Industry · API and drug product manufacturers
For API and drug product manufacturers
Stability, OOS, limits and process capability evaluated soundly, for release and inspection.
What we solve for you
Assay, purity, qNMR, dissolution
We need assay and purity, but we do not have a suitable reference standard.
See solutionStability, degradation, forced degradation
One result in our stability study looks different, and we do not know whether it is a trend or scatter.
See solutionOOS, control charts, release data
An OOS result is holding the batch, and the investigation has been stuck for weeks.
See solutionCleaning validation
For our multi-product facility we have to justify the worst-case marker and the limit.
See solutionProcess modelling, QbD, process capability
Our Cpk is too tight, and we do not know which parameter drives the variation.
See solution
Evaluated for you, done yourself or learned
Evaluated for you
You send the data, we deliver the reviewed report. From EUR 1,490 net, typically 5 working days after complete data.
See reportPilot project
One question on your data, with a success criterion agreed in writing beforehand. From EUR 1,490 net, fully creditable.
See pilot projectDo it yourself
One seat for you, cancel monthly. EUR 0, 250 or 750 per user and month, net.
Try it freeLearn
Your team learns it on its own data, online or in Leipzig. EUR 490 to 1,990 per person, in-house EUR 3,500 to 9,900, net.
See learning
Next step
Which case is on your desk right now?
30 minutes on Microsoft Teams with the CovaSyn team. If it is not a fit, we will say so.