NFL Biosciences has developed a particular expertise in the development of botanical drugs, and has built up a solid network of partners with the required expertise.
Botanical drug development often begins with the empirical observation of a plant’s therapeutic properties, which can help increase the chances of success in subsequent efficacy demonstration studies. Initially, a complete understanding of the mechanism of action is not required. As development progresses, knowledge of this mechanism deepens.
Development stages include pre-clinical studies, as well as phase I, II and III clinical trials to demonstrate safety and efficacy. The manufacturing of botanical medicines must also comply with specific production and quality control regulations. Marketing authorizations are issued by regulatory agencies such as the FDA in the United States and the EMA in Europe, which require similar criteria for demonstrating safety and clinical efficacy to those for synthetic medicines.
The whole process aims to ensure that botanical medicines offer effective and safe therapeutic solutions, drawing on both empirical observation and scientific rigor in order to improve patients’ quality of life.