“The “regulatory” is today undisputable integral part of any bio medicinal scientific project and the role is continuously increasing. The regulatory needs to be today understood as strategical pillar of project success – as new scientific discoveries facing a lot of challenges created by regulatory rules from the beginning of the process till the placing on the market. The demand for strategic approach and early assessing of regulatory approaches is very important in the translation value chain – as the regulatory is often identified as one of the risk factors creating delays and extra costs. “