Sixteen Steps from First Assessment to ISO 9001:2015 Certification
What a national regulatory authority or pharmaceutical manufacturer must put in place, in what order, and how long each implementation stage realistically takes.
We publish a small, selective collection of original articles each year, written by senior consultants drawing directly from our project experience across the UK, Europe, and Africa.
What a national regulatory authority or pharmaceutical manufacturer must put in place, in what order, and how long each implementation stage realistically takes.
An analysis of common breakdown points—from part-time quality ownership to missing records—and practical steps to re-engage leadership and restore momentum.
A practical practitioner’s guide to planning, executing, and following up a Good Distribution Practice (GDP) requalification audit for investigational medicines.
How to identify high-friction manual steps in Chemistry, Manufacturing, and Controls (CMC) variation workflows worth automating, while keeping critical compliance under human control.
The regulatory agencies involved (NAFDAC, SON, Trademark Registry) and the correct sequence to approach them.
Author: Dele Aiyemowa with Bolarinwa Yusuf
Key indicators of site compliance culture during the opening hours of a facility inspection.
Author: Bolarinwa Yusuf
Operational methodologies for multi-jurisdictional health system evaluations across English and French regions.
Author: Benjamin Botwe