Our analytical laboratory allows us to provide our clients with evidence on how the quality of a drug varies with time under the influence of a variety of environmental factors including temperature, humidity, and light. Our laboratory supports our testing capabilities, allowing us to conduct robust studies and provide ideal storage conditions.
Our testing capabilities encompass virtually any drug formulation including sterile and non-sterile solutions, tablets, capsules, and more. Our stability testing supports short- and long-term programs, depending on the needs of our clients. The results of our stability testing provides us with information that allows us to establish a re-test period, shelf-life, and storage recommendations.
Our stability storage chambers are continuously monitored by a state-of-the-art network of computer modules and cameras, supported by backup systems, to provide and maintain optimal conditions for our clients' products.
Our goal is to create safe, effective, high-quality medicines for our clients and the end-user. For that reason, we ensure ICH guidelines are followed throughout the process of stability testing. The purpose of stability testing programs is to ensure a drug product’s safety and efficacy remain within its specifications throughout the shelf-life. Through our many years of experience, we have developed analytical methods that detect and quantify the degradation of products. This capability allows us to develop new solutions for our clients.
Our DEA (C2-C5) and FDA certified facilities have the capacity to handle new drug entities, technology transfers, and scale-ups in one-centralized location from concept to commercialization. Our continuous commitment to confidentiality and timeliness has allowed us to build not only a commercial partnership, but a relationship with our clients.