Why work with a pesticide regulatory consultant?
The regulatory landscape for pesticides and biopesticides is complex. Without the help of an internal or external pesticide registration consultant, it can be difficult to navigate the regulatory maze to know what data you will need for seamless dossier preparation and submission. Data gaps can lead to costly delays in getting your product to market and/or keeping it there.
Our team of pesticide registration consultants consists of regulatory specialists with expertise in chemistry, residues and metabolism, environmental fate, ecotoxicology, and human toxicology. We bring comprehensive knowledge of global regulatory frameworks, pesticide testing, and dossier preparation and submission to make your program a success. You can benefit from our well-established industry links with governing bodies, industry colleagues, and working groups to stay informed on any regulatory changes and to keep programs compliant and on schedule, easing the burden on your team.
What Our Pesticide Registration Consultants Offer
Our support can be tailored to your requirements. We can provide services up to a full package to optimize your internal resources, reduce time to market, and manage multiple testing programs, ensuring seamless coordination between testing and regulatory needs. We can operate as subject-matter experts in your interactions with regulatory authorities. Our activities include, but are not restricted to:
- Regulatory and scientific consultancy regarding testing strategy and study design
- Literature searches
- Data gap analysis and data matching
- Consultancy regarding EFSA Guidance on water treatment processes, including the assessment of the formation of water treatment transformation products ( tTP) and hazard/risk assessment of tTP
- Writing of scientific and/or regulatory documents (e.g., expert statements, position papers, justifications on decisions, manuscripts for peer-reviewed journals)
- Justification for technical equivalence
- Preparation of robust study summaries in IUCLID and OECD
- Evaluation of Quantitative Structure-Activity Relationship (QSARs) and read-across for metabolites, impurities, etc. (including DEREK, SARAH, Leadscope, OECD Toolbox, ECOSAR, and others)
- Human risk assessment and derivation of safe exposure levels
- Toxicological qualification of impurities
- Evaluation of physico-chemical properties and analytical methods
- Support in substance identification
- Environmental exposure modelling (design, strategy, and refinement)
- Environmental hazard and risk assessment
- Assessment of endocrine-disruptor properties (ED)
- Higher tier exposure modelling and risk assessments
- Classification and labeling (CLP and CLH)
- Preparation of safety data sheets (SDS)
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Our pesticide regulatory consultants can take care of the procedure for the registration or renewal of your active substance or plant protection product, partially or entirely, depending on your needs. Our consultants offer:
- Project coordination/management and study monitoring
- Contacts with regulatory authorities (e.g., EFSA, ECHA, MS, EC, JMPR, and HSE)
- Preparation of regulatory dossiers (IUCLID and other formats)
- Active substance approval and renewal (NAS, AIR) procedures in the EU
- Basic substance applications in the EU
- Plant protection product registration and renewal in the EU (dRRs for Art. 33, Art. 43, etc.)
- Maximum Residue Limit (MRL) petitions (e.g., EU, CODEX, etc.)
- Pre- and post-submission regulatory support
To benefit from the expertise of our pesticide registration consultants, find out how we can help with your regulatory questions and get your program going.
We also offer regulatory affairs solutions for pharmaceutical, biotech and industrial chemical companies.