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)
Avrio Biopharma (Avrio Biopharmaceuticals, LLC)
United States
Avrio Biopharmaceuticals LLC is a US-based CDMO operating a cGMP facility focused on clinical trial services, formulation development, aseptic fill and finish, lyophilization, CMC support, and packaging and labeling. They offer comprehensive pre-formulation services, parenteral and solid/semisolid/liquid dosage form development, lyophilization cycle development, ophthalmics, emulsions, suspensions, and liposome/microsphere encapsulation. The company also provides clinical trial management, regulatory submissions support, and has received California Drug Manufacturing and Medical Device Manufacturing licenses. Their product portfolio includes generic formulations of gabapentin, pregabalin, and modafinil.
Formulation DevelopmentSterile Fill/FinishFill/Finish (Vials)
Axcellerate Pharma LLC
United States
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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