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.
Auditing→
An independent check against EU GMP, graded by risk, with practical help to close what I find.
Consultancy
I build and remediate the whole system with your team, then hand it over for them to run.
Not sure which? →
A Readiness Review tells you, with a fixed price for what comes next.
How a project runs
Most of my projects are for start-ups and small businesses with limited resources. Five quality systems built from nothing so far.
01
Scope and fixed price
We agree exactly what is needed, then the price. If you are not sure what you need, a Readiness Review tells us both.
02
Build or remediate
I write and fix the system, sized for your stage and able to grow.
03
Train your team
The people who will run the system are trained on it as it is built, not after.
04
Hand over
A system your team understands and owns, with a handover pack so nothing depends on me.
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. I set out what is not working, then do the work to fix it. If you only need an independent view, that is a self-inspection.
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.
Before you get in touch
Not for you if
Turning work away is part of doing it properly. If any of these is you, I am the wrong person, and I would rather say so now.
You want the templates without the system. I don’t sell document packs.
You need someone placed through a recruiter for six months. I’m not available for contract placements.
There’s nobody who will own the system after I’ve built it. Come back when the first quality hire is signed. Otherwise it decays, and neither of us wants that.
You want a guarantee you’ll pass. Nobody can give you that honestly.
You want a response that says what the inspector wants to hear. I write responses you can actually keep.
Your inspection is FDA. My credentials are MHRA and EU GMP, and you want someone the agency recognises.
Price
What a quality system build costs
What a conventional consultancy typically quotes to build a quality system. Use it as your yardstick when you compare quotes.
Every project is fixed price, quoted after a scoping call, sized for your stage and your team. No open-ended day rates unless you ask for them.
Already know what you need? Tell me and I will scope it directly. Not sure? A Readiness Review, from £1,950, gives you a prioritised list and a fixed price for the work.
Not sure where to start?
A Readiness Review gives you a prioritised list of what to fix, and a fixed price for fixing it.