Lugano · Switzerland — GxP technology & compliance
Packages & pricing

How we price, and how to start small.

Consulting work is scoped, not listed, so there is no rate card here. What we can set out is the mechanics: the three ways to buy, what is fixed and what is not, and what moves a number up or down. A firm figure follows a short conversation, usually within the same week.

FixedPackage work is quoted as a price, not an estimate
No PM feeOur own coordination time is not billed
Senior onlySenior delivery only, with no blended-rate calculation
Free first callBefore anything is quoted
Start wherever you like

Not everything has to be a programme.

A good share of our longest relationships began with something small — two days of second opinion, one assessment, a single specification reviewed before approval. If you want to see how we work before committing to anything, say so and we will scope something that size deliberately.

  • —A specification or validation package reviewed before formal approval.
  • —One system assessed, rather than the whole estate.
  • —A half-day workshop on a decision you are stuck on.
  • —A second opinion on a position you have already taken, before it is reviewed in an audit or inspection.
Engagement rates

Three ways to buy, three risk profiles

The right model depends on how well defined the work is. If the scope is clear, take fixed price and let us carry the estimation risk. Rates are issued with the proposal, once we know what we are quoting for.

Time-basedDaily rate

Senior consultant, embedded

On site or remote, directed by you. Maximum flexibility on scope, minimum commitment on volume.

  • Standard engagement, remote or Switzerland-based
  • Reduced rate above 60 days committed
  • Travel and accommodation at cost, agreed in advance
Daily rate on requestreduced above 60 committed days
Service-basedFixed price

Defined deliverable, fixed fee

We estimate, we carry the risk. If it takes longer than planned, the difference is ours to absorb.

  • Priced from the packages below, or scoped bespoke
  • Payment against milestones rather than monthly time
Quoted per scopefixed on signature · see packages below
On callMonthly retainer

Committed availability

For regulated operations without senior cover in house. The terms are agreed in advance, so nothing has to be negotiated when a deviation or an inspection arises.

  • Priority response within an agreed window
  • An agreed block of advisory time each month
  • No renegotiation in the middle of an inspection
Monthly retainer on requestterm agreed case by case
TrainingPer session

Moonet Academy

Delivered by the person who writes the protocols. In house at your site, or open enrolment in Lugano.

  • Half-day module, up to 12 participants
  • Full-day module, up to 12 participants
  • Custom module built on your systems and your findings
Per session, quotedhalf day, full day or custom
Fixed-fee packages

Deliverable sets we already maintain

Built, tested and reused. You pay for adaptation to your system and for execution, not for a template written from zero.

PKG-01 · 4–6 wks

GxP Cloud Archival Validation

Validation plan, supplier assessment, functional risk assessment, IQ/OQ/PQ, RTM, FMEA and the supporting SOP set.

PKG-02 · 6–8 wks

AI / ML GxP Enablement

Use case triage, intended use, model qualification, change control for updating systems, drift monitoring.

PKG-03 · 3–5 wks

Data Integrity Assessment

ALCOA+ across an agreed system list, audit trail and access review, CAPA costed and sequenced.

PKG-04 · 5–8 wks

OT Security Baseline

Asset inventory, IEC 62443 zones and conduits, CVE exposure, mitigation plan with GxP impact per control.

Retained support

Continuity on a monthly basis

For organisations that need continuity on a defined set of systems without adding a permanent senior role.

ValidationMonthly

Retained validation support

An agreed monthly envelope of validation deliverables, produced within your quality system. System ownership and approval remain with you.

  • Change control and periodic review across an agreed system list
  • New system validation added by prior agreement
  • Inspection support planned in advance rather than assumed
Quoted per scopebased on the system list and the monthly envelope
CloudMonthly

Retained cloud qualification support

A qualified Azure or AWS environment kept qualified, with evidence regenerated when the platform changes.

  • Landing zone design and IaC pipelines (one-off setup, quoted)
  • Ongoing qualification evidence and supplier assessment upkeep
  • Scheduled backup, restore and archival testing
Monthly, quotedplus one-off build
AIMonthly

Retained AI governance support

Governance, qualification and monitoring for models operating in or near a regulated process.

  • Governance framework maintained against evolving guidance
  • Re-qualification on model change, within the monthly envelope
  • Drift monitoring review and periodic report for QA
Monthly, quotedper model family
Launchpad6 months

Launchpad for startups & SMEs

The programme that takes a small company from ad hoc practices to a framework that supports a first inspection, with a senior partner on the expensive decisions.

  • Month 1 — position and prioritised roadmap
  • Months 2–3 — foundation documents sized to your company
  • Months 4–6 — validate what matters first, train your team
Programme fee, quotedstaged across the six months
Transparency

What moves a price up, and what brings it down

Set out plainly, so the quote you receive contains no surprises.

Increases the price

Usually discovered late, which is why we ask early.

  • LegacySystems with no current documentation to build from
  • DeadlineRegulator-imposed dates requiring parallel workstreams
  • ApprovalsMore than two review cycles, or many approvers
  • On siteWork that cannot be done remotely, outside Switzerland

Reduces the price

Worth doing before you ask for a quote.

  • TemplatesA usable quality system we can write into
  • One ownerA single decision-maker on your side
  • VolumeSeveral systems of the same class in one engagement
  • NoticePlanned work rather than remediation under pressure

We do not publish rates or package prices, for one reason: the number that matters is the cost of the outcome, and that depends on your systems rather than on our calendar. Tell us the scope and you will have a figure quickly — including, where it applies, a figure small enough to be a trial.

Tell us the system and the deadline.

A short call, no charge. You will leave it with an order of magnitude and a plain answer on whether we are the right fit.

First callNo charge
CurrencyCHF, excl. VAT
EntityMoonet Sagl · CHE-272.426.095