We transfer your process from the laboratory to industrial production.
A change in production scale brings with it numerous challenges. We don't just rely on experience, but test and optimize every production process on a small scale first. This is how we carry out the digital transformation of your processes (Pharma 4.0). With the results, we simulate the implementation in an industrial environment, so we find optimal conditions even before the first test production.
This saves you valuable time and gets you to market faster!
Careful test planning in the laboratory for the Scale upThis is the basis for rapid implementation and proper implementation of regulatory requirements.
We check the successful implementation of the scale-up through the necessary process validations, including detailed documentation. With our digital transformation and modeling of production, subsequent adjustments and changes are no longer a problem.
We have made our mistakes before. We spare them and ourselves. All team members are seasoned managers with many years of experience in manufacturing, supply chain, quality and regulatory.
We know cost pressure and pressure on results from our own experience.
Contact our experts to discuss your specific issue.
We take the pressure off you and your core team for specific projects. We bring in hands-on experience from experienced managers. We organize your projects as "low risk" GMP projects, with maximum speed and within budget. You minimize regulatory risks and have clear responsibilities including a transparent organization. You have a very experienced project team with a high level of technological expertise. 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)