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Evaluation

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REACH Study Evaluation & Compliance Management

We possess the expertise and resources to oversee the initiation of new studies in full compliance with EU REACH and REACH-like requirements. Our assistance extends to situations where authorities have identified deficiencies or inaccuracies in submitted dossiers.

Especially in the case of substances presenting significant hazard potential, specific studies are necessary to validate or refute presumed substance characteristics. Authoritative conclusive decisions in such cases have far-reaching implications for all registrants who have registered the respective substance within the volume band that necessitates an additional study according to their regulation requirements.

To efficiently navigate the process of commissioning a new study and, crucially, to harmonize the collaborative efforts of all involved parties, we offer our support in the following areas:

  • Evaluation and review of regulatory decisions, along with strategic planning.
  • Solicitation and assessment of laboratory proposals.
  • Calculation and billing of study fee allocations.
  • Facilitating communication among consortium members, co-registrants, regulatory authorities, and laboratories.
  • Count on our proficiency to ensure meticulous study management, complying with all EU REACH and REACH-like guidelines, and optimizing the coordination of stakeholders in your regulatory endeavors.
  • Technical oversight and monitoring of the study and archive study reports as well.
  • Expert-driven Integration of Newly Acquired Study Findings into the Registration Dossier, performed by our specialists.
  • Cost Sharing and Calculation of Consortium Fees
  • Budget Monitoring
  • Calculation and Invoicing of Letter of Access and License to Use Fees
  • Recalculation and Processing of Reimbursements to Co-Registrants, Data Owners, and Beneficiaries
  • Study Commissioning and Monitoring
  • Preparation of Registration-Required Documents (IUCLID Dossier, CSR, eSDS) offered by our parent company, Chemservice.
  • Partner with us for comprehensive consortium management, ensuring compliance, efficient data sharing, and streamlined administration of your regulatory obligations.