Process validation

We carry out projects quickly and without loss of quality. You have short project durations, thus lower costs and a quick return on investment. Contact us for an initial discussion! Our projects often combine Technical and regulatory issues: •Technology & technology transfer (adapt, improve technologies) •Optimise in production •Quality projects (Quality by Design "QbD", Process Analytical Technology "PAT", test design, validations, qualifications) •Short processing times in administration •Improve the supply chain We optimise supply chains, develop suppliers, um/damit: •"Shorten "Lead Times •the supplier reacts quickly •broaden the supplier base •find new suppliers •Relocate productions We take over technical projects like: •"Scale up" in biotechnology and pharmaceuticals •Model and simulate production steps in biotechnology and pharmaceuticals •Improve production processes (quality, process) •modelling new or modified buildings ("virtual factory") •simulate

We manage investment projects for you, such as production expansions, installation of new plants, greenfield construction projects, brownfield construction projects. We focus on the rapid implementation of your project. With these short project durations, you have low project costs and a high return on investment. We adapt our project management to the very specific circumstances of our clients Contact us for an initial discussion! This makes our project management flexible enough to handle the changes that occur in every project. Our focus is on short "time to market" and thus low project costs. This is the only way for projects to pay off quickly. We execute projects very quickly and achieve significant time savings compared to traditional project management. Pharmaceutical production •After qualification and commissioning, we also take care of the start of production. •Optimisation of the production parameters •Validation •Transfer to routine operation

We carry out the entire technology transfer or production transfer from a manufacturer to a contract manufacturer (CMO, CDMO) for you. Contact us for an initial discussion! In the process, we look for the right CMO for you and prepare a pre-selection. You decide on the best manufacturer, then we carry out the entire transfer for you: •Planning resources •Timetable including work packages •Structure the cooperation with the CMO •Prepare all necessary documents •technical transfer •Adjusting the production parameters, optimisation •we validate the transferred production process •handed over to routine production We bring all the necessary specialists into the project ourselves, or work hand in hand with your internal team. Depending on how it is needed. We carry out transfers very quickly. This shortens the project duration and reduces your costs: They are quickly back on the market! This reduces transfer costs in the long term. Contact us for an initial discussion!

The step from the laboratory to manufacturing for clinical trials is a major challenge. Simple hand movements in the laboratory often cannot be easily translated into process steps of industrial manufacturing. We are specialised in such scale ups. Contact us for an initial discussion! Analysis We prepare your laboratory data and compare it with the possible process parameters at the contract manufacturer. If data or optimisations are still missing. We develop the test plan for this. We carry out certain scale-up trials (non GMP) at our technical centre. We accompany specific trials (e.g. with your API) on your premises or those of a plant manufacturer. Models and simulation From the data, we generate the process models you need for scaling up. You will also need these models for the submission documents. We use the data to simulate different scale-up concepts. So if you later transfer from the special CDMO for clinical production to the CDMO for commercial production