Project Management Pharma

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!

We plan and perform your complete process validation. From the first gap analysis and risk management, planning, execution and reporting. We support you with full project management, providing support where needed. You free your ressources for your projects, we take care for validations and all connected activities. You reach your goals safely, quicker and faster.

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