Articles tagged with “quality-by-design”

ICH Q8 Explained: A Guide to Pharmaceutical Development & QbD

Learn about the ICH Q8 guideline for pharmaceutical development. This in-depth guide explains Quality by Design (QbD), QTPP, CQAs, and the design space concept.

40 min read

11/15/2025

ich q8 quality by design qbd pharmaceutical development design space qtpp critical quality attributes ich guidelines control strategy ctd module 3.2.p.2

ICH E6(R3) Explained: A Guide to the 2025 GCP Update

An in-depth analysis of the ICH E6(R3) Good Clinical Practice guidelines for 2025. Explore key changes in Quality by Design, data governance, and decentralized

35 min read

10/13/2025

ich e6(r3)good clinical practice gcp guidelines clinical trials quality by design decentralized trials data governance regulatory compliance