A Swiss practice built on one principle: the person you hire is the person who delivers.
Moonet Sagl is based in Lugano, in the Italian-speaking canton of Ticino — an hour from Milan, within reach of the Basel and Zug corridors, inside the Swiss regulatory perimeter. Founded in 2022. Two partners, a small team, and a circle of independent specialists and partner firms we work with regularly.
Two careers that between them cover both halves of the problem
The firm's positioning rests on the fact that the regulatory competence and the engineering competence sit in the same two people, and are applied to the same engagement.
Alessio Bertolucci
Founder & Managing Director · Compliance lead
Over twenty years across pharmaceutical, biotech and medical device multinationals before independent practice. Leads validation, data integrity and inspection work — the side of an engagement that has to stand up in front of a regulator.
Matteo Bertolucci
Co-founder & CTO · Technology lead
Automation, MES and software engineering across life sciences and high-tech, including AI/ML and robotics outside the regulated world. Leads the build side, together with the validation and data integrity work on ERP, MES and IT/OT systems, and the qualification of technologies with no established GxP precedent.
Transparent staffing, defined responsibilities and client-owned approval
We operate within the client's quality management system and agreed procedures. Moonet can prepare, review and execute assigned deliverables, but GxP ownership, quality oversight and final approval remain with the client unless responsibilities are explicitly defined otherwise in the engagement. The proposed team is identified before work begins, and any independent specialist or partner firm is disclosed and qualified as required by the client.
- —The engagement scope, deliverables, responsibilities and approval route are agreed before work starts.
- —Work is led by senior Moonet personnel and performed within the client's document, change and deviation controls.
- —Any independent specialist or partner firm is identified transparently and remains subject to the applicable confidentiality, competence and client-approval requirements.
- —Client data and deliverables remain subject to the engagement agreement, and references are provided only with client permission.
Where we work, and what we are
Lugano, Ticino
Switzerland's Italian-speaking canton. An hour from Milan, inside the Swiss regulatory perimeter, within reach of Basel and Zug.
Six countries
Engagements across Switzerland, Denmark, Ireland, Italy, Germany and the United States, in four working languages.
Member of the Microsoft AI Cloud Partner Program
This supports our work with Azure and Dynamics 365 technologies. It is not a regulatory certification, and it is not an endorsement of Moonet's GxP services by Microsoft.
Tell us what is due, and when.
If there is a date attached to your problem, put it in the first line. A short call, no charge — and we will say plainly if the work is not a fit for us.