Compare CDMOs with analytical method development and validation expertise. Filter by analytical technique, molecule type, and regulatory filing support.
Analytical method development creates the test procedures used to measure drug product quality attributes (potency, purity, impurities, dissolution, etc.). Method validation demonstrates that these procedures are suitable for their intended purpose per ICH Q2 (R2) guidelines. Together, they form the analytical foundation for every pharmaceutical product.
CDMOs offering method development and validation services support the entire product lifecycle: from early development (screening methods, forced degradation) through clinical manufacturing (validated methods for batch release) to commercial production (transfer, trending, lifecycle management). Strong analytical CDMOs reduce development timelines by executing method work in parallel with formulation and process development.
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