Publication

Regulatory Readiness Level–Pharma (RRL‑P)

A maturity ladder mapped to GMP/quality-system concepts to make readiness measurable and comparable.

References

Publications are written to be. Where standards or regulations are referenced, we link official sources in Standards & References.

GMPICH Q10Readiness

DOI Download PDF Contact (private agreement)

Executive summary

Makes readiness measurable: a common language for prioritization and planning.
Turns gaps into action-oriented work packages and review checkpoints.
Provides an evidence-first narrative for stakeholders (implementation details shared privately).

Public material is outcome-focused. Implementation details are shared only under private detail sharing (private agreement / limited scope / selective sharing).

Integrity

Verify downloads with the site manifest:

MANIFEST.sha256 manifest.json

How to cite

Cite as: Regulatory Readiness Level–Pharma (RRL‑P). Zenodo. https://doi.org/10.5281/zenodo.15486646

BibTeX:

@misc{rrlp2025,
 title = {Regulatory Readiness Level–Pharma (RRL‑P)},
 year = {2025},
 publisher = {Zenodo},
 doi = {10.5281/zenodo.15486646},
 url = {https://doi.org/10.5281/zenodo.15486646}
}

More context

Public updates and references are available on LinkedIn.

LinkedIn Back to publications

Last updated: 2025-12-20