Lugano · Switzerland — GxP technology & compliance
Moonet Launchpad

Compliant technology, with a quality framework sized to your organisation.

A fixed-fee six-month programme for startups, spin-offs and SMEs approaching their first GMP inspection. You get senior support for decisions that are expensive to reverse — architecture, supplier choice and quality system scope — while quality ownership and approval remain with your organisation.

6 moFrom ad hoc practices to a proportionate, inspection-supporting framework, on a fixed fee
Fixed feeAgreed before we start, paid by phase
Your sizeA quality system sized for you, not copied from a multinational
HandoverYour team runs it when we leave
The problem

Small companies get compliance advice designed for large ones

Templates developed for large organisations can be disproportionate for a company of twenty people. Applied without adaptation, they create procedures the organisation cannot consistently follow. We design a smaller framework that still defines ownership, evidence and oversight clearly.

What usually happens

A quality system that is not used

Forty SOPs bought as a package, left unadapted, referencing roles that do not exist in the organisation. The first inspection finds the gap between what is written and what is done.

Or the opposite

Nothing, until it is urgent

Compliance postponed until a partner, an investor or a regulator asks. Then everything at once, under a deadline, at a higher cost — and usually with a system already built the wrong way.

Launchpad

Proportionate, sequenced, yours

We start from the technology already in use, the intended GxP use and the applicable regulatory expectations. We then prioritise the controls and evidence needed to reduce risk, identifying where redesign is necessary.

The programme

Six months, four phases

Month 1

Position

Full picture of your systems, your GxP scope and your gap against the inspection you will face. Delivered as a prioritised roadmap.

Months 2–3

Foundation

The documents everything else hangs on: validation policy, risk approach, supplier assessment template, change control — written to your size.

Months 4–6

Build

We validate the systems that matter first, in priority order, and train your team to run the process afterwards.

Ongoing

On call

Optional retainer for the questions that arrive without warning, and for the inspection when it comes.

Examples

What this looks like in practice

Four situations we see repeatedly. If one of them is roughly your situation, the programme will fit.

ATMP spin-off

Choosing a LIMS before it becomes irreversible

Three vendors shortlisted, supplier assessments run, contract clauses drafted before signature — so the audit trail requirements are settled before the system is bought rather than after.

Device startup

Everything is in spreadsheets

Which spreadsheets are GxP records, which can stay exactly as they are, and a validated path for the few that matter. Most of them turn out not to.

Diagnostics

A first AI model heading toward a regulated decision

Intended-use statement, GxP boundary and acceptance criteria written before development, so QA is not asked to approve a finished black box six months later.

Growing CDMO

From two clients to twelve

Segregation model, per-client traceability and an audit-readiness pack that does not need rebuilding every time a new customer arrives with their own quality agreement.

Fit

Launchpad is right for you if…

Good fit

Where the programme delivers most.

  • SizeRoughly 5 to 80 people, no dedicated validation function
  • StageBuilding or scaling before a first inspection or partner audit
  • TechModern stack — cloud, SaaS, AI — with no GxP precedent internally
  • IntentYou want to own the system afterwards, not outsource it indefinitely

Not a fit

We will say so on the first call.

  • Established QAYou already have a functioning validation team — take services instead
  • Findings openAn active regulatory deadline calls for remediation rather than a programme
  • Certificate onlyIf the objective is documentation to present to an investor, we are not the right fit
  • No ownerIf nobody internally has time to act as counterpart, the programme is unlikely to succeed.

Tell us what you are building.

Forty-five minutes, no charge. We will tell you plainly whether you need Launchpad, a single package, or nothing yet.

DurationAround six months
FeeFixed, quoted up front
PaymentBy phase