Readiness Review
Know where you stand before the inspector does.
A fixed-price review of your quality system, contamination control and environmental monitoring against EU GMP and MHRA expectations. You get an honest, prioritised list of what to fix first.
Who it is for
A licence application is coming
You are building a facility or a new operation and need to know what an inspector will look for before you apply.
An inspection date is set
Your site is due an MHRA inspection and you want an independent view of where the gaps are while there is still time to close them.
A partner is asking questions
A CDMO, client or investor wants evidence your quality system and contamination control will stand up.
Something has drifted
A deviation, an EM trend or a change of team has left you unsure the system still works the way it should.
What you get
The review
- Quality management system: structure, key procedures, change control, deviations and CAPA
- Contamination control strategy and how it links to the risk assessments behind it
- Environmental monitoring programme: locations, methods, limits, trending and investigations
- A site walk-through, in person or remote, depending on your stage
What you walk away with
- A written report in plain language
- Findings graded by risk, so you know what matters to an inspector and what can wait
- A prioritised action list with owners you can assign straight away
- A debrief call to walk your team through it
How it works
01
Scoping call
We agree the scope, the date and the documents to share. The price is fixed at this point.
02
Document review
I review your QMS, CCS and EM programme before the visit, so site time is spent on what matters.
03
Site review
A walk-through of the facility, the processes and the people, against what the documents say.
04
Report and debrief
A written report and a prioritised action list, followed by a debrief with your team.
Price
Fixed price, agreed before we start.
Scope depends on the size of the site and how far the quality system has got. After a short scoping call you get a fixed quote, before you commit to anything.
Not for you if
- You need a QP to certify batches. I can help you prepare for that, but I am not a QP.
- You want a document that says everything is fine. The value of the review is an honest list.
- You are looking for US FDA readiness. My work is focused on UK and EU GMP.
Book a Readiness Review
Tell me what is coming up and when. I will come back to you with a proposed scope and a fixed price.