Registration of Plant Protection Products in EUROPE

Writing of the complete dossiers in EU under regulation (EC) No. 1107/2009

• Approval / renewal dossiers (using IUCLID) for your active substances
• Registration / renewal dossiers (at dRR format) for your products including risk assessments and the B.A.Ds
• B.A.Ds. (Biological Assessment Dossiers), detailed and concise draft Registration Report, Section 3. Agronomical and physiological explanations added

Risk assessments

• Risk Assessments covering Operator, Worker, Bystander, Resident, Consumer, Environmental and Ecotoxicological exposures for each active substance and the concerned metabolites
• Risk assessment management for multiple scenarios (for one or more active substances and the relevant metabolites, for all zones and for several crops/uses) using EFSA, PRIMo, ESCAPE, PERSAM and FOCUS models (STEPS 1-2, PELMO, PEARL, GeoPEARL, SWASH, MACRO, PRZM, TOXWA, SWAN) and where applicable, national and zonal models

Regulatory strategy in EU

A complete study of regulatory strategy concerning countries (zones), uses, and RMS, thanks to an attentive listening concerning your own business strategy

Pre-evaluation & feasibility studies (Data Gap Analysis)

• Data gap analysis of your projects, with an adapted feasibility study, a proposal of the best strategies and of a global financial project plan
• Data Matching: preliminary analysis to determine the list of relevant protected active substance data and writing of the Data Matching
• For New active substances, detailed research to anticipate relevant regulatory problems
• Financial study and business plan

Assistance for all the administrative steps

• Assistance for all the administrative steps to follow via the EFSA platform (declarations, notifications of studies, communications, pre-submission advices…)
• Communications with the Rapporteur Member State (RMS) chosen for the active substance to plan a program of submission/evaluation
• Notification of the registration dossiers to the zonal Rapporteur Member States (zRMS) and the concerned Member States (cMS)
• Regular contact with EU authorities to follow the approval, the renewal and the registration processes until the European Commission and Ministerial decisions (following-up of your projects)

Scientific assistance

Management and co-ordination of GLP studies and GEP trials, choice of CROs, validation of protocols, analysis of interim and review of final reports

Personal services, adapted to your strategy

• Mutual Recognition dossiers (art.40 application), Label extensions, Generic dossiers (art.34 application), Parallel trade permits (art. 52 application), Efficacy trial permits, Second trade name dossiers…;
• Technical equivalence dossiers for your new sources of active substances;
• Comparative Assessment dossiers for your Products containing Active Substance(s) listed as Candidate(s) for Substitution (CfS);