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Evaluation Process Management

Business Development and Business Intelligence Intern

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

Management & Representation
Preliminary Compliance Submissions
Annual Compliance Management

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