We have been implementing projects for the life sciences industry for over three decades. GMP sets the pace and we know the rules - from hygiene, rooms and equipment to documentation and monitoring.
beyond Engineering
We combine regulatory precision with technological vision - for pharmaceutical projects that see compliance as the foundation of true sustainability.
Our expertise
With our experience in GMP compliance, qualification and validation, we bring new systems and upgrades safely to their destination.
We bring technology and regulations together - understandably, efficiently and comprehensibly down to the last detail.
With our end-to-end approach, we support your GMP projects from the initial analysis through to successful approval for operation. This is an interdisciplinary challenge in which we bring together all those involved: Architects, engineers, pharmacists, construction project managers and qualifiers.
The trade in therapeutic products (medicinal products and medical devices) is subject to numerous and detailed regulations on the one hand, and on the other hand it is sometimes difficult to distinguish them from food supplements, cosmetics or consumer goods. To gain an initial overview, GMP advice is essential.
The trade in therapeutic products (medicinal products and medical devices) is subject to numerous and detailed regulations on the one hand, and on the other hand it is sometimes difficult to distinguish them from food supplements, cosmetics or consumer goods. To gain an initial overview, GMP advice is essential.
Qualification means putting a system to the test - in other words, demonstrating on the test bench that a system, a technical device or an installation has been designed in accordance with GMP, works perfectly and actually leads to the expected results.
This requires the GMP-compliant design - Design Qualification (DQ), the scheduled installation or set-up - Installation Qualification (IQ), proof of a function that meets all operational requirements - Operational Qualification (OQ) and the demonstration of an overall performance that meets the requirements - Performance Qualification (PQ).
Along this cascade, we do everything we can to implement the relevant GMP regulations safely and pragmatically.
This requires the GMP-compliant design - Design Qualification (DQ), the scheduled installation or set-up - Installation Qualification (IQ), proof of a function that meets all operational requirements - Operational Qualification (OQ) and the demonstration of an overall performance that meets the requirements - Performance Qualification (PQ).
Along this cascade, we do everything we can to implement the relevant GMP regulations safely and pragmatically.
We validate your processes and systems in accordance with the relevant GMP regulations to ensure that your products meet the quality requirements in the long term. To do this, the authorities must have a documented validation program that proves that the process can effectively and reproducibly manufacture a product that meets the specified specifications and quality characteristics while complying with the defined parameters.
In addition, quality risk management is now essential to proactively identify, scientifically assess and control potential quality risks and continuously improve processes. The results will not only please the supervisory authorities, but will also pay off economically for you.
In addition, quality risk management is now essential to proactively identify, scientifically assess and control potential quality risks and continuously improve processes. The results will not only please the supervisory authorities, but will also pay off economically for you.
buildings
Buildings for the requirements of tomorrow
We develop solutions that combine efficiency, flexibility and sustainability - for buildings that grow with their tasks.
TECHNOLOGIES
We combine digital innovation with real added value
Curiosity and expertise are the driving force behind our innovation. A sense of personal responsibility is the basis for the quality of our sustainable solutions.
reference projects
We accompany construction projects at the cutting edge of innovation
With our experience and passion for progress, we realize spaces and infrastructures that not only function - but create the future.
Ready for the next generation of GMP/QVC?
Magnus Willers
GMP/QVC Leader
GMP/QVC Leader


