
Develop Full Technical Dossier
Companies may take a lead position to register a substance, or may want to submit an opt-out dossier, wherein a wide range of expertise and competencies are required. In such a situation,GPC has a dedicated team of highly qualified and experienced professionals who have the capability to develop full Technical Dossier and Chemical Safety Assessment reports.
GPC’s model for technical dossier preparation involves:
• Detailed research on relevant existing information
• Acquiring existing (qualified) data
• Seeking permission to use scientific literature
• Prepare robust study summary
• Identify areas where wavers may be applicable
• Identification of data gaps
• Identification of Read Across
• Managing and Monitoring of New Studies (where required)
• Final checks – dossier completeness and compliance
• Submission via IT system