American Preclinical Services (APS) is an AAALAC and ISO17025 accredited, USDA registered and GLP compliant Contract Research Laboratory specializing in medical device and pharmaceutical testing. By utilizing our catalogue of services, which include regulatory consulting services, ISO10993 biocompatibility testing, analytical services, interventional & surgical research, toxicology, pharmacology, physician training and bioskills, and complete pathology services, you will be able to develop and conduct a full preclinical program, all under one roof.  Learn more by contacting us at www.americanpreclinical.com.

AMRI, a global contract research and manufacturing organization, partners with the pharmaceutical and biotechnology industries to improve patient outcomes and quality of life. With locations in North America, Europe and Asia, AMRI’s team combines scientific expertise and market-leading technology to provide a complete suite of solutions in Discovery, Development, Analytical Services, API Manufacturing and Drug Product. We’ve got it down to an exact science.

Aspen Research Corporation is a premier contract research organization that provides analytical services and materials R&D. Our  ISO 17025 accreditation and GLP program enable the company to be at the forefront of extractable and leachable studies, food contact notification studies, method development and pre-clinical support studies. Aspen partners with biotech, pharmaceutical and medical device industries to deliver the support that is needed for product development and regulatory submission.

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The U.S. Food and Drug Administration and European Medicines Evaluation Agency (EMEA) have expressed concerns over potential toxicity and efficacy effects of chemicals released into drug products through exposure to components used in manufacturing and packaging. These chemicals are referred to as Extractables and Leachables (E&L). Accurate and definitive E&L studies should be performed in compliance with USP, ICH, PQRI, and ISO 10993. All E&L studies by Daicel Pharma Services are conducted in their US-FDA audited analytical facility and fully support regulatory compliance. Daicel Pharma Services offers GMP Analytical Services with comprehensive Extractable and Leachables Studies and GMP Stability Studies. Daicel’s Extractable and Leachables studies test a large number of packing materials, manufacturing systems, and drug products, as well as offer Glass Delamination studies to meet the demanding testing specifications of regulatory authorities. Learn more at www.daicelpharmaservices.com

Intertek’s global network of laboratories is designed to exceed our customers' expectations with innovative Assurance-Testing-Inspection-Certification services for their operations and supply chain.  Our Whitehouse NJ laboratory is an FDA and DEA registered cGMP compliant facility with expertise in Method Development/Validation, Stability, Trace Organics, Elemental Impurities, and QC Testing.

Performing an E&L study is an important part of verifying the safety of a medical, pharmaceutical or packaging product.

Design of an E&L study requires an understanding of the materials used in the construct of the product and the expected use conditions. E&L studies are best conducted using an analytical strategy which is formed by expectations of potential extractables, and which has sufficient breadth for discovery of unexpected components. The laboratory which conducts the study must have sufficient expertise in unknown identification to properly leverage information from multiple techniques, databases and control experiments to allow for positive unknown identification. They must also have the breadth of instrumentation which allows for analysis of a wide range of potential analytes. Finally, they must also be experts at analytical method development utilizing this knowledge to develop quantitative methods for the components identified.

Jordi Labs specializes in the analysis of plastics and has the experience and knowledge to make your E&L study a success. Jordi partners with our customers to develop and execute E&L studies empowered by over 30 years of analytical experience and state of the art instrumentation.

MilliporeSigma, life science leader, is a business of Merck KGaA, Darmstadt, Germany. Our products and services to help you safely and efficiently develop and manufacture therapeutics. Our BioReliance Validation Services accelerate and simplify your path to market by selecting, testing and validating the filters, assemblies, and single-use systems for drug manufacturing processing.

Every year, hundreds of medical device, pharmaceutical, and tissue companies make Nelson Labs their testing laboratory of choice. For them, the decision is easy. Nelson Labs is a clear leader in the microbiology testing industry, offering more than 700 laboratory tests and employing more than 700 scientists and staff in state-of-the-art facilities. We are known for exceptional quality and rigorous testing standards, but it’s our focus on the bigger picture that sets us apart. We look beyond test results and partner with you to achieve your long-term business goals — mitigating risk, being first to market, and succeeding with your customers.

