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Celebrating 23 YEARS of Regulatory Excellence!
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2025 Books!
ALSO Check Out our Books with the
FDA-Approved E6(R3) GOOD CLINICAL PRACTICE GUIDANCE
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Book CG1-FDAE6R3: 2025 Comprehensive Clinical Research Desk Reference for Drug and Medical Device Trials
(With FDA/ICH GCP E6(R3))
$ 46.95
Book 1A-FDAE6R3: 2025 Selected Regulations & Guidance for Drug Studies
(With FDA/ICH GCP E6(R3))
$ 24.95
Book 1B-FDAE6R3: 2025 FDA Good Clinical Practice Guide
(With FDA/ICH GCP E6(R3))
$ 26.95
Book 1C-FDAE6R3: 2025 Good Clinical Practice Regulations in the US & the EU
(With FDA/ICH GCP E6(R3))
$ 24.95
Book 2-FDAE6R3: 2025 Selected Regulations and Guidance for Medical Device Studies
(With FDA/ICH GCP E6 (R3))
$ 21.95
Book 3A: 2025 Selected Regulations and Guidance on Protection of Human Subjects: Clinical Investigator, IRB & Sponsor Responsibilities
$ 22.95
Book 3D v5.0: Version 5.0 Common Terminology Criteria for Adverse Events (CTCAE)
$ 13.95
Book 3D v6.0: Version 6.0 Common Terminology Criteria for Adverse Events (CTCAE)
$ 17.95
Book 4: 2025 Selected Regulations/Guidance on Good Manufacturing Practice
$ 18.95
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
$ 18.95
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
$ 17.95
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
$ 17.95
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)
$ 17.95
Book 14: 2025 Selected Recently-Finalized FDA Guidance Documents
$ 18.95
Book 16: 2025 Preambles to Good Clinical Practice Regulations
$ 28.95
Book 17: 2025 Preambles to Good Manufacturing Practice Regulations
$ 24.95
Book 19: 2024 Preambles to Good Laboratory Practice Regulations
$ 22.95
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
$ 17.95
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
$ 28.95
Book 24B: EU 2025 Guideline on Good Pharmacovigilance Practices, Vol. II: Annexes
$ 28.95
Book 25: 2025 Laws, Regulations, and Guidance on Pediatric Studies
$ 17.95
Book 28: Clinical Laboratory Improvement Amendments of 1988 (CLIA): Survey Procedures and Interpretive Guidelines
$ 24.95
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)
$ 12.95
Book M4: 2025 Mini Pocket-Sized (3" x 5") Clinical Research Dictionary
$ 12.95
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