Industry · Generics and specialty pharma
For generics and specialty pharma
Impurities, nitrosamines, stability and method transfer, fast and documented for GMP.
What we solve for you
Structure elucidation and identity
The spectra have been sitting there for days, and nobody has time to assign them properly.
See solutionUnknown peaks, impurities, extractables and leachables
A peak above the identification threshold is blocking release, a stability study or a submission.
See solutionAssay, purity, qNMR, dissolution
We need assay and purity, but we do not have a suitable reference standard.
See solutionMutagenicity and nitrosamines (ICH M7)
The authority wants to see our nitrosamine assessment, and external reports take weeks.
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 solutionChange and comparability
The column is discontinued, the instrument is new, the supplier has changed: can we do this without revalidation?
See solutionCleaning validation
For our multi-product facility we have to justify the worst-case marker and the limit.
See solutionHPLC methods and validation
Scouting eats up weeks of instrument time, and validation ties up the whole lab.
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.