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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