Planitox acts as a consultant through solutions in regulatory toxicology and scientific support in crisis situations.
We contribute to the most diverse industries by preparing technical support documents for product registration processes, demands from regulatory bodies and the organization’s internal needs.
We also work with the legal and medical areas of companies in times of crisis. We have expertise in handling adverse situations related to health and safety, whether related to the worker (occupational health), the population (public health) or consumers.
Our team of professionals is highly qualified and able to help with solutions for our clients’ challenges.
Monitoring the conduct of toxicological studies
Specialized technical assistance working directly with toxicological analysis laboratories so that your studies are in compliance with regulatory requirements. The service may include planning the conduct of analyses, reviewing study plans and final reports, and technical discussion of results.
Assistance in meeting legal requirements
Consultancy specialized in analyzing and responding to demands from regulatory bodies — national and/or international. Acting in partnership with registered companies or consultants in the area, providing technical and scientific support for regulatory or legal action.
Human health risk assessment
Scientific methodology that analyzes the risk of a chemical to human health. This method is adopted by the main regulatory agencies when making decisions about the release, maintenance or deregistration of products. The assessment of risk to human health is a tool for the safety of products that have already been marketed or those whose registrations are being sought.
Toxicological evaluation
Identification of adverse effects that a substance can cause in an organism. In addition to being an integral part of the chemical registration process, it is an indispensable document for the preparation of the risk assessment for human health.
Technical advice
Preparation of documents that attest technical information in toxicology and health – with a focus on meeting customer needs. Whether for internal clarifications, legal demands or to support decision-making, our toxicological opinions are prepared taking into account the most current and consolidated aspects of toxicology.
PATE (Company Technical Analysis Opinion)
The preparation of the PATE is part of the necessary requirements for the registration process of a pesticide in Brazil (RDC 294/19). The Planitox team prepares the chapters related to the document’s toxicology, which includes a critical analysis of the results of the toxicological studies and the methodology used, and leaves the company in compliance with the legislation in force, which provides for the criteria for toxicological evaluation and classification.
QSAR (Quantitative Structure-Activity Relationship)
Process of evaluating the toxicity of chemical substances through the application of in silico models (QSAR) from various platforms that can predict the toxicological properties of compounds, based on the knowledge of their chemical structure.
This technological solution uses a database to assess chemical, biological and environmental fate characteristics of the compost, saving time and resources.
Technical assistance in crisis situations
Consultancy specialized in providing scientific support in crisis situations related to human health. The toxicological orientation helps companies to make appropriate decisions regarding safety and health, to maintain or recover their image in the face of unexpected occupational health and public health problems.
Technical assistance in legal proceedings
Accompaniment as a technical assistant in civil proceedings involving issues related to adverse effects, contamination, poisoning and health problems in general.
Preparation of leaflet and label
Preparation of toxicological information for pesticide labels and package inserts, as provided for in RDC 296/2019.
Classification of chemicals according to GHS
Classification according to the GHS, a globally harmonized system for classification and labeling of chemicals.
Calculation of PDE (Permitted Daily Exposure)
Preparation of the document required for the pharmaceutical industry in Brazil by the regulatory body – the National Health Surveillance Agency (Anvisa). The PDE (Permitted Daily Exposure) represents the specific amount of a substance to which the population can be exposed without any health risk. Permitted Daily Exposure Calculation is performed for hazard identification and review of relevant toxicological data. The objective is to support the reassessments of the maximum allowed residual limits carried between products, regarding validations