Regulatory standards we cover

We track global regulations to ensure our qualification standards reflect the latest guidance. 

Diligent's SMEs closely track evolving regulations across our clients' jurisdictions. We apply the latest guidance to our audit standards and questionnaire templates to ensure every Vendor is qualified against current regulatory expectations.

Our Vendor Qualification Questionnaire templates and GxP audits cite over 90 global authorities, supporting a rigorous, defensible qualification process. Below is a sampling of the regulations reflected in our qualifications:

FDA & CFR

  • 21 CFR 312

  • 21 CFR 320

  • 21 CFR 50

  • 21 CFR 54

  • 21 CFR 56

  • 21 CFR 58

  • 21 CFR Part 11

EMA & EU

  • Directive 2004/9/EC

  • Directive 2004/10/EC

  • EU 536/2014

  • EU Annex 11

  • Eudralex Volume 10

  • GDPR

MHRA

  • GLP Regulations SI 1999/3106

  • MHRA Clinical Trial Regulations 2020

  • MHRA Device Regulations

  • MHRA GCP Guide

  • MHRA GCP SI 2004/1031

ICH & CFR

  • ICH E21

  • ICH E2A

  • ICH E6 (R3)

  • ICH E8

  • ICH E9

  • ICH E17

PMDA

  • MHLW GLP Ordinance No. 21

  • MHLW Ordinance No. 28

  • MHLW Ordinance No. 36

And other authorities & standards, including

  • ANVISA

  • Chinese FDA

  • DIA

  • Health Canada

  • HIPAA

  • ISPE

  • ISO

  • WHO

  • And more

FDA & CFR

  • 21 CFR 312

  • 21 CFR 320

  • 21 CFR 50

  • 21 CFR 54

  • 21 CFR 56

  • 21 CFR 58

  • 21 CFR Part 11

ICH & CFR

  • ICH E21

  • ICH E2A

  • ICH E6 (R3)

  • ICH E8

  • ICH E9

  • ICH E17

EMA & EU

  • Directive 2004/9/EC

  • Directive 2004/10/EC

  • EU 536/2014

  • EU Annex 11

  • Eudralex Volume 10

  • GDPR

PMDA

  • MHLW GLP Ordinance No. 21

  • MHLW Ordinance No. 28

  • MHLW Ordinance No. 36

MHRA

  • GLP Regulations SI 1999/3106

  • MHRA Clinical Trial Regulations 2020

  • MHRA Device Regulations

  • MHRA GCP Guide

  • MHRA GCP SI 2004/1031

And other authorities & standards, including

  • ANVISA

  • Chinese FDA

  • DIA

  • Health Canada

  • HIPAA

  • ISPE

  • ISO

  • WHO

  • And more

Diligent helps clinical trial Sponsors ask the right questions of every Vendor they partner with. Learn more about the Vendor categories you can qualify through Diligent.

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