We have successfully served as Authorized Representative for the biotech, pharmaceutical and medical device companies seeking to market in Europe and for Sponsors seeking to conduct clinical trials with investigational medicinal products in the EU.
If a Sponsor does not have a place of business in the EU, then a legal representative of the sponsor established in the Community must be appointed, in accordance with Article 19 of Directive 2001/20/EC. As your liaison, we communicate effectively with EMA and national competent authorities, and we provide seamless support and regulatory guidance to expedite marketing of your product.