Services

With its many years of experience, the AGREXIS team can support you effectively at all stages of registration of agrochemicals  and biorationals within the EU.

Regulatory Fitness

  • Data gap analysis
  • Registrability / Re-registration assessments / Preliminary risk assessments
  • Data protection and access
  • Second opinion
  • Pre-submission meetings

Regulatory Strategy & Management

  • Task Force management
  • Due diligence
  • Data sharing
  • Regulatory management
  • Public & Government Affairs

Dossier

  • Chemical active substance approval / renewal
  • Biorationals
  • Product registrations
  • Pre-submission meetings
  • MRL submissions
  • Technical equivalence


Regulatory Science &
Product Safety

  • Completeness and compliance of data set
  • Preliminary risk assessments
  • Complete coverage in risk assessments
  • Study design and monitoring
  • Modelling
  • Literature search and review
  • Peer reviews


Efficacy

  • Registration support services
  • Data gap analysis
  • Trial planning and monitoring
  • Data compilation


Project Management

  • Project plan
  • Project execution and communication

Task Force Management

  • Chair and secretary of task forces
  • Project execution and communication
  • Covering regulatory/scientific as well as administrative aspects
  • Financial administration
  • Representation of clients in task forces
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