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Peptides
CDMO
Scale-Up and Manufacturing
EVENTA submission to the U.S. Food and Drug Administration (FDA) seeking approval to market a generic version of a previously approved branded drug. This application relies on the safety and efficacy findings of the original drug.
EVENT
EVENTHow Neuland developed an innovative, lower-cost process and successfully scaled the manufacture of a high-purity pharmaceutical intermediate for Phase III clinical trials.
NEWSTesting performed under extreme storage conditions (e.g., high temperature and humidity) to forecast long-term stability and establish a preliminary shelf-life for a drug substance more quickly.
The principle of assuming full responsibility for project outcomes, adhering to defined quality, timeline, and regulatory requirements outlined in a service agreement.