Our team provides a broad range of expert services within regulatory affairs.
We prepare dossiers for active substance and product (PPP) registration in the EU and in individual EU countries, either largely independently or in close cooperation with clients (sometimes at their own facilities). We also offer expert regulatory affairs consultation, including advanced services such as liaison between clients and authorities and preparation of strategic position papers.
Our expertise includes standard and higher tier refinements for risk assessments, study monitoring, data (re-)evaluation, literature searches, complex statistical assessments, and the publication of scientific papers.
Regulatory affairs are constantly in flux and we are continuously working to stay abreast of current developments. We also constantly strive to improve our services in this area.
Phone: +49 172 7149572
Phone: +49 173 1845861
Phone: +49 2171 55997 14
Phone: +49 2171 55997 17