Why an experienced SME regulatory consultant is key for non-EU companies

For any non-EU small and medium-sized pharmaceutical company, having a gateway to the European market is crucial. Those companies seeking to take advantage of the European Medicines Agency’s (EMA) SME status will need to work through an EU registered third party, ideally an experienced SME regulatory consultancy. The benefit of having a consultancy for the […]

What is SME Status and how does it benefit innovators?

The European Medicines Agency offers a significant and unique benefit to Small and Medium-Sized Enterprises developing medicines for human or veterinary use. The purpose of SME Status is to promote innovation and the development of new medicines. The SME Regulation, which was established in 2005, led to the creation of the SME office which “provides […]