Build a coherent, traceable and defensible dossier
MCARE supports companies in preparing, reviewing and following up plant protection product registration dossiers.
The objective is not merely to gather documents, but to verify that data meet requirements, that sections are consistent and that claimed uses are properly supported.
From administrative requirements to scientific data
The intervention level depends on dossier maturity and applicable requirements.
Framework & strategy
Needs qualification, requirement identification, schedule, data sources and gap matrix.
Active substance
Identity, physico-chemical properties, methods, toxicology, ecotoxicology, environmental fate and residues.
Formulated product
Composition, properties, classification, efficacy, selectivity, uses, safety and label consistency.
Gap analysis
Document inventory, reference verification and identification of missing data.
Structuring
Section organisation, summary tables, summaries and links between studies and claims.
Consistency control
Verification of rates, uses, crops, formulations, conclusions and labelling elements.
Follow-up
Response preparation, technical additions and client support during evaluation.
Clear documentation reduces regulatory risk
A strong dossier quickly shows what is provided, the origin of each data item, the conclusions retained and how they support the requested uses.