinical Trials $ 16.95
Book 3D:  Common Terminology Criteria for Adverse Events (CTCAE) Book 3D: Common Terminology Criteria for Adverse Events (CTCAE) $ 11.95
Book 4:  Selected Regulations/Guidance on Good Manufacturing Practice Book 4: Selected Regulations/Guidance on Good Manufacturing Practice $ 15.95
Book 4B:  International Reference on Cleaning Validation under Good Manufacturing Practice Book 4B: International Reference on Cleaning Validation under Good Manufacturing Practice $ 16.95
Book 4C:  EU Rules on Medicinal Products Volume 4: Good Manufacturing Practice Guidelines Book 4C: EU Rules on Medicinal Products Volume 4: Good Manufacturing Practice Guidelines $ 15.95
Book 5A:  Administrative Simplification Provisions of HIPAA: The Act, Regulations and DHHS (OCR) Guidance Book 5A: Administrative Simplification Provisions of HIPAA: The Act, Regulations and DHHS (OCR) Guidance $ 15.95
Book 5B:  HIPAA Privacy for Researchers: Guidance from the NIH Book 5B: HIPAA Privacy for Researchers: Guidance from the NIH $ 15.95
Book 6:  Clinical Trials in The EU: Selected Legislation, Guidelines and the Declaration of Helsinki Book 6: Clinical Trials in The EU: Selected Legislation, Guidelines and the Declaration of Helsinki $ 15.95
Book 7:  Selected Laws/Regulations/Guidance on Drug Marketing, Advertising, and Labeling Book 7: Selected Laws/Regulations/Guidance on Drug Marketing, Advertising, and Labeling $ 15.95
Book 8:  Introduction to the Drug Approval Process and Dictionary of Clinical Research Terminology Book 8: Introduction to the Drug Approval Process and Dictionary of Clinical Research Terminology $ 15.95
Book 9:  Regulations/Guidance on Good Laboratory Practice and Nonclinical Research Book 9: Regulations/Guidance on Good Laboratory Practice and Nonclinical Research $ 15.95
Book 10:  Selected Regulations/Guidance on Biologics, Blood Products and Good Tissue Practice Book 10: Selected Regulations/Guidance on Biologics, Blood Products and Good Tissue Practice $ 15.95
Book 11:  Clinical Research Guide for Drugs, Devices, and Natural Health Products in Canada Book 11: Clinical Research Guide for Drugs, Devices, and Natural Health Products in Canada $ 15.95
Book 12:  Selected Regulations/Guidance on GCP in India Book 12: Selected Regulations/Guidance on GCP in India $ 15.95
Book 13:  FDA Guidance on Clinical Study Reports and Statistical Principles for Clinical Trials Book 13: FDA Guidance on Clinical Study Reports and Statistical Principles for Clinical Trials $ 15.95
Book 14:  Selected Recently-Finalized FDA Guidance Documents Book 14: Selected Recently-Finalized FDA Guidance Documents $ 15.95
Book 15:  Volunteering for a Clinical Trial: A Q&A Guide Book 15: Volunteering for a Clinical Trial: A Q&A Guide $ 10.95
Book 16:  Preambles to Good Clinical Practice Regulations Book 16: Preambles to Good Clinical Practice Regulations $ 26.95
Book 17:  Preambles to Good Manufacturing Practice Regulations Book 17: Preambles to Good Manufacturing Practice Regulations $ 22.95
Book 18:  SPANISH LANGUAGE ICH Guideline for GCP & FDA CDER Handbook on Drug Approval Book 18: SPANISH LANGUAGE ICH Guideline for GCP & FDA CDER Handbook on Drug Approval $ 15.95
Book 19:  Preambles to Good Laboratory Practice Regulations Book 19: Preambles to Good Laboratory Practice Regulations $ 22.95
Book 20:  ORI Introduction to the Responsible Conduct of Research Book 20: ORI Introduction to the Responsible Conduct of Research $ 15.95
Book 21:  2014 Pharmaceutical Administration, Regulations, and Drug Development in Japan Book 21: 2014 Pharmaceutical Administration, Regulations, and Drug Development in Japan $ 15.95
Book 22:  Frequently Asked Questions and Guidance on Clinical Research from the OHRP Book 22: Frequently Asked Questions and Guidance on Clinical Research from the OHRP $ 15.95
Book 23:   	 Part 11 & Drug Development:  Regulation, Preamble & FDA Guidance on Electronic Records & Electronic Signatures Book 23: Part 11 & Drug Development: Regulation, Preamble & FDA Guidance on Electronic Records & Electronic Signatures $ 15.95
Book 24:  European Union Guidelines on Pharmacovigilance for Medicinal Products for Human Use Book 24: European Union Guidelines on Pharmacovigilance for Medicinal Products for Human Use $ 15.95
Book 24A:  EU 2015 Guideline on Good Pharmacovigilance Practices, Vol. I: Modules Book 24A: EU 2015 Guideline on Good Pharmacovigilance Practices, Vol. I: Modules $ 26.95
Book 24B:  EU 2015 Guideline on Good Pharmacovigilance Practices, Vol. II: Annexes Book 24B: EU 2015 Guideline on Good Pharmacovigilance Practices, Vol. II: Annexes $ 26.95
Book 25:  Laws, Regulations, and Guidance on Pediatric Studies Book 25: Laws, Regulations, and Guidance on Pediatric Studies $ 15.95
Book 26:  People's Republic of China: Selected Laws and Regulations on Drug Research & Good Manufacturing Practice Book 26: People's Republic of China: Selected Laws and Regulations on Drug Research & Good Manufacturing Practice $ 15.95
Book 27:  2014 FDA Investigations Operations Manual Book 27: 2014 FDA Investigations Operations Manual $ 29.95
Book M1:  Mini Pocket-Sized (3" x 5") ICH Guidelines for GCP (E6) and Clinical Safety Data Management (E2A) Book M1: Mini Pocket-Sized (3" x 5") ICH Guidelines for GCP (E6) and Clinical Safety Data Management (E2A) $ 10.95
Book M2:  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: 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) $ 10.95
Book M3:   	 BRAZILIAN PORTUGUESE LANGUAGE Mini Pocket-Sized 3" x 5") ICH Guidelines for GCP (E6) and Clinical Safety Data Management (E2A) Book M3: BRAZILIAN PORTUGUESE LANGUAGE Mini Pocket-Sized 3" x 5") ICH Guidelines for GCP (E6) and Clinical Safety Data Management (E2A) $ 10.95
M4:  Mini Pocket-Sized (3" x 5") Clinical Research Dictionary M4: Mini Pocket-Sized (3" x 5") Clinical Research Dictionary $ 10.95