A clear and strategic regulatory strategy is vital to the success of any product development plan. RApport is able to help you define your strategy based on our experience and extensive knowledge of regulatory pathways and guidance documentation. We will advise you on potential inclusion in the PRIME and early access schemes: accelerated approval, exceptional circumstances, conditional approval. Our support will enable you to make a clear decision on your path to approval.
Each product is different. RApport will help you develop strategic tools such as Target Product Profiles and Risk Registers so that you can assess and manage the regulatory risks at each stage of your project. Our support will enable you to stay on the right path, guided by your end vision.
RApport has a special interest in providing small and medium size companies (SMEs) with experienced development support. You may have no or limited internal regulatory support - whatever the case, we can work as an integral member of the internal development team to provide as much or as little support as needed to drive your project forward.
As a European SME ourselves we can help non EU SMEs access EMA support, including advice from the SME office and reduced fees for Scientific Advice and Marketing Authorisation Applications.