Testing stability, or shelf-life, is an important requirement in determining products strength, purity, and quality until the end of claimed shelf-life or product expiry date. Studies can go as long as 5 years, and can be conducted at different intervals, from a few hours to multiple years. Completion of assay, dissolution, and impurities studies are both time consuming and expensive in pharmaceutical and also necessary stabilty tests to be performed for nutraceutical and cosmetics products to ensure product quality throughout product life-cycle.
In many cases, businesses do not have the resources or expertise to conduct these long-term testing of products, and are forced to seek third party laboratory services. Third party laboratories often stick to the exact service requested from clients, regardless of any changes. Considering the complexity of many long-term studies, professional guidance is necessary in managing and taking ownership of stability studies . Since regulatory authority always sugeest that product manufacturer/Product owners are responsible to maintain and ensure product quality in the market hence it is required that Product manufacturers understands the importance of stability studies and required regulations before proceeding to offer such services to contract testing laboratories.
Krins Life Sciences associate team members and service partners have extensive experience in stability studies, both organizationally and individually. Krins has the resources to successfully deliver short and long term stability studies service support, all for a fair price.