Reliable, uncomplicated market authorisation.
The comprehensive support offered by PhytoLab begins with brainstorming and continues through the subsequent product and method development stages, right through to registration and market authorisation. The registration procedure demands special know-how relating to quality, efficacy and safety, particularly where plant-based products are concerned.
We draw up high-quality marketing authorisation dossiers that are tailored to the specific requirements of our customers all over the world. If products contain active constituents which are in accordance with the definition of "well established medicinal use", we prepare the medical expertise on the basis of bibliographic references with substantiation from various sources as and when applicable, whereby PhytoLab's pharmaceutical service experts coordinate all of the pharmacological, toxicological and clinical tests and trials required for your product.
We then complete the marketing authorisation dossier, ready for submission to the regulatory authorities, including the analytical report. We can also prepare your application and draw up draft information documents (label for the container, patient information leaflet, summary of product characteristics).
Our modular service spectrum gives you a complete overview of all of the stages involved in a registration process. You can either take advantage of the complete full-service package or contract our services for individual stages.
