Our team provides a broad range of support services within regulatory affairs. Core registration support includes dossier preparation (Efate and Ecotox) and close cooperation with clients (sometimes at their own facilities) on projects for the EU registration of active substances and PPPs and registration of products in individual EU countries. We also offer expert regulatory affairs consultation, including advanced services such as registration negotiations between customers and authorities and preparation of strategic position papers. We also address various topics within regulatory science including refinements for risk assessments, data (re-)evaluation, literature searches 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. To this end, we recently performed a comprehensive data analysis of study packages across companies to derive general regulatory advice for environmental safety issues regarding aquatic and terrestrial organisms.
More details about our regulatory affairs support services can be found here.