Dossiers and Documentation

With ZIETA extended service offering, we are in a position to assist in the following

  • Skeletal dossiers – Chemical and IUCLID5
  • REACh compliant IUCLID5 document from IUCLID4 document
  • Confirmatory analytical laboratory testing, including the identification of chemical unknowns and impurities.
  • Chemical Safety Assessment (CSA), an essential component of Chemical Safety Reports (CSR)
  • Expert advice on requirements for toxicological and eco-toxicological testing required for the chemical safety assessment.
Member Dossier

A member dossier is created from a complex and extensive collection of data into IUCLID 5.2

The typical member dossier would contain the following
  • Information from manufacturing facilities
  • Analytical test results (Existing or New test data)
  • Chemical structure and its properties
  • Information from lead registrant regarding C&L
  • Token Number (Letter of Access)
Our process

ZIETA has developed a extensive set of tools and process to create a member dossier. Every dossier is audited internally by a team of experts before being presented to the client.

Our process involves following but not limited to
  • Discovery of SIEF & Consortium status and lead registrant’s information
  • Communication with the lead registrant to capture the cost exposure of our Client
  • Gather all the pertinent information for member dossier from lead registrant
  • Creation and review of SIEF report with REACh Manager
  • Finalize the direction for substance registration at each legal entity level
  • Communication and collection of data from all manufacturing facilities for site specific information
  • Creation and evaluation of IUCLID 5.2 pertaining to sections of Member dossier
  • Coordination between lead registrant and Client to get the LR token and dossier
  • Final review and submission of IUCLID 5.2 to Client

or more information please contact us by phone or by email to sales@zietatech.com

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