We transfer your process from the laboratory to industrial production.
Independent of suppliers and contract manufacturers (CMOs). Consulting and implementation.
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.
Contact our experts to discuss your specific issue.
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)
