Element’s pharmaceutical laboratories provide specialized pharmaceutical testing services, including environmental monitoring, characterization, formulation development, microbial, sterility, stability and elemental impurity testing on a wide range of products, from raw materials to finished products.
Innovation and globalization are creating exciting new opportunities for the prescription drug, biologics, nutraceuticals, and medical device industries. With the natural ambition to bring new products to market safely, quickly and cost-effectively comes a requirement for world-class pharmaceutical testing to demonstrate compliance with ever-expanding regulatory requirements.
Element has a proud track record at the forefront of pharmaceutical testing. With over 150 pharmaceutical experts worldwide, we understand the demands of the global pharmaceutical sector, supporting your needs as your product moves from prototype to finished product.
We work in partnership to accelerate development and minimize your costs by providing accurate and independent assurance of safety and performance.
Serving customers worldwide
Element’s global network of pharmaceutical laboratories offers a broad spectrum of pharmaceutical development and testing services. Our core services include analytical method development; batch release; Active Pharmaceutical Ingredients and raw material analysis and characterization; organic and elemental impurities determination; plastics and polymer testing; biological sample testing; analytical test in support of pharmacokinetic, pre-clinical and clinical trials; and stability studies. We also provide USP <71> sterility and rapid sterility testing options, USP <797> support for compounding facilities and environmental monitoring services.
We recognize that no two challenges are the same, tailor solutions to meet your individual needs, and ensure that you are consulted at every stage of the pharmaceutical testing process.
Extractables and Leachables Studies
Element's extractables and leachables studies offer tailored solutions that ensure patient safety and compliance with industry standards.
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.
Our Environmental Monitoring programs allow pharmaceutical manufacturers and compounders to measure and monitor cleanliness and contamination levels within their facilities.
Element’s comprehensive bioanalytical testing services are dedicated to bringing industry-leading scientific expertise to help customers advance drug development programs.
Pharmaceutical Method Development and Research
Element provides a full suite of pharmaceutical method development and research services to bring your products to market at optimal speed.
We provide USP <797>, USP <800> and cGMP FDA compliance expertise and testing solutions for home infusion, pharmacies, hospital pharmacies and human drug outsourcing facilities
Pharmaceutical X-Ray Diffraction
Element is a leader in the field of X-ray Powder Diffraction (XRPD) analysis, with over 30 years of experience in the global pharmaceutical market. Let our scientists guide you on your journey to find advanced solutions for your challenging projects.
Excipient Raw Materials and Container Testing
Element has comprehensive capabilities that can be applied to the testing of excipient, raw materials, and pharmaceutical containers, enabling you to ensure the quality and safety of your product.
CMC Product Development Services
Our CMC product development services include formulation development, parenteral and topical product development, microbiology testing services, and consultancy.
Material Sciences Testing
Element offers comprehensive materials testing capabilities to provide you with the guarantees you need for safety, quality, and performance.
Element offers Disinfection Qualification studies for the pharmaceutical industry and Disinfectant Efficacy studies for the antimicrobial industry.
Trace Metal Services
Element is a recognized world-leader in trace metal analysis, providing testing for elemental impurities by ICPOES and ICPMS in compliance with USP, EP (2.4.20), and ICH Q3D guidelines.
Medical Product Testing
With a clear understanding of your markets, regulations, and challenges, we provide our expertise and experience with cGMP, GLP, ISO/IEC 17025 testing to help your product reach the market sooner and with safety and quality built in.