Skip to content

21 CFR Part 58 — Good Laboratory Practice (GLP) Readiness Advisory

A strategy call with someone who has spent 25 years building compliance systems used by 100,000+ professionals in 160+ countries – not a generalist who read the standard last week.

31
Controls
7
Domains
32
Mapped Frameworks
United States
Jurisdiction

Why work with Ivanka on 21 CFR Part 58 — Good Laboratory Practice (GLP)

Title 21 Code of Federal Regulations Part 58 establishes Good Laboratory Practice (GLP) regulations for nonclinical laboratory studies supporting applications for research or marketing permits for FDA-regulated products. Covers organization, facilities, equipment, testing operations, records, and reporting requirements to ensure the quality and integrity of safety data.

Most consultants approach 21 CFR Part 58 — Good Laboratory Practice (GLP) as a checkbox exercise. Ivanka approaches it as a strategic lever. With 25 years of building The Art of Service – a compliance platform now covering 692 frameworks and 819,000+ cross-framework mappings – she doesn't just understand the standard. She understands how it connects to everything else your organisation is already doing.

This matters because 21 CFR Part 58 — Good Laboratory Practice (GLP) doesn't exist in isolation. Ivanka will map your current compliance posture against the 31 controls across 7 domains, identify gaps, and show you where existing controls from other frameworks you may already follow can be leveraged – saving months of redundant work.

Relevant credentials

  • MIT Entrepreneurial Masters graduate – rigorous analytical approach to enterprise challenges
  • EXIN Expert Panel member – helping shape global certification standards

What you get in 30 minutes

Gap Assessment Review

Ivanka reviews your 21 CFR Part 58 — Good Laboratory Practice (GLP) readiness scores and identifies the critical gaps that carry the highest risk. No generic advice – specific to your domains and controls.

Implementation Roadmap

A clear, prioritised plan for addressing gaps across 7 domains. She maps what you can leverage from existing compliance work and what requires new investment.

Cross-Framework Strategy

21 CFR Part 58 — Good Laboratory Practice (GLP) maps to 32 other frameworks. Ivanka shows you where a single control implementation can satisfy multiple regulatory requirements at once.

Domains covered in 21 CFR Part 58 — Good Laboratory Practice (GLP)

01Disqualification of Testing Facilities (Subpart K)
02Records and Reports (Subpart J)
03Test Articles and Protocol (Subparts F & G)
04Equipment and Operations (Subparts D & E)
05Facilities (Subpart C)

Plus 2 additional domains. See the full assessment →

This is for you if

  • You need to achieve 21 CFR Part 58 — Good Laboratory Practice (GLP) compliance but don’t know where to start or how to prioritise
  • You’ve been told you’re “compliant” but suspect gaps exist that haven’t been properly assessed
  • You manage compliance for organisations across every sector and need expert guidance, not generic templates
  • You want to leverage existing compliance efforts across multiple frameworks rather than starting from scratch
  • You need a strategic plan your leadership team and board will actually understand and support

Start with a free assessment. Then let's talk strategy.

Take the free 21 CFR Part 58 — Good Laboratory Practice (GLP) readiness diagnostic. In 5 minutes you'll have a clear picture of where your gaps are. Then book the strategy call and Ivanka will show you exactly how to close them.

Start your free 21 CFR Part 58 — Good Laboratory Practice (GLP) assessment

Free · No login required · Results in 5 minutes

Or go directly to the $149 Report + Strategy Call