Life Sciences

Phase Appropriate Analytical Method Development & Validation Prepare your program for its next phase of development with our robust and adaptable analytical methods. Our team supports analytical method development and method validation across the entire development and commercialization timeline. We approach each project with clear considerations of your current progress and phase requirements to achieve […]

Enable Strategic Development with Solid State Characterization Identify your drug substance’s important compound characteristics with our preformulation support. As part of preclinical development, solid form screening facilitates prototype deliverability and defines the optimal formulation composition through comprehensive active pharmaceutical ingredient (API) insights. We determine the physicochemical properties of APIs with a combination of characterization techniques.

Identify Physicochemical Properties During Preformulation Achieve a rational and streamlined pharmaceutical preformulation process by understanding the physicochemical properties of your compound. Our team’s physicochemical characterization testing helps you make informed decisions about drug substance selection, and achieve effective process development and manufacturing design of both drug substance and drug product. Our approach to understanding physicochemical

Comprehensive Analytical Method Management Leverage our comprehensive analytical method transfer, method validation, and maintenance services to support your drug products and medical devices. Analytical testing is a foundational activity throughout every phase of pharmaceutical and medical device development and commercialization. Our team provides reliable, responsive support for managing analytical methods throughout your product’s lifecycle. We

Achieve Compliance with Reliable Cleaning Validation Minimize manufacturing downtime with our meticulous cleaning validation. We analyze surfaces for potential contaminants to ensure your processes maintain compliance. Whether your program is developing new processes, expanding product lines, or remediating previous methods, our expert team offers support at any phase. From API or detergent residue to each

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