GMP compliance

In the sector of the regulated industry, compliance with laws and a number of other rules, regulations and guidelines is mandatory.

Based on our experience we can offer you support in the field of validation and qualification strategy as well as with the compilation of all required documents and their verification at machines, plants, facility equipment and computer-aided systems.

Whether you are building a new plant, implement a new production or packaging system, modify one of your existing systems or have to cyclically revalidate such systems, we provide advice to your engineering and quality assurance departments for implementation of economic and efficient validation strategies and help them realize said strategies.

We are looking forward to prove our expertise and performance to you.

Patient safety, quality, data

Qualification and validation in a regulated environment are critical prerequisites for a high degree of patient safety, product quality and data integrity.

These aspects are our focus, from the first to the last phase of the life cycle.

By strategic implementation of risk analyses during the concept and project phases, we achieve a high degree of efficiency. Consistent implementation and integration of the resulting measures in combination with tracking of the identified and assessed risks generate excellent transparency.