Approval and authorisation support for plant protection products under Regulation (EC) No 1107/2009 and other national frameworks, in Europe and internationally: dossier preparation, testing and submissions.
*Dossier Preparations
Preparation of regulatory dossiers for plant protection products, including plant growth regulators
*Data Gap Analyses (DGA)
Analyses of data gaps in PPP submissions and how to close them
*International Uniform Chemical Information Database (IUCLID)
IUCLID dossiers for PPP (e.g. Summary of Product Characteristics, SPCs)
*Applications and Exchanges with Authorities
Applications and follow-up with authorities for PPP approvals and authorisations
*Risk Assessments (RAs)
Risk assessment and modelling for PPP: environmental fate, ecotoxicology, metabolites and residues
*Global Efficacy Services
Simulated-use and field testing for PPP
*Efficacy Coordination and Monitoring
Coordinated and monitored efficacy testing for PPP, including Good Experimental Practices (GEP)
*Coordination and Monitoring of Laboratory Testing
Phys-Chem regulatory support and study monitoring for PPP laboratory testing, including Good Laboratory Practices (GLP) and non-GLP testing
*Study Monitoring of all types and Dossier Monitoring
Monitoring of regulatory studies and dossiers for PPP, from protocol to final report
*ED Assessments
Endocrine disruption assessments for PPP
Contact us to discuss your PPP dossier