Plant
Protection
Our Plant Protection team offer a wide range of support services from full Dossier preparation, submission and ongoing support to specific National/Local requirements and product review/scoping/compliance. Through our close and transparent collaboration with a range of expert partners across the chemical and regulatory industry, we offer a complete service package solution. The allocation of a dedicated Project Manager – and interactive, online tracking boards – keeps you in touch.
Expert judgement and Data Waivers
We provide clarity for financial budgeting and commercial sales. Product pre-submission reviews and data gap identification ensure the most accurate estimations of total regulatory cost and timeframe. Our reports can include details of the current & likely future requirements for your products and active substances
Product Review and Data Gap Analysis
Using qualified outsourced partners, we ensure specialist advice is clear and cost effective. Justified and robust data waivers often enable significant reductions in time and cost of compliance for more complex regulatory end points.
Post submission support
We understand the importance of a continued support prior to Authorisation and beyond. Our services provide a clear and defined support throughout the evaluation process, to commercial launch and further.
Scoping for Compliance
Our wide range of experience and industry knowledge enables the efficient and clear review of the regulatory controls which apply to your products.
Compilation, submission and ongoing support of Dossiers
We provide a fully budgeted service to meet a wide range of regulatory formats and requirements. These include the following:
- New Active Substance and reference products.
- Active Substance and Product renewals.
- Technical equivalence.
- National product administrative applications.
- Data-exempt applications (& identification of data protection time frames)
- Mutual Recognition – with specific Member State requirements including environmental fate modelling, candidate for substitution evaluation and efficacy climatic comparisons.
- Full Zonal applications with follow-on Concerned Member State submissions.
Data Waivers Project planning and budgeting
The foundation of our success is in managing your expectations with detailed budgeting, timetabling and defined targets. We pride ourselves in our openness, clarity and interactive regular reporting.
Liaison with Regulatory Authorities
Regular contact with Regulatory Authorities, understanding of their position – whilst robustly defending yours – ensures communication is handled effectively and efficiently.
Study commissioning and monitoring
We understand the importance of a continued support prior to Authorisation and beyond. Our services provide a clear and defined support throughout the evaluation process, to commercial launch and further.
Task Forces and Co-operation - Cost-sharing
We are experienced in providing independent management of shared projects, from simple co-sponsored studies to multi-party Task Forces. We offer bespoke administration services and can arrange all legal documentation.
Specialist Components
Efficacy
Our team is experienced in Biological Assessment Dossier preparation for all required formats ranging from bridging datasets to allow for renewal applications to large multi crop/target/climate dossiers. We provide full efficacy services supported by a team with extensive practical agronomy experience, including:
- Data Gap Analysis to provide proposals on your required efficacy package.
- Trials programme/protocol design to match product and label claims.
- Data handling and analysis using specialist software such as ARM.
- Trial report compilation service to include reviewing and quality auditing of the raw trials data, statistical analysis and generation of summarized and fully prepared final reports.
- Risk assessment to non-target Flora and Fauna including adjacent and succeeding crop assessments.
Our Risk of Resistance investigations include in-house expert statements/judgement as to the applicability of available information. We provide full Comparative Assessments for candidates for substitution and relevance assessments of Efficacy studies across climatic zones utilizing extensive case arguments based on agronomic/climatic and edaphic traits.
- Qualified review of study compliance with Good Experimental Practice & European and Mediterranean Plant Protection Organization (EPPO) standards.
- Study monitoring & management with testing facilities to ensure harmonisation of datasets.
Mammalian toxicology
Data gap evaluations to confirm toxicology study requirements for your proposed formulation & further support through study contracting and monitoring. We undertake classification assessments to provide labels & Safety Data Sheets compliant to the EU Classification Labelling & Packaging regulation 1272/2008 and the Globally Harmonised System worldwide.
Exposure assessments
- Operators: using models including AOEM, PHED database and UK POEM.
- Workers, Bystanders and Residents: using the latest use of specific modelling guidance.
Liaison with Regulatory Authorities
Regular contact with Regulatory Authorities, understanding of their position – whilst robustly defending yours – ensures communication is handled effectively and efficiently.
Environmental Fate
Data gap evaluations to confirm required studies for your proposed formulation & further support through study contracting and monitoring.Tiered Environmental exposure modelling and refinements for Predicted Environmental Concentrations in Soil, Surface Water, Groundwater, Drainflow and Groundwater metabolites. All exposure modelling is tailored to your specific product and use. We can commission studies & manage higher tier refinements with our expert partners.
Ecotoxicology
Data gap evaluations to confirm required studies for your proposed formulation & further support through study contracting and monitoring. Tiered Environmental exposure modelling and refinements for Predicted Environmental Concentrations in Soil, Surface Water, Groundwater, Drainflow and Groundwater metabolites. All exposure modelling is tailored to your specific product and use. We can commission studies & manage higher tier refinements with our expert partners.