Dossier

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

  • Complete analysis of available data
  • Pre-submission meeting
  • Literature search and evaluation
  • Data protection evaluation
  • Preparation of dossier and electronic submission
  • Post-submission support

Biorationals are a very diverse group of agricultural inputs and require tailor-made solutions.

  • Biostimulants covered under Regulation (EU) 2019/1009 on EU fertilizing products
  • Biopesticides (microorganisms, plant extracts and pheromones) are regulated under (EC) No. 1107/2009

AGREXIS can offer the following services in order to ensure success of your regulatory project

  • Analysis of (publicly) available data
  • Data gap analysis in light of the latest data requirements
  • Literature search and read-across from published data
  • Definition of scenarios
  • Bridging and waivers
  • Pre-submission meetings
  • Preparation of dossiers, including risks assessments
  • Advice and monitoring of a 5-Batch study
  • Quality check of an existing 5-Batch report including method validation data to ensure regulatory compliance
  • Calculation of proposed technical specification based on 5-Batch data
  • Preparation of application documents including submission to the competent authorities
  • Follow up of the technical equivalence procedure with preparation of additional requested data
  • Performing (Q)SAR analysis for prediction of (eco-)toxicological properties of impurities
  • Assessment of the new source in view of EU reference source
  • GAP scoping
  • Regulatory submission strategy and data-gap analysis
  • Preparation and submission of the Product Authorisation Dossier (dRR)
  • Biological Assessment Dossier
  • Zonal and national dossiers
  • Post-submission support (rebuttals, commenting on authorities’ assessments etc)
  • Full review of proprietary and unprotected residue data
  • Assistance in the definition of a time- and cost- effective testing program if needed
  • Monitoring of any studies needed (residue trials, processing studies, animal feeding studies, etc.)
  • Preparation of all necessary documentation for the MRL application, including application form, overview document and a dossier containing all supporting data
  • Post submission work, including communication with authorities and writing rebuttals

css.php