DOSSIER

The DOSSIER Unit of ChemService manages the drafting and filing of registration Dossiers to Authorities for:

AVAILABLE ServiCES

ChemService provides the following consulting services, besides drafting of full or partial Dossiers:

  • Data-gap analysis.
  • Scientific literature research and test on existing data.
  • Testing and registration strategy development.
  • Performing of studies and/or their monitoring.
  • Task Force management for the development and preparation of registration Dossiers. on active ingredients and/or formulated products.
  • Filing of registration documents and Dossiers to Authorities.
  • Contacts and follow-up with Authorities.

Specific TECHNICAL SKILLS

Our services comprise:

  • Scientific litterature research and regular review of available scientific literature.
  • Assessment of human risk: operator’s risk (UK POEM, German model, CHESAR), residents and employees, consumers (EFSA Primo model, CONSEXPO).
  • Environmental risk assessment for all units (aquatic and terrestrial) on all organisms (mammals, birds, insects, non-target, bees, soil organisms, etc.).
  • Models for environmental destination of surface and fail water (FOCUS, etc.).
  • Data gap analysis, and focus of registration strategies with indications of studies to be developed, as well as possible scientific grounds for non-filing of certain studies.
  • In-depth insight and knowledge of in silico (Q)SAR more commonly used methods, such as OECD Toolbox, CAESAR, VEGA, ToxTree, DEREK and of in vitro tests (OECD 437, OECD 438; OECD 439, OECD 431, etc.).
  • Knowledge of the modalities related to the use of "weight of evidence" and "read-across" in regulatory process allows us to optimize the available information and make our services highly competitive as well as ethically sustainable by minimizing the use of in vivo test on vertebrate animals.
  • Scientific monitoring of complex studies like operator’s exposure, determination of leaf residues (DFR), studies with radio-marked elements.
  • Usage of specific software packages for the preparation and the electonic filing of registration  Dossiers: CADDY, IUCLID.

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