Our services include:
Registration and Re-Registration Support
We integrate industry-leading scientific lab work and our deep experience in international regulatory requirements to help you meet and understand the complex regulatory requirements for your products.
- Analysis of regulatory requirements for agrochemicals, biocides and biopesticides
- Data gap analysis and proposal of testing strategies for your products
- Development of a regulatory approach that is focused on the fastest route-to-market
- Study monitoring and project management
- Dossier preparation and post-submission follow-up
- Development of waivers and weight of evidence arguments
Risk Assessment & Evaluation
We will guide you so that you procure reliable and defensible data for both standard and higher-tier risk assessments so you can prove that your products meet the regulatory safety requirements.
- Toxicology and human health risk assessment (operator, worker, bystander and consumer)
- Environmental fate and simulation modeling
- Assessment of the risks of exposure to non-target organisms (ecotoxicology)
- Risk evaluation and development of mitigation strategies
Dossier Submission & Defense
Let our experts help you move through your new registration or re-registration confidently. We give you expert advice and consulting services so you can focus your resources on the core regulatory issues for the approval of your product.
- Pre-submission meetings with key regulatory agencies and their experts
- Negotiation of registration strategies with national agencies and EU Rapporteur Member State (RMS)
- Replying to post-submissipon queries
- Admendments to existing approvals
- Follow-up through the entire evaluation process