Method Development and Validation

Method Development and Validation

ARL Bio Pharma has extensive experience in analytical method development/validation for a variety of drug substances and products.

Our laboratory validates analytical methods based on ICH and USP guidelines and high-quality industry practices. Method parameters may include: precision, limit of detection, limit of quantitation, accuracy, linear range, specificity, robustness, system suitability, ruggedness and freeze-thaw.

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