Risk Assessment & Regulatory Support

It is nearly impossible to make sound decisions without quality data. But how can you move forward with your new product if you don’t have solid risk assessment information? Battelle can determine what data you need to make effective risk management decisions in all key areas. 

We work with our clients to ensure their regulatory compliance strategy is cost effective and provides the best platform for a positive outcome. We use state-of-the-art computer modeling to support the development of key regulatory decisions. Meet our experts.  

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

We can help you understand and reduce your risks and move through the registration process with confidence. Battelle offers a full range of regulatory services to help you get your agrochemical and biocide products to market quickly and efficiently.