Efficacy and Biological Assessment Dossiers
We provide comprehensive efficacy assessment and regulatory support with a particular focus on plant protection products.
Our work covers the scientific evaluation, interpretation and documentation of biological performance data required to support product authorisation, renewals, extensions and amendments.
A core area of expertise is the preparation and review of Biological Assessment Dossiers (BADs). We compile and evaluate efficacy trial data, assess whether the available evidence supports the intended uses and claims, and translate complex biological data into clear, scientifically robust and regulator-ready conclusions.
Our expertise includes efficacy against target organisms, crop safety and phytotoxicity, effects on succeeding and adjacent crops, resistance-related considerations, assessment of use patterns and GAPs, and the evaluation of rates, timings and application conditions. We also support extrapolation and bridging approaches, data gap analysis and the development of scientifically justified strategies where the available dataset requires refinement.
Beyond dossier preparation, we establish or review trial programmes, including the monitoring and management of field and greenhouse trials, and existing efficacy datasets with regard to regulatory adequacy, consistency and practical relevance. This includes identifying weaknesses at an early stage and supporting the efficient integration of biological data into the wider product authorisation strategy.
Where relevant, we also provide efficacy-related scientific assessments and expert input for biocidal products and other regulated product areas, adapting the evaluation approach to the applicable regulatory framework and intended product claims.
Our efficacy work combines regulatory experience, biological expertise and a practical understanding of product use to provide clear, robust and defensible assessments for regulatory decision-making.
