You should not wait until your product is (almost) ready for use before dealing with the marketing authorization process.
THE FORCE is there to help you with all strategic questions right from the start.
The market entry of a pharmaceutical, medical device, or food supplement is complex: lengthy approval procedures, regulations that require careful research, ongoing differences in the requirements of different markets – there are many reasons why challenges can arise on different levels.
At least from a regulatory perspective, however, they can be taken into account in advance and proactively resolved with the right strategy. To ensure that you have the necessary capacities for this, we use our experience to take on:
- The classification of your product: If your product is in the borderline area between medicinal product, medical device, and food supplement, your first step is to define in which class it should be registered. This decision depends not only on the nature of your product but also on the complete strategy, as the consequences range from market access to future communications to the public.
- Developing a marketing authorization or market access strategy for pharmaceuticals: There are different ways to bring your product to market within Europe. Depending on the situation and the product, your medicinal product may be eligible for the central EU marketing authorization procedure or for a national marketing authorization for one or more selected markets. Taking into account all country-specific requirements, we put together the optimal strategy for your medicinal product so that it can be successfully authorized and launched in the target market.
- The development of a market entry strategy for medical devices: For medical devices a wide range of constantly changing regulations must be taken into account as well, as most recently seen with the new Medical Device Regulation (MDR). By considering all directives, standards and regulations as early as possible, we develop a strategy to effectively register your medical device for the respective target market and to avoid later time-consuming and cost-intensive adjustments.
- The advice meetings with authorities or Notified Bodies: We prepare both the scientific advice in the development phase and the procedural advice on an imminent approval procedure. Subsequently, we also take over communication with the competent approval and health authorities or the Notified Bodies.
- The planning and implementation of a marketing authorization procedure or certification: Regardless of whether you want to launch your product in a specifically targeted state or in the entire European Economic Area, we prepare the corresponding process, ensure that all necessary documents are submitted to the competent authorities or Notified Body, and take care of the implementation of the procedure.