Engineering, qualification and CSV for GxP plants,
directly on site, in running operations.

We plan, qualify and validate your plants, systems and processes: plant and process engineering, qualification to EU GMP Annex 15 from URS through DQ/IQ/OQ/PQ to requalification, CSV and data integrity to GAMP 5, plus QMS work, project management and interim management. The result is a plant that runs and documentation that holds up in the audit. We work on site in your running GMP operations as a matter of principle, not remotely.

As early as possible: bringing us in at URS and design qualification avoids expensive rework in IQ, OQ and PQ. We equally join projects already under way, for instance when deadlines slip, documentation is missing or an audit is due. A 30 minute first consultation, with no obligation, is enough to determine the right entry point.

That depends on the scope, which is why we do not quote flat rates. You choose between three models: a fixed-price package with a clearly defined outcome, billing on a time and material basis, or reinforcement directly in your team. Before the start you receive a transparent offer with a clear scope and no hidden items. The first step costs nothing: a first consultation with no obligation, answered directly by engineering, not by sales.

We work with your team, not around it. Your people know the plant and the processes; we bring methodology, documentation practice and additional capacity, and we hand over so the knowledge stays with you. If a role is missing entirely, we fill it temporarily, for instance as project management or in an interim function.

Yes, project management and interim management in GxP projects are one of our five service pillars. We are accountable for schedule, cost and quality, keep stakeholders aligned and run the project even in running GMP operations. The founder works on it himself: you speak with the person who delivers.

We work for biotech and pharma, active ingredient and production sites, medical technology to ISO 13485 and life science supply chains in Switzerland and Germany. We are a good fit for companies that expect audit-proof work in running GMP operations and want a partner on site rather than a consulting report. If you build, modify, qualify or validate in a regulated environment, you are in the right place.