Dossier Defence

  • Review and commenting of authorities‘ assessments at EU and national level
  • Expert statements
  • Risk refinements
  • Expert discussions and negotiations with authorities

Dossier Preparation & Submission

  • Active substance dossiers for EU approval
  • Product dossiers for national / zonal registration / union authorisation
  • Efficacy dossiers
  • Preliminary or stand-alone risk assessments and exposure estimates
  • Expert statements
  • Modelling and development of exposure scenarios
  • Definition of MRLs
  • Full documentation including electronic formats
  • Dossier submission and archiving

Organization of Data Packages

  • Identity of substance: physical and chemical properties
  • Analysis of substance in plant, soil, water, body fluids and tissues
  • Efficacy and residue programmes across the EU; one-study concept
  • Environmental fate studies including all kinds of field studies as well as monitoring programmes and higher tier modelling
  • Toxicology: all relevant in-vitro and in-vivo studies
  • Ecotoxicology: terrestrial and aquatic non-target organisms, micro-/ mesocosm and field studies

Check of Completeness

  • Evaluation of data gaps according to latest regulatory requirements
  • Project plan / strategy proposal for completion of data package and dossier preparation (incl. cost and time estimates)

General Consultancy & Project Management

  • Regulatory and scientific consultancy
  • Assistance during product development and the registration process
  • Selection of contract laboratories
  • Contracting studies
  • Study monitoring
  • Contacts to registration authorities within the EU, CIS countries and the Americas
  • Regulatory updates
  • Task Force / Consortium management