Compare CDMOs with analytical method development and validation expertise. Filter by analytical technique, molecule type, and regulatory filing support.
592 companies listed
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.
Portugal
Bluepharma is a Portuguese CRDMO with over 55 years of experience, offering an integrated approach from R&D through to commercial manufacturing of medicines. The company produces 2 billion units of oral solid pharmaceutical forms and has an industrial plant for high potency products. Bluepharma's facilities are EMA/Infarmed and FDA approved, and the company has expanded into advanced therapies beyond small molecules.
South Korea
Caregen Co., Ltd. is a South Korean biotechnology company and global leader in biomimetic peptide synthesis. The company manufactures peptide-based APIs and health/cosmetic ingredients, with FDA inspection history and drug pipeline activities in dermatology and ophthalmology applications.
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