Dossier

AGREXIS offers full support with the preparation of all types of regulatory dossiers for agrochemicals and biocides. In compliance with current data requirements, we can guide and support you, from pre-and post-submission meetings with authorities, to writing the dossier and preparing and discussing waivers and rebuttals.

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  • Data gap analysis in light of the latest data requirements
  • Complete analysis of (publicly) available data
  • Literature search and evaluation
  • Data protection evaluation
  • Preparation of dossier and submission
  • Post-submission support (rebuttals, commenting authorities’ assessments etc)

pdf-iconActive substance approval [PDF Download]

  • GAP scoping
  • Regulatory submission strategy and data-gap analysis
  • Preparation and submission of the Product Authorisation Dossier (dRR)
  • Zonal and national dossiers
  • Post-submission support (rebuttals, commenting authorities’ assessments etc)

pdf-iconPPP authorisation [PDF Download]

  • Complete analysis of (publicly) available data
  • Data gap analysis in light of the latest data requirements
  • Literature search and evaluation
  • Data protection evaluation
  • Preparation of product/product family authorisation dossiers, including risks assessments
  • R4BP, national and EU authorisation applications for all Product Types (PTs)

pdf-iconBiocidal Product Authorisation [PDF Download]