Companies choose Nelson Laboratories for our:

• Thought leaders and approachable experts. We give you direct access to industry authorities who understand your business and add value every step of the way.
• Customer-centric culture. We take the time to understand your vision. Your goals become our goals.
• Real-time project management tools and a dedicated client portal. We provide proactive information, keeping you informed and in control.
• Metric-driven testing processes. We're our own toughest customer, holding ourselves to goals exceeding 99% for things that matter most to you, like quality, turn-around time, and testing accuracy.
• Global compliance expertise and support. We act as a trusted advisor, helping you navigate the ever-changing compliance landscape.

See how we can help you mitigate risk, be first to market, and succeed with your customers.

Next Breath, a cGMP compliant laboratory, offers focused analytical development services for injectable delivery systems.  Our team engages with customers to define the characteristics of elastomeric component that are best suited for your drug product. We will assess functionality for intended use, extractables and leachables, and physical chemical compatibility. We provide dedicated support for migration studies with placebo or active drug to help you identify potential leachables and to optimize your formulation. Next Breath keeps progress moving forward through stability studies, regulatory approval and post-market approval. For more information, please visit our website: www.nextbreath.net

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 46 countries and approximately 23,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development and optimize value in delivering life-changing therapies to improve health.

The dedicated and highly specialized extractables and leachables (E&L) team in the PPD® Laboratories GMP lab has more than 15 years of experience providing comprehensive support for all aspects of E&L studies, including overall study design/consulting, container/closure selection as well as manufacturing process qualification and validation. Our E&L team and toxicology experts work with clients to make informed decisions on which extractable compounds will be monitored as leachables in long-term stability studies, development of extractable and leachable methods, leachable stability testing, batch extractables testing and USP compendia testing support.

Primera Analytical Solutions is a cGMP and GLP contract analytical laboratory in great standing with the FDA. At Primera, quality and client satisfaction are our primary objectives. We strive to excel at a broad number of services such as Method Development and Validation, Impurity Studies to include Genotoxic Impurities (LCMSMS, GCMS, ICPMS), Extractables & Leachables, Stability and Photostability Studies, Dissolution Studies, Abuse-Deterrent Studies, Product Release Testing, Method Transfers, Inhalation Products, and Raw Material Testing. In addition, our scope of services extends to Bioanalytical and Biopharmaceutical Testing.

Our Bioanalytical Group is highly experienced in PK/PD, Metabolite Characterization, Bioavailability and Bioequivalence Studies. Our Biopharmaceutical Group is adept at Bioassay Method Development and Validation, Impurities by ELISA, Anti-Drug Antibody Assays (ADA), peptide mapping and so much more. Our expert team strives to provide you with both timely reports and a level of service unsurpassed in our industry.

SafeBridge Consultants, Inc. is the premier resource for high-level safety, health and environmental support to the pharmaceutical and biotechnology industry. SafeBridge is comprised of industry leaders in health-based risk assessment, toxicology, industrial hygiene and industrial hygiene analytical services. Since 1998 SafeBridge has developed the "brand name" in the pharmaceutical industry as a leader in the field of advanced worker protection and product protection programs for active pharmaceutical ingredients and drug products. SafeBridge has its primary locations and offices in Mountain View, California, New York City, Exton, Pennsylvania  and Ware and Liverpool, England.

Toxikon is a leading preclinical contract research organization (CRO) providing in vivo, in vitro, and analytical testing services for the pharmaceutical, biotechnology, and medical device industries – helping those companies gain approval for their products quickly and bring them to market successfully. We deliver exceptional product development services from concept to final product.

VR Analytical is a leading Extractables and Leachables contract research organization, and is actively involved in the development of industry best practices and interpreting regulatory expectations as the E/L science has evolved. VR Analytical develops and offers customized test packages that bio/pharmaceutical end users and suppliers need to mitigate the potential risk of E/L substances reaching patients, and to help companies prepare for regulatory submission. For more information, visit www.vranalytical.com

Waters Corporation, the world's leading specialty measurement company, has pioneered chromatography, mass spectrometry and thermal analysis innovations serving the life, materials and food sciences for more than 60 years. With approximately 7,000 employees worldwide, Waters operates directly in 35 countries, including 15 manufacturing facilities, and with products available in more than 100 countries.