Readiness Review
Know where you stand before the inspector does.
A fixed-price review, remote or on site, 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.
Remote review from £1,950. Full review with a site visit from £4,500. Plus VAT where applicable.
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
- Video calls with the people who run the system, to check how the work is actually done
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 against EU GMP and the plans you are working to.
03
Remote or site review
Video calls with your team, or a day on site for the full review, testing 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.
What you receive at each step
Every stage leaves you with a document, so you can see the agreed scope was covered and your team keeps what it has learned.
After step 01
Scope and quote letter
The agreed scope, the documents I need from you, the dates and the fixed price. The baseline everything else is checked against.
After step 02
Document review log
Every document I reviewed, with its version and date, so there is a record of exactly what was looked at.
After step 03
Session notes
Who took part, what we covered and the questions raised, sent after each call so nothing relies on memory.
After step 04
Report, action plan and close-out
Findings graded by risk and referenced to EU GMP, a prioritised action plan with owners, and a close-out note confirming every item in scope was covered.
Why the references matter. Each finding cites the GMP requirement behind it, so your team understands the reason for the fix, not just the fix. That is the knowledge you keep after I have gone.
Price
Both are fixed price, agreed after a short scoping call and before you commit to anything. Every report is reviewed and signed off by me.
Remote review
From £1,950
Plus VAT where applicable.
- ✓Review of your documents, systems and plans
- ✓Video calls with the people who run the system
- ✓Written gap report, prioritised by inspection risk
- ✓60-minute debrief call
- ✓Two days of my time, start to finish
Full review
From £4,500
Plus VAT where applicable. Travel charged at cost.
- ✓Everything in the remote review
- ✓One day on site with a trained Mozeka associate auditor
- ✓Facility, process and people walk-through against what the documents say
- ✓Report reviewed and signed off by Tamryn Hassel
- ✓Debrief with your team
A larger site, or a system that is further along, can take longer. You will know the fixed price before we start.
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.