Prepare your program for its next phase of development with our robust and adaptable analytical methods. Our team supports analytical method development and method validation across the entire development and commercialization timeline. We approach each project with clear considerations of your current progress and phase requirements to achieve a ‘fit for purpose’ method that maximizes efficiency and quality. Regardless of your starting point or sample type, we guide you through the process, drawing on our extensive experience with a diverse range of molecules, materials, formulations, and packaging configurations.
As methods are established, our team works with you to draft custom validation protocols, provide thorough reporting at the conclusion of method development, and deliver reports appropriate for regulatory submission once method validation is completed. Our protocols retain flexibility for customization as we collaborate to support a phased approach that coincides with your pharmaceutical product development timeline. We also support client-supplied protocols.
Analytical method development is an ongoing component of your drug development program and evolves in tandem with your product. Our experienced team selects methods tailored to each stage of your program, ensuring efficient timelines, cost-effectiveness, and compliance with quality requirements. We draft custom validation protocols or follow protocols you provide to meet and comply with ICH and FDA guidelines. Our experience spans the spectrum of development, including Phase I, II, and III.