Technology Transfer Pharma

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

Based on your requirements, we search for and find suitable contract manufacturers. We prepare your tender documents and make a pre-selection of suitable contract manufacturers (CMOs, CDMOs). Contact us for an initial discussion! We evaluate the CMOs for this in a structured scheme. We use not only the bid price, but also the important parts of the bid: •Flexibility •Smallest order quantity ("MOQ") •Terms of payment •Logistics opportunities •Development support •Potential for the future This allows you to choose the best contract manufacturer for your project! You then transfer your technology or product, or hand over this work package to us. We transfer even complex productions and technologies within 6 -12 months. This means you are on the market very quickly, your resources are not blocked. Contact us for an initial discussion!

Statistical experimental design We plan your trials in development and production. With our statistical methods, you can optimise production during normal operation. This saves you technical batches and thus costs. Nevertheless, you gain resilient and robust improvements. Statistical design of experiments is the fastest and most cost-effective way to carry out developments and optimisations. Contact us for an initial discussion! CPV "Continouus Process Verification With CPV, the manufacturing process is checked for variable proportions, trends and opportunities for improvement. As such, it is part of the "Life Cycle Management" to further operate the process in a controlled manner within narrow limits. We evaluate your process data statistically and thus show potential for improvement. This way you use your data productively and can achieve strong savings and improvements in quality. So it pays off! Contact us for an initial discussion! Quality by Design "QbD