Method Development & Validation
Our experience with method development, optimization, and validation crosses multiple industries and technologies.
We follow compendia methods (USP, EP, JP), client-supported methods or methods that we’ve developed and validated for our clients. Compendia methods are verified in compliance with industry requirements. Client-supported methods are typically transferred following a specific method transfer protocol.
Method Development and Feasibility – We apply Quality by Design principles to all method development phases. After thoroughly understanding your needs, we leverage our expertise to thoroughly vet issues, optimize your method, and ensure (prior to validation) that the method will meet your user, regulatory, and business requirements.
Method Validation – We validate all of our methods with all applicable regulatory requirements, such as USP, EP, and ICH or your own specific requirements. Validations are always performed under a pre-approved protocol.
Method Verification – We offer significant experience in compendia verification methods or in method transfer situations. Verifications are always performed under a pre-approved protocol.