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.

Catalent is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world.

With broad, deep-scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is a preferred Contract Development and Manufacturing Organization (CDMO) partner for personalized medicines, blockbuster drugs and consumer health brand extensions.

Catalent helps accelerate over 1,000 partner programs and launch over 150 new products every year. Its flexible manufacturing platforms at over 50 global sites supply over 80 billion doses of nearly 8,000 products annually. Its rapidly growing expert workforce exceeds 18,000, including more than 3,000 scientists and technicians. Headquartered in Somerset, New Jersey, Catalent, Inc. (NYSE:CTLT), is in S&P 500® company, and generated nearly $5 billion in revenue in its 2022 fiscal year.

Cormica: Your Partner in Extractables & Leachables Compliance

Cormica specialises in extractables and leachables (E&L) testing for medical devices and combination products. We help ensure the safety of your products through meticulous analytical methods and a deep understanding of regulatory requirements.

Our E&L Expertise

• Comprehensive E&L Testing: We identify and quantify potential sources of harmful contamination.
• Advanced Characterization: State-of-the-art GC-MS, LC-MS, and ICP-MS techniques for accurate chemical analysis.
• Regulatory Guidance: We help you navigate the complexities of E&L compliance for global markets.

Why Cormica?

• Experience: Leveraging the expertise of our Wickham Micro, MET, and Cormica Bradford Ltd. laboratories.
• Quality: GMP, GLP, and ISO 17025 accreditations ensure reliable results.
• Partnership: We tailor testing strategies to your product's specific needs.

If you have any questions, please reach out to sales@cormica.com

At Cytiva, we envision a world in which access to life-changing therapies transforms human health. With a rich heritage dating back hundreds of years, our wealth of technical expertise and talent, a broad and deep portfolio, and exceptional service help researchers and biopharma advance therapeutics at every stage from discovery to delivery.

Cytiva is part of Danaher,a global science and technology leader. Along with Danaher’s diagnostic and life sciences businesses, we bring an innovative mindset to our collaborations with customers to help them improve patient outcomes.

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.

Kindeva Drug Delivery is a global contract development and manufacturing organization focused on drug-device combination products. We develop and manufacture products across a broad range of drug-delivery formats, including pulmonary & nasal, injectable, and transdermal. Our service offerings span early-stage feasibility through commercial scale drug product fill-finish, container closure system manufacturing, and drug-device product assembly. Kindeva serves a global client base from our state-of-the-art manufacturing, research, and development facilities located across the U.S. and U.K.

Labcorp provides industry leading preclinical medical device safety & efficacy testing, consulting services and risk assessment solutions for medical devices, combination drug delivery systems, pharma container closure systems, and bioprocessing manufacturing systems. Our more than 40 years of offering specialized preclinical testing in areas like biocompatibility, analytical chemistry, microbiology and efficacy & surgical services, supports you and your device technology from the earliest stages of study design and safety considerations through GLP assessments and post-approval revisions. Our 150+ dedicated and highly experienced specialists have deep knowledge of being able to quickly deliver for your preclinical needs. Advance steadily with our regulatory and compliance guidance that will provide you the answers, clarity and confidence required to accelerate the development of your device or product. Leverage our expertise and capacity to handle your preclinical testing needs—however simple or complex. Let’s work together to give your device a healthy start.

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.

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 global MedTech service provider focused on accelerating compliance and market success. Through our unparalleled expertise and industry knowledge, we deliver specialized solutions and expedite the journey along the full product lifecycle for Med Device and IVD companies, from concept to commercialization to post-market.
Our portfolio of services enables the delivery of end-to-end solutions across the complete med device product lifecycle, with our:
• Regulatory and Quality Consulting
• Clinical Trials
• Reimbursement
• Technology Solutions
• Lab Services (Jordi Labs)
With the acquisition of Jordi Labs in 2022, RQM+ Lab Services deliver full lifecycle materials science and chemical characterization capabilities. RQM+/Jordi Labs is often referred to as the 'Gold Standard' in extractable-leachable testing and is held in extremely high regard by the FDA. Our expertise spans from conceptual bench top testing and prototyping through design verification and validation, preclinical testing, and post-market lifecycle management.
Services include:
• Material and Chemical Characterization
• Toxicological Risk Assessments
• Extractable-leachable Analysis
• Biological Evaluations
• Polymer Investigation
• Expert Scientific Consulting Across the Development
Lifecycle and Post-Market Phas

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.

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)

Solvias helps innovative companies advance their path to commercialization with CMC analytical solutions powered by deep scientific expertise and a relentless focus on our customers’ success. With years of expertise in small molecules, biologics and cell and gene therapies, our talented subject matter experts have the know-how, creativity, and tenacity to solve even the most complex analytical challenges.  Solvias offers comprehensive solutions from raw materials to drug products to final release testing as well as API development and manufacturing for small molecules. Customers have a single, trusted analytical partner for their entire development journey.

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.