1

Your cart is empty.

The Most-Trusted Regulations & Guidelines Books on the Market.

Celebrating 15 Years of Excellence.

Now Shipping April 2017 Books

Prices

Book Title

0-250 copies 

251-500 copies 

501-750 copies

751+ copies

Book 1A:  Selected Regulations and Guidance for Drug Studies 15.95 14.95 13.95 12.95
Book 1B:  FDA Good Clinical Practice 2015 Reference Guide 15.95 14.95 13.95 12.95
Book CG1: Comprehensive Clinical Research Desk Reference for Drug/Device Trials 44.95 39.95 34.95 29.95
Book 1SP:  SPANISH LANGUAGE 2012 Selected FDA Regulations and ICH Guidelines for US Drug Approval 19.95 18.95 17.95 16.95
Book 2:  Selected Regulations and Guidance for Medical Device Studies 15.95 14.95 13.95 12.95
Book 3A:  Regulations and Guidance on the Protection of Human Subjects:  Clinical Investigator, IRB, and Sponsor Responsibilities 15.95 14.95 13.95 12.95
Book 3B:  Selected Documents on International Ethical Conduct, Federalwide Assurances, & OHRP Compliance in Academic Research 15.95 14.95 13.95 12.95
Book 3C:  THe Official Investigator's Handbook for Conducting Cancer Clinical Trials 16.95 15.95 14.95 13.95
Book 3D:  Common Terminology Criteria for Adverse Events (CTCAE) 11.95 10.95 9.95 8.95
Book 4:  Selected Regulations and Guidance on Good Manufacturing Practice 15.95 14.95 13.95 12.95
Book 4B:  International Reference on Cleaning Validation under Good Manufacturing Practice 16.95 15.95 14.95 13.95
Book 4C:  EU Rules on Medicinal Products, Volume 4: Good Manufacturing Practice Guidelines 15.95 14.95 13.95 12.95
Book 5A:  Administrative Simplification Provisions of HIPAA 15.95 14.95 13.95 12.95
Book 5B:  HIPAA Privacy Guidance from the NIH 15.95 14.95 13.95 12.95
Book 6:  Clinical Trials in the EU: Legislation, Guideline, and the Declaration of Helsinki 15.95 14.95 13.95 12.95
Book 7:  Regulations & Guidance on Drug Marketing, Advertising and Labeling 15.95 14.95 13.95 12.95
Book 8:  Drug Approval Process and Clinical Research Dictionary 15.95 14.95 13.95 12.95
Book 9:  Regulations/Guidance: GLP & Nonclinical Studies 15.95 14.95 13.95 12.95
Book 10:  Regulations & Guidance on Biologics, Blood Products and Good Tissue Practice 15.95 14.95 13.95 12.95
Book 11:  Regulations and Guidance for GCP in Canada 15.95 14.95 13.95 12.95
Book 12:  Regulations and Guidance for GCP in India 15.95 14.95 13.95 12.95
Book 13:  FDA Guidance on Clinical Study Reports and Statistical Principles 15.95 14.95 13.95 12.95
Book 14:  Selected Recently-Finalized FDA Guidances 15.95 14.95 13.95 12.95
Book 15:  Volunteering for a Clinical Trial: a Q & A Guide 10.95 9.95 8.95 7.95
Book 16:  Preambles on Good Clinical Practice 26.95 25.95 24.95 23.95
Book 17:  Preambles on Good Manufacturing Practice 22.95 21.95 20.95 19.95
Book 18:  SPANISH LANGUAGE ICH GCP and CDER Handbook on the Drug Approval PRocess 15.95 14.95 13.95 12.95
Book 19:  Preambles on Good Laboratory Practice 22.95 21.95 20.95 19.95
Book 20:  ORI Introduction to the Responsible Conduct of Research 15.95 14.95 13.95 12.95
Book 21:  2013 Pharmaceutical Administration in Japan 15.95 14.95 13.95 12.95
Book 22:  FAQs and Guidance on Research from the OHRP 15.95 14.95 13.95 12.95
Book 23:  Part 11 and Drug Development 15.95 14.95 13.95 12.95
Book 24:  2012 EU Guidelines on Pharmacovigilance (Volume 9A) 15.95 14.95 13.95 12.95
Book 24A:  2015 EU Guidelines on Pharmacovigilance 26.95 25.95 24.95 23.95
Book 24B:  Appendices to 2015 EU Guidelines on Pharmacovigilance 26.95 25.95 24.95 23.95
Book 25:  Laws, Regulations and Guidance on Pediatric Studies 15.95 14.95 13.95 12.95
Book 26:  CHINA - Laws and Regulations on Drug Research and GMP 15.95 14.95 13.95 12.95
Book 27:  2014 FDA Investigations Operations Manual 29.95 28.95 27.95 26.95
Book M1:  Mini Pocket-Size (3" x 5") ICH Guidelines for GCP (E6) and Clinical Safety Data Management (E2A) 10.95 9.95 8.95 7.95
Book M2:  Mini Pocket-Size (3" x 5") Code of Federal Regulations on GCP 10.95 9.95 8.95 7.95
Book M3:  BRAZILIAN PORTUGUESE LANGUAGE Mini Pocket-Size (3" x 5") ICH Guidelines for GCP (E6) and Clinical Safety Data Management (E2A) 10.95 9.95 8.95 7.95
Book M4:  Mini Pocket-Size (3" x 5") Clinical Research Dictionary 10.95 9.95 8.95 7.95