---
title: Bioanalytical, Biomarker & CMC Analytical CRO | Crystal Bio Solutions
description: GLP/GCLP bioanalysis, biomarker, CMC analytical and quantitative clinical pharmacology for biologics, ADCs and cell and gene therapy. US labs.
---
Cookie Settings
-2.png?width=330&height=150&name=Logo_CBS-%E6%A8%AA%E7%89%88-%E5%8E%9F%E8%89%B2(RGB)-2.png)
- [Bioanalysis & Biomarkers](https://www.crystalbiosolutions.com/services/bioanalysis-and-biomarkers)
- [Characterization & CMC Analytical](https://www.crystalbiosolutions.com/characterization-cmc-analytical)
- [Clinical Pharmacology](https://www.crystalbiosolutions.com/services/clinical-pharmacology)
- [Regulatory Affairs](https://www.crystalbiosolutions.com/services/regulatory-affairs-biologics-adc-cgt)
- [Clinical Support](https://www.crystalbiosolutions.com/clinical-research-services)
- [Resources](https://www.crystalbiosolutions.com/news-and-events)
- [About Us](https://www.crystalbiosolutions.com/about-us)
- [Contact Us](https://www.crystalbiosolutions.com/contact-us)
# Scientific Depth, Technical Breadth.
Leveraging decades of experience and scientific expertise to deliver high-quality data across diverse therapeutic modalities and study designs.
# One Stop from Strategy to Approval.
From complex assay development to regulatory-compliant study execution, our expert team guard your every step.
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# Global Experts, Local Solutions.
Explore our global network of therapeutic-specific key opinion leaders, subject-matter experts, vendors, and pre-qualified investigator trial sites in the United States, Europe, and Asia.
## Services & Solutions
Providing one-stop solutions with customized strategies.
 Bioanalytical
Biomarker Expert-driven, GLP-compliant bioanalysis and biomarker solutions built for diverse modalities and innovative pipelines.  Characterization and
CMC Analytical Beyond just testing: customized assay development for complex biologics, extended characterization, and extensive hands-on expertise.  Clinical
Pharmacology We provide strategic insight backed by robust data gathering and interpretation, to accelerate decision-making from IND to NDA.  Regulatory
Affairs Navigating global regulations with confidence is a challenge. We provide submission-ready strategies built on deep FDA and ICH expertise.
[](https://www.crystalbiosolutions.com/hs/cta/wi/redirect?encryptedPayload=AVxigLIWM77QbnE%2FGyVIcGt446mOC%2FWhvTIwAFptUMyp1cQRHHY4kngYoUMhUor52N4VGXrhOtJtnilhGFQQSwlbhjazH%2FPl4G1tYBclzv7b7cPKDTMGU7zKIw89llLSyIZyKOAyIKshtHFKzoea5rnbbNvb%2FBLSfCx%2B0TDqJsRB6kedjXauNJEa2wHHr5vt2bBZVg833Mw2qobmziE2mR8iYRLRQSyY&webInteractiveContentId=264126601418&portalId=146565877&hsLang=en)
## Techniques & Capabilities
Providing breadth and depth of scientific and technical expertise.
Immunoassay Sensitive and specific assays to quantify biologics and biomarkers.  Molecular Assay Advanced nucleic acid–based methods for gene and cell therapies.  Cell-based Assay Functional assays to evaluate drug activity and safety in vitro.  LC-MS High-precision mass spectrometry for quantitative and structural analysis.  Physiochemical Characterization of drug stability, purity, and critical quality attributes.  Method Transfer Seamless transfer and validation of methods across global labs. 
[](https://www.crystalbiosolutions.com/hs/cta/wi/redirect?encryptedPayload=AVxigLIWM77QbnE%2FGyVIcGt446mOC%2FWhvTIwAFptUMyp1cQRHHY4kngYoUMhUor52N4VGXrhOtJtnilhGFQQSwlbhjazH%2FPl4G1tYBclzv7b7cPKDTMGU7zKIw89llLSyIZyKOAyIKshtHFKzoea5rnbbNvb%2FBLSfCx%2B0TDqJsRB6kedjXauNJEa2wHHr5vt2bBZVg833Mw2qobmziE2mR8iYRLRQSyY&webInteractiveContentId=264126601418&portalId=146565877&hsLang=en)
Global Clients Completed projects Platform Methods Instruments
## Scientists Supporting Scientists
Connect with our experts and streamline your project success
[Free Consultation](https://www.crystalbiosolutions.com/contact-us?hsLang=en)
## News and Blogs
### Promote Your Products & Services
Generate the leads with our Call-To-Action module
[Start 30-days Trial](https://lpd-themes.com/growfast/)
- [Our Services](https://www.crystalbiosolutions.com)
- [Bioanalysis and Biomarker](https://www.crystalbiosolutions.com/services/bioanalysis-and-biomarkers)
- [CMC Analytical](https://www.crystalbiosolutions.com/characterization-cmc-analytical)
- [Clinical Pharmacology](https://www.crystalbiosolutions.com/services/clinical-pharmacology)
- [Regulatory Affairs](https://www.crystalbiosolutions.com/services/regulatory-affairs-biologics-adc-cgt)
- [Clinical Support](https://www.crystalbiosolutions.com/clinical-research-services)
- [Information](https://www.crystalbiosolutions.com/news-and-events)
- [Resources](https://www.crystalbiosolutions.com/news-and-events)
- [News & Events](https://www.crystalbiosolutions.com/news-and-events)
- [Careers](https://www.crystalbiosolutions.com/careers-at-crystal-bio-solutions)
- [About us](https://www.crystalbiosolutions.com/about-us)
- [Contact](https://www.crystalbiosolutions.com/contact-us)
- [Email \>](mailto:cbs_bd@crystalpharmatech.com)
- [Contact Form](https://www.crystalbiosolutions.com/contact-us)
- [Our Locations](https://www.crystalbiosolutions.com/locations)
- [Crystal Group \>](https://www.crystalpharmatech.com/)
- [Crystal Pharmatech](https://www.crystalpharmatech.com/)
- [Crystal NAX](https://www.crystalnax.com/)
- [Privacy Policy](https://www.crystalbiosolutions.com/policies/privacy-policy)
- [Terms of Service](https://www.crystalbiosolutions.com/policies/terms-of-service)
Copyright © 2026 Crystal Bio Solutions, All rights reserved
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