Built by a manufacturer currently on active MIA submission (2025)

The AI operating system for compliant pharmaceutical manufacturing — from facility setup to market launch

One platform that acts as your compliance expert, manufacturing consultant, validation engineer and QA lead. Covers pharma, homeopathic, herbal, food supplements and cosmetics — from URS to market.

So you reach inspection stage faster, with documented evidence of readiness, without expensive consultants or implementation hell.

Structured to reflect MHRA GMP guidance · No lock-in · Cancel any time

A real example of what goes wrong

"A manufacturer invested £100,000 building a cleanroom — before their User Requirements Specification was approved. The cleanroom had to be rebuilt. Two years and £750,000 later, they were back where they should have started."

This is the mistake MIA GMP Navigator is built to prevent

The cost of getting the sequence wrong

£100k+

Cleanroom built before URS approval — had to be rebuilt

£750k

Final build cost when £300k was achievable with correct spec

2+ yrs

Timeline lost from doing steps in the wrong order

£1,200

Per day for a Qualified Person brought in too early

What it looks like

A workflow system that enforces a structured GMP sequence based on industry best practice.

Many of the most expensive GMP mistakes come from incorrect sequencing. This platform enforces a structured GMP sequence based on industry best practice — and creates a documented trail that proves it to MHRA inspectors.

At any point, you know exactly where you stand — and what is missing.

mia.espelina.com/dashboard

Inspection readiness score

64%

Current stage

Stage 1 — URS & Planning

1URS & Planning

64%

2Cleanroom Design & BuildLocked

3IQ / OQ / PQ ValidationLocked

4QMS SetupLocked

5MIA ApplicationLocked

6MHRA Inspection ReadinessLocked

7Product Registration & Market LaunchLocked

Why this works

Three things no consultant gives you

Enforced sequencing

URS is locked as a gateway. The system prevents progression to cleanroom build until URS is approved — eliminating the most expensive mistake in GMP.

Real-time readiness score

See exactly what is missing and what you need before an MHRA inspector walks through your door. No surprises on inspection day.

Role gap detection

QP, QA, QC, AP, RP — the system tells you which roles are unfilled and what that means for your MIA application.

Who this is for

Built for a specific type of manufacturer

This is for you if

✓You are a first-time MIA applicant
✓You are a small UK manufacturer — homeopathic, herbal, nutraceutical or cosmetic
✓You do not have in-house GMP sequencing experience
✓You are building or planning a cleanroom
✓You want to reach MHRA inspection stage without expensive mistakes
✓You are currently navigating the MIA application process alone

This is not for you if

✗You are a large pharmaceutical company with an established QA department
✗You already have a dedicated GMP compliance team in place
✗You are already inspection-ready and past the MIA application stage
✗You are looking for a document-only solution with no workflow tracking

Common questions

Things people ask before signing up

Why not just hire a GMP consultant?

Consultants advise — they do not enforce sequence or track your progress 24/7. A consultant gives you guidance in a meeting. This system runs continuously, documents everything, and prevents you from making expensive mistakes between meetings. At £1,200/day for a QP, this platform pays for itself in hours.

Is this accepted by MHRA?

The platform is structured to reflect MHRA GMP guidance and MIA application expectations. It does not replace regulatory submissions — it prepares you for them and documents your readiness at every stage.

What if I have already started my build?

The system audits your current stage, identifies what is complete and what is missing, and realigns you to the correct sequence from where you are. It is never too late to get on track.

Can I use it for just one stage?

Yes. Start at Stage 1 — URS & Planning — with no commitment beyond that. If it is all you need right now, that is fine. The platform is designed to grow with you as you progress through each stage.

Pricing

Costs less than one day of a QP — and works every day until inspection

A Qualified Person costs £1,200/day. This platform starts at £299/month and runs 24/7 until you are inspection-ready.

Starter

£299

/month

Prevents £100k+ sequencing errors

–Setup wizard — category, product, machinery
–Stage 1 — URS and Planning with AI chat
–Roles clarity tool — QP, QC, QA, PM, AP, RP
–GMP Glossary — 36 official definitions
–Claims checker — MHRA borderline guidance
–Regulatory updates feed

From URS to market — without the costly mistakes

Join manufacturers navigating MHRA the right way.

Structured to reflect MHRA GMP guidance · Start at Stage 1 · Cancel any time

One avoided mistake pays for 3 years of subscription.

Espelina Pharma OSBuilt by Espelina Ltd