aca24@aca-pharma.de/

+49 341 33 73 33 60

Project initiation and management

  • ◦ Consortium foundation/administration
  • ◦ Strategic advice and consulting
  • ◦ Cost management
  • ◦ Time scheduling
  • ◦ Inquiry dossier

Data acquisition/evaluation

  • ◦ Substance sameness/similarity evaluation
  • ◦ Data base search/data gap analyses
  • ◦ Testing program generation
  • ◦ Testing facility selection
  • ◦ Alternative testing strategies
  • ◦ Justified waiving
  • ◦ Study initiation and monitoring

Dossier preparation and registration services

  • ◦ IUCLID data entry
  • ◦ PBT/vPvB assessment
  • ◦ DNEL/PNEC derivation
  • ◦ Risk assessment/exposure scenarios
  • ◦ Chemical safety assessment/chemical safety report
  •    (CSR)
  • ◦ Technical dossier compilation

Downstream user (DU) services

  • ◦ Analysis of rights and obligations of DU
  • ◦ Alignment with extended safety data sheet
  • ◦ Scaling
  • ◦ Development of exposure scenarios
  • ◦ DU CSR, DU report
  • ◦ Communication with ECHA
  • ◦ SVHC communication obligation support
  • ◦ Classification and labelling according to CLP (GHS)
  • ◦ Inhouse seminars concerning uses/eSDS compliance

Third party services

  • ◦ Protection of client identity and confidentiality

Only representative services

  • ◦ Registration services and communication with ECHA
  •    for non-EU companies

 

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