ACTA performs cGMP method validation in accordance with USP and ICH requirements. ACTA prepares Validation Protocols for the study and will furnish you with a Validation Report that will meet the requirements of the FDA. Parameters normally validated are accuracy, precision, specificity, limit of detection, limit of quantitation, linearity, range and robustness.
ACTA’s staff is highly experienced with method development for all types of dosage forms. Our equipment is used to develop rugged and accurate methods to meet your requirements. ACTA develops methods for non-compendial and compendial products that need stability indicating methods.