Extractables and Leachables USA sponsors and exhibitors are leaders in the field who present innovative products and services to an audience of industry professionals and decision makers.
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.
Extractables and Leachables Studies at Daicel Pharma Services
Understanding complex chemical interactions is critical to designing a proper extractables and leachables program. Examples include migration from container closure systems, manufacturing components or delivery devices into pharmaceuticals and biologics.
Daicel Pharma Services has over ten years of experience in designing and managing large customized E&L studies with the goal of submitting data for FDA review and approval. Daicel is familiar with guidelines from organizations such as the FDA, ISO, ICH, BPOG, and USP. Our capabilities include:
Daicel Pharma Services offers innovative analytical solutions to support timely and safe drug development with improved cost efficiency. Our GMP facilities are FDA compliant and offer a full suite of solutions including stability studies, microbiology, peptide and biologics.
Whether your project requires full or supplemental support, we have the experience and flexible service options to meet your needs, on time and within budget.
Jordi Labs specializes in the analysis of medical devices, pharmaceutical packaging and food contact applications. We have 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 more than 4 decades of analytical experience and state of the art instrumentation. Our lab is ISO 17025:2017 accredited and we offer cGMP compliant services when required.
PPD Laboratories provides high-quality science with industry-leading technologies supported by a commitment to exceptional quality. Our customers benefit from comprehensive lab services spanning bioanalytical, biomarkers, GMP, central lab testing and vaccine sciences. Our laboratory services accelerate pharmaceutical development for small molecules, biologics, vaccines and cell and gene therapies, allowing customers to make faster decisions about their compounds.
From the everyday consumer to scientists in the laboratory, we all rely on accurate information to make critical decisions. Waters Corporation is the world's leading specialty measurement company focused on improving human health and well-being through the application of high-value analytical technologies and industry leading scientific expertise.
For more than sixty years, Waters has continually pioneered chromatography, mass spectrometry and thermal analysis innovations under a variety of brands including Waters, TA Instruments, ERA, VICAM, and Andrew Alliance. Whether it’s discovering new pharmaceuticals, assuring the safety of the world’s food and water supplies, or ensuring the integrity of a chemical entity in production, we are constantly working with our thousands of customers to change the world.
With a global workforce of more than 7,400 employees, Waters operates in 35 countries, including 14 manufacturing facilities and with products available in more than 100 countries. Our diverse organization is well-positioned to Deliver Benefit through innovations that enhance human health and well-being.