Element’s comprehensive bioanalytical testing services are dedicated to bringing industry-leading scientific expertise to help customers advance drug development programs by providing accurate and high-quality data.
A partnership with a strong, agile bioanalytical contract research organization (CRO) and contract development manufacturing organization (CDMO) with a deep bench of scientific and regulatory expertise can help you successfully navigate the complexities of bioanalytics, ensuring therapies meet rigorous scientific and regulatory demands.
Element offers a full spectrum of bioanalytical testing services to support challenging drug development projects throughout the product development lifecycle, from drug discovery and design to preclinical and clinical development through to filing, approval, and launch. Element’s purpose-built laboratories are equipped with essential instrumentation, and our consultative team of scientific experts stand ready to provide phase-appropriate bioanalytical laboratory support tailored to your specific needs, from custom method development to validation and sample analysis. Our expertise extends to biomarker validation, preclinical in vivo sample testing, and a complete offering of DMPK/ADME services and toxicity assessments.
Our team of dedicated experts recognizes that adherence to regulatory guidance is critical to any drug development program and has an in-depth understanding of regulatory guidance and requirements, including Food and Drug Administration (FDA), European Medicines Agency (EMA), International Organization for Standardization (ISO), Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP).
Bioanalytical laboratory services
- Bioanalysis and clinical biomarker method development, validation, and sample analysis
- DMPK & ADME assays to support preclinical and clinical research as well as safety and efficacy assessments
- Preclinical in vitro toxicity assays to ISO-10993-5 standards and clearance assays
The Element advantage
Expedite the regulatory approval of your drug candidate with Element as your bioanalytical CRO and testing partner. With access to advanced equipment, a deep bench of scientific and regulatory expertise, and a commitment to flexibility and efficiency, you will benefit from quick turnaround times without sacrificing the highest quality standards.
For more information about our clinical biomarker and bioanalytical testing services or to request a quote, contact us today.
Nearly 190 Years of Making Certain
More from Element
As you develop your vaccines, having assurance that they are safe is a critical regulatory requirement. Element provides vaccine analysis and safety testing.
Clinical Biomarker Support
Element's trusted team of experts can help drug developers identify, optimize, and execute the optimal approach to meet their clinical bioanalysis needs.
DMPK & ADME Services
Element offers a wide range of ADME and DMPK laboratory services, and we can accept both in vivo and in vitro samples.
Clearance Assays & Toxicity Testing
Element offers comprehensive, independent assessments of drug in vitro cytotoxicity and preclinical toxicology in addition to a well-developed collection of residual and clearance assays to confirm molecular clearance in animal-derived, complex matrices, including food.
Biopharmaceuticals and Biologics Analysis
Element’s significant expertise in all stages of biologics R&D, from in-house protein biochemistry and molecular biology to cellular biology and QC experience, supports the entire product development life cycle.