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)
Syngene International
India
Syngene International is a leading Indian Contract Research, Development and Manufacturing Organization (CRDMO) that provides integrated services spanning drug discovery through commercial manufacturing for both small and large molecules. The company has long-term research collaborations with Bristol Myers Squibb (extended until 2035) and Amgen. Syngene recently opened its first US manufacturing facility in Rockville, Maryland, and added a bioconjugation suite in Bengaluru for end-to-end ADC development. The company has 20 kL single-use drug substance capacity for biologics.
Small Molecule APISmall Molecule Drug ProductBiologics Drug Substance
Sypharma Pty Ltd
Australia
Sypharma is an Australian specialty contract manufacturing group operating since 2005. They develop and manufacture therapeutic goods, veterinary products, and specialty consumer products. They specialize in contract manufacturing for early clinical through Phase III clinical trials and have multipurpose cleanrooms for oral, topical, and parenteral drug products. They manufacture both large and small volume parenterals and have a veterinary manufacturing suite. Licensed by FDA, TGA, and ISO 13485 certified. They partnered with Schott on sterile fill/finish capabilities.
Small Molecule Drug ProductFormulation DevelopmentFill/Finish (Vials)
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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