Capability
Analytical Services CDMOs
Compare CDMOs with comprehensive analytical services for release testing, stability, method development, and characterization. Filter by testing type, accreditation, and capacity.
873 companies listed
If the data isn't GMP, it doesn't count toward release or a filing — that's the whole game with analytical services. Every batch you release and every submission you make rests on analytical data: identity, assay, impurities, dissolution, sterility. A contract lab produces the evidence that your product meets spec. Cheap, non-GMP numbers can't be used for either purpose, so verify the quality system first. What are you actually buying? Release and stability testing under ICH conditions, method development and validation per ICH Q2, and the scientific depth to run down an out-of-specification result instead of just reporting it. Data integrity is now a top FDA inspection finding, so ask how they handle audit trails and chromatographic review. For biologics, confirm characterization and comparability capability, not just small molecule HPLC. 873 CDMOs here list analytical services. Compare them by testing scope, accreditation, and molecule type.
About Analytical Services
Analytical services underpin every stage of pharmaceutical development and manufacturing. From raw material testing through in-process controls to finished product release, analytical data provides the evidence that a drug product meets its specifications. GMP analytical laboratories must operate under validated methods, calibrated equipment, and documented procedures.
CDMOs offering analytical services range from full-service integrated organizations (manufacturing + analytics) to specialized contract testing laboratories. The most valuable analytical partners offer: method development and validation, release and stability testing, regulatory filing support (CTD Module 3), and the scientific depth to troubleshoot out-of-specification results.
Companies (873)
Axcellerate Pharma LLC
United States
Axcellerate Pharma LLC is an award-winning CDMO based in Piscataway, New Jersey, providing CRO and CDMO services for both large and small molecules. Their capabilities span cGMP API manufacturing (small molecules), sterile aseptic filling (vials, syringes, cartridges, bags), lyophilization, mammalian cell culture, microbial fermentation, oligonucleotide synthesis, PEGylation, and commercial manufacturing including generics, controlled substances, hormones/steroids, and cytotoxic/oncology compounds. The company operates from a multi-faceted facility that includes ISO Class 5-8 sterile areas, dedicated process areas for biologics development, chemical development, and sterile manufacturing.
Small Molecule APIAPI ManufacturingBiologics Drug Substance
Bend Bioscience Inc.
United States
Bend Bioscience (formed from CoreRx, Societal CDMO, and other specialist CDMOs) is a U.S.-based small molecule pharmaceutical CDMO offering end-to-end development and manufacturing from pre-clinical to commercial scale. They specialize in oral bioavailability enhancement via spray dried dispersions, particle engineering, multiparticulates, and modified release technologies. They operate FDA, EMA, ANVISA, and DEA-inspected facilities across three U.S. locations (Oregon, Georgia, Florida) with capabilities spanning oral solids, liquids, topicals, and powders for inhalation.
Small Molecule Drug ProductOral Solid DoseFormulation Development
Frequently Asked Questions
What analytical services do pharmaceutical CDMOs typically offer?+
Core services include: raw material identity and purity testing, in-process testing, finished product release testing (assay, impurities, dissolution, content uniformity), stability studies (ICH conditions), method development and validation (per ICH Q2), extractables and leachables studies, microbiology testing (sterility, endotoxin, bioburden), and specialized characterization (particle size, polymorphism, thermal analysis).
Why is GMP compliance important for analytical services?+
GMP-compliant analytical data is required for regulatory submissions and batch release. Non-GMP data cannot be used for these purposes. GMP compliance means: validated analytical methods, qualified and calibrated instruments, trained and qualified analysts, complete documentation (audit trail, data integrity), sample management and chain of custody, and regular audits by regulatory authorities or clients.
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