Chemistry, Manufacturing and Controls (CMC) & CDMO Testing Services

The biopharma CDMO industry faces increasing pressure to deliver complex therapeutic programs on accelerated timelines while maintaining rigorous quality standards. CDMOs must navigate diverse client portfolios spanning small molecules, biologics, and advanced therapies, each requiring specialized analytical capabilities and regulatory compliance across multiple jurisdictions. 

Element's comprehensive testing solutions are purpose-built for CDMO operations, providing the analytical backbone that enables contract manufacturers to expand service offerings and deliver exceptional client outcomes. Our specialized expertise transforms analytical challenges into competitive advantages, supporting CDMOs from discovery through commercial manufacturing. We offer the flexibility to scale with business cycles and client demands, from project-based testing to comprehensive long-term partnerships. You optimize analytical spending while maintaining quality, improving your competitive positioning and ability to serve diverse client portfolios effectively.  

Our FDA-registered laboratories throughout North America ensure consistent, high-quality testing for your client programs. You gain reliable access to specialized analytical capabilities and standardized protocols, enabling seamless project execution across multiple locations. 

Our extensive testing portfolio spans method development through commercial release testing, enabling CDMOs to accept diverse client programs with confidence. State-of-the-art analytical instrumentation and validated methodologies enable you to expand service offerings into complex therapeutic areas. Access cutting-edge capabilities for biologics and ATMPs, cell/gene therapies, and emerging modalities without investing in specialized equipment in-house.