Reliable Material Characterization Services for Biological Risk Assessment Complete materials characterization in accordance with ISO 10993-1:2018 plays a critical role in evaluating your medical device’s biological safety. We support testing to determine critical physical and chemical information based on the materials of construction, the nature and duration of body contact, and what safety and toxicology […]
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Reliable Combination Product Development The demand for sophisticated drug-delivery devices and combination products continues to drive novel product development and innovation within the medical device industry. We understand that the convergence of drugs and devices bring exciting new opportunities, business, and a host of new challenges and regulations. Our team offers the experience and expertise
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Comprehensive Analytical Services Analytical methods using an appropriate testing scheme are essential for the effective characterization and evaluation of pharmaceutical drug products. The data informs critical decisions about the safety, purity, and effectiveness of your products and materials. We offer a comprehensive selection of sources for analytical methods to support your testing needs, including compendial
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Empowering Your Success Through Trusted Microbiology Testing Ensure the safety and effectiveness of your pharmaceutical, biopharmaceutical, or medical device product with our reliable microbiological lab testing services. With a strong focus on GMP compliance and industry standards, we prioritize accuracy in every microbiology test we perform. Our experienced professionals offer tailored solutions aligned with USP/NF,
Maintain Quality Control with Functional & Performance Testing Ensure patient compliance and effective drug delivery of your intended dosage form by evaluating its physical properties. From the more subtle and qualitative attributes like visual appearance and mouth feel to the measurable performance of hardness, friability, and disintegration, our team helps evaluate numerous factors about your
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Complete Elemental Testing for Trace Metals & Impurities Comply with quality control standards by leveraging our analytical services to monitor label-claims and demonstrate control of trace-level elemental impurities. Our team provides full-service GMP laboratory capabilities to assess the levels of elemental impurities in your raw materials, in-process formulations, and finished pharmaceutical or medical device products.
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Chemical Characterization to Ensure Product Safety Utilize our comprehensive approach towards chemical characterization to identify extractables and leachables. These compounds may be organic or inorganic in nature, typically from devices which contain additives. These additives include materials such as lubricants, accelerators, monomers, and high molecular weight oligomers from incomplete polymerization, and residual solvents. Extractables may
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Ensure Safe & Effective Manufacturing with Reference Standards We support the development and application of reference standards in a manner that considers the unique requirements of your materials and processes. These standards play a foundational role in determining quantitative data, qualitative data, and calibration, which are critical to achieving scientifically valid results. Our team is
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Reliable Stability Studies & Shelf-Life Testing Enhance the shelf life of your drug product and ensure regulatory compliance with our stability testing and storage services. Our team manages state-of-the-art laboratories equipped with stability storage chambers mapped and continuously monitored using a validated, continuous monitoring system. These facilities fulfill requirements for stability studies, shelf-life testing, and
Comprehensive Finished Product Testing and Batch Release Services Ensure your finished product meets critical specifications consistently. Our team is dedicated to verifying the production of your drug product, maintaining its intended use, quality, and performance characteristics. Despite the increasing complexity of therapeutic molecules, derived from diverse synthesis processes, we possess the expertise and infrastructure to