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