Our laboratories are purposefully equipped with leading-edge instrumentation for the most discriminating analytical applications, and our teams of engaged scientific experts have decades of experience in a variety of disciplines, including analytical sciences, polymer chemistry and failure analysis, resulting in industry-leading support for the diagnostics industry.
Overcome challenges and better understand device failure or deficits in product accuracy with the rigorous scientific approach our teams of knowledgeable scientists apply to each project. With a proven track record of success accelerating diagnostic test development, reducing product failure and helping to advance technological innovations within the diagnostics industry, our expert, consultative teams of scientists will act as a true extension of your team, advancing your goals and ensuring your needs are met throughout the entire diagnostic product development lifecycle.
Comprehensive diagnostic product development support
- Formulation and process development
- Intellectual property and litigation support
- cGMP small-batch manufacturing
- Contaminant identification and failure analysis
- Stability programs
- Regulatory support
- Cleaning and process validation
Next-generation COVID-19 diagnostic test development partner
Element is actively seeking co-development partnerships to support development and optimization of the next generation of COVID-19 diagnostic tests. Our expertise spans a broad range of diagnostic tests, including:
- Molecular diagnostic tests
- Antigen diagnostic tests
- Serology and antibody tests
- Neutralizing antibody (NAbs) assays
- Virus neutralization assays
Our consultative teams of scientific and regulatory experts can support COVID-19 emergency Use Authorization (EUA) submissions to the FDA, in addition to developing and optimizing diagnostic tests. Learn more about our COVID-19 diagnostic test capabilities.
The Element advantage
Leading diagnostic manufacturers trust Element’s decades of industry experience as well as the depth and breadth of scientific expertise to ensure the needs of their project are met and expectations are exceeded. We have the necessary resources and expertise to support the entire diagnostic product development lifecycle, from concept to regulatory approval and beyond. Accelerate time to market for your diagnostics with Element by your side.
To learn more about our diagnostic product development and testing services, or to speak with one of our experts, contact us today.
COVID-19 Diagnostic Test Development
Developers of COVID-19 diagnostic tests trust Element to serve as their nimble and responsive viral diagnostic test development partner.
Pharmaceutical Stability Storage and Testing
Element offers advanced pharmaceutical stability testing and ICH storage services to ensure the maintenance of product quality, safety and efficiency throughout the shelf life.
Small Batch Manufacturing
Product formulation is a unique and highly technical challenge, but Element's experienced chemists can support you on your journey toward product improvement or new product development.
Our Environmental Monitoring programs allow pharmaceutical manufacturers and compounders to measure and monitor cleanliness and contamination levels within their facilities.