Reliable and Timely Batch Testing Ensure timely turnarounds and clear communication with our lot release testing services. Our testing team has extensive experience performing cGMP batch release testing on a diverse range of drug products. Whether your product is a small molecule, biologic, nucleic acid-based therapeutic, or combination product, we have the knowledge and expertise […]
Custom Analytical Methods, Testing, & Verification We recognize that every scientific endeavor is unique, which is why we take pride in offering tailor-made analytical solutions that align with your project’s unique objectives. Our commitment to precision and innovation sets us apart as your choice laboratory for custom analytical testing. Our seasoned team of analytical experts
Trusted Compendial Testing to Global Standards Ensure your raw materials and drug product meets global standards with our compendial testing services. Compendial standards define the quality, purity, strength, and identity of pharmaceutical raw materials and finished products. These standards are established and maintained by authoritative pharmacopoeias or compendia organizations, which differ between countries. Compendial testing
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Ensure Compliance with EO Sterilization Validation Evaluate the efficacy of your sterilization procedures using ethylene oxide by partnering with our team for testing support. We support EO sterilization validation using ISO 10993-7 guidance so your processes comply with regulatory requirements and ensure quality compliance. Many medical devices require some form of terminal sterilization and often
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Expert Microbiology for Medical Devices Meet the latest regulatory requirements and safeguard patient safety with medical device microbiology testing performed by our team. We provide guidance on determining the most appropriate testing procedures for your product and manufacturing procedures. Our bioburden, BI, sterility, and endotoxin testing services are powered by our unique and specialized knowledge
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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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