Our analytical method development team produces accurate and reliable methods that deliver consistent results. If you need experienced method development chemists to measure the concentration of an active pharmaceutical ingredient (API) in a specific compounded dosage form, CCTL can help. If you need to identify and quantify the excipients, intermediates, raw materials, preservatives, antioxidants, impurities and more within a formulation, we can ensure that your product maintains the proper identity, purity, potency, and performance.
Whatever your scientific business challenges, CCTL can resolve them. Our multi-disciplinary chemists specialize in non-routine testing and have successfully completed thousands of projects, on time and on budget. We regularly provide pharmaceutical method development services.To learn more about our method development services or our other analytical laboratory capabilities, contact us today.
Method Validation in Pharmaceutical Analysis
Beyond method development, our skilled method validation chemists can verify existing methods to help ensure approval of regulatory submissions. Our team can also improve upon existing methods by identifying gaps and proposing a detailed remediation plan. This can even include tailoring existing test methods to your drug substance or drug product, which can save on both time and cost in developing an analytical method. Our contract research lab can even take on difficult LC-MS method validations and complex ELISA assays. Our experienced staff can develop methods for even the most complex formulations within your timeframe. We develop custom proposals to complete the analyses you require when certifying a new drug product or amending a current drug application.
If you need to transfer a validated analytical method to a new site, CCTL can document and perform the method transfer. Our chemists can even provide training to the team at the receiving laboratory to make sure the method transfer meets regulatory requirements. Whether your product requires comparative testing or inter-laboratory method validation, we have the resources to ensure your method transfer goes smoothly.
If you have a method development or validation project that cannot be done in-house due to its complexity, or you need the work completed on a tighter schedule than your in-house laboratory can handle, CCTL can help. As development partners, we can design detailed protocols for method development, validation, and technology transfer based on the product’s phase in the drug development process.