Evaluation Process Management
Companies that have registered substances, where the substances are identified for evaluation by the regulators, requires them to closely follow the evaluation process with full techno-legal justifications and arguments drawn from high-level scientific information and its interpretation. A timely follow-up of the process and a thorough understanding of the evaluation stages are crucial. GPC supports companies to follow-up the evaluation process on their behalf, whereas Reach Akademi toxicologists, eco-toxicologists, environmental fate and chemistry experts, along with chemical safety assessors and legal experts can defend the evaluation process for the company on its behalf.
Reach Akademi evaluation process management covers the
following:
• Evaluation Process Consultation
•
Interaction with Regulators / competent bodies
•
Interaction with other Joint Submission members
•
Action Plan based upon Draft Decision review – Response,
Justifications, Proposals
• Action Plan based upon
Final Decision review – Study, CRO monitoring, Cost-sharing,
Dossier update
• CRO Management & Monitoring
•
Study interpretation & Endpoint summary
preparation
• Update of Chemical Safety
Assessment
• Follow-up with regulators on the closure
of Evaluation process
