American Elements is the world’s largest manufacturer of engineered and advanced materials with a catalogue of 35,000 products including specialty chemicals and salts, laboratory reagents, catalysts, additives, solvents, organometallic compounds, inorganic pigments, and coating materials for commercial and research applications including automotive, aerospace, military, medical, electronic, and green/clean technologies. We specialize in the properties, applications, and cost effective manufacturing of advanced materials, including ultra high purity refining and nanoscale materials which allows us to meet the needs of global research, laboratories facilities, all U.S. and many foreign national laboratories, universities throughout the world, and customers in a wide range of industry fields.

Aspen Research Laboratories is a contract research organization that is known for superior understanding of materials science, and analytical testing. Our ISO 17025 accredited laboratory offers materials characterization, method development, design and execution of extractables and leachables studies, and challenge testing for recycled plastics intended for use in food contact. Our experienced and highly qualified team of scientists collaborates with pharmaceutical, medical device manufacturers, single use suppliers, packaging companies and many other industries to solve challenges and expedite product development.

Boston Analytical is a cGMP compliant, FDA/DEA registered, ISO/IEC-17025:2005 certified analytical laboratory located in Salem, NH. Boston Analytical provides testing services to Pharmaceutical, Biopharmaceutical and Medical Device companies worldwide including Analytical Testing and Method Development, Microbiological Testing and Environmental Monitoring Services, Biologics, Stability Testing & ICH-compliant Storage, Impurities Testing and Extractables & Leachables Studies.

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

Element is little more than a decade old, but can trace its origins back to 1827. With roots based in industrial testing and measurement  in the Victorian era, Element businesses have been involved in materials and product testing that gave the world the Model T ford, put Concorde into the skies and has helped keep Venice afloat. 

Element was formed in 2010, after a management buy-out of the testing division of the Netherlands-based Stork Engineering Group, backed by 3i Group plc. Starting with 860 people in 27 laboratories, the Group has grown dramatically in the last ten years, as many organisations have moved their testing requirements to specialist providers.

Instem - Technology Solutions & Outsourced Services for Computational Toxicology

Our leading computational toxicology products and services, originally developed by Leadscope Inc., and now part of the Instem solution portfolio, are helping organizations around the globe to unlock valuable knowledge contained in both public and proprietary sources of research data.

Our computational toxicology solutions support a variety of applications including the ICH M7 pharmaceutical impurities guideline, assessment of extractables and leachables, and classification and labelling.

Leadscope Model Applier: Easy-to-use software to apply prediction models, perform an expert review, and create insightful reports.

Predict™ In Silico Tox Service
A technology-enabled service delivering fast, efficient, comprehensive in silico toxicology predictions

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.

The World’s Leading MedTech CRO Offering Global End-to-End Development Services.
 
Driven by our regulatory expertise and in-depth therapeutic knowledge, NAMSA has assisted thousands of MedTech Sponsors make a positive impact to healthcare since 1967. Today, our team of global Associates delivers market-leading Contract Research Organization (CRO) services to Clients in all major markets of the world. NAMSA provides unparalleled medical device testing capabilities, strategic guidance and tactical support to fast-track market introduction and commercialization. From concept to post-market, we are proud to fully support Clients through the delivery of exceptional outcomes throughout every stage of the MedTech development continuum.

Why Choose Nelson Laboratories

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 800 laboratory tests and employing more than 500 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.

It's where the magic happens, where our experts thrive, and where we help propel our clients' products crucial steps closer to entering the market. We're proud to be a trusted partner to leaders in the pharmaceutical and life sciences industry, and to play an integral role in bettering the lives of the global community. We'd love to show you what we offer, and what we're capable of.

Our labs are equipped with a cutting-edge IT infrastructure that runs our pharmaceutical enterprise-grade applications, servers, and backups in accordance with the highest security, performance, and regulatory standards, including Data Integrity. They also feature an extensive range of equipment that's constantly upgraded to deliver the highest level of testing diversity and quality our clients depend on.

Pacific BioLabs is a contract research organization (CRO) offering testing and research support services primarily focused on supporting the pharmaceutical (small molecules), biopharma (large molecules), and medical device industries. Serving companies from local to global, our clients range from small biotech and medical device startups to Fortune 500 pharmaceutical giants.

