“BUILDING DOSSIERS NOT WALLS” Regulatory affairs environment can be very complex depending on the type of product. From our experience medicinal products are on the top of complexity. Many times we also face that certain products are borderline and our knowledge on different types of legislation certainly gives you assurance that your product will be placed on the market under the applicable legislative act. Very important is also establishment of Quality System in Regulatory Affairs, as the regulatory affairs is a key input to all other departments and partners who need the information for production, labelling, monitoring safety and last but not least promotional activities. Many recalls of the products from the market is due to insufficient communication on the last approved status with all stakeholders. We will make sure communication flow in your organisation will be written in the form of intelligible procedure to overcome time and budget consuming hurdles.