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

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.

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 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.

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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“VR Analytical is a leading provider of extractables and leachables (E&L) testing services. We offer customized test packages that bio-pharmaceutical end users and suppliers need to mitigate the potential risk of E&L substances reaching patients. Using a science-based, partnership-driven approach, and supported by one of the industry’s largest extractables databases, we help our customers find the most efficient paths to regulatory approval. Our knowledge of the E&L regulatory landscape is based on years of direct contribution to the industry, through participation in standards setting organizations, and presentation of novel research conducted in our lab.

As a global company with operations across Asia, Europe, and North America, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable global pharmaceutical and healthcare industry to advance discoveries and deliver groundbreaking treatments to patients. Through its unique business models, WuXi AppTec's integrated, end-to-end services include chemistry drug CRDMO (Contract Research, Development and Manufacturing Organization), biology discovery, preclinical testing and clinical research services, cell and gene therapies CTDMO (Contract Testing, Development and Manufacturing Organization), helping customers improve the productivity of advancing healthcare products through cost-effective and efficient solutions. WuXi AppTec received AA ESG rating from MSCI in 2021 and its open-access platform is enabling more than 5,600 collaborators from over 30 countries to improve the health of those in need – and to realize the vision that "every drug can be made and every disease can be treated."