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Intro call

Quality and regulatory · Change and comparability

The column is discontinued, the instrument is new, the supplier has changed: can we do this without revalidation?

Column, instrument or site changed: we check what works without revalidation and propose replacements.

Who needs this in your company

Roles

Industries

What we can do

We check changes against the allowed adjustments per USP <621>, find replacement columns with the same selectivity and scale to a new column geometry. For method comparisons we use equivalence tests such as TOST and the Chow test and classify the change under ICH Q12.

What you get

  • Allowed change yes or no, with reasoning
  • Proposal for a replacement column or instrument
  • Comparison protocol
Do it yourself: Can I make this method change without revalidation?

Typical cases

Evaluated for you or done yourself

The same calculations, different ways to you. Which one fits, we work out in the intro call.

  • CovaSyn in your AI (MCP)

    The same calculations directly in Claude, ChatGPT or your own AI.

    Learn more

  • Evaluation report

    You send the data, we deliver the reviewed report.

    From EUR 1,490 net, typically 5 working days after complete data

    Learn more

  • Pilot project

    One question on your data, with a success criterion agreed in writing beforehand.

    From EUR 1,490 net, fully creditable

    Learn more

  • Partners and academic

    For software and instrument partners and for research.

    Terms per partner, academic free on application

    Learn more

Limits of the result

  • Equivalence is only proven with your system suitability data.

More from this area

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.