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Solutions

We support every stage of human health safety assessment: from data-generating studies to risk assessment, from documentation for authorities to regulatory strategy. Services can be contracted individually or as an integrated program.

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Studies and characterization of the hazard

We define which studies are necessary, monitor their execution with contracted laboratories, and interpret the results. We derive the reference toxicological parameters, perform the toxicological classification, and evaluate the use of alternative methodologies (NAMs).

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Assessment of exposure and risk to human health.

Exposure assessment and risk characterization for operators, workers, residents, and passersby, including assessments using the ANVISA (Brazilian Health Regulatory Agency) assessment tool and international methodologies. Dietary risk assessment, support for Maximum Residue Limits (MRLs), and definition of safe intervals, with higher-tier refinements when necessary .

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Dossiers, technical documentation and scientific defense

We structure toxicological and human health dossiers and prepare DAROC (Toxicological Information Form), Medical Information Sheet, PATE (Preliminary Technical Assessment Form), and technical reports. We prepare responses to toxicological requirements and defenses, and participate in technical meetings with regulatory authorities.

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Strategy and regulatory intelligence

We assess product registrability and data gaps, support the prioritization of products with lower toxicological impact, and monitor regulatory changes affecting the portfolio.

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Bioinputs

Technical and regulatory support for biopesticides, biostimulants, inoculants, and biofertilizers, monitoring the evolution of the Brazilian regulatory framework for these products.

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Regulatory and security foresight

Monitoring and analyzing signs of change, such as new regulations, decrees, and reassessments, and building scenarios to anticipate regulatory and safety trends in the agricultural sector, supporting portfolio and strategy decisions.

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Training

Tailor-made training and workshops for technical, regulatory, and management teams, built around each client's needs. Online or in-person, in Portuguese, Spanish, or English.

Examples of topics: regulatory toxicology, human health risk assessment, alternative methodologies (NAMs), regulatory updates, international regulatory landscape, and foresight applied to regulatory strategy.

Scientific rigor and regulatory foresight for strategic decisions in agribusiness.

Tell us about your product and target market, and we'll outline the next technical steps.

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