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.

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.

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.

 

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)

Waters Corporation, the world's leading specialty measurement company, has pioneered chromatography, mass spectrometry and thermal analysis innovations serving the life, materials and food sciences for more than 60 years. With approximately 7,000 employees worldwide, Waters operates directly in 35 countries, including 15 manufacturing facilities, and with products available in more than 100 countries.