The CEBIS USA BA team is proficient in a variety of bio-analytical services, such as method development, assay validation, and sample analysis using cutting-edge LC/MS/MS technology.
As a provider of comprehensive regulated bioanalytical solutions, CEBIS supports the needs of Research and Development of the pharmaceutical industry.
We collaborate closely with your scientific team to establish robust assays for both parent drugs and metabolites based on our expertise spanning over decades.
Using sub-picogram detection, endogenous, chiral, and hormonal assays, we have expertise in crafting complex proprietary methods for both generics and NCEs and achieve rapid turn-around times. Our team collaborates closely with you in the development and validation of robust, replicable methods.
The data we deliver meets and exceeds quality standards, readily meeting the demands of regulatory agencies.
Each item of equipment in the BA lab runs certified software that complies with CFR 21 Part 11. All of the studies’ bioanalytical data is thoroughly audited by quality assurance, and compliance is periodically checked by internal audits.