Meeting regulatory criteria for testing and reporting can be a difficult process, especially for new product development. Our team at Dynamic Biosciences can provide the scientific services with appropriate documentation to meet your needs.
We have experience studying a range of compounds and materials, using AOAC and USP certified methods. In addition, we have developed novel analysis with appropriate rigorous testing to satisfy FDA regulatory needs.
We have experience with analytical processes to satisfy ICH/ISO guidelines and recommendations through USP and/or AOAC methods to meet your regulatory needs (FDA/USDA). These include a range of projects from drug stability studies, molecular quantification, water testing and microbial analysis.
GMP Pharmaceutical Stability Studies
Drug stability studies through ICH informed process allows us to provide your company with commercial stability studies, batch release and quality control testing. Stability studies are critical to your product development, manufacturing, and for FDA compliance. They can represent a variety of technical hurdles, such as a range of environmental conditions under constant observation, range of molecular analysis from active pharmaceutical ingredient to extractable contaminants, and BSL2 level microbial contamination.
A range of expertise is necessary to support all levels of your analysis and development. At Dynamic Biosciences we leverage our team of PhD trained scientists with backgrounds in chemistry, molecular biology, microbiology, and pharmaceutical analysis.