VelaLabs offers GMP-compliant protein characterization applying a state-of- the-art analytical portfolio. A highly qualified and trained staff performs analytics based on a sound scientific rationale and in accordance with the relevant guidelines (ICH, EMEA, FDA).
By offering a structured, clearly laid out “method flow” approach that reflects the various stages of drug development, each customer can be served exactly to its needs. Based on our experience with regulatory agencies, we recommend the following method status:
> Preclinical testing: developed or qualified
> Toxicity study / clinical phase I: qualified or validated
> Clinical phase II and III: validated or verified
Exceptions: Methods, which are related to safety and tolerance items have to be validated even at the time point where the drug is “first in man”