51³Ô¹ÏÍøhas 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.
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.
Pharmaceutical Testing Services
Element’s pharmaceutical laboratories provide specialized pharmaceutical testing services on a wide range of products, from raw materials to finished products, including but not limited to:
- Characterization
- Formulation development
- Microbial testing
- Sterility testing
- Stability studies
- Elemental impurity testing
- 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
We also provide USP <71> sterility and rapid sterility testing options, USP <797> support for compounding facilities and environmental monitoring services.
Why choose Element
Element’s global network of pharmaceutical laboratories offers a broad spectrum of pharmaceutical development and testing 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. We work in partnership to accelerate development and minimize your costs by providing accurate and independent assurance of safety and performance.
Please visit our About Us page to learn more about Element’s credentials. Contact an expert today to discuss how we can support your Pharmaceutical testing needs.
Our Services
51³Ô¹ÏÍøhas one of the most comprehensive ranges of materials testing and qualifications services for the Pharmaceutical industry.Â
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.
Environmental Monitoring
Our Environmental Monitoring programs allow pharmaceutical manufacturers and compounders to measure and monitor cleanliness and contamination levels within their facilities.
Pharmaceutical Method Development and Research
51³Ô¹ÏÍøprovides a full suite of pharmaceutical method development and research services to bring your products to market at optimal speed.
Compounding PharmaciesÂ
We provide USP <797> and cGMP FDA compliance expertise and testing solutions for home infusion, pharmacies, hospital pharmacies and human drug outsourcing facilities.
Pharmaceutical X-Ray Diffraction
51³Ô¹ÏÍøis 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.
Raw Materials and Excipient Testing
51³Ô¹ÏÍøhas 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.
Drug Discovery and Development
Discover active drug candidates faster and accelerate time to market with Element's integrated CDMO services platform that supports the entire development lifecycle.
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
51³Ô¹ÏÍøoffers comprehensive materials testing capabilities to provide you with the guarantees you need for safety, quality, and performance.
Disinfection Qualification
51³Ô¹ÏÍøoffers Disinfection Qualification studies for the pharmaceutical industry and Disinfectant Efficacy studies for the antimicrobial industry.
Trace Metal Services
51³Ô¹ÏÍøis 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 medical product testing to help your product reach the market sooner and with safety and quality built in.
Microbiological Development and Quality Control Testing
Our microbiology lab provides microbiology testing services and quality control for a variety of drug products, ensuring they are safe, quality, and compliant with relevant regulatory standards.
API Manufacturing
You'll benefit from a single CDMO partner throughout the product lifecycle, starting with the identification of synthetic routes for early-phase API supply, through small-scale commercial API supply.
Analytical Testing Services
We offer a comprehensive array of analytical testing services and expert scientific consultancy from our GMP/GLP and ISO/IEC 17025 accredited laboratories, to meet the needs of clients across the life sciences sector.