Capability
Method Development & Validation CDMOs
Compare CDMOs with analytical method development and validation expertise. Filter by analytical technique, molecule type, and regulatory filing support.
592 companies listed
About Method Development & Validation
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.
Companies (592)
The Ritedose Corporation
United States
The largest US CDMO specializing in sterile Blow-Fill-Seal (BFS) technology for aseptic manufacturing of unit-dose medications. Based in Columbia, South Carolina with a 500,000+ sq ft facility and production capacity of over 2.6 billion units annually. Delivered more than 12 billion doses since 2012 with no patient interruptions. Provides both CDMO services and has a generics division. Offers the largest nebulized drug portfolio in the US. Key products include ophthalmic, respiratory, and inhalation medications. Has co-developed 80%+ of new BFS products over the past decade. 100% customer retention for 25 years. Recent investments include $17M cGMP lab expansion and seventh Syntegon packaging line. 16 FDA-approved products.
Aseptic ProcessingSterile Fill/FinishSterile Injectable
Thermo Fisher Scientific Inc.
China
One of the world's largest pharmaceutical CDMOs through its Patheon pharma services division. Provides end-to-end pharmaceutical development and manufacturing services for both small molecules and biologics, from API manufacturing through drug product, sterile fill/finish, packaging, and commercial supply. Operates 31+ FDA-registered facilities globally. 158 FDA inspections on record (52 NAI, 104 VAI, 2 OAI). Also provides cell therapy manufacturing solutions (CTS Rotea cell processing system), laboratory informatics, bioprocessing equipment, and reagents. 4 FDA-approved drug products. Revenue >$40B (full company).
Frequently Asked Questions
What is included in ICH Q2 method validation?+
ICH Q2 requires demonstration of: specificity (method measures what it claims), accuracy (closeness to true value), precision (repeatability, intermediate precision, reproducibility), linearity and range, detection limit (LOD), quantitation limit (LOQ), and robustness. For dissolution and biological assays, additional parameters may apply. The new ICH Q14 guideline on analytical procedure development provides a lifecycle framework.
When should method development start?+
Method development should begin alongside formulation development. Early-phase methods (phase I/II) can be qualification-level, but they should be designed with validation in mind. Method validation is required before pivotal clinical manufacturing (phase III) and regulatory submission. Starting early avoids the common pitfall of discovering late-stage analytical issues that delay regulatory filings.
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