Consultancy
Quality systems built around microbiological risk.
I build, review and remediate quality systems and contamination control strategies for small pharmaceutical manufacturers, so contamination control is part of the system from day one rather than bolted on after the first excursion.
Where most clients start
01
We’re building this from nothing
A new facility, a first licence application and no quality system yet. I build the system with you, sized for where you are now and able to grow.
02
There’s a date coming
An inspection, a CDMO quality agreement or a first QA hire, and not enough time. I focus effort on what an inspector will test.
03
Something has gone wrong
An inspection found drift, or a deviation has raised questions you cannot close. I find the root cause and fix the system, not just the symptom.
04
There’s an organism we can’t explain
An environmental monitoring result that needs a microbiologist. I tell you what it means for your facility and what to do next.
What I build
Quality management system builds
The full system for a new site or operation: quality manual, core procedures, change control, deviations, CAPA, training and document control, designed around how your team actually works.
QMS review and remediation
For established sites where the system has drifted. A clear view of what is not working, then a plan and the hands-on work to fix it.
Contamination control strategy
A CCS that meets EU GMP Annex 1, built from the risk assessments up and linked to your environmental monitoring, cleaning and disinfection, and personnel controls.
Microbiology support
Environmental monitoring programmes, investigations, organism identification and trending, from someone who has run QC microbiology departments.
How I work
With your team, not instead of it
Your people will run the system after I leave, so they help build it. I write what needs writing, train the people who need training, and hand over a system your team understands and owns.
Sized for where you are
A start-up does not need a global pharma quality system. I build what an inspector will expect for your stage and scale, and make it easy to extend as you grow.
Price
Every project is fixed-price, quoted after a scoping call.
Most clients begin with a Readiness Review, which tells us both exactly what is needed and gives you a fixed price for doing it.
Not sure where to start?
A Readiness Review gives you a prioritised list of what to fix, and a fixed price for fixing it.