We will transfer your process from the laboratory to industrial production.
We will transfer your process from the laboratory to industrial production.
Scaling up production presents numerous challenges. We don't just rely on experience; we test and optimise every production run on a small scale first. This is how we digitally transform your processes (Pharma 4.0). Using the results, we simulate implementation in an industrial setting, allowing us to find optimal conditions before the very first test production.
This saves you valuable time and gets you to market faster!
The foundation for optimised production is being laid here. Precise optimisations using our own simulation tools (Digital Transformation) identify the correct process windows and operating points of the plants.
We are verifying the successful implementation of the scale-up through the necessary process validations, including detailed documentation. With our digital transformation and manufacturing modelling, subsequent adjustments and changes are no longer a problem.
We've made our mistakes before. We'll save them and ourselves the trouble. All team members are seasoned managers with many years of experience in manufacturing, supply chain, quality, and regulatory affairs.


We know cost pressure and profit pressure from our own experience.
We've made our mistakes before. We'll save them and ourselves the trouble. All team members are seasoned managers with many years of experience in manufacturing, supply chain, quality, and regulatory affairs.
We know cost pressure and profit pressure from our own experience.
We relieve you and your core team for specific projects. We bring „hands-on experience“ from seasoned managers. We organise your projects as „low risk“ GMP projects, with maximum speed and within the budget framework. You minimise regulatory risks and have clear responsibilities along with a transparent organisation. You will 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 – 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)