Life Sciences

Expert Characterization Testing Services Protect patient safety with our characterization techniques. Characterization testing supports patient safety by evaluating medical devices or packaging for any materials in potentially hazardous quantities for the intended exposure. Chemical characterization provides the data necessary to identify extractable and/or leachable compounds present in a medical device or, in the case of […]

Accurate Microbial Identification Testing Ensure your program stays ahead of huge risks, including time-consuming inventory recalls and jeopardized patient safety, with our microbial identification services. Our team has years of experience performing analytical testing on various drug substances, drug products, and medical devices. We apply the highest level of quality and attention to detail to

Validate Your Sterilization Process with Confidence Achieve peace of mind in your biological indicator testing requirements with our expert guidance. Biological indicator testing is essential to prove your sterilization process effectiveness, but the evaluation procedure is often challenging with certain products due to design or sterilization requirements. Biological indicators are used in the validation, performance

Ensure Safety and Compliance Particulate Matter Testing provides a total count of the number of visible or subvisible undissolved particles in your liquid injectable pharmaceutical or biopharmaceutical product. Our team performs these counts using laser diffraction instrumentation (USP <788>, Method 1) or through visual observation under a microscope (USP <788>, Method 2). USP Subvisible Particulate

Bacterial Endotoxin Testing for Product Safety and Compliance Ensure the quality of your products with our endotoxin testing services. Endotoxins are a type of bacterial toxin known to cause serious illness, especially in people with weakened immune systems. Bacterial endotoxin testing (BET) is crucial to uphold the quality and safety of your products. Our experts

Ensure Product Safety and Compliance Ensure product safety and safeguard your patients with our sterility testing. Our comprehensive sterility testing services adhere to pharmaceutical, biopharmaceutical, and medical device industry standards by following the guidance from the United States Pharmacopoeia USP <71> and ISO 11737-2. Our technical teams have extensive experience and demonstrated proficiency with a

Ensuring Antimicrobial Efficacy and Quality of Your Products Evaluate the ability of your preservative system to prevent and control microbial growth in your formulations with our Antimicrobial Effectiveness Test (AET) services. This service is also sometimes referred to as the Preservative Effectiveness Testing (PET). There is a risk of microbial contamination when manufacturing sterile and

Validate Product Safety & Process Efficacy Ensure the quality of your starting materials and the safety of your pharmaceutical and medical device products by assessing the microbial levels present and confirming absence of pathogens. We have expertise in a wide range of raw materials and product dosage forms. Our experienced microbiologists work closely with you

Informative Freeze Thaw Stability Testing Prepare your product and packaging for freeze thaw cycling with stability studies powered by our expert team. The various environmental conditions your product is exposed to during shipping and storage have the potential to compromise overall stability and return it to the base state. Our team helps you predict possible

Diverse Stability Storage Conditions Enhance the stability testing and stability storage of your drug product and ensure regulatory compliance with our support. Our team manages state-of-the-art laboratories equipped with fully secured stability storage chambers that are mapped and continuously monitored using a validated, continuous monitoring system. These facilities follow ICH guidelines to fulfill your requirements