If you think compliance is expensive - Try non-compliance.

If your product is intended or already has been evaluated as eligible for the EMA Centralized Procedure (CP) and you are an entity out of the EU meeting EMA SME criteria, we can be your representative in front of the EMA and help you get your SME status in the EU.

If you are medical,  in vitro, or digital device manufacturer, based out of the EU, we can be your European Authorised Representative (EAR) and Person Responsible for Regulatory Compliance (PRRC) following MDR & IVDR Article 15 and represent you in front of EUDAMED. 

If you have a medicinal product eligible for EU National (NP), Decentralized (DCP), or Mutual Recognition (MRP) Procedure in one or more Member States (MS), be aware that there are countries with strong local requirements, such as Croatia, France, Hungary, Poland, or Slovakia. But,  we have a strong local network and can liaise you with all these authorities.

The U.S. agent must either reside in the U.S. or maintain a place of business in the U.S. 

The responsibilities of the U.S. agent are limited and include: assisting the FDA in communications with foreign establishments & assisting the FDA in scheduling inspections of foreign establishments. Our extended team members in the US can support you.