Plant Protection
TSGE offers a full regulatory consultancy service to the agrochemical industry.
We prepare and advise on documentation such as completeness checks, endpoint listings and summary dossiers to meet the requirements of the Plant Protection Products Directive 91/414/EEC. For new and existing active substances, TSGE has the expertise to prepare all sections of a summary dossier including consumer exposure, operator exposure, environmental modelling and environmental risk assessments to support applications for Annex I listing. We can also support you in label or formulation changes and can prepare whole or part summary dossiers including biological dossiers. Once Annex I inclusion has been achieved TSGE can prepare Annex III summaries and re-registration submissions across Europe.
Our dossier preparation service also includes copying and submitting of the dossier to the Rapporteur Member State and liaising with national regulatory authorities as the registration progresses.
TSGE experts are also available to provide scientific support and advice on study design, study interpretation and regulatory strategy.
If you would like any further information on our services, please do not hesitate to contact us.