Over the past twenty years, Grove’s regulatory affairs consultants have provided expert advice and guidance to clients across the Central and Eastern European region. Questions addressed have covered the following areas and more:
‘Due to the registration pathway (repeat-use MRP) in Central and Eastern Europe, could you (Grove) assess the registration risks for us in Poland, Romania, Czech, Hungary, Slovakia, Slovenia, Croatia, Estonia, Latvia and Lithuania. We would also like you to evaluate the potential impact on our currently registered product’s SPC and identify any likely future developments.
Please provide us with strategic advice with regards to the likelihood of successfully registering our products in all ten countries. What do we need to do in terms of risk mitigation and/or other activities to maximize the probability of successful registration?’
‘We recognize that there is significant business growth potential in Poland. We would like Grove to undertake a market research study so that we are able to gain a better understanding of the size of the multiple sclerosis market, the number of patients, currentMS drug treatments and the potential for our new MS medicinal product. Furthermore, we would ask Grove to provide us with insight in the following areas: hospital tenders; full supply chain and wholesale distribution for MS products; competitor insights.’