Regulatory services by people who care
Services
What are your needs? What can we do for you?
We support you regarding all regulatory needs in the areas of Plant Protection Products/Biopesticides, Biostimulants, Biocides, Environmental Risk Assessments of Human Pharmaceuticals and Endocrine Disrupting properties.
Starting from the “Kick off” up to managing all notification and registration procedures.
Our Services are
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(Extended) data gap analysis, including first step risk analysis, evaluation of additional study requirements, budget planning and proposal for a time schedule
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Test strategies for (re-)registration of actives/products according to different operation procedures and international guidance
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Quantitative structure-activity relationship (Q)SAR and evaluation of their relevance in comparison to results from experimental studies
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Preparation of scientific expert statements, discussion of relevance for data requirements and, where necessary, preparation of scientific position papers for data waivers
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Literature research in relevant databases, literature review according to EFSA Guidance
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Organization and contracting of laboratory and field studies for all regulatory sections and monitoring of studies
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Organization of pre and post-submission meetings with authorities
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Preparation of complete dossiers following EU Guidance and national requirements, adoption to country specific requests for registration of products, including model calculations, risk evaluation and measures for risk mitigation, use strategies in line with regulatory and market requirements
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Electronic data processing, document and database management, client specific data allocation depending on regulatory requirements
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Defence of actives/products on international level, discussion with competent authorities
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Workshops for clients with focus on specific regulatory topics, webinars
Our Services on Plant Protection Products
Our Service on Human Pharmaceuticals
Our Services on Potential Endocrine Disrupting Properties
Our Services on Active Substance Check
Our Services on IUCLIDs and Poison Center Notifications
