Drug development process
Drug development is activity regulated by authorities, and it progresses in phases from preclinical and clinical studies to the application for marketing authorization. When the application for marketing authorization is submitted, the authorities assess the risk-benefit ratio of the drug. In order to be granted a marketing authorization, the drug must be both safe and efficient.
Drug development is divided into the preclinical phase and the clinical phase, which is further divided into sub-phases. In the preclinical phase, new drug candidates and indications of their clinical safety and efficacy are studied in laboratory and animal tests. When sufficient documentation exists on preclinical phase, it is possible to apply for permission to perform clinical tests. The harmful effects and safety of the drug are systematically monitored even after the marketing authorization.
Pharmaceutical research and development is inherently to a certain extent unpredictable and the development has a long span. Oftentimes plans must be adjusted during projects. Our R&D expertise and the chosen business model make it possible to enter into licensing agreements with international pharmaceutical companies within the next few years.