Life Sciences

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

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

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

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