Rapid Response Services
Element's Rapid Response team cater to your time-sensitive analytical needs with bespoke investigatory analysis of pharmaceutical products.
Available to our European, Middle East and Asian clients, our Rapid Response solutions cover a wide range of analytical needs from impurity characterization, to investigational problem-solving, and comprehensive analytical method development & validation.
Our capabilities cover all aspects of pharmaceutical and consumer healthcare product testing, boasting cutting-edge instrumentation and expertise to help customers resolve complex issues efficiently.
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Extractables & Leachables Studies
Element has one of the largest and most experienced extractables and leachables (E&L) practices in the world.
Backed by regulatory expertise, extensive experience, and a vast extractables database, our comprehensive E&L solutions ensure the safety of materials used across the healthcare sector.
We deliver tailored studies for pharmaceutical, biologic, medical device, reduced risk, combination products and more, in accordance with regulatory expectations.
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Extractables and Leachables Studies
Element's extractables and leachables studies offer tailored solutions that ensure patient safety and compliance with industry standards.
Medical Device Testing
As a comprehensive testing partner, you’ll enjoy the benefit of a single supplier source for all of your testing needs, from mechanical testing and environmental simulation to EMC and wireless device testing.
Pharmaceutical Testing
Element’s pharmaceutical laboratories provide specialist pharmaceutical testing services, including chemical, physical, microbial, and stability testing on a vast array of products, from raw materials to finished products.
ISO 18562 Testing: Biocompatibility Analysis
Element provides ISO 18562 biocompatibility analysis for respiratory and ventilation devices to support global device approval.
USP 665, 1665 and BPOG Services
Ensure compliance for single-use systems (SUS). Our testing services provide high-quality results, safeguarding patient safety, fulfilling your regulatory requirements, and expediting time to market.
Excipient Raw Materials and Container Testing
Find out how we make certain that quality and safety of your excipient raw materials and containers are maintained.
Chemistry, Manufacturing, and Controls (CMC) Consulting Services
We provide consulting services for Chemistry, Manufacturing, and Controls (CMC) product development in the pharmaceutical and biotechnological industries.
ICH Stability Testing of Pharmaceuticals and Biologics
We'll help you develop comprehensive stability programs that meet ICH Q1A-F requirements for IND, ANDA, and NDA approvals of small and large molecule drugs.