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Our analytical testing laboratory develops its testing methods based on the specific needs of our clients. Our scientists remain up-to-date with the most sophisticated analytical instrumentation, testing methods, and problem-solving techniques. Our analytical method development team can produce accurate and reliable methods that deliver consistent results for measuring potency or/and impurities included an active pharmaceutical ingredient (API) and complex formulations.
Our experienced staff can develop methods for the most complex formulations/dosage forms within your timeframe. Our skilled scientists can validate or verify existing methods to help ensure cGMP/GLP compliance of regulatory submissions, improve upon existing methods by identifying gaps and proposing a detailed remediation plan, and work with a standard chromatographic methodology or very complicated assay method validations for both small and large molecules.
If you have a method development or validation project that cannot be done in-house due to its complexity, or you need the work performed in a faster timeframe than your laboratory can handle, we can help. As development partners, we can design detailed protocols for method development, validation, and transfer based on the product’s phase in the drug development process.
Learn how we can help you realize your research objectives through assay method development, validation, and transfers.