Your microbiologist and quality specialist, without the headcount.

Quality consultancy and auditing for small pharmaceutical manufacturers, with contamination control at the core.

Every system is designed around microbiological risk, so contamination control runs through the facility, the processes and the people from day one, not after the first excursion.

21 years

in GMP quality and pharmaceutical microbiology

5

quality systems built from nothing for new manufacturers

EU GMP & GDP

sterile, non-sterile, ATMP and distribution

Built for start-ups and small businesses with limited resources.

Most of my work is with companies that need a strong quality system but do not have a big team to build or run one: cell and gene therapy and biologics start-ups, virtual developers moving into their own facility, and small manufacturers going for a first licence or keeping one. You get the quality system a big company would build, sized for a team of five.

Where are you right now?

Most clients come to me at one of five moments.

Each needs something different. Find yours and you will see what I would do first.

01We’re building this from nothingA new facility, a first licence and no quality system yet.What I do: I design your QMS and contamination control strategy with your team, sized for your stage.Consultancy →02There’s a date comingAn MHRA inspection, a licence application or a CDMO quality agreement.What I do: A Readiness Review tells you exactly what to fix first, at a fixed price.Readiness Review →03Something has gone wrongInspection findings, a deviation you cannot close, or a system that has drifted.What I do: I find the root cause and remediate the system so it holds next time.Remediation →04We need an independent auditA supplier, a contractor or your own site needs a credible, documented audit.What I do: Audits led by an MHRA-facing Lead Auditor, to one method, reported the same way every time.Auditing →05There’s an organism we can’t explainAn environmental monitoring result that needs a microbiologist’s answer.What I do: I tell you what it means for your facility, your product and your investigation.Talk to me →

Free guide

Six settle plate mistakes that undermine your EM data

What goes wrong with passive air monitoring, and what good looks like. An 11-page practical guide, written by a pharmaceutical microbiologist.

The first step

Readiness Review

A fixed-price review of where your quality system stands against EU GMP, with contamination control looked at specifically. Remote, or with a day on site. You get a clear answer on what is ready, what is not, and what to fix first.

Not for you if you want a system signed off without anyone looking at it, or you need a QP to certify batches.

Remote review

From £1,950

Plus VAT where applicable.

Full review with a site visit from £4,500. Compare →

  • ✓Remote review of your documents, systems and plans
  • ✓Written gap report, prioritised by inspection risk
  • ✓Contamination control looked at specifically
  • ✓60-minute debrief call to walk through the findings
  • ✓Two days of my time, start to finish

Book a Readiness Review →

How Mozeka works

Consultancy

We build, review and remediate quality systems and contamination control strategies, from the first licence onwards.

Auditing

Supplier, contractor and self-inspection audits, delivered to one method and reported the same way every time.

Training

Tailored GMP, microbiology and contamination control training for quality and operations teams.

Readiness Review

A fixed-price review of where you stand before a licence application or inspection, with a prioritised action list.

From £1,950 remote, £4,500 with a site visit. Plus VAT where applicable. See what’s included →

Coming in 2027

The Subculture by Mozeka

A reference of pharma-relevant microorganisms that tells you what a recovery means for your facility.

The Mozekan

A club for start-ups building their first quality system: QMS Factory, training and Mozeka’s consultants when you need them.

Not sure where you stand?

Start with a Readiness Review, or read the free settle plate guide first.