Sector specifics
Our response
The pharmaceutical industry is characterized by particularly high quality requirements, process auditability, and stringent standards (GMP, GxP). Every component of the automation, dosing, quality control, or diagnostics system must be designed, implemented, and documented in a way that ensures repeatability, safety, and compliance with audit requirements.
In the design and automation of pharmaceutical installations, what is crucial is not only the technical execution of systems, but also the preparation of complete audit documentation, which confirms compliance with good manufacturing practices and is ready for inspections by regulators and customers.
Engineering outsourcing in the pharmaceutical industry is often used to supplement design and execution competencies—especially where internal teams are engaged in production and maintenance, while at the same time industry and audit experience is needed
In pharmaceutical projects, we work with the URS as the governing document for design, automation, and validation. We support both the development of a URS from scratch and the verification of existing requirements for technical feasibility and regulatory compliance.
Yes — in the engineering and technical scope.
We participate in the preparation and execution of IQ (Installation Qualification) and OQ (Operational Qualification) tests, supporting validation teams with technical documentation, functional tests, and results analysis. The PQ scope is carried out in cooperation with the client’s team, in accordance with their quality procedures.
Yes — provided the right operating model is in place.
We deliver outsourcing in a model where engineers are integrated into the client’s project structures, with a clear division of responsibilities, access rights aligned with GMP procedures, and full documentation transparency. This makes it possible to strengthen the team without compromising the quality regime.
We can get involved from the concept and URS stage, through design and integration, up to IQ/OQ support and technical acceptance. We tailor the scope and collaboration model to the project stage and the structure of the customer’s team.
We operate in design and audit modes, as well as through engineering outsourcing—adapting the form of cooperation to the nature of the project and the client’s needs.