CMC- Analytical Methods Development

Analytical methods are indispensable tools in the pharmaceutical industry, ensuring product quality throughout its lifecycle. These methods control the product's quality during manufacturing, release, and storage. Proper method development is crucial to guarantee the method's adequacy for the specific product. When selecting a method, compliance with relevant compendia (e.g., USP, EP) is strongly recommended to minimize regulatory hurdles and the need for method validation.

Analytical methods must comprehensively address all critical quality attributes (CQAs) of the product. CQAs are essential characteristics that ensure the product's safety, efficacy, and quality.

At Tandem BioPharma CMC Consulting services, we specialize in defining the required critical quality attributes for the product and selecting appropriate analytical methods. Our team works closely with clients to develop tailored analytical methods, ensuring they meet the highest standards of quality and compliance. We also provide comprehensive method validation services to verify the method's accuracy, precision, specificity, and other performance characteristics.