The studies are essential for the approval of an active substance and / or product.
These studies must now be conducted according to Good Laboratory Practice (GLP). This will be done internally if your company has GLP and technical resources, but most often externally in a Contract Research Organisation (CRO).
Prior auditing of laboratories and rigorous monitoring of studies are both necessary for their successful implementation: discussion about the concept and associated costs, verification of the study plan and its compliance with the appropriate guideline (EC, OECD , EPPO, EPA), contacts with the Study Director, follow-up of the results and verification of the successive versions of the report until the final report is published.
Staphyt Regulatory team has a long experience in monitoring and auditing all types of studies. Our team has already inspected most of the European and several American contract laboratories.
We offer our experience and support to monitor all kind of studies for a registration dossier: physico-chemistry, analytic methods, toxicology, environmental fate and ecotoxicology.