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.

Boston Analytical offers full Extractables & Leachables testing for the Pharmaceutical, Bio-Pharmaceutical, Medical Device, and Consumer Products industries. Extractables & Leachables in drug products have become an area of concern to patient safety and to the FDA. We have staff with vast experience working directly with the FDA to address concerns and demonstrate drug product safety. Our processes adhere to ISO 10993, USP <661.1>, <661.2>, <1663>, <1664>, <1664.1>, as well as industry best practices from the Product Quality Research Institute (PQRI) and BioPhorum Operations Group (BPOG).

EKG Labs is an analytical laboratory that supports medical device and pharmaceutical companies seeking to fast-track their product development. We excel at providing analytical and regulatory services which enable our clients to fulfill complex regulatory requirements and bring their product to market faster. EKG Labs leverages its wealth of medical device and pharmaceutical knowledge to provide a variety of research and development services including:

• Extractables and Leachables
• ISO 10993 Chemical Characterization
• Impurity Identification
• Elemental Impurities
• Method Development
• Method Validation

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.

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. 

Leadscope Inc., (an Instem Company) produces high quality QSAR models and databases.  Our Model Applier meets all the requirements of ICH M7 Guidance on testing for impurities.  Our consensus prediction incorporates the statistical QSAR models; expert alerts results and experimental data.  Additional classification models are available for skin sensitization, irritation and corrosion and acute toxicity.

 

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.

GMP Lab E&L Capabilities

GMP Lab Experience and Expertise

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Smithers offers a range of testing services for the medical and pharmaceutical industries, helping clients demonstrate compliance to specifications set by the
FDA, EMA, USP, ASTM, and ISO. Our services include:

• Pharmaceutical and Medical Device Extractables & Leachables analysis
• Drug Delivery Device and Accessories Testing
• Healthcare Product and Packaging Validation
• Support Demonstrating Regulatory Compliance
• Materials Selection, Characterization and Testing

COMMON CONTAINER AND DEVICE PLATFORMS

• Closure Technologies and Accessories (Pre-fillable Syringes, Cartridges, Vials, Caps, Stoppers, Plunger Stoppers, PFS Back-stops, Needle Safety Accessories, Needles)
• Finished Handheld Injectors (Auto-injectors; Pen Injectors, Prefilled Syringes, Safety PFS, etc.)
• Needle-Free Injectors
• On-body Injectors (Patch Pumps, Large Volume Injectors)
• Specialty Injectors (Microneedles)

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.