As an independent family owned and operated CRO, Pacific BioLabs, strategically located in the San Francisco Bay area, is committed to providing the highest quality GMP, GLP, and non-regulatory in vivo, in vitro, microbiology, and analytical testing services. In contrast to big-box CROs, we deliver results abiding by the most demanding timelines with the personalized and flexible service our clients have come to expect.

Pacific BioLabs – The Service Leader in Life Sciences Testing – delivering personalized client service for over 40 years!

PPD, part of Thermo Fisher Scientific, 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. 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 full-program 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.

Twitter: @PPDCRO

RQM+ is a leading MedTech CRO with the world’s largest global team of regulatory and quality experts. Building upon 40 years of regulatory expertise, we also provide comprehensive laboratory testing, product development, reimbursement strategy and clinical trial services – reducing risk and supporting market access throughout the entire product lifecycle for medical devices, digital therapeutics and diagnostics. With more former FDA, Medicines and Healthcare Products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ team has deep expertise in all clinical specialties. RQM+ currently works for eight of the top 10 medical device manufacturers and seven of the top 10 IVD companies.

SafeBridge has a unique team of occupational and environmental toxicologists, industrial hygienists, chemists and safety and environmental professionals with extensive experience inside the pharmaceutical industry. SafeBridge provides professional consulting services and analytical support to clients across the United States and internationally including the United Kingdom, Ireland, continental Europe, the Middle East, Asia and Canada.

Are you looking for an efficient contract research service provider for your Bioanalytical, Preclinical, Phase I-IV, or CMC analytical needs in the area of small and large molecules, peptides, proteins, biomarkers, controlled substances and more? From small molecule bioanalysis to large molecules, in vitro studies, & more, Sannova continues to grow with the new areas of pharmaceutical science. Sannova works with clinical organizations around the world to complete your studies in smooth coordination. With varied and specialized equipment, Sannova is able to handle a wide range of your CMC needs with the utmost focus on quality.

We are the world’s leading testing, inspection and certification company.

We are recognized as the global benchmark for quality and integrity. Our 96,000 employees operate a network of 2,700 offices and laboratories, working together to enable a better, safer and more interconnected world.

Wherever you are, whatever your industry, our experts worldwide provide specialized solutions to make your business faster, simpler and more efficient.

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)

Thermo Fisher Scientific is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner, and safer. Through our Thermo Scientific brand we help customers accelerate innovation and enhance productivity.

Producers of bio/pharmaceuticals are challenged to become more efficient in discovering and developing candidate drugs while ensuring quality and increasing manufacturing productivity. Thermo Fisher Scientific has innovative solutions to support every stage of the bio/pharmaceutical process, from discovery through to production and QC. We offer cutting edge instruments, software, and consumables to monitor and control extractables and leachables during your research and production. 

The study of extractables and leachables helps to ensure that products we use every day are safe and free of undesired contaminants. A range of analytical workflows and techniques are required for comprehensive impurity profiling, including; sample preparation, gas or liquid chromatography mass spectrometry, inductively coupled plasma mass spectrometry, and other complementary detection techniques such as Charged Aerosol Detection (CAD) and UV. Thermo Fisher Scientific has an extensive portfolio for comprehensive impurity profiling of pharmaceuticals to support your compliance testing.

Our deep understanding of the challenges faced by scientists developing lifesaving medicines allows us to forge partnerships that bring next generation drugs to market faster. Partner with us to accelerate your research and optimize your extractables and leachables analysis.

Learn more  https://www.thermofisher.com/us/en/home/industrial/pharma-biopharma/pharma-biopharma-learning-center/pharmaceutical-qa-qc-information/extractables-leachables-information.html?CID=E.22CMD.PB106.06783.01

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WuXi AppTec has a state-of-the-art analytical chemistry laboratory, along with experienced scientists, chemists, and toxicologists, located in St. Paul, Minnesota. Our extractables/leachables team partners with our customers to support product safety with regulatory consulting, pre-clinical testing, and post-commercialization product testing support.  Our regulatory and technical experience with active participation and/or leadership on global committees allows us to anticipate regulatory trends.  Our chemistry program driving principle is complete chemical characterization.  This is our standard of practice as our chemists work closely with our toxicologists, who write the chemical safety assessment of each chemical identified in the chemistry report, to provide the most mass-accurate data and virtually no unknowns in our chemistry reports.  Our technical and regulatory experts advise on test design and strategies for test plans while working closely to account for the product, indication, and patient population.  Furthermore, we stand behind our work – from test plans through clearance – responding to questions or other regulatory requests as part of the submission process.