We're committed to delivering the critical information you need for your regulatory submission
You’ll get the personalized attention and support you deserve when you partner with Element. We treat your goals as our own - and together, we'll evaluate risk and ensure safety and efficacy. Throughout our partnership, you can expect:
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• Extensive E&L databases
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• A deep understanding of materials and chemicals with extensive unknown identification knowledge
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• In-depth pharmaceutical and medical device project experience
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• Lean scheduling to provide additional capacity and address urgent needs
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• Dedicated support from subject matter experts at the forefront of the evolving regulatory landscape
Explore a partnership with Element
Let us know what you're looking for - click the orange "Get more information" button and fill out a short form. A member of our team will be in touch with you. Keep scrolling to learn more about Element's E&L network, and scroll further down for more information about our global E&L capabilities.
The Element E&L Network: Site-specific specialties for standard and customized E&L studies
More than 75 dedicated E&L chemists are committed to safety, quality, and best-in-class customer service. In addition to a range of high-tech equipment and redundancy, our laboratories in North America and the UK are FDA and/or Health Canada inspected, offer GMP and/or GLP, and hold or are pursuing ISO 17025 accreditation. Looking for more information? Keep scrolling to learn more about how Element's E&L experts can help you achieve regulatory approval and comply with regulations.
Get the risk-based E&L data your submission needs
We'll help you navigate the path to regulatory approval with the most efficient, risk-based protocols and fully interpretive reports that include detailed scientific justification for study protocols, goals, testing, and methods. You'll get the data you need - along with scientific justification - in time for regulatory submissions.
We'll help you meet E&L best practices and industry regulations
We'll help you evaluate potential risk when vendors change materials. Our consultative E&L experts will be by your side throughout the product lifecycle, helping you achieve regulatory approval and maintain compliance. Plus, you'll stay up to date with changes in guidelines and industry requirements. Our experts actively participate in working groups that develop E&L best practices including the PQRI, USP Expert Panels, ELSIE and BPOG.
To start the conversation, just fill out a short form and a member of our team will be in touch with you.
Get to know Element
Scroll down to explore a handful of our many services to help you navigate the most efficient path to market, quickly achieve regulatory approval, and maintain compliance to regulations.
Click on the orange "Get more information" button and fill out the form. A member of our team will be in touch with you.
Let us know what you're looking for
Your global partner from discovery to market
Still researching? Here are a handful of our many services to help achieve regulatory approval quickly and efficiently.
Extractables and Leachables Studies
Our extractables and leachables studies offer tailored solutions that ensure patient safety and compliance with industry standards.
Pharmaceutical and Biopharmaceutical Unknown Identification and Impurity Testing
Our experts work closely with customers at every stage of the product lifecycle to identify unwanted compounds and ensure products are pure, safe, and quality.
Troubleshooting and Updating Analytical Methods
Element provides troubleshooting and updating analytical methods services to help you achieve more consistent product quality, more efficient manufacturing, reduce cost and save money.
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.
Forced Degradation Studies
Element’s forced degradation, stress testing services per ICH Q1A guidelines assess the stability of drug substances or drug products with effects on purity, potency, and patient safety.
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.
Elemental Impurity Testing and Analysis
Element’s trace metal laboratories provide expert elemental impurities testing and analysis in compliance with USP and ICH Q3D guidelines to ensure the safety of drugs and drug products.
CMC Product Development Services
Our CMC product development services include formulation development, parenteral and topical product development, microbiology testing services, and consultancy.