Expertise
New method, new site, new instrument, validation and transfer only work if they're planned properly, and documented well enough to survive scrutiny.
We design validation protocols matched to the method and its intended use, execute the studies, and write up outcomes so they hold together under audit, not just technically correct, but clearly reasoned.
Method transfer between sites or labs is where a lot of programmes lose time. We bridge that gap: aligning acceptance criteria up front, and troubleshooting the inevitable discrepancies before they turn into a stalled project.
Defining the validation approach according to ICH Q2 or the relevant pharmacopeial monograph and lifecycle principles.
Checking whether gaps remain in validation status during a phase transition or at commercialisation.
Identifying transfer risks before execution, not after.
A successful validation is often assumed to guarantee a successful transfer, but it doesn't. A method can perform perfectly in the originating lab and still fail once it moves, because of differences in equipment, analyst expertise, environmental conditions, sample preparation or plain laboratory culture.
In practice, the same handful of gaps show up again and again: incomplete knowledge transfer, insufficient analyst training, acceptance criteria that were never clearly defined, equipment and reagent differences between labs, an underestimated robustness gap, uncontrolled procedural drift, and simply too little communication between the sending and receiving lab. Treating validation as a one-off event, rather than something that needs continued monitoring across its lifecycle, tends to be where it starts.
Usually project-based consultancy, run alongside your lab so knowledge stays in-house once the project ends.
Tell us what you're working on, we'll get back to you with a plan that fits.
