Exponent has considerable experience in the preparation and submission of dossiers for new and existing active substances in the European Union. Many of our staff have held previous posts as European regulators including involvement in expert groups and drafting of guidelines for Directive 91/414/EEC. We also have the benefit of experience in working in contract research and also for a range of agrochemical companies providing a unique combination of regulatory experience, practical study design and monitoring which is enhanced by a commercial awareness. Our multi-disciplinary team can provide a complete service in dossier preparation for submissions at EU or Member State level including:
- Preparation of dossiers for new active substances (or specific sections of dossiers if required).
- Support of existing substances in the context of the EU Review Programme including preparation of re-submission dossiers for active substances that have been voluntarily withdrawn from the review process.
- Annex III dossiers for re-registration of products post-Annex 1 inclusion.
- Annex III dossiers for new products or to support label changes and/or formulation changes.
- Biological assessment dossiers summarising efficacy and crop safety data to a format acceptable to the target Member State(s) to support new or re-registrations.
Our service can include data gap analyses for active substances or products, set-up and monitoring studies, compilation of all required documents (including CADDY) and the conduct of exposure and risk assessments. Furthermore, we have excellent contacts with the EU regulatory authorities which can be put to good use representing our clients when providing post-submission support.