Biopesticides & BioControl Agents
Exponent’s considerable team has extensive experience gained both as consultants and from previous working experience in the crop protection industry, regulatory authorities and Contract Research Organisations. This gives us an excellent mix of skills and perspectives to deliver advice and services on regulatory strategy, technical challenges and dossier preparation.
Exponent can provide a complete and tailored service to support the registration of bio-control agents, including:
- Development of regulatory strategy and technical assistance including data gap analyses, preliminary and higher tier risk assessments and submission scoping;
- Placing and monitoring studies needed to support product registration;
- Regulatory dossier preparation for national, EU or global submissions including study summaries, risk assessments, regulatory overviews and position documents;
- Classification and labelling support including the preparation of submissions on harmonised classification and labelling;
- Preparation of efficacy / biological dossiers in appropriate formats;
- Preparation of literature reviews in line with EU requirements using our internal Library Services;
- Pre-submission support when dealing with regulatory authorities at EU member state level, the EU Commission, EFSA and ECHA;
- Post-submission support and liaison with regulatory authorities to help clients to navigate the regulatory process through to conclusion;
- Task Force management;
- Production and submission of dossiers in electronic formats such as CADDY and IUCLID.