When it comes to drug development, ensuring the safety and efficacy of the end product is of the upmost importance. That's where Element comes in. You'll benefit from our extensive experience testing pharmaceutical raw materials, intermediates, excipients, key starting (KSM), finished products, specialty chemicals, containers, and packaging.
Stay up to date with regulatory standards and guidance - and get results that comply with FDA requirements for excipient when you partner with Elements. Together, we'll establish a raw material qualification program tailored to your needs. Plus, we offer method development, verification, and validation as well as analytical method optimization, going beyond compendial methods to ensure the highest quality control standards are met.
Focus on developing and manufacturing safe and effective drug products while we ensure you meet regulatory requirements and industry standards.
Comprehensive raw material, excipient, and container QC and testing services
You need reliable testing services to ensure your products meet regulatory requirements. Leverage our experienced scientists and consultative approach, knowing your products are in good hands. Test raw materials to make sure they meet specifications for use and optimize your manufacturing processes with in-process testing- all while ensuring safety and quality with our comprehensive materials and lot release testing. Plus, you can ensure the integrity of your products with container and packaging testing.
Specialty chemical testing services
Gain a better understanding of the chemical components used in your product development and improve the final product quality. Enhance your manufacturing processes with valuable insights from our team of expert scientists. In regulated environments, you need comprehensive solutions for a wide range of chemical-related challenges, no matter the size or complexity. You can rely on us to cater to all your testing needs with our expertise and technical know-how.
The Element advantage
Ensure the integrity, safety, quality, and purity of small and large molecule drugs with Element’s flexible and comprehensive testing quality control testing programs for raw materials, excipients, and containers tailored to the needs of each unique drug product and therapeutic. Avoid costly delays and overcome challenges with the support of Element’s engaged, consultative team of regulatory and scientific experts.
To learn about our customized approach to controlling the quality of raw materials, excipients, pharmaceutical containers and packaging, or to speak with one of our experts, contact us today.
Comprehensive raw material, excipient, and container QC and testing services
Still researching? Click the links to explore one of our many services to help achieve regulatory approval quickly and efficiently.
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Pharmaceutical Container and Packaging Testing
We provide professional testing services for containers, container closures and pharmaceutical packaging on polymers and glass containers to several pharmacopeia methods, including USP, EP, and JP methods.
Pharmaceutical Raw Material and Finished Product Testing
Our raw material and finished product testing bring peace of mind to manufacturers of drug products ensuring the safety, purity, and quality of both starting materials and manufactured products.
Compendial Testing
ICH, USP, EP, BP and JP monograph tests of raw material, drug substance/product, starting material, cell banks, vectors, bulk harvest and control cells.
Extractables and Leachables Studies
Element's extractables and leachables studies offer tailored solutions that ensure patient safety and compliance with industry standards.