We scale your process from the laboratory to industrial production.
We scale your process from the laboratory to industrial production.
A change in manufacturing scale brings numerous challenges with it. We not only rely on experience, but test and optimize every manufacturing process on a small scale first. This is how we carry out the digital transformation of your processes (Pharma 4.0). Using the results, we simulate the implementation in an industrial environment, thus finding optimal conditions even before the first test production.
This saves you valuable time and gets you to market faster!
Here, the foundation for optimized production is being laid. Precise optimizations using our own simulation tools (digital transformation) find the right process windows and operating points of the systems.
We verify the successful implementation of the scale-up through the necessary process validations, complete with detailed documentation. With our digital transformation and manufacturing modeling, subsequent adaptation and modification are no longer an issue.
We made our mistakes earlier. We spare them and ourselves those. All team members are seasoned managers with many years of experience in manufacturing, supply chain, quality, and regulatory.


We know cost pressure and pressure for results from our own experience.
We made our mistakes earlier. We spare them and ourselves those. All team members are seasoned managers with many years of experience in manufacturing, supply chain, quality, and regulatory.
We know cost pressure and pressure for results from our own experience.
We relieve you and your core team for specific projects. We contribute „hands-on experience“ from seasoned managers. We organize your projects as „low risk“ GMP projects, with maximum speed and within the budget framework. You minimize regulatory risks and have clear responsibilities along with a transparent organization. You have a highly experienced project team with high technological competence. We are 7 experienced practitioners (QA, QC, QM, Manufacturing, Data Science, R&D, Supply Chain) with additional FTEs – depending on the project scope (FTEs from 10 to approx. 40).
Best Practices for the Development, Scale-up, and Post-approval Change Control of IR and MR Dosage Forms in the Current Quality-by-Design Paradigm – PMC (nih.gov)
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